Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2025-12-25 @ 9:51 PM
Study NCT ID:
NCT01423851
Status:
COMPLETED
Last Update Posted:
2022-03-09
First Post:
2011-08-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety and Tolerability Study of Oral NS-018 in Patients With Primary Myelofibrosis (MF), Post-polycythemia Vera MF or Post-essential Thrombocythemia MF
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055728', 'term': 'Primary Myelofibrosis'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D011087', 'term': 'Polycythemia Vera'}, {'id': 'D013920', 'term': 'Thrombocythemia, Essential'}], 'ancestors': [{'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D019046', 'term': 'Bone Marrow Neoplasms'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D013922', 'term': 'Thrombocytosis'}, {'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'trialinfo@nspharma.com', 'phone': '201-986-3860', 'title': 'Medical Affairs', 'phoneExt': '+1', 'organization': 'NS Pharma, Inc.'}, 'certainAgreement': {'otherDetails': 'This confidential document is the property of NS Pharma, Inc. No unpublished information contained herein may be disclosed without prior written approval from NS Pharma, Inc. Access to this document must be restricted to relevant parties.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Part 1 and Part 2: From screening to until study discontinuation (approximate 8 years 10 months)', 'description': 'Safety population: NS-018-101 study was dose finding study, PI could increase or decrease dose-level per protocol. Totals are based on number of patients and not on dose-level cohort. Patients can appear in more than one dose-level cohort.', 'eventGroups': [{'id': 'EG000', 'title': 'Part 1: 75 mg QD', 'description': 'Patients self-administered orally 75 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Part 1: 125 mg QD', 'description': 'Patients self-administered orally 125 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Part 1: 200 mg QD', 'description': 'Patients self-administered orally 200 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 9, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Part 1: 300 mg QD', 'description': 'Patients self-administered orally 300 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 14, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG004', 'title': 'Part 1: 400 mg QD', 'description': 'Patients self-administered orally 400 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'Part 1: 100 mg BID', 'description': 'Patients self-administered orally 100 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 4, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG006', 'title': 'Part 1: 200 mg BID', 'description': 'Patients self-administered orally 200 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 11, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG007', 'title': 'Part 1: 250 mg BID', 'description': 'Patients self-administered orally 250 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG008', 'title': 'Part 1: 300 mg BID', 'description': 'Patients self-administered orally 300 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 12, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG009', 'title': 'Part 1: 400 mg BID', 'description': 'Patients self-administered orally 400 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 7, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG010', 'title': 'Part 2: 300 mg QD', 'description': 'Patients self-administered orally 300 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 29, 'seriousNumAtRisk': 29, 'deathsNumAffected': 1, 'seriousNumAffected': 13}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 12, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 8, 'numAffected': 3}, {'groupId': 'EG010', 'numAtRisk': 29, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 12, 'numAffected': 7}, {'groupId': 'EG009', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 29, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 29, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 29, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 29, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 12, 'numAffected': 5}, {'groupId': 'EG009', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 29, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 29, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Abdominal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Anal pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Anal sphincter atony', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Faeces discoloured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 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'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'N-terminal prohormone brain natriuretic peptide increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Part 1 and Part 2: Number of Subjects With Adverse Events and Serious Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '12', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '29', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: 75 mg QD', 'description': 'Patients self-administered orally 75 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG001', 'title': 'Part 1: 125 mg QD', 'description': 'Patients self-administered orally 125 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG002', 'title': 'Part 1: 200 mg QD', 'description': 'Patients self-administered orally 200 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG003', 'title': 'Part 1: 300 mg QD', 'description': 'Patients self-administered orally 300 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG004', 'title': 'Part 1: 400 mg QD', 'description': 'Patients self-administered orally 400 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG005', 'title': 'Part 1: 100 mg BID', 'description': 'Patients self-administered orally 100 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG006', 'title': 'Part 1: 200 mg BID', 'description': 'Patients self-administered orally 200 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG007', 'title': 'Part 1: 250 mg BID', 'description': 'Patients self-administered orally 250 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG008', 'title': 'Part 1: 300 mg BID', 'description': 'Patients self-administered orally 300 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG009', 'title': 'Part 1: 400 mg BID', 'description': 'Patients self-administered orally 400 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG010', 'title': 'Part 2: 300 mg QD', 'description': 'Patients self-administered orally 300 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}], 'classes': [{'title': 'Not TEAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}]}]}, {'title': 'Any AE', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '12', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '29', 'groupId': 'OG010'}]}]}, {'title': 'Any Treatment Emergent AE', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '12', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '29', 'groupId': 'OG010'}]}]}, {'title': 'Drug Related TEAE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '10', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}, {'value': '24', 'groupId': 'OG010'}]}]}, {'title': 'Any Serious TEAE', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '13', 'groupId': 'OG010'}]}]}, {'title': 'TEAE Leading to Discontinuation of study drug', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '5', 'groupId': 'OG010'}]}]}, {'title': 'Hospitalization or Prolongation of Existing Hospitalization', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '11', 'groupId': 'OG010'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From screening to until study discontinuation (approximate 8 years 10 months)', 'description': 'AEs (non-serious, serious) as variables of safety and tolerability of NS-018 were assesed. The number of patients were presented as Overall summary of AEs including treatment-emergent AEs (TEAEs); Treatment-emergent SAEs; Drug-related TEAEs; Treatment-emergent AEs leading to permanent discontinuation of study drug; Hospitalization or prolongation of existing hospitalization; Death.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all patients who received at least 1 dose of study drug.\n\nNS-018-101 study was dose-finding study, Principal investigator (PI) could increase or decrease dose-level per protocol. Totals are based on number of patients and not on dose-level cohort. Patients can appear in more than one dose-level cohort.'}, {'type': 'PRIMARY', 'title': 'Part 2: Number of Patient With Objective Response Using International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) and European Leukemia Net (ELN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: 300 mg QD', 'description': 'Patients self-administered orally 300 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Cycle 7 Day 1 (duration of cycle was 4 weeks)', 'description': 'Six response categories are listed: complete remission (CR) and partial remission signify treatment effects that are consistent with disease modification, whereas drug-induced improvements in MF-symptomatic burden were annotated as clinical improvement, anemia response, spleen response, orsymptoms response. Additional criteria are provided for progressive disease, stable disease, and relapse. The objective response was defined as the number of patients with confirmed complete remission (CR) + partial response (PR) + clinical improvement (CI) during the treatment period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy population included all patients who received at least one dose of study drug and had one baseline and at least one post-baseline efficacy assessment. Here, the overall number of subjects analyzed signifies only the subjects with available data that were analyzed evaluated on that specific cycle day.'}, {'type': 'PRIMARY', 'title': 'Part 2: Change From Baseline in Spleen Size', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: 300 mg QD', 'description': 'Patients self-administered orally 300 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '-335918.1', 'spread': '558459.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline to Cycle 7 Day 1 (duration of cycle was 4 weeks)', 'description': 'Change from baseline in spleen size was assessed by magnetic resonance imaging (MRI) (computed tomography \\[CT\\] scan for patients not able to tolerate MRI).', 'unitOfMeasure': 'cubic millimeter (mm3)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy population included all patients who received at least one dose of study drug and had one baseline and at least one post-baseline efficacy assessment. Here, the overall number of subjects analyzed signifies only the subjects with available data that were analyzed evaluated on that specific cycle day.'}, {'type': 'PRIMARY', 'title': 'Part 2: Change From Baseline in Bone Marrow Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: 300 mg QD', 'description': 'Patients self-administered orally 300 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}], 'classes': [{'categories': [{'title': 'Increased by at least 1 grade level', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Increased by at least 2 grade level', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Decreased by at least 1 grade level', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Decreased by at least 2 grade level', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline to Cycle 7 Day 1 (duration of cycle was 4 weeks)', 'description': 'Bone marrow was assessed by aspiration and biopsy for grade changes in osteomyelofibrosis. Fibrosis was graded according to European Consensus Myelofibrosis Grading Criteria, ranging from grade 0, which corresponds to normal bone marrow, to grade 3, in which coarse bundles of collagen fibrosis are identifiable with significant osteosclerosis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy population included all patients who received at least one dose of study drug and had one baseline and at least one post-baseline efficacy assessment. Here, the overall number of subjects analyzed signifies only the subjects with available data that were analyzed evaluated on that specific cycle day.'}, {'type': 'SECONDARY', 'title': 'Part 1: Number of Patients With Objective Response Using International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: 75 mg QD', 'description': 'Patients self-administered orally 75 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG001', 'title': 'Part 1: 125 mg QD', 'description': 'Patients self-administered orally 125 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG002', 'title': 'Part 1: 200 mg QD', 'description': 'Patients self-administered orally 200 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG003', 'title': 'Part 1: 300 mg QD', 'description': 'Patients self-administered orally 300 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG004', 'title': 'Part 1: 400 mg QD', 'description': 'Patients self-administered orally 400 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG005', 'title': 'Part 1: 100 mg BID', 'description': 'Patients self-administered orally 100 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG006', 'title': 'Part 1: 200 mg BID', 'description': 'Patients self-administered orally 200 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG007', 'title': 'Part 1: 250 mg BID', 'description': 'Patients self-administered orally 250 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG008', 'title': 'Part 1: 300 mg BID', 'description': 'Patients self-administered orally 300 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG009', 'title': 'Part 1: 400 mg BID', 'description': 'Patients self-administered orally 400 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Cycle 7 Day 1 (duration of cycle was 4 weeks)', 'description': 'Six response categories are listed: complete remission (CR) and partial remission signify treatment effects that are consistent with disease modification, whereas drug-induced improvements in MF-symptomatic burden were annotated as clinical improvement, anemia response, spleen response, orsymptoms response. Additional criteria are provided for progressive disease, stable disease, and relapse. The objective response was defined as the number of patients with confirmed "complete remission (CR) + partial response (PR) + clinical improvement (CI)" during the treatment period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy population included all patients who received at least one dose of study drug and had one baseline and at least one post-baseline efficacy assessment. NS-018-101 study was dose finding study, PI could increase or decrease dose-level per protocol. Patients can appear in more than one dose-level cohort.\n\nFor 300 mg QD, data from 7 patients were available. 4 patients were enrolled originally and 2 patients were dose-reduced from 400 mg QD and 1 patient was dose-reduced from 250 mg BID.'}, {'type': 'SECONDARY', 'title': 'Part 1: Change From Baseline in Spleen Size', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: 75 mg QD', 'description': 'Patients self-administered orally 75 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG001', 'title': 'Part 1: 125 mg QD', 'description': 'Patients self-administered orally 125 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG002', 'title': 'Part 1: 200 mg QD', 'description': 'Patients self-administered orally 200 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG003', 'title': 'Part 1: 300 mg QD', 'description': 'Patients self-administered orally 300 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG004', 'title': 'Part 1: 400 mg QD', 'description': 'Patients self-administered orally 400 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG005', 'title': 'Part 1: 100 mg BID', 'description': 'Patients self-administered orally 100 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG006', 'title': 'Part 1: 200 mg BID', 'description': 'Patients self-administered orally 200 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG007', 'title': 'Part 1: 250 mg BID', 'description': 'Patients self-administered orally 250 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG008', 'title': 'Part 1: 300 mg BID', 'description': 'Patients self-administered orally 300 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG009', 'title': 'Part 1: 400 mg BID', 'description': 'Patients self-administered orally 400 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.67', 'spread': '2.89', 'groupId': 'OG001'}, {'value': '-8.25', 'spread': '3.18', 'groupId': 'OG002'}, {'value': '-3.17', 'spread': '3.97', 'groupId': 'OG003'}, {'value': '-3.00', 'spread': '3.00', 'groupId': 'OG005'}, {'value': '-4.33', 'spread': '6.66', 'groupId': 'OG006'}, {'value': '-7.00', 'spread': 'NA', 'comment': 'As only 1 participant was evaluable, hence SD is not calculable.', 'groupId': 'OG007'}, {'value': '-2.00', 'spread': '3.00', 'groupId': 'OG008'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline to Cycle 7 Day 1 (duration of cycle was 4 weeks)', 'description': 'Change from baseline in spleen size was assessed by palpation.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy population included all patients who received at least one dose of study drug and had one baseline and at least one post-baseline efficacy assessment. NS-018-101 study was dose finding study, PI could increase or decrease dose-level per protocol. Patients can appear in more than one dose-level cohort.\n\nAt 200 mg BID cohort, 3 patients were enrolled originally, 2 patients were dose-escalated from 100 mg BID cohort and 8 patients were dose-reduced from 300 mg BID or 400 mg BID cohort.'}, {'type': 'SECONDARY', 'title': 'Part 1: Change From Baseline in Bone Marrow Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: 75 mg QD', 'description': 'Patients self-administered orally 75 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG001', 'title': 'Part 1: 125 mg QD', 'description': 'Patients self-administered orally 125 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG002', 'title': 'Part 1: 200 mg QD', 'description': 'Patients self-administered orally 200 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG003', 'title': 'Part 1: 300 mg QD', 'description': 'Patients self-administered orally 300 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG004', 'title': 'Part 1: 400 mg QD', 'description': 'Patients self-administered orally 400 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG005', 'title': 'Part 1: 100 mg BID', 'description': 'Patients self-administered orally 100 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG006', 'title': 'Part 1: 200 mg BID', 'description': 'Patients self-administered orally 200 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG007', 'title': 'Part 1: 250 mg BID', 'description': 'Patients self-administered orally 250 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG008', 'title': 'Part 1: 300 mg BID', 'description': 'Patients self-administered orally 300 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG009', 'title': 'Part 1: 400 mg BID', 'description': 'Patients self-administered orally 400 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}], 'classes': [{'categories': [{'title': 'Increased by at least 1 grade level', 'measurements': [{'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG008'}]}, {'title': 'Increased by at least 2 grade level', 'measurements': [{'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG008'}]}, {'title': 'Decreased by at least 1 grade level', 'measurements': [{'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG008'}]}, {'title': 'Decreased by at least 2 grade level', 'measurements': [{'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline to Cycle 7 Day 1 (duration of cycle was 4 weeks)', 'description': 'Bone marrow was assessed by aspiration and biopsy for grade changes in osteomyelofibrosis. Fibrosis was graded according to European Consensus Myelofibrosis Grading Criteria, ranging from grade 0, which corresponds to normal bone marrow, to grade 3, in which coarse bundles of collagen fibrosis are identifiable with significant osteosclerosis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy population included all patients who received at least one dose of study drug and had one baseline and at least one post-baseline efficacy assessment. Here, the overall number of subjects analyzed signifies only the subjects with available data that were analyzed evaluated on that specific cycle day.'}, {'type': 'SECONDARY', 'title': 'Part 1: Change From Baseline in Quality of Life Assessments Using Myelofibrosis Symptom Assessment Form (MF-SAF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: 75 mg QD', 'description': 'Patients self-administered orally 75 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG001', 'title': 'Part 1: 125 mg QD', 'description': 'Patients self-administered orally 125 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG002', 'title': 'Part 1: 200 mg QD', 'description': 'Patients self-administered orally 200 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG003', 'title': 'Part 1: 300 mg QD', 'description': 'Patients self-administered orally 300 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG004', 'title': 'Part 1: 400 mg QD', 'description': 'Patients self-administered orally 400 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG005', 'title': 'Part 1: 100 mg BID', 'description': 'Patients self-administered orally 100 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG006', 'title': 'Part 1: 200 mg BID', 'description': 'Patients self-administered orally 200 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG007', 'title': 'Part 1: 250 mg BID', 'description': 'Patients self-administered orally 250 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG008', 'title': 'Part 1: 300 mg BID', 'description': 'Patients self-administered orally 300 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG009', 'title': 'Part 1: 400 mg BID', 'description': 'Patients self-administered orally 400 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}], 'classes': [{'title': 'Brief Fatigue Inventory Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.4', 'groupId': 'OG001'}, {'value': '-1.3', 'spread': '2.0', 'groupId': 'OG002'}, {'value': '0.8', 'spread': '1.3', 'groupId': 'OG003'}, {'value': '-1.9', 'spread': '0.1', 'groupId': 'OG005'}, {'value': '0.4', 'spread': '0.2', 'groupId': 'OG006'}, {'value': '0.7', 'spread': 'NA', 'comment': 'As only 1 participant was evaluable, hence SD is not calculable.', 'groupId': 'OG007'}, {'value': '-0.8', 'spread': '1.1', 'groupId': 'OG008'}]}]}, {'title': 'Splenomegaly-associated Symptom Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '-0.5', 'spread': '1.1', 'groupId': 'OG002'}, {'value': '0.5', 'spread': '0.8', 'groupId': 'OG003'}, {'value': '-0.3', 'spread': '1.8', 'groupId': 'OG005'}, {'value': '-1.1', 'spread': '1.2', 'groupId': 'OG006'}, {'value': '-4.0', 'spread': 'NA', 'comment': 'As only 1 participant was evaluable, hence SD is not calculable.', 'groupId': 'OG007'}, {'value': '-1.8', 'spread': '1.5', 'groupId': 'OG008'}]}]}, {'title': 'Catabolic/Proliferative Symptoms Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '1.2', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '-0.7', 'spread': '0.5', 'groupId': 'OG002'}, {'value': '-0.4', 'spread': '2.4', 'groupId': 'OG003'}, {'value': '-0.4', 'spread': '1.0', 'groupId': 'OG005'}, {'value': '1.5', 'spread': '1.6', 'groupId': 'OG006'}, {'value': '-8.0', 'spread': 'NA', 'comment': 'As only 1 participant was evaluable, hence SD is not calculable.', 'groupId': 'OG007'}, {'value': '-0.6', 'spread': '1.0', 'groupId': 'OG008'}]}]}, {'title': 'Overall Quality of Life Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '-1.0', 'spread': '1.4', 'groupId': 'OG002'}, {'value': '0.0', 'spread': '3.6', 'groupId': 'OG003'}, {'value': '-1.7', 'spread': '2.1', 'groupId': 'OG005'}, {'value': '-1.5', 'spread': '2.1', 'groupId': 'OG006'}, {'value': '0.0', 'spread': 'NA', 'comment': 'As only 1 participant was evaluable, hence SD is not calculable.', 'groupId': 'OG007'}, {'value': '-1.7', 'spread': '1.5', 'groupId': 'OG008'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Cycle 7 Day 1 (duration of cycle was 4 weeks)', 'description': 'MF SAF is a 20-item instrument comprised of 4 subscales: 1) the Brief Fatigue Inventory \\[= average of 9 fatigue scores\\], 2) Splenomegaly associated symptoms \\[= average of 4 splenomegaly and associated scores\\], 3) Catabolic/proliferative Symptoms \\[= average of 3 catabolic/proliferative associated scores\\] and 4) Overall Quality of Life. The items were on a scale from 1 to 10 where 1= most favorable, and 10= least favorable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy population included all patients who received at least one dose of study drug and had one baseline and at least one post-baseline efficacy assessment. NS-018-101 study was dose finding study, PI could increase or decrease dose-level per protocol. Patients can appear in more than one dose-level cohort.\n\nFor 300 mg QD, data from 7 patients were available. 4 patients were enrolled originally and 2 patients were dose-reduced from 400 mg QD and 1 patient was dose-reduced from 250 mg BID.'}, {'type': 'SECONDARY', 'title': 'Part 2: Change From Baseline in Quality of Life Assessments Using Myeloproliferative Neoplasm Symptom Assessment Form (MPN SAF (MPN 10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: 300 mg QD', 'description': 'Patients self-administered orally 300 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.7', 'spread': '3.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Cycle 7 Day 1 (duration of cycle was 4 weeks)', 'description': 'Symptoms are evaluated by the MPN-SAF Total Symptom Score (TSS). The MPN-SAF TSS is assessed by the patients themselves and this includes fatigue, concentration, early satiety, inactivity, night sweats, itching, bone pain, abdominal discomfort, weight loss, and fevers. Scoring is from 0 (absent/as good as it can be) to 10 (worst imaginable/as bad as it can be) for each item. The MPN-SAF TSS is the summation of all the individual scores (0-100 scale). Symptoms response requires \\>50% reduction in the MPN-SAF TSS.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy population included all patients who received at least one dose of study drug and had one baseline and at least one post-baseline efficacy assessment. Here, the overall number of subjects analyzed signifies only the subjects with available data that were analyzed evaluated on that specific cycle day.'}, {'type': 'SECONDARY', 'title': 'Part 1 and Part 2: Change in Baseline in Janus Kinase 2 (JAK2) V617F Allele Burden Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '11', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: 75 mg QD', 'description': 'Patients self-administered orally 75 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG001', 'title': 'Part 1: 125 mg QD', 'description': 'Patients self-administered orally 125 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG002', 'title': 'Part 1: 200 mg QD', 'description': 'Patients self-administered orally 200 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG003', 'title': 'Part 1: 300 mg QD', 'description': 'Patients self-administered orally 300 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG004', 'title': 'Part 1: 400 mg QD', 'description': 'Patients self-administered orally 400 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG005', 'title': 'Part 1: 100 mg BID', 'description': 'Patients self-administered orally 100 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG006', 'title': 'Part 1: 200 mg BID', 'description': 'Patients self-administered orally 200 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG007', 'title': 'Part 1: 250 mg BID', 'description': 'Patients self-administered orally 250 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG008', 'title': 'Part 1: 300 mg BID', 'description': 'Patients self-administered orally 300 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG009', 'title': 'Part 1: 400 mg BID', 'description': 'Patients self-administered orally 400 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG010', 'title': 'Part 2: 300 mg QD', 'description': 'Patients self-administered orally 300 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.360', 'spread': 'NA', 'comment': 'As only 1 participant was evaluable, hence SD is not calculable.', 'groupId': 'OG001'}, {'value': '-0.210', 'spread': 'NA', 'comment': 'As only 1 participant was evaluable, hence SD is not calculable.', 'groupId': 'OG002'}, {'value': '7.410', 'spread': '2.758', 'groupId': 'OG003'}, {'value': '-6.720', 'spread': '10.479', 'groupId': 'OG005'}, {'value': '8.255', 'spread': '4.320', 'groupId': 'OG006'}, {'value': '-4.900', 'spread': '9.065', 'groupId': 'OG007'}, {'value': '-9.033', 'spread': '5.352', 'groupId': 'OG008'}, {'value': '-4.368', 'spread': '14.602', 'groupId': 'OG009'}, {'value': '1.782', 'spread': '8.978', 'groupId': 'OG010'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part 1 and Part 2: From baseline to Cycle 7 Day 1 (duration of cycle was 4 weeks)', 'description': 'The JAK2 V617F allele burden mean changes from baseline (%) are presented as pharmacodynamics parameters.', 'unitOfMeasure': 'Percentage of JAK2 V617F Level', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PD population included all patients who received at least one dose of study drug and had a baseline and at least one post-baseline PD assessment (for at least one PD parameter). Here, the overall number of subjects analyzed signifies only the subjects with available data that were analyzed evaluated on that specific cycle day.'}, {'type': 'SECONDARY', 'title': 'Part 2: Change From Baseline in Phosphorylated Signal Transducer and Activator of Transcription 3 (Phospho-STAT3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: 300 mg QD', 'description': 'Patients self-administered orally 300 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}], 'classes': [{'title': 'Cycle 1 Day 1: Change percentage of Phospho-STAT3 Levels in CD14+ Positive cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-9.406', 'spread': '19.357', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 1 Day 15: Change percentage of Phospho-STAT3 Levels in CD14+ Positive cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.738', 'spread': '16.191', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2 Day 1: Change percentage of Phospho-STAT3 Levels in CD14+ Positive cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.422', 'spread': '20.092', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 1 Day 1: Change percentage of Phospho-STAT3 Levels in CD3+ CD4+ Positive cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-10.614', 'spread': '11.178', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 1 Day 15: Change percentage of Phospho-STAT3 Levels in CD3+ CD4+ Positive cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.217', 'spread': '20.717', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2 Day 1: Change percentage of Phospho-STAT3 Levels in CD3+ CD4+ Positive cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.878', 'spread': '16.304', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 1 Day 1: Change percentage of Phospho-STAT3 Levels in CD3+ CD8+ Positive cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.707', 'spread': '11.222', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 1 Day 15: Change percentage of Phospho-STAT3 Levels in CD3+ CD8+ Positive cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.533', 'spread': '14.513', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2 Day 1: Change percentage of Phospho-STAT3 Levels in CD3+ CD8+ Positive cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.644', 'spread': '6.615', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline to Pre-dose at Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 (duration of cycle was 4 weeks)', 'description': 'The Phospho-STAT3 mean changes from baseline (%) are presented as pharmacodynamics parameters.\n\nFor phospho-STAT3 values (Phase 2 only), study samples were incubated (± IL-6) and labeled with CD markers. Surface markers included CD3+ (CD4+ \\[helper T cells\\] and CD8+ \\[cytotoxic T cells\\]) and CD14+ (monocytes) to which intracellular phospho STAT3 was targeted. The levels of phospho-STAT3 in CD14+, CD3+CD4+ and CD3+CD8+ cell subtypes were quantified. Phosphorylated-STAT3 levels were evaluated in the cell types before and after IL-6 incubation (stimulation) and reported both as mean fluorescence intensity (MFI) and the percentage of positive cells. For each sample time point, the MFI was normalized to a fold change.\n\nThe fold change was calculated by MFI after IL-6 treatment/MFI before IL-6 treatment. The percent positive cells were normalized by subtracting the percent positive cells before IL-6 treatment from the percent positive cells after IL-6 treatment.', 'unitOfMeasure': 'Percentage of Phospho-STAT 3 Levels', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PD population included all patients who received at least one dose of study drug and had a baseline and at least one post-baseline PD assessment (for at least one PD parameter). Here, number analyzed reflects number of patients evaluated on that specific cycle day.\n\nData from 17 out of 24 participants were available and contributed to the analysis. Samples from 7 patients were analyzed, but data were not available due to quantities not sufficient.'}, {'type': 'SECONDARY', 'title': 'Part1 and Part 2: Observed Maximum Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '27', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: 75 mg QD', 'description': 'Patients self-administered orally 75 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG001', 'title': 'Part 1: 125 mg QD', 'description': 'Patients self-administered orally 125 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG002', 'title': 'Part 1: 200 mg QD', 'description': 'Patients self-administered orally 200 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG003', 'title': 'Part 1: 300 mg QD', 'description': 'Patients self-administered orally 300 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG004', 'title': 'Part 1: 400 mg QD', 'description': 'Patients self-administered orally 400 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG005', 'title': 'Part 1: 100 mg BID', 'description': 'Patients self-administered orally 100 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG006', 'title': 'Part 1: 200 mg BID', 'description': 'Patients self-administered orally 200 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG007', 'title': 'Part 1: 250 mg BID', 'description': 'Patients self-administered orally 250 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG008', 'title': 'Part 1: 300 mg BID', 'description': 'Patients self-administered orally 300 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG009', 'title': 'Part 1: 400 mg BID', 'description': 'Patients self-administered orally 400 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG010', 'title': 'Part 2: 300 mg QD', 'description': 'Patients self-administered orally 300 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}], 'classes': [{'title': 'Cycle 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '27', 'groupId': 'OG010'}]}], 'categories': [{'measurements': [{'value': '66.5600', 'spread': '79.0171', 'groupId': 'OG000'}, {'value': '404.5333', 'spread': '26.4258', 'groupId': 'OG001'}, {'value': '377.8000', 'spread': '184.2086', 'groupId': 'OG002'}, {'value': '726.0667', 'spread': '232.0338', 'groupId': 'OG003'}, {'value': '1643.0333', 'spread': '789.0036', 'groupId': 'OG004'}, {'value': '242.0333', 'spread': '174.3374', 'groupId': 'OG005'}, {'value': '351.0000', 'spread': '257.1729', 'groupId': 'OG006'}, {'value': '853.5833', 'spread': '271.7900', 'groupId': 'OG007'}, {'value': '1077.4750', 'spread': '366.9158', 'groupId': 'OG008'}, {'value': '1261.7000', 'spread': '658.9141', 'groupId': 'OG009'}, {'value': '957.9852', 'spread': '306.7937', 'groupId': 'OG010'}]}]}, {'title': 'Cycle 1 Day 8 (Part 1 only)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}]}], 'categories': [{'measurements': [{'value': '30.6700', 'spread': '13.3077', 'groupId': 'OG000'}, {'value': '324.8667', 'spread': '57.3280', 'groupId': 'OG001'}, {'value': '539.6667', 'spread': '160.0954', 'groupId': 'OG002'}, {'value': '805.4333', 'spread': '236.8877', 'groupId': 'OG003'}, {'value': '1554.6667', 'spread': '351.6765', 'groupId': 'OG004'}, {'value': '412.8000', 'spread': '232.9342', 'groupId': 'OG005'}, {'value': '606.8333', 'spread': '233.7812', 'groupId': 'OG006'}, {'value': '806.8333', 'spread': '464.3206', 'groupId': 'OG007'}, {'value': '969.0167', 'spread': '342.3090', 'groupId': 'OG008'}, {'value': '1352.2200', 'spread': '307.1358', 'groupId': 'OG009'}]}]}, {'title': 'Cycle 1 Day 15 (Part 2 only)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '24', 'groupId': 'OG010'}]}], 'categories': [{'measurements': [{'value': '732.5000', 'spread': '313.5822', 'groupId': 'OG010'}]}]}, {'title': 'Cycle 2 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '23', 'groupId': 'OG010'}]}], 'categories': [{'measurements': [{'value': '67.6467', 'spread': '55.6250', 'groupId': 'OG000'}, {'value': '450.6667', 'spread': '187.4735', 'groupId': 'OG001'}, {'value': '556.9000', 'spread': '52.8463', 'groupId': 'OG002'}, {'value': '1066.0000', 'spread': '271.1854', 'groupId': 'OG003'}, {'value': '1556.0000', 'spread': '676.3941', 'groupId': 'OG004'}, {'value': '408.6000', 'spread': '127.0765', 'groupId': 'OG005'}, {'value': '596.1333', 'spread': '362.6751', 'groupId': 'OG006'}, {'value': '830.7333', 'spread': '166.0701', 'groupId': 'OG007'}, {'value': '1272.5600', 'spread': '420.7722', 'groupId': 'OG008'}, {'value': '1040.6500', 'spread': '321.5215', 'groupId': 'OG009'}, {'value': '1035.3087', 'spread': '445.9895', 'groupId': 'OG010'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 0.5 to 24 hours post-dose for Part 1: Cycle 1 Day 1, Cycle 1 Day 8, Cycle 2 Day 1 and for Part 2: Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 (duration of cycle was 4 weeks)', 'description': 'To determine the Cmax as pharmacokinetic parameters of NS-018.', 'unitOfMeasure': 'nanogram/milliliter (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population include all patients who received at least one dose of study drug and have at least 50% of the planned samples above the limit of quantitation to provide evaluable PK profile, Here, number analyzed reflects number of patients evaluated on that specific cycle day.\n\nPart 2: 1 patient was completely excluded from PK Population due to critical samples missing, 1 patient was excluded from the analysis due to sample missing at timepoint, So the overall number of participants was 27.'}, {'type': 'SECONDARY', 'title': 'Part 1 and Part 2: Time to Maximum Plasma Concentration (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '27', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: 75 mg QD', 'description': 'Patients self-administered orally 75 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG001', 'title': 'Part 1: 125 mg QD', 'description': 'Patients self-administered orally 125 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG002', 'title': 'Part 1: 200 mg QD', 'description': 'Patients self-administered orally 200 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG003', 'title': 'Part 1: 300 mg QD', 'description': 'Patients self-administered orally 300 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG004', 'title': 'Part 1: 400 mg QD', 'description': 'Patients self-administered orally 400 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG005', 'title': 'Part 1: 100 mg BID', 'description': 'Patients self-administered orally 100 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG006', 'title': 'Part 1: 200 mg BID', 'description': 'Patients self-administered orally 200 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG007', 'title': 'Part 1: 250 mg BID', 'description': 'Patients self-administered orally 250 mg of NS-018 twice daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG008', 'title': 'Part 1: 300 mg BID', 'description': 'Patients self-administered orally 300 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG009', 'title': 'Part 1: 400 mg BID', 'description': 'Patients self-administered orally 400 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG010', 'title': 'Part 2: 300 mg QD', 'description': 'Patients self-administered orally 300 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}], 'classes': [{'title': 'Cycle 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '27', 'groupId': 'OG010'}]}], 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '0.92', 'upperLimit': '2.00'}, {'value': '1.08', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '2.00'}, {'value': '2.00', 'groupId': 'OG002', 'lowerLimit': '1.00', 'upperLimit': '2.17'}, {'value': '1.04', 'groupId': 'OG003', 'lowerLimit': '1.00', 'upperLimit': '2.00'}, {'value': '1.00', 'groupId': 'OG004', 'lowerLimit': '1.00', 'upperLimit': '2.00'}, {'value': '1.00', 'groupId': 'OG005', 'lowerLimit': '1.00', 'upperLimit': '1.08'}, {'value': '1.00', 'groupId': 'OG006', 'lowerLimit': '1.00', 'upperLimit': '1.00'}, {'value': '1.46', 'groupId': 'OG007', 'lowerLimit': '1.00', 'upperLimit': '2.13'}, {'value': '1.02', 'groupId': 'OG008', 'lowerLimit': '1.00', 'upperLimit': '23.58'}, {'value': '2.00', 'groupId': 'OG009', 'lowerLimit': '1.00', 'upperLimit': '6.00'}, {'value': '2.00', 'groupId': 'OG010', 'lowerLimit': '0.92', 'upperLimit': '3.00'}]}]}, {'title': 'Cycle 1 Day 8 (Part 1 only)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}]}], 'categories': [{'measurements': [{'value': '0.78', 'groupId': 'OG000', 'lowerLimit': '0.50', 'upperLimit': '1.05'}, {'value': '1.00', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '1.12'}, {'value': '1.00', 'groupId': 'OG002', 'lowerLimit': '1.00', 'upperLimit': '2.00'}, {'value': '1.54', 'groupId': 'OG003', 'lowerLimit': '1.02', 'upperLimit': '2.25'}, {'value': '2.00', 'groupId': 'OG004', 'lowerLimit': '1.00', 'upperLimit': '2.05'}, {'value': '1.00', 'groupId': 'OG005', 'lowerLimit': '0.50', 'upperLimit': '1.08'}, {'value': '1.00', 'groupId': 'OG006', 'lowerLimit': '0.50', 'upperLimit': '1.02'}, {'value': '1.98', 'groupId': 'OG007', 'lowerLimit': '1.00', 'upperLimit': '3.00'}, {'value': '1.52', 'groupId': 'OG008', 'lowerLimit': '0.83', 'upperLimit': '4.42'}, {'value': '2.03', 'groupId': 'OG009', 'lowerLimit': '2.00', 'upperLimit': '4.00'}]}]}, {'title': 'Cycle 2 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '23', 'groupId': 'OG010'}]}], 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '2.05'}, {'value': '1.00', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '2.03'}, {'value': '1.00', 'groupId': 'OG002', 'lowerLimit': '1.00', 'upperLimit': '1.00'}, {'value': '1.05', 'groupId': 'OG003', 'lowerLimit': '0.83', 'upperLimit': '2.00'}, {'value': '1.00', 'groupId': 'OG004', 'lowerLimit': '0.82', 'upperLimit': '1.02'}, {'value': '1.00', 'groupId': 'OG005', 'lowerLimit': '0.53', 'upperLimit': '1.00'}, {'value': '1.00', 'groupId': 'OG006', 'lowerLimit': '1.00', 'upperLimit': '2.08'}, {'value': '2.07', 'groupId': 'OG007', 'lowerLimit': '1.00', 'upperLimit': '4.00'}, {'value': '2.08', 'groupId': 'OG008', 'lowerLimit': '1.00', 'upperLimit': '5.53'}, {'value': '2.00', 'groupId': 'OG009', 'lowerLimit': '1.00', 'upperLimit': '3.00'}, {'value': '1.08', 'groupId': 'OG010', 'lowerLimit': '0.92', 'upperLimit': '3.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose, 0.5 to 24 hours post-dose for Part 1: Cycle 1 Day 1, Cycle 1 Day 8, Cycle 2 Day 1 and for Part 2: Cycle 1 Day 1, Cycle 2 Day 1 (duration of cycle was 4 weeks)', 'description': 'To determine the Tmax as pharmacokinetic parameters of NS-018.', 'unitOfMeasure': 'hours (h)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population include all patients who received at least one dose of study drug and have at least 50% of the planned samples above the limit of quantitation to provide evaluable PK profile, Here, number analyzed reflects number of patients evaluated on that specific cycle day.\n\nPart 2: 1 patient was completely excluded from PK Population due to critical samples missing, 1 patient was excluded from the analysis due to sample missing at timepoint, So the overall number of participants was 27.'}, {'type': 'SECONDARY', 'title': 'Part1 and Part 2: Area Under the Plasma Concentration-time Curve (AUC0-24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}, {'value': '26', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: 75 mg QD', 'description': 'Patients self-administered orally 75 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG001', 'title': 'Part 1: 125 mg QD', 'description': 'Patients self-administered orally 125 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG002', 'title': 'Part 1: 200 mg QD', 'description': 'Patients self-administered orally 200 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG003', 'title': 'Part 1: 300 mg QD', 'description': 'Patients self-administered orally 300 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG004', 'title': 'Part 1: 400 mg QD', 'description': 'Patients self-administered orally 400 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG005', 'title': 'Part 1: 100 mg BID', 'description': 'Patients self-administered orally 100 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG006', 'title': 'Part 1: 200 mg BID', 'description': 'Patients self-administered orally 200 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG007', 'title': 'Part 1: 250 mg BID', 'description': 'Patients self-administered orally 250 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG008', 'title': 'Part 1: 300 mg BID', 'description': 'Patients self-administered orally 300 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG009', 'title': 'Part 1: 400 mg BID', 'description': 'Patients self-administered orally 400 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG010', 'title': 'Part 2: 300 mg QD', 'description': 'Patients self-administered orally 300 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}], 'classes': [{'title': 'Cycle 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}, {'value': '26', 'groupId': 'OG010'}]}], 'categories': [{'measurements': [{'value': '246.3454', 'spread': '325.7347', 'groupId': 'OG000'}, {'value': '1510.0507', 'spread': '123.2939', 'groupId': 'OG001'}, {'value': '1326.3929', 'spread': '815.0175', 'groupId': 'OG002'}, {'value': '2299.2216', 'spread': '877.2554', 'groupId': 'OG003'}, {'value': '5162.4119', 'spread': '2485.9489', 'groupId': 'OG004'}, {'value': '1022.0977', 'spread': '521.6626', 'groupId': 'OG005'}, {'value': '1241.5005', 'spread': '461.6010', 'groupId': 'OG006'}, {'value': '2117.1396', 'spread': '449.2456', 'groupId': 'OG007'}, {'value': '5666.7063', 'spread': '5182.5571', 'groupId': 'OG008'}, {'value': '7592.4070', 'spread': '3031.4332', 'groupId': 'OG009'}, {'value': '3672.2041', 'spread': '1551.7435', 'groupId': 'OG010'}]}]}, {'title': 'Cycle 2 Day 1 (Part 1 only)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}]}], 'categories': [{'measurements': [{'value': '253.6953', 'spread': '306.7728', 'groupId': 'OG000'}, {'value': '1905.2058', 'spread': '938.2984', 'groupId': 'OG001'}, {'value': '1816.8251', 'spread': '559.9071', 'groupId': 'OG002'}, {'value': '3175.6938', 'spread': '794.6091', 'groupId': 'OG003'}, {'value': '5443.2874', 'spread': '986.8497', 'groupId': 'OG004'}, {'value': '1561.1245', 'spread': '621.5414', 'groupId': 'OG005'}, {'value': '3470.6269', 'spread': '2587.3663', 'groupId': 'OG006'}, {'value': '5876.1106', 'spread': '5133.4208', 'groupId': 'OG007'}, {'value': '6132.2596', 'spread': '3393.0644', 'groupId': 'OG008'}, {'value': '3828.0995', 'spread': 'NA', 'comment': 'As only 1 participant was evaluable, hence SD is not calculable.', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 0.5 to 24 hours post-dose for Part 1: Cycle 1 Day 1, Cycle 2 Day 1 and for Part 2: Cycle 1 Day 1 (duration of cycle was 4 weeks)', 'description': 'To determine the AUC0-24 as pharmacokinetic parameters of NS-018.', 'unitOfMeasure': 'hour*nanogram/milliliter (h*ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK Population includes all patients who received at least one dose of study drug and have at least 50% of the planned samples above the limit of quantitation to provide evaluable PK profile, regardless of whether derived from parent drug or metabolites.\n\nPart 2: One patient was completely excluded from the PK Population due to critical samples missing; Two patients were excluded from the analysis due to sample missing at time point. so the overall number of participants analyzed was 26.'}, {'type': 'SECONDARY', 'title': 'Part 1 and Part 2: Terminal Elimination Half-life (t½)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '7', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}, {'value': '27', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: 75 mg QD', 'description': 'Patients self-administered orally 75 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG001', 'title': 'Part 1: 125 mg QD', 'description': 'Patients self-administered orally 125 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG002', 'title': 'Part 1: 200 mg QD', 'description': 'Patients self-administered orally 200 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG003', 'title': 'Part 1: 300 mg QD', 'description': 'Patients self-administered orally 300 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG004', 'title': 'Part 1: 400 mg QD', 'description': 'Patients self-administered orally 400 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG005', 'title': 'Part 1: 100 mg BID', 'description': 'Patients self-administered orally 100 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG006', 'title': 'Part 1: 200 mg BID', 'description': 'Patients self-administered orally 200 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG007', 'title': 'Part 1: 250 mg BID', 'description': 'Patients self-administered orally 250 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG008', 'title': 'Part 1: 300 mg BID', 'description': 'Patients self-administered orally 300 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG009', 'title': 'Part 1: 400 mg BID', 'description': 'Patients self-administered orally 400 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG010', 'title': 'Part 2: 300 mg QD', 'description': 'Patients self-administered orally 300 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}], 'classes': [{'title': 'Cycle 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '7', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}, {'value': '27', 'groupId': 'OG010'}]}], 'categories': [{'measurements': [{'value': '2.4878', 'spread': '2.1008', 'groupId': 'OG000'}, {'value': '5.1659', 'spread': '0.5209', 'groupId': 'OG001'}, {'value': '3.6685', 'spread': '2.2953', 'groupId': 'OG002'}, {'value': '4.4899', 'spread': '1.5478', 'groupId': 'OG003'}, {'value': '6.0302', 'spread': '2.4730', 'groupId': 'OG004'}, {'value': '9.7153', 'spread': '5.2865', 'groupId': 'OG005'}, {'value': '10.0780', 'spread': '1.3932', 'groupId': 'OG006'}, {'value': '5.9468', 'spread': '3.8500', 'groupId': 'OG007'}, {'value': '30.0521', 'spread': '42.0129', 'groupId': 'OG008'}, {'value': '13.4566', 'spread': '7.3992', 'groupId': 'OG009'}, {'value': '5.4384', 'spread': '1.7469', 'groupId': 'OG010'}]}]}, {'title': 'Cycle 1 Day 8 (Part 1 only)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}]}], 'categories': [{'measurements': [{'value': '1.9170', 'spread': '0.5066', 'groupId': 'OG000'}, {'value': '2.4735', 'spread': '0.3469', 'groupId': 'OG001'}, {'value': '2.0217', 'spread': '0.2653', 'groupId': 'OG002'}, {'value': '2.6237', 'spread': '0.5050', 'groupId': 'OG003'}, {'value': '2.8480', 'spread': '1.3889', 'groupId': 'OG004'}, {'value': '2.3007', 'spread': '0.0899', 'groupId': 'OG005'}, {'value': '3.5204', 'spread': '1.6584', 'groupId': 'OG006'}, {'value': '2.6280', 'spread': '0.8577', 'groupId': 'OG007'}, {'value': '3.2062', 'spread': '0.8054', 'groupId': 'OG008'}, {'value': '2.8287', 'spread': '1.2416', 'groupId': 'OG009'}]}]}, {'title': 'Cycle 2 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '23', 'groupId': 'OG010'}]}], 'categories': [{'measurements': [{'value': '3.7488', 'spread': '2.9554', 'groupId': 'OG000'}, {'value': '5.6743', 'spread': '1.3845', 'groupId': 'OG001'}, {'value': '5.4356', 'spread': '0.7253', 'groupId': 'OG002'}, {'value': '5.9316', 'spread': '0.8500', 'groupId': 'OG003'}, {'value': '8.5232', 'spread': '5.0118', 'groupId': 'OG004'}, {'value': '16.5535', 'spread': '6.8417', 'groupId': 'OG005'}, {'value': '8.7138', 'spread': '6.8781', 'groupId': 'OG006'}, {'value': '10.8357', 'spread': '1.0282', 'groupId': 'OG007'}, {'value': '13.7574', 'spread': '8.1372', 'groupId': 'OG008'}, {'value': '7.7683', 'spread': '5.3755', 'groupId': 'OG009'}, {'value': '2.8030', 'spread': '1.2594', 'groupId': 'OG010'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 0.5 to 24 hours post-dose for Part 1: Cycle 1 Day 1, Cycle 1 Day 8, Cycle 2 Day 1 and for Part 2: Cycle 1 Day 1, Cycle 2 Day 1 (duration of cycle was 4 weeks)', 'description': 'To determine the t½ as pharmacokinetic parameters of NS-018.', 'unitOfMeasure': 'hour (h)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population include all patients who received at least one dose of study drug and have at least 50% of the planned samples above the limit of quantitation to provide evaluable PK profile, Here, number analyzed reflects number of patients evaluated on that specific cycle day.\n\nPart 2: 1 patient was completely excluded from PK Population due to critical samples missing, 1 patient was excluded from the analysis due to sample missing at timepoint, So the overall number of participants was 27.'}, {'type': 'SECONDARY', 'title': 'Part1 and Part 2: Accumulation Ratio (AR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '22', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: 75 mg QD', 'description': 'Patients self-administered orally 75 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG001', 'title': 'Part 1: 125 mg QD', 'description': 'Patients self-administered orally 125 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG002', 'title': 'Part 1: 200 mg QD', 'description': 'Patients self-administered orally 200 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG003', 'title': 'Part 1: 300 mg QD', 'description': 'Patients self-administered orally 300 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG004', 'title': 'Part 1: 400 mg QD', 'description': 'Patients self-administered orally 400 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG005', 'title': 'Part 1: 100 mg BID', 'description': 'Patients self-administered orally 100 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG006', 'title': 'Part 1: 200 mg BID', 'description': 'Patients self-administered orally 200 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG007', 'title': 'Part 1: 300 mg BID', 'description': 'Patients self-administered orally 300 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG008', 'title': 'Part 1: 250 mg BID', 'description': 'Patients self-administered orally 250 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG009', 'title': 'Part 1: 400 mg BID', 'description': 'Patients self-administered orally 400 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'OG010', 'title': 'Part 2: 300 mg QD', 'description': 'Patients self-administered orally 300 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9778', 'spread': 'NA', 'comment': 'As only 1 participant was evaluable, hence SD is not calculable.', 'groupId': 'OG000'}, {'value': '1.2517', 'spread': '0.5579', 'groupId': 'OG001'}, {'value': '1.1728', 'spread': '0.0372', 'groupId': 'OG002'}, {'value': '1.3581', 'spread': '0.3108', 'groupId': 'OG003'}, {'value': '1.2026', 'spread': '0.4755', 'groupId': 'OG004'}, {'value': '1.9941', 'spread': '0.6140', 'groupId': 'OG005'}, {'value': '3.3229', 'spread': '0.3197', 'groupId': 'OG006'}, {'value': '3.0501', 'spread': '2.6306', 'groupId': 'OG007'}, {'value': '1.5452', 'spread': '0.4025', 'groupId': 'OG008'}, {'value': '1.2514', 'spread': 'NA', 'comment': 'As only 1 participant was evaluable, hence SD is not calculable.', 'groupId': 'OG009'}, {'value': '1.0543', 'spread': '0.2572', 'groupId': 'OG010'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part 1 and Part 2: Cycle 2 Day 1 (duration of cycle was 4 weeks)', 'description': 'To determine the AR as pharmacokinetic parameters of NS-018. AR was calculated as AR = (AUC0-24) Cycle 2 Day 1/ (AUC0-24) Cycle 1 Day 1.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK Population includes all patients who received at least one dose of study drug and have at least 50% of the planned samples above the limit of quantitation to provide evaluable PK profile (i.e. at least Cmax and AUC evaluable), regardless of whether derived from parent drug or metabolites.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part 1: 75 mg QD', 'description': 'Patients self-administered orally 75 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'FG001', 'title': 'Part 1: 125 mg QD', 'description': 'Patients self-administered orally 125 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'FG002', 'title': 'Part 1: 200 mg QD', 'description': 'Patients self-administered orally 200 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'FG003', 'title': 'Part 1: 300 mg QD', 'description': 'Patients self-administered orally 300 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'FG004', 'title': 'Part 1: 400 mg QD', 'description': 'Patients self-administered orally 400 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'FG005', 'title': 'Part 1: 100 mg BID', 'description': 'Patients self-administered orally 100 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'FG006', 'title': 'Part 1: 200 mg BID', 'description': 'Patients self-administered orally 200 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'FG007', 'title': 'Part 1: 250 mg BID', 'description': 'Patients self-administered orally 250 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'FG008', 'title': 'Part 1: 300 mg BID', 'description': 'Patients self-administered orally 300 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'FG009', 'title': 'Part 1: 400 mg BID', 'description': 'Patients self-administered orally 400 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'FG010', 'title': 'Part 2: 300 mg QD', 'description': 'Patients self-administered orally 300 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}], 'periods': [{'title': 'Whole Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '8'}, {'groupId': 'FG008', 'numSubjects': '8'}, {'groupId': 'FG009', 'numSubjects': '8'}, {'groupId': 'FG010', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '8'}, {'groupId': 'FG008', 'numSubjects': '8'}, {'groupId': 'FG009', 'numSubjects': '8'}, {'groupId': 'FG010', 'numSubjects': '29'}]}], 'dropWithdraws': [{'type': 'Disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '4'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '2'}, {'groupId': 'FG010', 'numSubjects': '10'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '3'}, {'groupId': 'FG009', 'numSubjects': '4'}, {'groupId': 'FG010', 'numSubjects': '12'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '2'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '4'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '3'}, {'groupId': 'FG009', 'numSubjects': '2'}, {'groupId': 'FG010', 'numSubjects': '3'}]}]}, {'title': 'Dose Finding Period - Escalation', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}]}, {'title': 'Dose Finding Period - Reduction', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '8'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '3'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '8'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '3'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects who met all the inclusion and none of the exclusion criteria were enrolled at 09 sites in the USA. The conduct of this study started on 02 June 2011 (the first patient screened) and the last patient last visit was on 22 April 2020.\n\nA total of 48 and 29 patients were enrolled during Phase 1 and Phase 2 of the study respectively.\n\nParticipants could be reduced or escalated to the noted dose at physician discretion.', 'preAssignmentDetails': 'The screening period was from Day -14 to Day 0 for Phase I and Phase II. Informed consent form (ICF) was signed prior to screening procedures. All the study assessments were performed as per the schedule of assessment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '8', 'groupId': 'BG007'}, {'value': '8', 'groupId': 'BG008'}, {'value': '8', 'groupId': 'BG009'}, {'value': '29', 'groupId': 'BG010'}, {'value': '77', 'groupId': 'BG011'}]}], 'groups': [{'id': 'BG000', 'title': 'Part 1: 75 mg QD', 'description': 'Patients self-administered orally 75 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'BG001', 'title': 'Part 1: 125 mg QD', 'description': 'Patients self-administered orally 125 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'BG002', 'title': 'Part 1: 200 mg QD', 'description': 'Patients self-administered orally 200 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'BG003', 'title': 'Part 1: 300 mg QD', 'description': 'Patients self-administered orally 300 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'BG004', 'title': 'Part 1: 400 mg QD', 'description': 'Patients self-administered orally 400 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'BG005', 'title': 'Part 1: 100 mg BID', 'description': 'Patients self-administered orally 100 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'BG006', 'title': 'Part 1: 200 mg BID', 'description': 'Patients self-administered orally 200 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'BG007', 'title': 'Part 1: 250 mg BID', 'description': 'Patients self-administered orally 250 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'BG008', 'title': 'Part 1: 300 mg BID', 'description': 'Patients self-administered orally 300 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'BG009', 'title': 'Part 1: 400 mg BID', 'description': 'Patients self-administered orally 400 mg of NS-018 twice daily (BID) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'BG010', 'title': 'Part 2: 300 mg QD', 'description': 'Patients self-administered orally 300 mg of NS-018 once daily (QD) in cycles of 28 days in duration (4 weeks) for Cycles 1, 2, 3, 4, 5, 6, 7 and until the patient experiences unacceptable toxicity that precludes any further treatment, disease progression, and/or as long as the patient is benefiting from treatment.'}, {'id': 'BG011', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '8', 'groupId': 'BG007'}, {'value': '8', 'groupId': 'BG008'}, {'value': '8', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '48', 'groupId': 'BG011'}]}], 'categories': [{'measurements': [{'value': '72.7', 'spread': '1.5', 'groupId': 'BG000'}, {'value': '70.3', 'spread': '14.8', 'groupId': 'BG001'}, {'value': '63.7', 'spread': '12.9', 'groupId': 'BG002'}, {'value': '67.3', 'spread': '9.4', 'groupId': 'BG003'}, {'value': '67.3', 'spread': '3.8', 'groupId': 'BG004'}, {'value': '65.0', 'spread': '8.9', 'groupId': 'BG005'}, {'value': '69.0', 'spread': '3.6', 'groupId': 'BG006'}, {'value': '63.0', 'spread': '11.8', 'groupId': 'BG007'}, {'value': '62.4', 'spread': '11.9', 'groupId': 'BG008'}, {'value': '69.3', 'spread': '7.7', 'groupId': 'BG009'}, {'value': '66.4', 'spread': '9.6', 'groupId': 'BG011'}]}]}, {'title': 'Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '29', 'groupId': 'BG010'}, {'value': '29', 'groupId': 'BG011'}]}], 'categories': [{'measurements': [{'value': '67.2', 'spread': '9.3', 'groupId': 'BG010'}, {'value': '67.2', 'spread': '9.3', 'groupId': 'BG011'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'For Age continuous, Part 1 and Part 2 data are presented in different rows (48+29=77).'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '8', 'groupId': 'BG007'}, {'value': '8', 'groupId': 'BG008'}, {'value': '8', 'groupId': 'BG009'}, {'value': '29', 'groupId': 'BG010'}, {'value': '77', 'groupId': 'BG011'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '14', 'groupId': 'BG010'}, {'value': '33', 'groupId': 'BG011'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '5', 'groupId': 'BG009'}, {'value': '15', 'groupId': 'BG010'}, {'value': '44', 'groupId': 'BG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White/Caucasian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '8', 'groupId': 'BG007'}, {'value': '8', 'groupId': 'BG008'}, {'value': '8', 'groupId': 'BG009'}, {'value': '29', 'groupId': 'BG010'}, {'value': '77', 'groupId': 'BG011'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '8', 'groupId': 'BG007'}, {'value': '8', 'groupId': 'BG008'}, {'value': '8', 'groupId': 'BG009'}, {'value': '26', 'groupId': 'BG010'}, {'value': '71', 'groupId': 'BG011'}]}]}, {'title': 'Black/African Heritage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '8', 'groupId': 'BG007'}, {'value': '8', 'groupId': 'BG008'}, {'value': '8', 'groupId': 'BG009'}, {'value': '29', 'groupId': 'BG010'}, {'value': '77', 'groupId': 'BG011'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '3', 'groupId': 'BG011'}]}]}, {'title': 'Asian/Oriental', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '8', 'groupId': 'BG007'}, {'value': '8', 'groupId': 'BG008'}, {'value': '8', 'groupId': 'BG009'}, {'value': '29', 'groupId': 'BG010'}, {'value': '77', 'groupId': 'BG011'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '2', 'groupId': 'BG011'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '8', 'groupId': 'BG007'}, {'value': '8', 'groupId': 'BG008'}, {'value': '8', 'groupId': 'BG009'}, {'value': '29', 'groupId': 'BG010'}, {'value': '77', 'groupId': 'BG011'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-04-21', 'size': 1235117, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-11-02T07:48', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Phase 1: 75, 125, 200, 300, 400 mg QD and 100, 200, 250, 300, 400 mg BID Phase 2: 300 mg QD'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 77}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'dispFirstSubmitDate': '2021-09-10', 'completionDateStruct': {'date': '2020-04-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-10', 'studyFirstSubmitDate': '2011-08-15', 'dispFirstSubmitQcDate': '2021-09-10', 'resultsFirstSubmitDate': '2021-11-12', 'studyFirstSubmitQcDate': '2011-08-25', 'dispFirstPostDateStruct': {'date': '2021-09-14', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2022-03-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-02-10', 'studyFirstPostDateStruct': {'date': '2011-08-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part 1 and Part 2: Number of Subjects With Adverse Events and Serious Adverse Event', 'timeFrame': 'From screening to until study discontinuation (approximate 8 years 10 months)', 'description': 'AEs (non-serious, serious) as variables of safety and tolerability of NS-018 were assesed. The number of patients were presented as Overall summary of AEs including treatment-emergent AEs (TEAEs); Treatment-emergent SAEs; Drug-related TEAEs; Treatment-emergent AEs leading to permanent discontinuation of study drug; Hospitalization or prolongation of existing hospitalization; Death.'}, {'measure': 'Part 2: Number of Patient With Objective Response Using International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) and European Leukemia Net (ELN)', 'timeFrame': 'Cycle 7 Day 1 (duration of cycle was 4 weeks)', 'description': 'Six response categories are listed: complete remission (CR) and partial remission signify treatment effects that are consistent with disease modification, whereas drug-induced improvements in MF-symptomatic burden were annotated as clinical improvement, anemia response, spleen response, orsymptoms response. Additional criteria are provided for progressive disease, stable disease, and relapse. The objective response was defined as the number of patients with confirmed complete remission (CR) + partial response (PR) + clinical improvement (CI) during the treatment period.'}, {'measure': 'Part 2: Change From Baseline in Spleen Size', 'timeFrame': 'From Baseline to Cycle 7 Day 1 (duration of cycle was 4 weeks)', 'description': 'Change from baseline in spleen size was assessed by magnetic resonance imaging (MRI) (computed tomography \\[CT\\] scan for patients not able to tolerate MRI).'}, {'measure': 'Part 2: Change From Baseline in Bone Marrow Assessment', 'timeFrame': 'From baseline to Cycle 7 Day 1 (duration of cycle was 4 weeks)', 'description': 'Bone marrow was assessed by aspiration and biopsy for grade changes in osteomyelofibrosis. Fibrosis was graded according to European Consensus Myelofibrosis Grading Criteria, ranging from grade 0, which corresponds to normal bone marrow, to grade 3, in which coarse bundles of collagen fibrosis are identifiable with significant osteosclerosis.'}], 'secondaryOutcomes': [{'measure': 'Part 1: Number of Patients With Objective Response Using International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT)', 'timeFrame': 'Cycle 7 Day 1 (duration of cycle was 4 weeks)', 'description': 'Six response categories are listed: complete remission (CR) and partial remission signify treatment effects that are consistent with disease modification, whereas drug-induced improvements in MF-symptomatic burden were annotated as clinical improvement, anemia response, spleen response, orsymptoms response. Additional criteria are provided for progressive disease, stable disease, and relapse. The objective response was defined as the number of patients with confirmed "complete remission (CR) + partial response (PR) + clinical improvement (CI)" during the treatment period.'}, {'measure': 'Part 1: Change From Baseline in Spleen Size', 'timeFrame': 'From Baseline to Cycle 7 Day 1 (duration of cycle was 4 weeks)', 'description': 'Change from baseline in spleen size was assessed by palpation.'}, {'measure': 'Part 1: Change From Baseline in Bone Marrow Assessment', 'timeFrame': 'From baseline to Cycle 7 Day 1 (duration of cycle was 4 weeks)', 'description': 'Bone marrow was assessed by aspiration and biopsy for grade changes in osteomyelofibrosis. Fibrosis was graded according to European Consensus Myelofibrosis Grading Criteria, ranging from grade 0, which corresponds to normal bone marrow, to grade 3, in which coarse bundles of collagen fibrosis are identifiable with significant osteosclerosis.'}, {'measure': 'Part 1: Change From Baseline in Quality of Life Assessments Using Myelofibrosis Symptom Assessment Form (MF-SAF)', 'timeFrame': 'From baseline to Cycle 7 Day 1 (duration of cycle was 4 weeks)', 'description': 'MF SAF is a 20-item instrument comprised of 4 subscales: 1) the Brief Fatigue Inventory \\[= average of 9 fatigue scores\\], 2) Splenomegaly associated symptoms \\[= average of 4 splenomegaly and associated scores\\], 3) Catabolic/proliferative Symptoms \\[= average of 3 catabolic/proliferative associated scores\\] and 4) Overall Quality of Life. The items were on a scale from 1 to 10 where 1= most favorable, and 10= least favorable.'}, {'measure': 'Part 2: Change From Baseline in Quality of Life Assessments Using Myeloproliferative Neoplasm Symptom Assessment Form (MPN SAF (MPN 10)', 'timeFrame': 'From baseline to Cycle 7 Day 1 (duration of cycle was 4 weeks)', 'description': 'Symptoms are evaluated by the MPN-SAF Total Symptom Score (TSS). The MPN-SAF TSS is assessed by the patients themselves and this includes fatigue, concentration, early satiety, inactivity, night sweats, itching, bone pain, abdominal discomfort, weight loss, and fevers. Scoring is from 0 (absent/as good as it can be) to 10 (worst imaginable/as bad as it can be) for each item. The MPN-SAF TSS is the summation of all the individual scores (0-100 scale). Symptoms response requires \\>50% reduction in the MPN-SAF TSS.'}, {'measure': 'Part 1 and Part 2: Change in Baseline in Janus Kinase 2 (JAK2) V617F Allele Burden Levels', 'timeFrame': 'Part 1 and Part 2: From baseline to Cycle 7 Day 1 (duration of cycle was 4 weeks)', 'description': 'The JAK2 V617F allele burden mean changes from baseline (%) are presented as pharmacodynamics parameters.'}, {'measure': 'Part 2: Change From Baseline in Phosphorylated Signal Transducer and Activator of Transcription 3 (Phospho-STAT3)', 'timeFrame': 'From Baseline to Pre-dose at Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 (duration of cycle was 4 weeks)', 'description': 'The Phospho-STAT3 mean changes from baseline (%) are presented as pharmacodynamics parameters.\n\nFor phospho-STAT3 values (Phase 2 only), study samples were incubated (± IL-6) and labeled with CD markers. Surface markers included CD3+ (CD4+ \\[helper T cells\\] and CD8+ \\[cytotoxic T cells\\]) and CD14+ (monocytes) to which intracellular phospho STAT3 was targeted. The levels of phospho-STAT3 in CD14+, CD3+CD4+ and CD3+CD8+ cell subtypes were quantified. Phosphorylated-STAT3 levels were evaluated in the cell types before and after IL-6 incubation (stimulation) and reported both as mean fluorescence intensity (MFI) and the percentage of positive cells. For each sample time point, the MFI was normalized to a fold change.\n\nThe fold change was calculated by MFI after IL-6 treatment/MFI before IL-6 treatment. The percent positive cells were normalized by subtracting the percent positive cells before IL-6 treatment from the percent positive cells after IL-6 treatment.'}, {'measure': 'Part1 and Part 2: Observed Maximum Concentration (Cmax)', 'timeFrame': 'Pre-dose, 0.5 to 24 hours post-dose for Part 1: Cycle 1 Day 1, Cycle 1 Day 8, Cycle 2 Day 1 and for Part 2: Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 (duration of cycle was 4 weeks)', 'description': 'To determine the Cmax as pharmacokinetic parameters of NS-018.'}, {'measure': 'Part 1 and Part 2: Time to Maximum Plasma Concentration (Tmax)', 'timeFrame': 'Pre-dose, 0.5 to 24 hours post-dose for Part 1: Cycle 1 Day 1, Cycle 1 Day 8, Cycle 2 Day 1 and for Part 2: Cycle 1 Day 1, Cycle 2 Day 1 (duration of cycle was 4 weeks)', 'description': 'To determine the Tmax as pharmacokinetic parameters of NS-018.'}, {'measure': 'Part1 and Part 2: Area Under the Plasma Concentration-time Curve (AUC0-24)', 'timeFrame': 'Pre-dose, 0.5 to 24 hours post-dose for Part 1: Cycle 1 Day 1, Cycle 2 Day 1 and for Part 2: Cycle 1 Day 1 (duration of cycle was 4 weeks)', 'description': 'To determine the AUC0-24 as pharmacokinetic parameters of NS-018.'}, {'measure': 'Part 1 and Part 2: Terminal Elimination Half-life (t½)', 'timeFrame': 'Pre-dose, 0.5 to 24 hours post-dose for Part 1: Cycle 1 Day 1, Cycle 1 Day 8, Cycle 2 Day 1 and for Part 2: Cycle 1 Day 1, Cycle 2 Day 1 (duration of cycle was 4 weeks)', 'description': 'To determine the t½ as pharmacokinetic parameters of NS-018.'}, {'measure': 'Part1 and Part 2: Accumulation Ratio (AR)', 'timeFrame': 'Part 1 and Part 2: Cycle 2 Day 1 (duration of cycle was 4 weeks)', 'description': 'To determine the AR as pharmacokinetic parameters of NS-018. AR was calculated as AR = (AUC0-24) Cycle 2 Day 1/ (AUC0-24) Cycle 1 Day 1.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Keywords provided by NS Pharma, Inc.:', 'JAK2 kinase inhibitor', 'NS-018', 'Myeloproliferative Neoplasms', 'Primary Myelofibrosis', 'post-Polycythemia Vera Myelofibrosis', 'post-Essential Thrombocythemia Myelofibrosis', 'Additional relevant MeSH terms:', 'Bone Marrow Diseases', 'Hematologic Diseases', 'Polycythemia Vera', 'Thrombocythemia, Essential', 'PMF', 'post-PV MF', 'post-ET MF'], 'conditions': ['Primary Myelofibrosis', 'Post-Polycythemia Vera Myelofibrosis', 'Post-Essential Thrombocythemia Myelofibrosis']}, 'referencesModule': {'references': [{'pmid': '27479177', 'type': 'DERIVED', 'citation': 'Verstovsek S, Talpaz M, Ritchie E, Wadleigh M, Odenike O, Jamieson C, Stein B, Uno T, Mesa RA. A phase I, open-label, dose-escalation, multicenter study of the JAK2 inhibitor NS-018 in patients with myelofibrosis. Leukemia. 2017 Feb;31(2):393-402. doi: 10.1038/leu.2016.215. Epub 2016 Aug 1.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the safety and tolerability of orally administered NS-018 in patients with Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis (post-PV MF), or Post-essential Thrombocythemia Myelofibrosis (post-ET MF)', 'detailedDescription': 'This is a Phase 1/2 study that is currently enrolling Janus kinase 2 (JAK2) failures into the Phase 2 portion of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary myelofibrosis, post-PV MF, or post-ET MF that requires therapy\n* MF patients must have received prior JAK2 inhibitor therapy, and been found to be intolerant, or refractory/relapsed from prior JAK2 inhibitor therapy, based on investigator assessment\n* ≥18 years old\n* ECOG Performance Status of ≤ 3\n* Estimated life expectancy of ≥12 weeks\n* Male or non-pregnant, non-lactating female patients\n* Serum creatinine of ≤1.5 × the upper limit of normal (ULN)OR estimated creatinine clearance (CrCl) ≥ 40 ml/min/1.73 m2\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 × the upper limit of normal (ULN) and total bilirubin ≤1.5 × ULN. If the total bilirubin is elevated between 1.5 x and 3 x ULN, patients with a direct bilirubin ≤ 1.5 X ULN are eligible during the Phase II portion.\n* Absolute neutrophil count (ANC) \\>1000/μL and Platelet count \\> 25,000/μL\n* QTcB ≤ 480 msec\n* No MF-directed treatment for at least 2 weeks prior to initiation of NS-018, including any use of corticosteroids for Myelofibrosis symptom or blood count management. Low dose corticosteroids ≤ 10 mg/day prednisone or equivalent is allowed for non-myelofibrosis purposes.\n\nExclusion Criteria:\n\n* Active, uncontrolled systemic infection\n* Patients with any unresolved toxicity greater than Grade 1 from previous anticancer therapy\n* Potentially curative therapy is available\n* Currently taking medication that is substantially metabolized by cytochrome P450 (CYP) 1A2 or CYP3A4 or taking medication known to be strong inhibitors or inducers of CYP3A4\n* Patients with a serious cardiac condition within the past 6 months\n* Pregnant or lactating\n* Radiation therapy for splenomegaly within 6 months prior to study entry\n* Splenectomy (Phase 2 portion of the study only)\n* Known HIV positive status\n* Known active hepatitis, a history of viral hepatitis B or hepatitis C'}, 'identificationModule': {'nctId': 'NCT01423851', 'briefTitle': 'Safety and Tolerability Study of Oral NS-018 in Patients With Primary Myelofibrosis (MF), Post-polycythemia Vera MF or Post-essential Thrombocythemia MF', 'organization': {'class': 'INDUSTRY', 'fullName': 'NS Pharma, Inc.'}, 'officialTitle': 'A Phase 1/2, Open-label, Dose-Escalation Multi-center Study to Assess the Safety, Tolerability, PK and PD of Orally Administered NS-018 in Patients With Primary Myelofibrosis (MF), Post-polycythemia Vera MF, or Post-essential Thrombocythemia MF', 'orgStudyIdInfo': {'id': 'NS-018-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention: Drug: NS-018', 'description': 'In Phase 1 part, subjects were treated with oral NS-018 at a dose of 75 - 400 mg once daily or 100 - 400 mg twice daily. In Phase 2 part, subjects were treated with oral NS-018 at a dose of 300 mg once daily.', 'interventionNames': ['Drug: NS-018']}], 'interventions': [{'name': 'NS-018', 'type': 'DRUG', 'description': 'Treatment will be administered continuously as oral daily therapy in cycles of 4 weeks in duration (28 day treatment cycles).', 'armGroupLabels': ['Intervention: Drug: NS-018']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259-5499', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic Scottsdale Recruiting', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '92093-0698', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'UC San Diego Moores Cancer Center', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic, Jacksonville', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Medical College', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson Cancer Center, Department of Leukemia', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Srdan Verstovsek, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MD Anderson Cancer Center, Houston, TX, 77030'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NS Pharma, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}