Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:49 PM
Study NCT ID:
NCT01731951
Status:
COMPLETED
Last Update Posted:
2021-09-21
First Post:
2012-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Imetelstat Sodium in Treating Participants With Primary or Secondary Myelofibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055728', 'term': 'Primary Myelofibrosis'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}], 'ancestors': [{'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C519562', 'term': 'imetelstat'}, {'id': 'C505952', 'term': 'GRN163L peptide'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'myf2001-info@geron.com', 'phone': '650-473-7700', 'title': 'Study Director', 'organization': 'Geron Corp.'}, 'certainAgreement': {'otherDetails': 'Consistent with Good Publication Practices and ICMJE guidelines, the sponsor shall have right to publish such primary (multicenter) data and information without approval from investigator. Investigator has right to publish study site-specific data after primary data published. If an investigator wishes to publish information from study, a copy of manuscript must be provided to sponsor for review at least 60 days before submission for publication or presentation', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose of study drug to the last dose of study drug or until subsequent anti-cancer therapy if earlier (Up to approximately 5.7 years)', 'description': 'All treated analysis set included all participants who received at least 1 dose of Imetelstat. All non-serious adverse events (at 5% threshold) and serious adverse event including requirements for expedited reporting of serious adverse events occurring within 30 days of the last dose of study drug are reported.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm A: Imetelstat 9.4 mg/kg (MF)', 'description': 'Participants with MF regardless of spliceosome mutation status or presence of ring sideroblasts received imetelstat 9.4 mg/kg, IV as 2-hour infusion on Day 1 of each 21-day cycle in Core Phase up to 9 cycles. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 19, 'seriousNumAtRisk': 19, 'deathsNumAffected': 13, 'seriousNumAffected': 17}, {'id': 'EG001', 'title': 'Arm B: Imetelstat 9.4 mg/kg as Induction + Maintenance (MF)', 'description': 'Participants with MF regardless of spliceosome mutation status or presence of ring sideroblasts received imetelstat 9.4 mg/kg, IV as 2-hour infusion on Days 1, 8, and 15 of 21-day cycle in Cycle 1 followed by 9.4 mg/kg on Day 1 of each 21-day cycle up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 16, 'seriousNumAtRisk': 16, 'deathsNumAffected': 15, 'seriousNumAffected': 12}, {'id': 'EG002', 'title': 'Arm D: Imetelstat 9.4 mg/kg (Blast-phase MF/Acute Myeloid Leukemia', 'description': 'Participants with blast-phase MF/AML received imetelstat 9.4 mg/kg, IV as 2-hour infusion weekly on Days 1, 8, 15, 22 of a 28-day cycle up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'deathsNumAffected': 9, 'seriousNumAffected': 9}, {'id': 'EG003', 'title': 'Arm E: Imetelstat 7.5 - 9.4 mg/kg (MF [With Spliceosome Mutation or Ring Sideroblasts])', 'description': 'Participants with MF and spliceosome mutations or ring sideroblasts present received 2 cycles (Cycles 1-2) of imetelstat 7.5 mg/kg, IV as 2-hour infusion on Day 1 of a 28-day cycle followed by maintenance therapy with the same regimen or the possibility of dose escalation to imetelstat 9.4 mg/kg weekly if response to the initial dose was insufficient up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'deathsNumAffected': 8, 'seriousNumAffected': 7}, {'id': 'EG004', 'title': 'Arm F: Imetelstat 7.5 - 9.4 mg/kg (MF [Without Spliceosome Mutation and Ring Sideroblasts])', 'description': 'Participants with MF without spliceosome mutations or ring sideroblasts present received 2 cycles (Cycles 1-2) of imetelstat 9.4 mg/kg, IV as 2-hour infusion on Day 1 of a 28-day cycle followed by maintenance therapy with the same regimen or imetelstat 7.5 mg/kg twice weekly on Days 1, 3 for 2 cycles of 28-day cycle (Cycles 3-4) followed by imetelstat 7.5 mg/kg 3-times-weekly on Days 1, 3, 5 of Cycles 5 and beyond of 28-day cycle up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 18, 'seriousNumAtRisk': 18, 'deathsNumAffected': 9, 'seriousNumAffected': 14}, {'id': 'EG005', 'title': 'Arm G: Imetelstat 7.5 - 9.4 mg/kg (MDS/MPN or MDS With Spliceosome Mutations or Ring Sideroblasts)', 'description': 'Participants with either MDS/MPN or MDS and spliceosome mutations or ring sideroblasts present received 2 cycles of 28-day cycle (Cycles 1-2) of imetelstat 7.5 mg/kg, IV as 2-hour infusion on Day 1 of a 28-day cycle followed by maintenance therapy with the same regimen or the possibility of dose escalation to imetelstat 9.4 mg/kg weekly if response to the initial dose was insufficient up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'deathsNumAffected': 6, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 11}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 18}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 12}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Early satiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 18}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Activated partial thromboplastin time prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 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disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Night sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'seriousEvents': [{'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'MF Participants: Percentage of Participants With Overall Response (OR) - (Clinical Improvement[CI] or Partial Remission[PR] or Complete Remission[CR]) Per International Working Group - Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Imetelstat 9.4 mg/kg (MF)', 'description': 'Participants with MF regardless of spliceosome mutation status or presence of ring sideroblasts received imetelstat 9.4 mg/kg, IV as 2-hour infusion on Day 1 of each 21-day cycle in Core Phase up to 9 cycles. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).'}, {'id': 'OG001', 'title': 'Arm B: Imetelstat 9.4 mg/kg as Induction + Maintenance (MF)', 'description': 'Participants with MF regardless of spliceosome mutation status or presence of ring sideroblasts received imetelstat 9.4 mg/kg, IV as 2-hour infusion on Days 1, 8, and 15 of 21-day cycle in Cycle 1 followed by 9.4 mg/kg on Day 1 of each 21-day cycle up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).'}, {'id': 'OG002', 'title': 'Arm E: Imetelstat 7.5 - 9.4 mg/kg (MF [With Spliceosome Mutation or Ring Sideroblasts])', 'description': 'Participants with MF and spliceosome mutations or ring sideroblasts present received 2 cycles (Cycles 1-2) of imetelstat 7.5 mg/kg, IV as 2-hour infusion on Day 1 of a 28-day cycle followed by maintenance therapy with the same regimen or the possibility of dose escalation to imetelstat 9.4 mg/kg weekly if response to the initial dose was insufficient up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).'}, {'id': 'OG003', 'title': 'Arm F: Imetelstat 7.5 - 9.4 mg/kg (MF [Without Spliceosome Mutation and Ring Sideroblasts])', 'description': 'Participants with MF without spliceosome mutations or ring sideroblasts present received 2 cycles (Cycles 1-2) of imetelstat 9.4 mg/kg, IV as 2-hour infusion on Day 1 of a 28-day cycle followed by maintenance therapy with the same regimen or imetelstat 7.5 mg/kg twice weekly on Days 1, 3 for 2 cycles of 28-day cycle (Cycles 3-4) followed by imetelstat 7.5 mg/kg 3-times-weekly on Days 1, 3, 5 of Cycles 5 and beyond of 28-day cycle up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).'}], 'classes': [{'categories': [{'measurements': [{'value': '36.84', 'groupId': 'OG000', 'lowerLimit': '15.2', 'upperLimit': '58.5'}, {'value': '35.7', 'groupId': 'OG001', 'lowerLimit': '10.6', 'upperLimit': '60.8'}, {'value': '0', 'comment': 'Upper and lower limits of 95% CI were not estimable due to limited number of participants with the event.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '33.3', 'groupId': 'OG003', 'lowerLimit': '11.6', 'upperLimit': '55.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to first 9 cycles of treatment (each cycle was of 21 days for Arms A and B and 28 days for Arms E and F)', 'description': 'OR:CI/PR/CR per IWG-MRT. CR:Bone marrow (BM):\\<5% blasts;≤Grade 1 MF, AND Peripheral blood:Hemoglobin (Hb) ≥100 g/liter (g/L) and \\<upper normal limit (UNL);Neutrophil count(NC) ≥1x10\\^9/L and \\<UNL; Platelet(PLT) count ≥100x10\\^9/L and \\<UNL;\\<2% immature myeloid cells(IMCs), AND Clinical: Resolution of disease symptoms; Spleen and liver not palpable; No evidence of extramedullary hematopoeisis(EMH). PR:All CR criteria plus peripheral blood: Hb≥85 but \\<100g/L and \\<UNL; NC ≥1x10\\^9/L and \\<UNL; PLT count ≥50 but \\<100x10\\^9/L and \\<UNL;\\<2%IMCs. CI:achievement of anemia (≥20 g/L increase in Hb level), spleen(baseline splenomegaly palpable at 5-10 cm, below left costal margin(LCM), becomes not palpable), symptoms response (50% reduction in total symptom score) without progressive disease (PD) (appearance of new splenomegaly- palpable at least \\[≥\\]5 cm below LCM)/increase in severity of anemia, thrombocytopenia/neutropenia. Data is reported separately for arms whose response was assessed per IWG-MRT.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible Analysis Set included subset of all participants who received at least one dose of study drug that excludes ineligible participants who did not satisfy each and every eligibility criteria for study entry. Data is reported for arm groups (Arms A, B, E and F) whose overall response was assessed by IWG-MRT criteria.'}, {'type': 'PRIMARY', 'title': 'Blastic MF/AML Participants: Percentage of Participants With Overall Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm D: Imetelstat 9.4 mg/kg (Blast-phase MF/Acute Myeloid Leukemia)', 'description': 'Participants with blast-phase MF/AML received imetelstat 9.4 mg/kg, IV as 2-hour infusion weekly on Days 1, 8, 15, 22 of a 28-day cycle up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'comment': 'Upper and lower limits of 95% CI were not estimable due to limited number of participants with the event.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to first 9 cycles of treatment (each cycle was of 28 days for Arm D)', 'description': 'For this pilot study, overall response was defined as achievement of a leukemic response (i.e. a clinically meaningful reduction in Blast cells). This was quantified as \\<5% peripheral blood and bone marrow blasts % that lasts for at least two months. Data is reported separately for this arm where response was assessed by this specific criterion.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All Treated Analysis Set included all participants who received at least one dose of study drug. Data is reported for Arm D: Imetelstat 9.4 mg/kg (Blastic MF/AML) participants whose overall response was assessed by a specific criterion.'}, {'type': 'PRIMARY', 'title': 'MDS Participants: Percentage of Participants With Overall Response (Hematologic Improvement [HI] or PR or CR) Per IWG Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm G: Imetelstat 7.5 - 9.4 mg/kg (MDS/MPN or MDS With Spliceosome Mutations or Ring Sideroblasts)', 'description': 'Participants with either MDS/MPN or MDS and spliceosome mutations or ring sideroblasts present received 2 cycles of 28-day cycle (Cycles 1-2) of imetelstat 7.5 mg/kg, IV as 2-hour infusion on Day 1 of a 28-day cycle followed by maintenance therapy with the same regimen or the possibility of dose escalation to imetelstat 9.4 mg/kg weekly if response to the initial dose was insufficient up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).'}], 'classes': [{'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '64.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to first 9 cycles of treatment (each cycle was of 28 days for Arm G)', 'description': 'OR: HI/PR/CR per IWG. CR: BM:≤5% myeloblasts (all cell lines normal maturation), Peripheral blood:Hgb ≥11g/dL, PLTs ≥100x10\\^9/L, Neutrophils ≥1.0x10\\^9/L, Blasts 0%. PR: All CR criteria if abnormal before treatment except- BM blasts decreased ≥50% over pretreatment but still \\>5%, Cellularity, morphology not relevant. HI responses:1) Erythroid: Hgb increase ≥1.5 g/dL, Relevant reduction of red blood cell(RBC) units transfusions by absolute ≥4 RBC transfusions/8 week (wk) compared with pretreatment transfusion number in previous 8 wk. Only RBC transfusions given for Hgb of ≤9.0 g/dL.2)PLTs:Absolute increase ≥30x10\\^9/L starting \\>20x10\\^9/L PLTs; Increase from \\<20x10\\^9/L to \\>20x10\\^9/L and by ≥100%; 3)Neutrophil: ≥100% increase, absolute increase \\>0.5x10\\^9/L; 4)Progression/relapse after HI:≥1 of following:≥50% decrement from maximum response levels in granulocytes/PLTs, Reduction in Hgb ≥1.5 g/dL,Transfusion dependence. Data is reported separately for arm whose response was assessed per IWG.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All Treated Analysis Set included all participants who received at least one dose of the study drug. Data is reported for Arm G: Imetelstat 9.4 mg/kg (MDS/MPN or MDS and spliceosome mutations or ring sideroblasts) participants whose overall response was assessed by IWG criteria.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Grade >= 3 TEAEs and Treatment Related Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Imetelstat 9.4 mg/kg (MF)', 'description': 'Participants with MF regardless of spliceosome mutation status or presence of ring sideroblasts received imetelstat 9.4 mg/kg, IV as 2-hour infusion on Day 1 of each 21-day cycle in Core Phase up to 9 cycles. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).'}, {'id': 'OG001', 'title': 'Arm B: Imetelstat 9.4 mg/kg as Induction + Maintenance (MF)', 'description': 'Participants with MF regardless of spliceosome mutation status or presence of ring sideroblasts received imetelstat 9.4 mg/kg, IV as 2-hour infusion on Days 1, 8, and 15 of 21-day cycle in Cycle 1 followed by 9.4 mg/kg on Day 1 of each 21-day cycle up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).'}, {'id': 'OG002', 'title': 'Arm D: Imetelstat 9.4 mg/kg (Blast-phase MF/Acute Myeloid Leukemia)', 'description': 'Participants with blast-phase MF/AML received imetelstat 9.4 mg/kg, IV as 2-hour infusion weekly on Days 1, 8, 15, 22 of a 28-day cycle up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).'}, {'id': 'OG003', 'title': 'Arm E: Imetelstat 7.5 - 9.4 mg/kg (MF [With Spliceosome Mutation or Ring Sideroblasts])', 'description': 'Participants with MF and spliceosome mutations or ring sideroblasts present received 2 cycles (Cycles 1-2) of imetelstat 7.5 mg/kg, IV as 2-hour infusion on Day 1 of a 28-day cycle followed by maintenance therapy with the same regimen or the possibility of dose escalation to imetelstat 9.4 mg/kg weekly if response to the initial dose was insufficient up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).'}, {'id': 'OG004', 'title': 'Arm F: Imetelstat 7.5 - 9.4 mg/kg (MF [Without Spliceosome Mutation and Ring Sideroblasts])', 'description': 'Participants with MF without spliceosome mutations or ring sideroblasts present received 2 cycles (Cycles 1-2) of imetelstat 9.4 mg/kg, IV as 2-hour infusion on Day 1 of a 28-day cycle followed by maintenance therapy with the same regimen or imetelstat 7.5 mg/kg twice weekly on Days 1, 3 for 2 cycles of 28-day cycle (Cycles 3-4) followed by imetelstat 7.5 mg/kg 3-times-weekly on Days 1, 3, 5 of Cycles 5 and beyond of 28-day cycle up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).'}, {'id': 'OG005', 'title': 'Arm G: Imetelstat 7.5 - 9.4 mg/kg (MDS/MPN or MDS With Spliceosome Mutations or Ring Sideroblasts)', 'description': 'Participants with either MDS/MPN or MDS and spliceosome mutations or ring sideroblasts present received 2 cycles of 28-day cycle (Cycles 1-2) of imetelstat 7.5 mg/kg, IV as 2-hour infusion on Day 1 of a 28-day cycle followed by maintenance therapy with the same regimen or the possibility of dose escalation to imetelstat 9.4 mg/kg weekly if response to the initial dose was insufficient up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).'}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}, {'value': '100', 'groupId': 'OG004'}, {'value': '100', 'groupId': 'OG005'}]}]}, {'title': 'Grade >=3 TEAEs', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '93.5', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '77.8', 'groupId': 'OG003'}, {'value': '83.3', 'groupId': 'OG004'}, {'value': '100', 'groupId': 'OG005'}]}]}, {'title': 'Treatment Related AEs', 'categories': [{'measurements': [{'value': '89.5', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '88.9', 'groupId': 'OG002'}, {'value': '77.8', 'groupId': 'OG003'}, {'value': '83.3', 'groupId': 'OG004'}, {'value': '100', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose of study drug up to 30 days from the last dose of study drug or until subsequent anti-cancer therapy if earlier (Up to approximately 5.7 years)', 'description': 'TEAEs defined as those events that 1) occur on or after the first dose of study drug, through the treatment phase, and for 30 days following the last dose of study drug or until subsequent anti-cancer therapy if earlier; 2) any event that is considered study drug-related regardless of the start date of the event; or 3) any event that is present at baseline but worsens in severity or is subsequently considered drug-related by the investigator. Grade \\>=3 TEAE defined as events that are severe, life-threatening or disabling, or fatal and considered related to imetelstat as per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03. An AE was considered related to the study drug if the event was assessed by the investigator as probably or possibly related.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Treated Analysis Set included all participants who received at least one dose of imetelstat.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Spleen Response Per IWG-MRT Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Imetelstat 9.4 mg/kg (MF)', 'description': 'Participants with MF regardless of spliceosome mutation status or presence of ring sideroblasts received imetelstat 9.4 mg/kg, IV as 2-hour infusion on Day 1 of each 21-day cycle in Core Phase up to 9 cycles. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).'}, {'id': 'OG001', 'title': 'Arm B: Imetelstat 9.4 mg/kg as Induction + Maintenance (MF)', 'description': 'Participants with MF regardless of spliceosome mutation status or presence of ring sideroblasts received imetelstat 9.4 mg/kg, IV as 2-hour infusion on Days 1, 8, and 15 of 21-day cycle in Cycle 1 followed by 9.4 mg/kg on Day 1 of each 21-day cycle up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).'}, {'id': 'OG002', 'title': 'Arm D: Imetelstat 9.4 mg/kg (Blast-phase MF/Acute Myeloid Leukemia)', 'description': 'Participants with blast-phase MF/AML received imetelstat 9.4 mg/kg, IV as 2-hour infusion weekly on Days 1, 8, 15, 22 of a 28-day cycle up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).'}, {'id': 'OG003', 'title': 'Arm E: Imetelstat 7.5 - 9.4 mg/kg (MF [With Spliceosome Mutation or Ring Sideroblasts])', 'description': 'Participants with MF and spliceosome mutations or ring sideroblasts present received 2 cycles (Cycles 1-2) of imetelstat 7.5 mg/kg, IV as 2-hour infusion on Day 1 of a 28-day cycle followed by maintenance therapy with the same regimen or the possibility of dose escalation to imetelstat 9.4 mg/kg weekly if response to the initial dose was insufficient up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).'}, {'id': 'OG004', 'title': 'Arm F: Imetelstat 7.5 - 9.4 mg/kg (MF [Without Spliceosome Mutation and Ring Sideroblasts])', 'description': 'Participants with MF without spliceosome mutations or ring sideroblasts present received 2 cycles (Cycles 1-2) of imetelstat 9.4 mg/kg, IV as 2-hour infusion on Day 1 of a 28-day cycle followed by maintenance therapy with the same regimen or imetelstat 7.5 mg/kg twice weekly on Days 1, 3 for 2 cycles of 28-day cycle (Cycles 3-4) followed by imetelstat 7.5 mg/kg 3-times-weekly on Days 1, 3, 5 of Cycles 5 and beyond of 28-day cycle up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to approximately 5.7 years', 'description': 'Spleen response per IWG-MRT criteria defined as baseline splenomegaly that is palpable at 5-10 cm, below the LCM, becomes not palpable, OR A baseline splenomegaly that is palpable at \\>10 cm, below the LCM, decreases by ≥50%. Baseline splenomegaly that is palpable at \\<5 cm, below the LCM, is not eligible for spleen response. Confirmation by Magnetic resonance imaging (MRI) or computerized tomography (CT) showing ≥35% spleen volume reduction is recommended (but not required). Spleen response was assessed only in participants with MF.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Arms A, B, E and F: Eligible Analysis Set included subset of all participants who received at least one dose of study drug that excludes ineligible participants who did not satisfy each and every eligibility criteria for study entry. Arm D: All Treated Analysis Set included all participants who received at least one dose of imetelstat.'}, {'type': 'SECONDARY', 'title': 'MF and Blastic MF/AML Participants: Number of Participants With Transfusion Independence (CI by Anemia Response) Per IWG-MRT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Imetelstat 9.4 mg/kg (MF)', 'description': 'Participants with MF regardless of spliceosome mutation status or presence of ring sideroblasts received imetelstat 9.4 mg/kg, IV as 2-hour infusion on Day 1 of each 21-day cycle in Core Phase up to 9 cycles. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).'}, {'id': 'OG001', 'title': 'Arm B: Imetelstat 9.4 mg/kg as Induction + Maintenance (MF)', 'description': 'Participants with MF regardless of spliceosome mutation status or presence of ring sideroblasts received imetelstat 9.4 mg/kg, IV as 2-hour infusion on Days 1, 8, and 15 of 21-day cycle in Cycle 1 followed by 9.4 mg/kg on Day 1 of each 21-day cycle up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).'}, {'id': 'OG002', 'title': 'Arm D: Imetelstat 9.4 mg/kg (Blast-phase MF/Acute Myeloid Leukemia)', 'description': 'Participants with blast-phase MF/AML received imetelstat 9.4 mg/kg, IV as 2-hour infusion weekly on Days 1, 8, 15, 22 of a 28-day cycle up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).'}, {'id': 'OG003', 'title': 'Arm E: Imetelstat 7.5 - 9.4 mg/kg (MF [With Spliceosome Mutation or Ring Sideroblasts])', 'description': 'Participants with MF and spliceosome mutations or ring sideroblasts present received 2 cycles (Cycles 1-2) of imetelstat 7.5 mg/kg, IV as 2-hour infusion on Day 1 of a 28-day cycle followed by maintenance therapy with the same regimen or the possibility of dose escalation to imetelstat 9.4 mg/kg weekly if response to the initial dose was insufficient up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).'}, {'id': 'OG004', 'title': 'Arm F: Imetelstat 7.5 - 9.4 mg/kg (MF [Without Spliceosome Mutation and Ring Sideroblasts])', 'description': 'Participants with MF without spliceosome mutations or ring sideroblasts present received 2 cycles (Cycles 1-2) of imetelstat 9.4 mg/kg, IV as 2-hour infusion on Day 1 of a 28-day cycle followed by maintenance therapy with the same regimen or imetelstat 7.5 mg/kg twice weekly on Days 1, 3 for 2 cycles of 28-day cycle (Cycles 3-4) followed by imetelstat 7.5 mg/kg 3-times-weekly on Days 1, 3, 5 of Cycles 5 and beyond of 28-day cycle up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to approximately 5.7 years', 'description': 'Transfusion dependency was defined by a history of at least 2 units of red blood cell transfusions in the last month for a hemoglobin level of less than 85 g/L that was not associated with clinically overt bleeding. A participant who was transfusion dependent at baseline was considered transfusion independent if the participant met either of the following conditions: Received no more than 1 unit of red blood cell transfusions in a rolling time interval of 30 days or more, and had a hemoglobin level increase over baseline more than 2 g/dL if participant baseline hemoglobin level was less than 85 g/L and received no transfusion. Anemia response per IWG-MRT Criteria- Transfusion-independent participants: a ≥20 g/L increase in hemoglobin level. Transfusion-dependent participants: becoming transfusion-independent. Data is reported separately for arms assessed as per the IWG-MRT criteria.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Arms A, B, E, F: Eligible Analysis Set included subset of all participants who received at least one dose of study drug that excludes ineligible participants who did not satisfy each and every eligibility criteria for study entry. Arm D: All Treated Analysis Set included all participants who received at least one dose of imetelstat, assessed per IWG-MRT.'}, {'type': 'SECONDARY', 'title': 'MDS Participants: Number of Participants With Transfusion Independence (HI by Erythroid Response) Per IWG Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm G: Imetelstat 7.5 - 9.4 mg/kg (MDS/MPN or MDS With Spliceosome Mutations or Ring Sideroblasts)', 'description': 'Participants with either MDS/MPN or MDS and spliceosome mutations or ring sideroblasts present received 2 cycles of 28-day cycle (Cycles 1-2) of imetelstat 7.5 mg/kg, IV as 2-hour infusion on Day 1 of a 28-day cycle followed by maintenance therapy with the same regimen or the possibility of dose escalation to imetelstat 9.4 mg/kg weekly if response to the initial dose was insufficient up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to approximately 5.7 years', 'description': 'Transfusion dependency was defined by a history of at least 2 units of red blood cell transfusions in the last month for a hemoglobin level of less than 85 g/L that was not associated with clinically overt bleeding. A participant who was transfusion dependent at baseline was considered transfusion independent if the participant met either of the following conditions: Received no more than 1 unit of red blood cell transfusions in a rolling time interval of 30 days or more, and had a hemoglobin level increase over baseline more than 2 g/dL if participant baseline hemoglobin level was less than 85 g/L and received no transfusion. HI responses included: 1) Erythroid: Hgb increase ≥1.5 g/dL, Relevant reduction of RBC units transfusions by absolute number of \\>=4 RBC transfusions/8 week compared with pretreatment transfusion number in previous 8 week. Only RBC transfusions given for Hgb of ≤9.0 g/dL. Data is reported separately for arm assessed as per IWG criteria.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Treated Analysis Set included all participants who received at least one dose of study drug. Data is reported for Arm G: Imetelstat 9.4 mg/kg (MDS/MPN or MDS and spliceosome mutations or ring sideroblasts) participants whose transfusion independence (HI by erythroid response) was assessed by IWG criteria.'}, {'type': 'SECONDARY', 'title': 'MF Participants: Time to Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Imetelstat 9.4 mg/kg (MF)', 'description': 'Participants with MF regardless of spliceosome mutation status or presence of ring sideroblasts received imetelstat 9.4 mg/kg, IV as 2-hour infusion on Day 1 of each 21-day cycle in Core Phase up to 9 cycles. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).'}, {'id': 'OG001', 'title': 'Arm B: Imetelstat 9.4 mg/kg as Induction + Maintenance (MF)', 'description': 'Participants with MF regardless of spliceosome mutation status or presence of ring sideroblasts received imetelstat 9.4 mg/kg, IV as 2-hour infusion on Days 1, 8, and 15 of 21-day cycle in Cycle 1 followed by 9.4 mg/kg on Day 1 of each 21-day cycle up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).'}, {'id': 'OG002', 'title': 'Arm E: Imetelstat 7.5 - 9.4 mg/kg (MF [With Spliceosome Mutation or Ring Sideroblasts])', 'description': 'Participants with MF and spliceosome mutations or ring sideroblasts present received 2 cycles (Cycles 1-2) of imetelstat 7.5 mg/kg, IV as 2-hour infusion on Day 1 of a 28-day cycle followed by maintenance therapy with the same regimen or the possibility of dose escalation to imetelstat 9.4 mg/kg weekly if response to the initial dose was insufficient up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).'}, {'id': 'OG003', 'title': 'Arm F: Imetelstat 7.5 - 9.4 mg/kg (MF [Without Spliceosome Mutation and Ring Sideroblasts])', 'description': 'Participants with MF without spliceosome mutations or ring sideroblasts present received 2 cycles (Cycles 1-2) of imetelstat 9.4 mg/kg, IV as 2-hour infusion on Day 1 of a 28-day cycle followed by maintenance therapy with the same regimen or imetelstat 7.5 mg/kg twice weekly on Days 1, 3 for 2 cycles of 28-day cycle (Cycles 3-4) followed by imetelstat 7.5 mg/kg 3-times-weekly on Days 1, 3, 5 of Cycles 5 and beyond of 28-day cycle up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).'}], 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000', 'lowerLimit': '0.7', 'upperLimit': '3.5'}, {'value': '1.4', 'groupId': 'OG001', 'lowerLimit': '0.7', 'upperLimit': '5.6'}, {'value': '2.9', 'groupId': 'OG003', 'lowerLimit': '1.9', 'upperLimit': '12.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From study Day 1 to the earliest date that a response was first documented (Up to approximately 5.7 years)', 'description': 'Time to response was defined as the duration from study Day 1 to the earliest date that a response is first documented. The response CI/CR/PR was assessed by IWG-MRT criteria.', 'unitOfMeasure': 'months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible Analysis Set included subset of all participants who received at least one dose of study drug that excludes ineligible participants who did not satisfy each and every eligibility criteria for study entry. Data is reported for arm groups (Arms A, B, E and F) whose overall response was assessed by IWG-MRT criteria. Only responders were analyzed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Blastic MF/AML Participants: Time to Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm D: Imetelstat 9.4 mg/kg (Blast-phase MF/Acute Myeloid Leukemia)', 'description': 'Participants with blast-phase MF/AML received imetelstat 9.4 mg/kg, IV as 2-hour infusion weekly on Days 1, 8, 15, 22 of a 28-day cycle up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).'}], 'timeFrame': 'From study Day 1 to the earliest date that a response was first documented (Up to approximately 5.7 years)', 'description': 'Time to response was defined as the duration from study Day 1 to the earliest date that a response is first documented. Response was defined as achievement of a leukemic response (i.e. a clinically meaningful reduction in Blast cells). This was quantified as \\<5% peripheral blood and bone marrow blasts % that lasts for at least two months. Data for time to response is reported as per criteria of response assessment.', 'reportingStatus': 'POSTED', 'populationDescription': 'All Treated Analysis Set included all participants who received at least one dose of the study drug. Only responders were analyzed for this outcome measure. Data is reported for Arm D: Imetelstat 9.4 mg/kg (Blastic MF/AML) participants whose overall response was assessed by a specific criterion.'}, {'type': 'SECONDARY', 'title': 'MDS Participants: Time to Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm G: Imetelstat 7.5 - 9.4 mg/kg (MDS/MPN or MDS With Spliceosome Mutations or Ring Sideroblasts)', 'description': 'Participants with either MDS/MPN or MDS and spliceosome mutations or ring sideroblasts present received 2 cycles of 28-day cycle (Cycles 1-2) of imetelstat 7.5 mg/kg, IV as 2-hour infusion on Day 1 of a 28-day cycle followed by maintenance therapy with the same regimen or the possibility of dose escalation to imetelstat 9.4 mg/kg weekly if response to the initial dose was insufficient up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).'}], 'classes': [{'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '4.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From study Day 1 to the earliest date that a response was first documented (Up to approximately 5.7 years)', 'description': 'Time to response was defined as the duration from study Day 1 to the earliest date that a response is first documented. Response was defined as HI, PR or CR per IWG criteria. Data for time to response is reported as per criteria of response assessment.', 'unitOfMeasure': 'months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All Treated Analysis Set included all participants who received at least one dose of the study drug. Only responders were analyzed for this outcome measure. Data is reported for Arm G: Imetelstat 9.4 mg/kg (MDS/MPN or MDS and spliceosome mutations or ring sideroblasts) participants whose overall response was assessed by IWG criteria.'}, {'type': 'SECONDARY', 'title': 'MF Participants: Duration of Response (DOR) Per IWG-MRT Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Imetelstat 9.4 mg/kg (MF)', 'description': 'Participants with MF regardless of spliceosome mutation status or presence of ring sideroblasts received imetelstat 9.4 mg/kg, IV as 2-hour infusion on Day 1 of each 21-day cycle in Core Phase up to 9 cycles. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).'}, {'id': 'OG001', 'title': 'Arm B: Imetelstat 9.4 mg/kg as Induction + Maintenance (MF)', 'description': 'Participants with MF regardless of spliceosome mutation status or presence of ring sideroblasts received imetelstat 9.4 mg/kg, IV as 2-hour infusion on Days 1, 8, and 15 of 21-day cycle in Cycle 1 followed by 9.4 mg/kg on Day 1 of each 21-day cycle up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).'}, {'id': 'OG002', 'title': 'Arm E: Imetelstat 7.5 - 9.4 mg/kg (MF [With Spliceosome Mutation or Ring Sideroblasts])', 'description': 'Participants with MF and spliceosome mutations or ring sideroblasts present received 2 cycles (Cycles 1-2) of imetelstat 7.5 mg/kg, IV as 2-hour infusion on Day 1 of a 28-day cycle followed by maintenance therapy with the same regimen or the possibility of dose escalation to imetelstat 9.4 mg/kg weekly if response to the initial dose was insufficient up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).'}, {'id': 'OG003', 'title': 'Arm F: Imetelstat 7.5 - 9.4 mg/kg (MF [Without Spliceosome Mutation and Ring Sideroblasts])', 'description': 'Participants with MF without spliceosome mutations or ring sideroblasts present received 2 cycles (Cycles 1-2) of imetelstat 9.4 mg/kg, IV as 2-hour infusion on Day 1 of a 28-day cycle followed by maintenance therapy with the same regimen or imetelstat 7.5 mg/kg twice weekly on Days 1, 3 for 2 cycles of 28-day cycle (Cycles 3-4) followed by imetelstat 7.5 mg/kg 3-times-weekly on Days 1, 3, 5 of Cycles 5 and beyond of 28-day cycle up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).'}], 'classes': [{'categories': [{'measurements': [{'value': '24.36', 'groupId': 'OG000', 'lowerLimit': '17.94', 'upperLimit': '40.74'}, {'value': 'NA', 'comment': 'Median and upper limit of 95% CI were not estimable due to limited number of participants with the event.', 'groupId': 'OG001', 'lowerLimit': '16.59', 'upperLimit': 'NA'}, {'value': '35.52', 'comment': 'Upper and lower limits of 95% CI were not estimable due to limited number of participants with the event.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From time of initial response until documented disease progression or death whichever occurs first (Up to approximately 5.7 years)', 'description': 'DOR measured from time of initial response (CR/PR/CI) until documented PD or death whichever occurs first. If no PD/death occurs DOR is censored at last disease evaluation date for responders. CR:BM: \\<5%blasts; ≤Grade 1 MF, AND Peripheral blood:Hb≥100 g/L and \\<UNL;Neutrophil count≥1x10\\^9/L and \\<UNL;PLT count≥100x10\\^9/L and \\<UNL;\\<2% IMCs, AND Clinical:Resolution of disease symptoms;Spleen and liver not palpable;No evidence of EMH.PR:All CR criteria plus peripheral blood:Hb≥85 but \\<100g/L and \\<UNL;NC≥1x10\\^9/L and \\<UNL;PLTcount ≥50 but\\<100x10\\^9/L and\\<UNL;\\<2%IMCs. CI:achievement of anemia(≥20 g/L increase Hb level),spleen(baseline splenomegaly-palpable at 5-10cm,below LCM,becomes not palpable) or symptoms response(50% reduction in total symptom score) without PD(appearance of new splenomegaly- palpable\\[\\>= 5 cm below LCM) or increase in severity of anemia, thrombocytopenia or neutropenia. Data is reported separately for arms whose DOR was assessed per IWG-MRT. Kaplan-Meier method was used.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible Analysis Set included subset of all participants who received at least one dose of study drug that excludes ineligible participants who did not satisfy each and every eligibility criteria for study entry. Data is reported for arm groups whose DOR was assessed by IWG-MRT criteria. Only responders were analyzed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Blastic MF/AML Participants: Duration of Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm D: Imetelstat 9.4 mg/kg (Blast-phase MF/Acute Myeloid Leukemia)', 'description': 'Participants with blast-phase MF/AML received imetelstat 9.4 mg/kg, IV as 2-hour infusion weekly on Days 1, 8, 15, 22 of a 28-day cycle up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).'}], 'timeFrame': 'From time of initial response until documented disease progression or death whichever occurs first (Up to approximately 5.7 years)', 'description': 'DOR was measured from the time of initial response until documented disease progression or death whichever occurs first. If no PD/death occurs the DOR is censored at last disease evaluation date for responders. Response is defined as achievement of \\<5% peripheral blood and bone marrow blast % that lasts for at least two months. PD is the appearance of new splenomegaly that is palpable at least 5 cm below the LCM. Data is reported separately for arm whose DOR was assessed by a specific criterion. Kaplan-Meier method was used.', 'reportingStatus': 'POSTED', 'populationDescription': 'All Treated Analysis Set included all participants who received at least one dose of the study drug. Data is reported for Arm D: Imetelstat 9.4 mg/kg (Blastic MF/AML) participants whose DOR was assessed by a specific criterion. Only responders were analyzed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'MDS Participants: Duration of Response Per IWG Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm G: Imetelstat 7.5 - 9.4 mg/kg (MDS/MPN or MDS With Spliceosome Mutations or Ring Sideroblasts)', 'description': 'Participants with either MDS/MPN or MDS and spliceosome mutations or ring sideroblasts present received 2 cycles of 28-day cycle (Cycles 1-2) of imetelstat 7.5 mg/kg, IV as 2-hour infusion on Day 1 of a 28-day cycle followed by maintenance therapy with the same regimen or the possibility of dose escalation to imetelstat 9.4 mg/kg weekly if response to the initial dose was insufficient up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median, upper and lower limits of 95% CI were not estimable as all DOR of responder participants were censored .', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the time of initial response (CR/PR/HI) until documented disease progression or death whichever occurs first (Up to approximately 5.7 years)', 'description': 'DOR: time of initial response (CR/PR/HI) until documented PD/death whichever occurs first. If no PD/death occurs DOR is censored at last disease evaluation date for responders. Data reported separately for arm assessed per IWG. Kaplan-Meier method was used.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All Treated Analysis Set included all participants who received at least one dose of the study drug. Data is reported for Arm G: Imetelstat 9.4 mg/kg (MDS/MPN or MDS and spliceosome mutations or ring sideroblasts) participants whose DOR was assessed by IWG criteria. Only responders were analyzed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Imetelstat 9.4 mg/kg (MF)', 'description': 'Participants with MF regardless of spliceosome mutation status or presence of ring sideroblasts received imetelstat 9.4 mg/kg, IV as 2-hour infusion on Day 1 of each 21-day cycle in Core Phase up to 9 cycles. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).'}, {'id': 'OG001', 'title': 'Arm B: Imetelstat 9.4 mg/kg as Induction + Maintenance (MF)', 'description': 'Participants with MF regardless of spliceosome mutation status or presence of ring sideroblasts received imetelstat 9.4 mg/kg, IV as 2-hour infusion on Days 1, 8, and 15 of 21-day cycle in Cycle 1 followed by 9.4 mg/kg on Day 1 of each 21-day cycle up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).'}, {'id': 'OG002', 'title': 'Arm D: Imetelstat 9.4 mg/kg (Blast-phase MF/Acute Myeloid Leukemia)', 'description': 'Participants with blast-phase MF/AML received imetelstat 9.4 mg/kg, IV as 2-hour infusion weekly on Days 1, 8, 15, 22 of a 28-day cycle up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).'}, {'id': 'OG003', 'title': 'Arm E: Imetelstat 7.5 - 9.4 mg/kg (MF [With Spliceosome Mutation or Ring Sideroblasts])', 'description': 'Participants with MF and spliceosome mutations or ring sideroblasts present received 2 cycles (Cycles 1-2) of imetelstat 7.5 mg/kg, IV as 2-hour infusion on Day 1 of a 28-day cycle followed by maintenance therapy with the same regimen or the possibility of dose escalation to imetelstat 9.4 mg/kg weekly if response to the initial dose was insufficient up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).'}, {'id': 'OG004', 'title': 'Arm F: Imetelstat 7.5 - 9.4 mg/kg (MF [Without Spliceosome Mutation and Ring Sideroblasts])', 'description': 'Participants with MF without spliceosome mutations or ring sideroblasts present received 2 cycles (Cycles 1-2) of imetelstat 9.4 mg/kg, IV as 2-hour infusion on Day 1 of a 28-day cycle followed by maintenance therapy with the same regimen or imetelstat 7.5 mg/kg twice weekly on Days 1, 3 for 2 cycles of 28-day cycle (Cycles 3-4) followed by imetelstat 7.5 mg/kg 3-times-weekly on Days 1, 3, 5 of Cycles 5 and beyond of 28-day cycle up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).'}, {'id': 'OG005', 'title': 'Arm G: Imetelstat 7.5 - 9.4 mg/kg (MDS/MPN or MDS With Spliceosome Mutations or Ring Sideroblasts)', 'description': 'Participants with either MDS/MPN or MDS and spliceosome mutations or ring sideroblasts present received 2 cycles of 28-day cycle (Cycles 1-2) of imetelstat 7.5 mg/kg, IV as 2-hour infusion on Day 1 of a 28-day cycle followed by maintenance therapy with the same regimen or the possibility of dose escalation to imetelstat 9.4 mg/kg weekly if response to the initial dose was insufficient up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).'}], 'classes': [{'categories': [{'measurements': [{'value': '42.61', 'groupId': 'OG000', 'lowerLimit': '19.12', 'upperLimit': '56.77'}, {'value': '26.73', 'groupId': 'OG001', 'lowerLimit': '16.46', 'upperLimit': '36.17'}, {'value': '4.93', 'groupId': 'OG002', 'lowerLimit': '1.05', 'upperLimit': '15.67'}, {'value': '12.09', 'groupId': 'OG003', 'lowerLimit': '7.06', 'upperLimit': '27.14'}, {'value': 'NA', 'comment': 'Median and upper limit of 95% CI were not estimable due to limited number of participants with the event.', 'groupId': 'OG004', 'lowerLimit': '12.22', 'upperLimit': 'NA'}, {'value': '28.42', 'comment': 'Upper limit of 95% CI was not estimable due to limited number of participants with the event.', 'groupId': 'OG005', 'lowerLimit': '6.64', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Study Day 1 to the date of death from any cause (Up to approximately 5.7 years)', 'description': 'OS was defined as the as the interval from Study Day 1 to the date of death from any cause. Survival time of living participants was censored on the last date a participant is known to be alive or lost to follow-up. Overall Survival was estimated by Kaplan-Meier method.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All Treated Analysis Set included all participants who received at least one dose of imetelstat.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm A: Imetelstat 9.4 mg/kg (MF)', 'description': 'Participants with MF regardless of spliceosome mutation status or presence of ring sideroblasts received imetelstat 9.4 milligram per kilogram (mg/kg), intravenously (IV) as 2-hour infusion on Day 1 of each 21-day cycle in Core Phase up to 9 cycles. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).'}, {'id': 'FG001', 'title': 'Arm B: Imetelstat 9.4 mg/kg as Induction + Maintenance (MF)', 'description': 'Participants with MF regardless of spliceosome mutation status or presence of ring sideroblasts received imetelstat 9.4 mg/kg, IV as 2-hour infusion on Days 1, 8, and 15 of 21-day cycle in Cycle 1 followed by 9.4 mg/kg on Day 1 of each 21-day cycle up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).'}, {'id': 'FG002', 'title': 'Arm D: Imetelstat 9.4 mg/kg (Blast-phase MF/Acute Myeloid Leukemia)', 'description': 'Participants with blast-phase myelofibrosis/acute myeloid leukemia (MF/AML) received imetelstat 9.4 mg/kg, IV as 2-hour infusion weekly on Days 1, 8, 15, 22 of a 28-day cycle up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).'}, {'id': 'FG003', 'title': 'Arm E: Imetelstat 7.5 - 9.4 mg/kg (MF [With Spliceosome Mutation or Ring Sideroblasts])', 'description': 'Participants with MF and spliceosome mutations or ring sideroblasts present received 2 cycles (Cycles 1-2) of imetelstat 7.5 mg/kg, IV as 2-hour infusion on Day 1 of a 28-day cycle followed by maintenance therapy with the same regimen or the possibility of dose escalation to imetelstat 9.4 mg/kg weekly if response to the initial dose was insufficient up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).'}, {'id': 'FG004', 'title': 'Arm F: Imetelstat 7.5 - 9.4 mg/kg (MF [Without Spliceosome Mutation and Ring Sideroblasts])', 'description': 'Participants with MF without spliceosome mutations or ring sideroblasts present received 2 cycles (Cycles 1-2) of imetelstat 9.4 mg/kg, IV as 2-hour infusion on Day 1 of a 28-day cycle followed by maintenance therapy with the same regimen or imetelstat 7.5 mg/kg twice weekly on Days 1, 3 for 2 cycles of 28-day cycle (Cycles 3-4) followed by imetelstat 7.5 mg/kg 3-times-weekly on Days 1, 3, 5 of Cycles 5 and beyond of 28-day cycle up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).'}, {'id': 'FG005', 'title': 'Arm G: Imetelstat 7.5 - 9.4 mg/kg (MDS/MPN or MDS With Spliceosome Mutations or Ring Sideroblasts)', 'description': 'Participants with either myelodysplastic syndromes/ myeloproliferative neoplasm (MDS/MPN) or MDS and spliceosome mutations or ring sideroblasts present received 2 cycles of 28-day cycle (Cycles 1-2) of imetelstat 7.5 mg/kg, IV as 2-hour infusion on Day 1 of a 28-day cycle followed by maintenance therapy with the same regimen or the possibility of dose escalation to imetelstat 9.4 mg/kg weekly if response to the initial dose was insufficient up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '18'}, {'groupId': 'FG005', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '12'}, {'groupId': 'FG005', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Documented Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Withdrawal of Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '6'}]}]}], 'recruitmentDetails': 'Participants were enrolled at 1 site in the United States from 29 October 2012 to 22 January 2014 (end of recruitment). Data analyses includes data through 24 May 2018. Study has 4 phases: Screening Phase, Core Phase:up to nine 21-day (Arms A,B) or 28-day (Arms D,E,F,G) cycle, Extension Phase: after Cycle 9 to continue treatment with imetelstat; Event Monitoring Phase:Follow-up for those who discontinued treatment to collect survival status, disease status, and subsequent treatment information.', 'preAssignmentDetails': 'A total of 80 participants with Intermediate-2 or high-risk primary myelofibrosis (PMF)/post-polycythemia vera/essential thrombocythemia (post-PV/ET) MF (Arms A, B, C, E and F) or blast-phase MF (Arm D only) or spliceosome-mutated (or with ring sideroblasts) myelodysplastic syndromes \\[MDS\\]/ myeloproliferative neoplasm \\[MPN\\] (Arm G only) were enrolled to receive imetelstat. Arm C (Imetelstat 9.4 mg/kg \\[with MF\\]) was never initiated, participants allocated to Arm C were reassigned to Arm A or B.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '80', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm A: Imetelstat 9.4 mg/kg (MF)', 'description': 'Participants with MF regardless of spliceosome mutation status or presence of ring sideroblasts received imetelstat 9.4 mg/kg, IV as 2-hour infusion on Day 1 of each 21-day cycle in Core Phase up to 9 cycles. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).'}, {'id': 'BG001', 'title': 'Arm B: Imetelstat 9.4 mg/kg as Induction + Maintenance (MF)', 'description': 'Participants with MF regardless of spliceosome mutation status or presence of ring sideroblasts received imetelstat 9.4 mg/kg, IV as 2-hour infusion on Days 1, 8, and 15 of 21-day cycle in Cycle 1 followed by 9.4 mg/kg on Day 1 of each 21-day cycle up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).'}, {'id': 'BG002', 'title': 'Arm D: Imetelstat 9.4 mg/kg (Blast-phase MF/Acute Myeloid Leukemia)', 'description': 'Participants with blast-phase MF/AML received imetelstat 9.4 mg/kg, IV as 2-hour infusion weekly on Days 1, 8, 15, 22 of a 28-day cycle up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).'}, {'id': 'BG003', 'title': 'Arm E: Imetelstat 7.5 - 9.4 mg/kg (MF [With Spliceosome Mutation or Ring Sideroblasts])', 'description': 'Participants with MF and spliceosome mutations or ring sideroblasts present received 2 cycles (Cycles 1-2) of imetelstat 7.5 mg/kg, IV as 2-hour infusion on Day 1 of a 28-day cycle followed by maintenance therapy with the same regimen or the possibility of dose escalation to imetelstat 9.4 mg/kg weekly if response to the initial dose was insufficient up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).'}, {'id': 'BG004', 'title': 'Arm F: Imetelstat 7.5 - 9.4 mg/kg (MF [Without Spliceosome Mutation and Ring Sideroblasts])', 'description': 'Participants with MF without spliceosome mutations or ring sideroblasts present received 2 cycles (Cycles 1-2) of imetelstat 9.4 mg/kg, IV as 2-hour infusion on Day 1 of a 28-day cycle followed by maintenance therapy with the same regimen or imetelstat 7.5 mg/kg twice weekly on Days 1, 3 for 2 cycles of 28-day cycle (Cycles 3-4) followed by imetelstat 7.5 mg/kg 3-times-weekly on Days 1, 3, 5 of Cycles 5 and beyond of 28-day cycle up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).'}, {'id': 'BG005', 'title': 'Arm G: Imetelstat 7.5 - 9.4 mg/kg (MDS/MPN or MDS With Spliceosome Mutations or Ring Sideroblasts)', 'description': 'Participants with either MDS/MPN or MDS and spliceosome mutations or ring sideroblasts present received 2 cycles of 28-day cycle (Cycles 1-2) of imetelstat 7.5 mg/kg, IV as 2-hour infusion on Day 1 of a 28-day cycle followed by maintenance therapy with the same regimen or the possibility of dose escalation to imetelstat 9.4 mg/kg weekly if response to the initial dose was insufficient up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '80', 'groupId': 'BG006'}]}], 'categories': [{'title': '<=18 years', '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'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '35', 'groupId': 'BG006'}]}, {'title': '>=65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '45', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '80', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '26', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '54', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '80', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Hispanic or Latino', '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'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '75', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '80', 'groupId': 'BG006'}]}], 'categories': [{'title': 'American Indian or Alaska Native', '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'}]}, {'title': 'Asian', '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'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}, {'title': 'Black or African American', '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'}]}, {'title': 'White', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '74', 'groupId': 'BG006'}]}, {'title': 'More than one race', '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'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Eastern Cooperative Oncology Group (ECOG) Performance Status Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '80', 'groupId': 'BG006'}]}], 'categories': [{'title': '0', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '19', 'groupId': 'BG006'}]}, {'title': '1', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '45', 'groupId': 'BG006'}]}, {'title': '2', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '16', 'groupId': 'BG006'}]}, {'title': '3', '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'}]}, {'title': '4', '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'}]}, {'title': '5', '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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'ECOG Performance Status has 5 Scores.0= Fully active, able to carry on all predisease performance without restriction;1= Restricted in physically strenuous activity but ambulatory and able to carry out work on a light/sedentary nature,2= Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours;3= Capable of only limited self-care; confined to bed/chair more than 50% of waking hours;4= Completely disabled. Cannot carry on any self-care.Totally confined to bed/chair;5= Dead. Number of participants for each score are reported.', 'unitOfMeasure': 'Participants'}, {'title': 'Myelofibrosis subtype', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '80', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Myelodysplastic Syndromes/ Myeloproliferative Neoplasm (MDS/MPN) or MDS', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '9', 'groupId': 'BG006'}]}, {'title': 'Blast-phase Myelofibrosis', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}]}, {'title': 'Primary Myelofibrosis', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '35', 'groupId': 'BG006'}]}, {'title': 'Post-Essential Thrombocythemia (ET) Myelofibrosis', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '14', 'groupId': 'BG006'}]}, {'title': 'Post-Polycythemia Vera (PV) Myelofibrosis', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '14', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Myelofibrosis subtypes included MDS/MPN or MDS, blast-phase myelofibrosis, primary myelofibrosis, post-ET myelofibrosis, and Post-PV myelofibrosis. Number of participants for each subtype are reported.', 'unitOfMeasure': 'Participants'}, {'title': 'Dynamic International Prognostic Scoring System (DIPSS)-Plus Risk Status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '79', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Intermediate-2 Risk (2 or 3 risk factors)', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '34', 'groupId': 'BG006'}]}, {'title': 'High Risk (4 or more risk factors)', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '45', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'DIPSS stratifies primary myelofibrosis (PMF) into four risk categories (low, intermediate 1, intermediate 2, and high risk), based on 5 clinical factors; Age\\>65, Hemoglobin \\<10 grams per deciliter (gm/dL), Leukocytes \\>10 (9)/L, circulating blasts ≥1%, and constitutional symptoms. Participants for each status are reported. Only categories with data are reported.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Number analyzed is the number of participants with data available for DIPSS-Plus risk status.'}, {'title': 'Spliceosomal Mutation Status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '77', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Had Spliceosomal Mutation', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '31', 'groupId': 'BG006'}]}, {'title': 'Had No Spliceosomal Mutation', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '46', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Spliceosome mutations represent a group of acquired genetic alterations that affect both myeloid and lymphoid malignancies.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Number analyzed is the number of participants with data available for spliceosomal mutation status.'}, {'title': 'Spliceosomal Mutation Type', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '31', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Splicing Factor 3B Subunit 1 (SF3B1)', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG005'}, {'value': '11', 'groupId': 'BG006'}]}, {'title': 'Serine And Arginine Rich Splicing Factor 2 (SRSF2)', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG005'}, {'value': '9', 'groupId': 'BG006'}]}, {'title': 'U2 Small Nuclear RNA Auxiliary Factor 1 (U2AF1)', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG005'}, {'value': '11', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Spliceosome mutations represent a group of acquired genetic alterations that affect both myeloid and lymphoid malignancies. Spliceosomal mutation type included SF3B1, SRSF2 and U2AF1. Number of participants for each type are reported.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Number analyzed is the number of participants with data available for spliceosomal mutation type.'}, {'title': 'Ringed Sideroblasts Present', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '69', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '18', 'groupId': 'BG006'}]}, {'title': 'No', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '51', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "Ring sideroblasts are erythroblasts with iron-loaded mitochondria visualized by Prussian blue staining (Perls' reaction) as a perinuclear ring of blue granules. Refractory anemia with ring sideroblasts (RARS) is a type of MDS that is characterized by anemia and the presence of at least 15 percent ring sideroblasts in the marrow.", 'unitOfMeasure': 'Participants', 'populationDescription': 'Number analyzed is the number of participants with data available for ringed sideroblasts present.'}, {'title': 'JAK2V617F Mutation', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '75', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Had JAK2V617F Mutation', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '51', 'groupId': 'BG006'}]}, {'title': 'Had No JAK2V617F Mutation', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '23', 'groupId': 'BG006'}]}, {'title': 'Unable to Determine', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'JAK2 V617F mutation is an acquired, somatic mutation present in the majority of participants with myeloproliferative cancer (myeloproliferative neoplasms) i.e. nearly 100% of participants with polycythemia vera and in about 50% of participants with essential thrombocytosis and primary myelofibrosis.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Number analyzed is the number of participants with data available for JAK2V617F Mutation.'}, {'title': 'Transfusion Dependent', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '80', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Had Transfusion Dependency', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '27', 'groupId': 'BG006'}]}, {'title': 'Had No Transfusion Dependency', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '53', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Transfusion dependency was defined by a history of at least 2 units of red blood cell transfusions in the last month for a hemoglobin level of less than 85 grams per deciliter (g/dL) that was not associated with clinically overt bleeding.', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All Treated Analysis Set included all participants who received at least one dose of imetelstat.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-10-05', 'size': 1463513, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-05-14T10:53', 'hasProtocol': True}, {'date': '2018-07-16', 'size': 610202, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-05-14T10:53', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'dispFirstSubmitDate': '2019-05-17', 'completionDateStruct': {'date': '2018-05-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-24', 'studyFirstSubmitDate': '2012-11-18', 'dispFirstSubmitQcDate': '2019-05-17', 'resultsFirstSubmitDate': '2021-07-08', 'studyFirstSubmitQcDate': '2012-11-18', 'dispFirstPostDateStruct': {'date': '2019-05-24', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-09-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-08-24', 'studyFirstPostDateStruct': {'date': '2012-11-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MF Participants: Percentage of Participants With Overall Response (OR) - (Clinical Improvement[CI] or Partial Remission[PR] or Complete Remission[CR]) Per International Working Group - Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) Criteria', 'timeFrame': 'Up to first 9 cycles of treatment (each cycle was of 21 days for Arms A and B and 28 days for Arms E and F)', 'description': 'OR:CI/PR/CR per IWG-MRT. CR:Bone marrow (BM):\\<5% blasts;≤Grade 1 MF, AND Peripheral blood:Hemoglobin (Hb) ≥100 g/liter (g/L) and \\<upper normal limit (UNL);Neutrophil count(NC) ≥1x10\\^9/L and \\<UNL; Platelet(PLT) count ≥100x10\\^9/L and \\<UNL;\\<2% immature myeloid cells(IMCs), AND Clinical: Resolution of disease symptoms; Spleen and liver not palpable; No evidence of extramedullary hematopoeisis(EMH). PR:All CR criteria plus peripheral blood: Hb≥85 but \\<100g/L and \\<UNL; NC ≥1x10\\^9/L and \\<UNL; PLT count ≥50 but \\<100x10\\^9/L and \\<UNL;\\<2%IMCs. CI:achievement of anemia (≥20 g/L increase in Hb level), spleen(baseline splenomegaly palpable at 5-10 cm, below left costal margin(LCM), becomes not palpable), symptoms response (50% reduction in total symptom score) without progressive disease (PD) (appearance of new splenomegaly- palpable at least \\[≥\\]5 cm below LCM)/increase in severity of anemia, thrombocytopenia/neutropenia. Data is reported separately for arms whose response was assessed per IWG-MRT.'}, {'measure': 'Blastic MF/AML Participants: Percentage of Participants With Overall Response', 'timeFrame': 'Up to first 9 cycles of treatment (each cycle was of 28 days for Arm D)', 'description': 'For this pilot study, overall response was defined as achievement of a leukemic response (i.e. a clinically meaningful reduction in Blast cells). This was quantified as \\<5% peripheral blood and bone marrow blasts % that lasts for at least two months. Data is reported separately for this arm where response was assessed by this specific criterion.'}, {'measure': 'MDS Participants: Percentage of Participants With Overall Response (Hematologic Improvement [HI] or PR or CR) Per IWG Criteria', 'timeFrame': 'Up to first 9 cycles of treatment (each cycle was of 28 days for Arm G)', 'description': 'OR: HI/PR/CR per IWG. CR: BM:≤5% myeloblasts (all cell lines normal maturation), Peripheral blood:Hgb ≥11g/dL, PLTs ≥100x10\\^9/L, Neutrophils ≥1.0x10\\^9/L, Blasts 0%. PR: All CR criteria if abnormal before treatment except- BM blasts decreased ≥50% over pretreatment but still \\>5%, Cellularity, morphology not relevant. HI responses:1) Erythroid: Hgb increase ≥1.5 g/dL, Relevant reduction of red blood cell(RBC) units transfusions by absolute ≥4 RBC transfusions/8 week (wk) compared with pretreatment transfusion number in previous 8 wk. Only RBC transfusions given for Hgb of ≤9.0 g/dL.2)PLTs:Absolute increase ≥30x10\\^9/L starting \\>20x10\\^9/L PLTs; Increase from \\<20x10\\^9/L to \\>20x10\\^9/L and by ≥100%; 3)Neutrophil: ≥100% increase, absolute increase \\>0.5x10\\^9/L; 4)Progression/relapse after HI:≥1 of following:≥50% decrement from maximum response levels in granulocytes/PLTs, Reduction in Hgb ≥1.5 g/dL,Transfusion dependence. Data is reported separately for arm whose response was assessed per IWG.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Grade >= 3 TEAEs and Treatment Related Adverse Events', 'timeFrame': 'From first dose of study drug up to 30 days from the last dose of study drug or until subsequent anti-cancer therapy if earlier (Up to approximately 5.7 years)', 'description': 'TEAEs defined as those events that 1) occur on or after the first dose of study drug, through the treatment phase, and for 30 days following the last dose of study drug or until subsequent anti-cancer therapy if earlier; 2) any event that is considered study drug-related regardless of the start date of the event; or 3) any event that is present at baseline but worsens in severity or is subsequently considered drug-related by the investigator. Grade \\>=3 TEAE defined as events that are severe, life-threatening or disabling, or fatal and considered related to imetelstat as per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03. An AE was considered related to the study drug if the event was assessed by the investigator as probably or possibly related.'}, {'measure': 'Number of Participants With Spleen Response Per IWG-MRT Criteria', 'timeFrame': 'Up to approximately 5.7 years', 'description': 'Spleen response per IWG-MRT criteria defined as baseline splenomegaly that is palpable at 5-10 cm, below the LCM, becomes not palpable, OR A baseline splenomegaly that is palpable at \\>10 cm, below the LCM, decreases by ≥50%. Baseline splenomegaly that is palpable at \\<5 cm, below the LCM, is not eligible for spleen response. Confirmation by Magnetic resonance imaging (MRI) or computerized tomography (CT) showing ≥35% spleen volume reduction is recommended (but not required). Spleen response was assessed only in participants with MF.'}, {'measure': 'MF and Blastic MF/AML Participants: Number of Participants With Transfusion Independence (CI by Anemia Response) Per IWG-MRT', 'timeFrame': 'Up to approximately 5.7 years', 'description': 'Transfusion dependency was defined by a history of at least 2 units of red blood cell transfusions in the last month for a hemoglobin level of less than 85 g/L that was not associated with clinically overt bleeding. A participant who was transfusion dependent at baseline was considered transfusion independent if the participant met either of the following conditions: Received no more than 1 unit of red blood cell transfusions in a rolling time interval of 30 days or more, and had a hemoglobin level increase over baseline more than 2 g/dL if participant baseline hemoglobin level was less than 85 g/L and received no transfusion. Anemia response per IWG-MRT Criteria- Transfusion-independent participants: a ≥20 g/L increase in hemoglobin level. Transfusion-dependent participants: becoming transfusion-independent. Data is reported separately for arms assessed as per the IWG-MRT criteria.'}, {'measure': 'MDS Participants: Number of Participants With Transfusion Independence (HI by Erythroid Response) Per IWG Criteria', 'timeFrame': 'Up to approximately 5.7 years', 'description': 'Transfusion dependency was defined by a history of at least 2 units of red blood cell transfusions in the last month for a hemoglobin level of less than 85 g/L that was not associated with clinically overt bleeding. A participant who was transfusion dependent at baseline was considered transfusion independent if the participant met either of the following conditions: Received no more than 1 unit of red blood cell transfusions in a rolling time interval of 30 days or more, and had a hemoglobin level increase over baseline more than 2 g/dL if participant baseline hemoglobin level was less than 85 g/L and received no transfusion. HI responses included: 1) Erythroid: Hgb increase ≥1.5 g/dL, Relevant reduction of RBC units transfusions by absolute number of \\>=4 RBC transfusions/8 week compared with pretreatment transfusion number in previous 8 week. Only RBC transfusions given for Hgb of ≤9.0 g/dL. Data is reported separately for arm assessed as per IWG criteria.'}, {'measure': 'MF Participants: Time to Response', 'timeFrame': 'From study Day 1 to the earliest date that a response was first documented (Up to approximately 5.7 years)', 'description': 'Time to response was defined as the duration from study Day 1 to the earliest date that a response is first documented. The response CI/CR/PR was assessed by IWG-MRT criteria.'}, {'measure': 'Blastic MF/AML Participants: Time to Response', 'timeFrame': 'From study Day 1 to the earliest date that a response was first documented (Up to approximately 5.7 years)', 'description': 'Time to response was defined as the duration from study Day 1 to the earliest date that a response is first documented. Response was defined as achievement of a leukemic response (i.e. a clinically meaningful reduction in Blast cells). This was quantified as \\<5% peripheral blood and bone marrow blasts % that lasts for at least two months. Data for time to response is reported as per criteria of response assessment.'}, {'measure': 'MDS Participants: Time to Response', 'timeFrame': 'From study Day 1 to the earliest date that a response was first documented (Up to approximately 5.7 years)', 'description': 'Time to response was defined as the duration from study Day 1 to the earliest date that a response is first documented. Response was defined as HI, PR or CR per IWG criteria. Data for time to response is reported as per criteria of response assessment.'}, {'measure': 'MF Participants: Duration of Response (DOR) Per IWG-MRT Criteria', 'timeFrame': 'From time of initial response until documented disease progression or death whichever occurs first (Up to approximately 5.7 years)', 'description': 'DOR measured from time of initial response (CR/PR/CI) until documented PD or death whichever occurs first. If no PD/death occurs DOR is censored at last disease evaluation date for responders. CR:BM: \\<5%blasts; ≤Grade 1 MF, AND Peripheral blood:Hb≥100 g/L and \\<UNL;Neutrophil count≥1x10\\^9/L and \\<UNL;PLT count≥100x10\\^9/L and \\<UNL;\\<2% IMCs, AND Clinical:Resolution of disease symptoms;Spleen and liver not palpable;No evidence of EMH.PR:All CR criteria plus peripheral blood:Hb≥85 but \\<100g/L and \\<UNL;NC≥1x10\\^9/L and \\<UNL;PLTcount ≥50 but\\<100x10\\^9/L and\\<UNL;\\<2%IMCs. CI:achievement of anemia(≥20 g/L increase Hb level),spleen(baseline splenomegaly-palpable at 5-10cm,below LCM,becomes not palpable) or symptoms response(50% reduction in total symptom score) without PD(appearance of new splenomegaly- palpable\\[\\>= 5 cm below LCM) or increase in severity of anemia, thrombocytopenia or neutropenia. Data is reported separately for arms whose DOR was assessed per IWG-MRT. Kaplan-Meier method was used.'}, {'measure': 'Blastic MF/AML Participants: Duration of Response', 'timeFrame': 'From time of initial response until documented disease progression or death whichever occurs first (Up to approximately 5.7 years)', 'description': 'DOR was measured from the time of initial response until documented disease progression or death whichever occurs first. If no PD/death occurs the DOR is censored at last disease evaluation date for responders. Response is defined as achievement of \\<5% peripheral blood and bone marrow blast % that lasts for at least two months. PD is the appearance of new splenomegaly that is palpable at least 5 cm below the LCM. Data is reported separately for arm whose DOR was assessed by a specific criterion. Kaplan-Meier method was used.'}, {'measure': 'MDS Participants: Duration of Response Per IWG Criteria', 'timeFrame': 'From the time of initial response (CR/PR/HI) until documented disease progression or death whichever occurs first (Up to approximately 5.7 years)', 'description': 'DOR: time of initial response (CR/PR/HI) until documented PD/death whichever occurs first. If no PD/death occurs DOR is censored at last disease evaluation date for responders. Data reported separately for arm assessed per IWG. Kaplan-Meier method was used.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'From Study Day 1 to the date of death from any cause (Up to approximately 5.7 years)', 'description': 'OS was defined as the as the interval from Study Day 1 to the date of death from any cause. Survival time of living participants was censored on the last date a participant is known to be alive or lost to follow-up. Overall Survival was estimated by Kaplan-Meier method.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Myelofibrosis', 'Myelodysplastic Syndromes', 'Myeloproliferative Neoplasm', 'Imetelstat', 'GRN163L'], 'conditions': ['Primary Myelofibrosis', 'Secondary Myelofibrosis', 'Myeloid Malignancies']}, 'referencesModule': {'references': [{'pmid': '26332545', 'type': 'DERIVED', 'citation': 'Tefferi A, Lasho TL, Begna KH, Patnaik MM, Zblewski DL, Finke CM, Laborde RR, Wassie E, Schimek L, Hanson CA, Gangat N, Wang X, Pardanani A. A Pilot Study of the Telomerase Inhibitor Imetelstat for Myelofibrosis. N Engl J Med. 2015 Sep 3;373(10):908-19. doi: 10.1056/NEJMoa1310523.'}]}, 'descriptionModule': {'briefSummary': 'This pilot clinical trial studies how well imetelstat sodium works in treating participants with primary or secondary myelofibrosis and other myeloid malignancies. Imetelstat sodium may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To evaluate overall response rate.\n\nSECONDARY OBJECTIVES:\n\nI. To evaluate the safety and tolerability of imetelstat (imetelstat sodium) in myelofibrosis (MF).\n\nII. To evaluate the efficacy of imetelstat in the reduction of spleen size, as measured by physical examination (palpable distance from the left costal margin).\n\nIII. To evaluate the efficacy of imetelstat in improving anemia or inducing red blood cell transfusion-independence in previously transfusion-dependent participants (per International Working Group for Myelofibrosis Research and Treatment \\[IWG-MRT\\] criteria).\n\nIV. To evaluate onset and durability of response as defined in primary and secondary endpoints\n\nEXPLORATORY OBJECTIVES:\n\nI. To evaluate the effect of imetelstat on bone marrow histology, karyotype and JAK2V617F allele burden II. To evaluate the effect of imetelstat on leukocytosis, circulating blast count, circulating immature myeloid cell count and thrombocytosis.\n\nOUTLINE: Participants receive imetelstat sodium intravenously (IV) over 2 hours on day 1. Participants may continue to receive imetelstat study treatment for as long as they derive clinical benefit or until study end. The study end when all participants discontinued study drug, the last participant enrolled has been treated for approximately 5.7 years, or imetelstat is commercially available in the United States, whichever occurs first.\n\nMaximum duration of study was approximately 5.7 years. Arm C was never initiated, and participants allocated to Arm C (Imetelstat 9.4 mg/kg \\[with MF\\]) were reassigned to Arms A and B.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of one of the following:\n* Primary myelofibrosis (PMF) per the revised World Health Organization (WHO) criteria.\n* Post-polycythemia vera/essential thrombocythemia myelofibrosis (Post-ET/PV MF) per the International Working Group for Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) criteria.\n* High-risk or Intermediate-2 risk MF (as defined by the Dynamic International Prognostic Scoring System \\[DIPSS-plus\\]).\n* Life expectancy of greater than or equal to (\\>=) 12 weeks.\n* Able to provide informed consent and be willing to sign an informed consent form.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.\n* Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \\[AST\\]) =\\<2.5 x upper limit of normal (ULN) (or =\\<5 x ULN if in the investigator's opinion the elevation is due to extramedullary hematopoiesis).\n* Serum glutamic pyruvate transaminase (SGPT) alanine aminotransferase (ALT) =\\<2.5 x ULN (or =\\<5 x ULN if in the investigator's opinion the elevation is due to extramedullary hematopoiesis).\n* Total bilirubin =\\<3.0 mg/dL (or direct bilirubin \\< 1 mg/dL).\n* Creatinine =\\<3.0 mg/dL.\n* Absolute neutrophil count \\>=1000/microliter (mcL).\n* Platelet count \\>=50,000/mcL.\n* Absence of active treatment with systemic anticoagulation and a baseline prothrombin time (PT) and activated partial thromboplastin time (aPTT) that does not exceed 1.5 x ULN.\n* Females of childbearing potential must have a negative pregnancy test =\\<7 days prior to registration, unless they are surgically sterile for at least 3 months (i.e., hysterectomy), OR postmenopausal for at least 12 months (follicle-stimulating hormone \\[FSH\\] \\>30 U/mL).\n* Females of childbearing potential must agree to take appropriate precautions to avoid pregnancy (with at least 99% certainty) from screening through end of study; permitted methods for preventing pregnancy must be communicated to study participants and their understanding confirmed.\n* Males must agree to take appropriate precautions to avoid fathering a child (with at least 99% certainty) from screening through follow-up; permitted methods for preventing pregnancy should be communicated to the participants and their understanding confirmed.\n\nExclusion Criteria:\n\n* Females who are pregnant or are currently breastfeeding.\n* Any chemotherapy (e.g., hydroxyurea), immunomodulatory drug therapy (e.g., thalidomide), immunosuppressive therapy, corticosteroids \\> 10 mg/day prednisone or equivalent, growth factor treatment (e.g., erythropoietin) or Janus kinase (JAK) inhibitor therapy =\\<14 days prior to registration.\n* Participants with another active malignancy.\n* Note: participants with early stage squamous cell carcinoma of the skin, basal cell carcinoma of the skin or cervical intraepithelial neoplasia are eligible for enrollment.\n* Known positive status for human immunodeficiency virus (HIV).\n* Any unresolved toxicity greater or equal to grade 2 from previous anticancer therapy, except for stable chronic toxicities not expected to resolve.\n* Incomplete recovery from any prior surgical procedures or had surgery =\\<4 weeks prior to registration, excluding the placement of vascular access.\n* Presence of acute active infection requiring antibiotics.\n* Uncontrolled intercurrent illness or any concurrent condition that, in the Investigator's opinion, would jeopardize the safety of the participant or compliance with the protocol."}, 'identificationModule': {'nctId': 'NCT01731951', 'briefTitle': 'Imetelstat Sodium in Treating Participants With Primary or Secondary Myelofibrosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Geron Corporation'}, 'officialTitle': 'A Pilot Open-Label Study of the Efficacy and Safety of Imetelstat (GRN163L) in Myelofibrosis and Other Myeloid Malignancies', 'orgStudyIdInfo': {'id': 'CR107110'}, 'secondaryIdInfos': [{'id': 'CP14B019', 'type': 'OTHER', 'domain': 'Janssen Research & Development, LLC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A: Imetelstat 9.4 mg/kg (Myelofibrosis [MF])', 'description': 'Participants with MF regardless of spliceosome mutation status or presence of ring sideroblasts received imetelstat 9.4 milligram per kilogram (mg/kg), intravenously (IV) as 2-hour infusion on Day 1 of each 21-day cycle in Core Phase up to 9 cycles. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).', 'interventionNames': ['Drug: Imetelstat']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B: Imetelstat 9.4 mg/kg as Induction + Maintenance (MF)', 'description': 'Participants with MF regardless of spliceosome mutation status or presence of ring sideroblasts received imetelstat 9.4 mg/kg, IV as 2-hour infusion on Days 1, 8, and 15 of 21-day cycle in Cycle 1 followed by 9.4 mg/kg on Day 1 of each 21-day cycle up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).', 'interventionNames': ['Drug: Imetelstat']}, {'type': 'EXPERIMENTAL', 'label': 'Arm D: Imetelstat 9.4 mg/kg (Blast-phase MF/Acute Myeloid Leukemia)', 'description': 'Participants with blast-phase myelofibrosis/acute myeloid leukemia (MF/AML) received imetelstat 9.4 mg/kg, IV as 2-hour infusion weekly on Days 1, 8, 15, 22 of a 28-day cycle up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).', 'interventionNames': ['Drug: Imetelstat']}, {'type': 'EXPERIMENTAL', 'label': 'Arm E: Imetelstat 7.5 - 9.4 mg/kg (MF [with Spliceosome Mutation or Ring Sideroblasts])', 'description': 'Participants with MF and spliceosome mutations or ring sideroblasts present received 2 cycles (Cycles 1-2) of imetelstat 7.5 mg/kg, IV as 2-hour infusion on Day 1 of a 28-day cycle followed by maintenance therapy with the same regimen or the possibility of dose escalation to imetelstat 9.4 mg/kg weekly if response to the initial dose was insufficient up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).', 'interventionNames': ['Drug: Imetelstat']}, {'type': 'EXPERIMENTAL', 'label': 'Arm F: Imetelstat 7.5 - 9.4 mg/kg (MF [without spliceosome mutation and ring sideroblasts])', 'description': 'Participants with MF without spliceosome mutations or ring sideroblasts present received 2 cycles (Cycles 1-2) of imetelstat 9.4 mg/kg, IV as 2-hour infusion on Day 1 of a 28-day cycle followed by maintenance therapy with the same regimen or imetelstat 7.5 mg/kg twice weekly on Days 1, 3 for 2 cycles of 28-day cycle (Cycles 3-4) followed by imetelstat 7.5 mg/kg 3-times-weekly on Days 1, 3, 5 of Cycles 5 and beyond of 28-day cycle up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).', 'interventionNames': ['Drug: Imetelstat']}, {'type': 'EXPERIMENTAL', 'label': 'Arm G: Imetelstat 7.5 - 9.4 mg/kg (MDS/MPN or MDS with Spliceosome Mutations or Ring Sideroblasts)', 'description': 'Participants with either myelodysplastic syndromes/ myeloproliferative neoplasm (MDS/MPN) or MDS and spliceosome mutations or ring sideroblasts present received 2 cycles of 28-day cycle (Cycles 1-2) of imetelstat 7.5 mg/kg, IV as 2-hour infusion on Day 1 of a 28-day cycle followed by maintenance therapy with the same regimen or the possibility of dose escalation to imetelstat 9.4 mg/kg weekly if response to the initial dose was insufficient up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years).', 'interventionNames': ['Drug: Imetelstat']}], 'interventions': [{'name': 'Imetelstat', 'type': 'DRUG', 'otherNames': ['GRN163L'], 'description': 'Imetelstat sodium administered as IV over 2 hours with treatment as long as participants derive clinical benefit or until end of study.', 'armGroupLabels': ['Arm A: Imetelstat 9.4 mg/kg (Myelofibrosis [MF])', 'Arm B: Imetelstat 9.4 mg/kg as Induction + Maintenance (MF)', 'Arm D: Imetelstat 9.4 mg/kg (Blast-phase MF/Acute Myeloid Leukemia)', 'Arm E: Imetelstat 7.5 - 9.4 mg/kg (MF [with Spliceosome Mutation or Ring Sideroblasts])', 'Arm F: Imetelstat 7.5 - 9.4 mg/kg (MF [without spliceosome mutation and ring sideroblasts])', 'Arm G: Imetelstat 7.5 - 9.4 mg/kg (MDS/MPN or MDS with Spliceosome Mutations or Ring Sideroblasts)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Study Clinical Team', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Geron Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Geron Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}