Ignite Creation Date:
2025-12-24 @ 9:31 PM
Ignite Modification Date:
2026-04-08 @ 12:58 AM
Study NCT ID:
NCT01696032
Status:
COMPLETED
Last Update Posted:
2024-08-27
First Post:
2012-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
SGI-110 in Combination With Carboplatin in Ovarian Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C580831', 'term': 'guadecitabine'}, {'id': 'D019772', 'term': 'Topotecan'}, {'id': 'C506643', 'term': 'liposomal doxorubicin'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D016190', 'term': 'Carboplatin'}], 'ancestors': [{'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D056831', 'term': 'Coordination Complexes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrialinfo@taihooncology.com', 'phone': '609-250-7336', 'title': 'Taiho Central', 'organization': 'Taiho Oncology, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Approximately 4 years', 'description': 'Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Stage 1: Guadecitabine+Carboplatin 30 mg/m2', 'description': 'Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 14, 'seriousNumAtRisk': 14, 'deathsNumAffected': 14, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Stage 1: Guadecitabine+Carboplatin 45 mg/m2', 'description': 'Guadecitabine 45 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles. Due to dose limiting toxicities, the guadecitabine dose for this group was reduced from 45 mg/m2 to 30 mg/m2 after Cycle 1 for 4 of 6 participants and the carboplatin dose was reduced for 2 of 6 participants.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 4, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Stage 2: Guadecitabine+Carboplatin 30 mg/m2', 'description': 'Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 50, 'seriousNumAtRisk': 51, 'deathsNumAffected': 43, 'seriousNumAffected': 26}, {'id': 'EG003', 'title': 'Stage 2: Treatment Choice', 'description': "Treatment was selected at the investigator's discretion and administered based on recommended dosing for topotecan (3.5-4.0 mg/m2/wk administered on Days 1, 8, and 15 via IV infusion); PLD (40-50 mg/m2 administered on Day 1 via IV infusion), paclitaxel (60-80 mg/m2/wk administered on Days 1, 8, 15, and 22 via IV infusion), or gemcitabine (800-1000 mg/m2 administered on Days 1, 8, and 15 via IV infusion).", 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 49, 'seriousNumAtRisk': 49, 'deathsNumAffected': 18, 'seriousNumAffected': 24}, {'id': 'EG004', 'title': 'Stage 2: Crossover Treatment Choice to Guadecitabine+Carboplatin 30 mg/m2', 'description': 'Crossover from treatment choice to the guadecitabine+carboplatin combination treatment arm was permitted for participants after evidence of disease progression.', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 27, 'seriousNumAtRisk': 27, 'deathsNumAffected': 22, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Lymphedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 33, 'numAffected': 33}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 26, 'numAffected': 26}, {'groupId': 'EG004', 'numAtRisk': 27, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 23, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 27, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Peripheral edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Adverse drug reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 27, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Hernia pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Early satiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Libido decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Perineal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Vaginal discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Vaginal ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Vulvovaginal swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pelvic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Vaginal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 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'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Lower respiratory tract infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Postoperative fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Stage 1: Dose Limiting Toxicities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1: Guadecitabine+Carboplatin 30 mg/m2', 'description': 'Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.'}, {'id': 'OG001', 'title': 'Stage 1: Guadecitabine+Carboplatin 45 mg/m2', 'description': 'Guadecitabine 45 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles. Due to dose limiting toxicities, the guadecitabine dose for this group was reduced from 45 mg/m2 to 30 mg/m2 after Cycle 1 for 4 of 6 participants and the carboplatin dose was reduced for 2 of 6 participants.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 12 months', 'description': 'Number of participants with dose limiting toxicities (DLTs) in Stage 1', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety data set includes data from all participants who received any amount of study drug, including any component of a multi-dose study treatment regimen.'}, {'type': 'PRIMARY', 'title': 'Stage 2: Progression Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2: Guadecitabine+Carboplatin 30 mg/m2', 'description': 'Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.'}, {'id': 'OG001', 'title': 'Stage 2: Treatment Choice', 'description': "Treatment was selected at the investigator's discretion and administered based on recommended dosing for topotecan (3.5-4.0 mg/m2/wk administered on Days 1, 8, and 15 via IV infusion); PLD (40-50 mg/m2 administered on Day 1 via IV infusion), paclitaxel (60-80 mg/m2/wk administered on Days 1, 8, 15, and 22 via IV infusion), or gemcitabine (800-1000 mg/m2 administered on Days 1, 8, and 15 via IV infusion)."}], 'classes': [{'categories': [{'measurements': [{'value': '114', 'groupId': 'OG000', 'lowerLimit': '63', 'upperLimit': '169'}, {'value': '64', 'groupId': 'OG001', 'lowerLimit': '52', 'upperLimit': '105'}]}]}], 'analyses': [{'pValue': '0.0654', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 24 months', 'description': 'Progression free survival (PFS) time was defined as the time interval from the date of the first dose of study medication until the earlier of disease progression or death. Participants were treated with their assigned treatment \\[guadecitabine+carboplatin (G+C) or treatment choice (TC)\\] until disease progression or unacceptable treatment-related toxicity occurred.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy data set included all participants who received any amount of study drug.'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1: Guadecitabine+Carboplatin 30 mg/m2', 'description': 'Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.'}, {'id': 'OG001', 'title': 'Stage 1: Guadecitabine+Carboplatin 45 mg/m2', 'description': 'Guadecitabine 45 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles. Due to dose limiting toxicities, the guadecitabine dose for this group was reduced from 45 mg/m2 to 30 mg/m2 after Cycle 1 for 4 of 6 participants and the carboplatin dose was reduced for 2 of 6 participants.'}, {'id': 'OG002', 'title': 'Stage 2: Guadecitabine+Carboplatin 30 mg/m2', 'description': 'Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.'}, {'id': 'OG003', 'title': 'Stage 2: Treatment Choice', 'description': "Treatment was selected at the investigator's discretion and administered based on recommended dosing for topotecan (3.5-4.0 mg/m2/wk administered on Days 1, 8, and 15 via IV infusion); PLD (40-50 mg/m2 administered on Day 1 via IV infusion), paclitaxel (60-80 mg/m2/wk administered on Days 1, 8, 15, and 22 via IV infusion), or gemcitabine (800-1000 mg/m2 administered on Days 1, 8, and 15 via IV infusion)."}, {'id': 'OG004', 'title': 'Stage 2: Crossover Treatment Choice to Guadecitabine+Carboplatin 30 mg/m2', 'description': 'Crossover from treatment choice to the guadecitabine+carboplatin combination treatment arm was permitted for participants after evidence of disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000', 'lowerLimit': '4.7', 'upperLimit': '50.8'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '45.9'}, {'value': '16', 'groupId': 'OG002', 'lowerLimit': '7.0', 'upperLimit': '28.6'}, {'value': '8', 'groupId': 'OG003', 'lowerLimit': '2.3', 'upperLimit': '19.6'}, {'value': '4', 'groupId': 'OG004', 'lowerLimit': '0.1', 'upperLimit': '19.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 24 months', 'description': 'The objective response rate (ORR) was defined as the proportion of participants who experienced an objective response (best overall response of complete response/full response or partial response, which was confirmed by a subsequent assessment at least 28 days later). Response categories were determined based on RECIST v1.1 criteria, or on modified Rustin (CA-125) criteria if response assessment could not be made using RECIST criteria.', 'unitOfMeasure': 'Percent', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy data set included all participants who received any amount of study drug.'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1: Guadecitabine+Carboplatin 30 mg/m2', 'description': 'Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.'}, {'id': 'OG001', 'title': 'Stage 1: Guadecitabine+Carboplatin 45 mg/m2', 'description': 'Guadecitabine 45 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles. Due to dose limiting toxicities, the guadecitabine dose for this group was reduced from 45 mg/m2 to 30 mg/m2 after Cycle 1 for 4 of 6 participants and the carboplatin dose was reduced for 2 of 6 participants.'}, {'id': 'OG002', 'title': 'Stage 2: Guadecitabine+Carboplatin 30 mg/m2', 'description': 'Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.'}, {'id': 'OG003', 'title': 'Stage 2: Treatment Choice', 'description': "Treatment was selected at the investigator's discretion and administered based on recommended dosing for topotecan (3.5-4.0 mg/m2/wk administered on Days 1, 8, and 15 via IV infusion); PLD (40-50 mg/m2 administered on Day 1 via IV infusion), paclitaxel (60-80 mg/m2/wk administered on Days 1, 8, 15, and 22 via IV infusion), or gemcitabine (800-1000 mg/m2 administered on Days 1, 8, and 15 via IV infusion)."}, {'id': 'OG004', 'title': 'Stage 2: Crossover Treatment Choice to Guadecitabine+Carboplatin 30 mg/m2', 'description': 'Crossover from treatment choice to the guadecitabine+carboplatin combination treatment arm was permitted for participants after evidence of disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.36', 'groupId': 'OG000', 'lowerLimit': '0.13', 'upperLimit': '0.59'}, {'value': '0.33', 'groupId': 'OG001', 'lowerLimit': '0.05', 'upperLimit': '0.68'}, {'value': '0.37', 'groupId': 'OG002', 'lowerLimit': '0.24', 'upperLimit': '0.50'}, {'value': '0.11', 'groupId': 'OG003', 'lowerLimit': '0.04', 'upperLimit': '0.22'}, {'value': '0.19', 'groupId': 'OG004', 'lowerLimit': '0.07', 'upperLimit': '0.35'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Progression free survival rate at 6 months is the proportion of participants who were alive and did not have disease progression at 6 months after start of treatment.', 'unitOfMeasure': 'Percent of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy data set included all participants who received any amount of study drug.'}, {'type': 'SECONDARY', 'title': 'Clinical Benefit Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1: Guadecitabine+Carboplatin 30 mg/m2', 'description': 'Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.'}, {'id': 'OG001', 'title': 'Stage 1: Guadecitabine+Carboplatin 45 mg/m2', 'description': 'Guadecitabine 45 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles. Due to dose limiting toxicities, the guadecitabine dose for this group was reduced from 45 mg/m2 to 30 mg/m2 after Cycle 1 for 4 of 6 participants and the carboplatin dose was reduced for 2 of 6 participants.'}, {'id': 'OG002', 'title': 'Stage 2: Guadecitabine+Carboplatin 30 mg/m2', 'description': 'Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.'}, {'id': 'OG003', 'title': 'Stage 2: Treatment Choice', 'description': "Treatment was selected at the investigator's discretion and administered based on recommended dosing for topotecan (3.5-4.0 mg/m2/wk administered on Days 1, 8, and 15 via IV infusion); PLD (40-50 mg/m2 administered on Day 1 via IV infusion), paclitaxel (60-80 mg/m2/wk administered on Days 1, 8, 15, and 22 via IV infusion), or gemcitabine (800-1000 mg/m2 administered on Days 1, 8, and 15 via IV infusion)."}, {'id': 'OG004', 'title': 'Stage 2: Crossover Treatment Choice to Guadecitabine+Carboplatin 30 mg/m2', 'description': 'Crossover from treatment choice to the guadecitabine+carboplatin combination treatment arm was permitted for participants after evidence of disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000', 'lowerLimit': '17.7', 'upperLimit': '71.1'}, {'value': '50', 'groupId': 'OG001', 'lowerLimit': '11.8', 'upperLimit': '88.2'}, {'value': '41', 'groupId': 'OG002', 'lowerLimit': '27.6', 'upperLimit': '55.8'}, {'value': '29', 'groupId': 'OG003', 'lowerLimit': '16.6', 'upperLimit': '43.3'}, {'value': '19', 'groupId': 'OG004', 'lowerLimit': '6.3', 'upperLimit': '38.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 24 months', 'description': 'Clinical benefit rate (CBR) was defined as the proportion of subjects who experienced a best overall response of complete response/full response or partial response (confirmed by a subsequent assessment at least 28 days later), or documented stable disease for at least 3 months after the first dose. Response categories were determined based on RECIST v1.1 criteria, then based on modified Rustin (CA-125) criteria if assessment could not be made using RECIST criteria.', 'unitOfMeasure': 'Percent of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy data set included all participants who received any amount of study drug.'}, {'type': 'SECONDARY', 'title': 'CA-125 Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1: Guadecitabine+Carboplatin 30 mg/m2', 'description': 'Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.'}, {'id': 'OG001', 'title': 'Stage 1: Guadecitabine+Carboplatin 45 mg/m2', 'description': 'Guadecitabine 45 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles. Due to dose limiting toxicities, the guadecitabine dose for this group was reduced from 45 mg/m2 to 30 mg/m2 after Cycle 1 for 4 of 6 participants and the carboplatin dose was reduced for 2 of 6 participants.'}, {'id': 'OG002', 'title': 'Stage 2: Guadecitabine+Carboplatin 30 mg/m2', 'description': 'Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.'}, {'id': 'OG003', 'title': 'Stage 2: Treatment Choice', 'description': "Treatment was selected at the investigator's discretion and administered based on recommended dosing for topotecan (3.5-4.0 mg/m2/wk administered on Days 1, 8, and 15 via IV infusion); PLD (40-50 mg/m2 administered on Day 1 via IV infusion), paclitaxel (60-80 mg/m2/wk administered on Days 1, 8, 15, and 22 via IV infusion), or gemcitabine (800-1000 mg/m2 administered on Days 1, 8, and 15 via IV infusion)."}, {'id': 'OG004', 'title': 'Stage 2: Crossover Treatment Choice to Guadecitabine+Carboplatin 30 mg/m2', 'description': 'Crossover from treatment choice to the guadecitabine+carboplatin combination treatment arm was permitted for participants after evidence of disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000', 'lowerLimit': '6.0', 'upperLimit': '61.0'}, {'value': '50', 'groupId': 'OG001', 'lowerLimit': '6.8', 'upperLimit': '93.2'}, {'value': '36', 'groupId': 'OG002', 'lowerLimit': '21.6', 'upperLimit': '52.0'}, {'value': '32', 'groupId': 'OG003', 'lowerLimit': '18.1', 'upperLimit': '48.1'}, {'value': '29', 'groupId': 'OG004', 'lowerLimit': '11.3', 'upperLimit': '52.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 24 months', 'description': 'Percentage of participants with CA-125 reduction by ≥ 50% from baseline', 'unitOfMeasure': 'Percent of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy data set included all participants who received any amount of study drug.'}, {'type': 'SECONDARY', 'title': 'Duration of Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1: Guadecitabine+Carboplatin 30 mg/m2', 'description': 'Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.'}, {'id': 'OG001', 'title': 'Stage 1: Guadecitabine+Carboplatin 45 mg/m2', 'description': 'Guadecitabine 45 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles. Due to dose limiting toxicities, the guadecitabine dose for this group was reduced from 45 mg/m2 to 30 mg/m2 after Cycle 1 for 4 of 6 participants and the carboplatin dose was reduced for 2 of 6 participants.'}, {'id': 'OG002', 'title': 'Stage 2: Guadecitabine+Carboplatin 30 mg/m2', 'description': 'Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.'}, {'id': 'OG003', 'title': 'Stage 2: Treatment Choice', 'description': "Treatment was selected at the investigator's discretion and administered based on recommended dosing for topotecan (3.5-4.0 mg/m2/wk administered on Days 1, 8, and 15 via IV infusion); PLD (40-50 mg/m2 administered on Day 1 via IV infusion), paclitaxel (60-80 mg/m2/wk administered on Days 1, 8, 15, and 22 via IV infusion), or gemcitabine (800-1000 mg/m2 administered on Days 1, 8, and 15 via IV infusion)."}, {'id': 'OG004', 'title': 'Stage 2: Crossover Treatment Choice to Guadecitabine+Carboplatin 30 mg/m2', 'description': 'Crossover from treatment choice to the guadecitabine+carboplatin combination treatment arm was permitted for participants after evidence of disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '225', 'groupId': 'OG000', 'lowerLimit': '42.0', 'upperLimit': '294.0'}, {'value': '195', 'comment': 'Not estimable with current data', 'groupId': 'OG001', 'lowerLimit': '114.0', 'upperLimit': 'NA'}, {'value': '186', 'groupId': 'OG002', 'lowerLimit': '147.0', 'upperLimit': '241.0'}, {'value': '173', 'groupId': 'OG003', 'lowerLimit': '121.0', 'upperLimit': '267.0'}, {'value': '182', 'groupId': 'OG004', 'lowerLimit': '147.0', 'upperLimit': '233.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 24 months', 'description': 'Duration of response is defined as the time between the date of the first documentation of complete response/full response or partial response, and the date of disease progression or date of death due to any cause, or the last adequate tumor assessment prior to the start of subsequent anti-cancer therapy including crossing over to G+C from TC arm, whichever occurred earlier. Only participants who responded were included in the duration of response calculation.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy data set included all participants who received any amount of study drug.'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1: Guadecitabine+Carboplatin 30 mg/m2', 'description': 'Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.'}, {'id': 'OG001', 'title': 'Stage 1: Guadecitabine+Carboplatin 45 mg/m2', 'description': 'Guadecitabine 45 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles. Due to dose limiting toxicities, the guadecitabine dose for this group was reduced from 45 mg/m2 to 30 mg/m2 after Cycle 1 for 4 of 6 participants and the carboplatin dose was reduced for 2 of 6 participants.'}, {'id': 'OG002', 'title': 'Stage 2: Guadecitabine+Carboplatin 30 mg/m2', 'description': 'Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.'}, {'id': 'OG003', 'title': 'Stage 2: Treatment Choice', 'description': "Treatment was selected at the investigator's discretion and administered based on recommended dosing for topotecan (3.5-4.0 mg/m2/wk administered on Days 1, 8, and 15 via IV infusion); PLD (40-50 mg/m2 administered on Day 1 via IV infusion), paclitaxel (60-80 mg/m2/wk administered on Days 1, 8, 15, and 22 via IV infusion), or gemcitabine (800-1000 mg/m2 administered on Days 1, 8, and 15 via IV infusion)."}, {'id': 'OG004', 'title': 'Stage 2: Crossover Treatment Choice to Guadecitabine+Carboplatin 30 mg/m2', 'description': 'Crossover from treatment choice to the guadecitabine+carboplatin combination treatment arm was permitted for participants after evidence of disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '341', 'groupId': 'OG000', 'lowerLimit': '100.0', 'upperLimit': '567.0'}, {'value': '195', 'comment': 'Not estimable with current data', 'groupId': 'OG001', 'lowerLimit': '25.0', 'upperLimit': 'NA'}, {'value': '331', 'groupId': 'OG002', 'lowerLimit': '231', 'upperLimit': '415'}, {'value': '221', 'groupId': 'OG003', 'lowerLimit': '145', 'upperLimit': '372'}, {'value': '279', 'groupId': 'OG004', 'lowerLimit': '161.0', 'upperLimit': '413.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 24 months', 'description': 'Overall survival was defined as the number of days from the day the participant was administered the first dose of study treatment to the date of death (regardless of cause). Survival time was censored on the last date the participant was known to be alive or lost to follow-up before reaching the event of death; in the TC group, time was censored at the date of crossover.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy data set included all participants who received any amount of study drug.'}, {'type': 'SECONDARY', 'title': 'Stage 1: Pharmacokinetic Parameter Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1: Guadecitabine+Carboplatin 30 mg/m2', 'description': 'Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.'}, {'id': 'OG001', 'title': 'Stage 1: Guadecitabine+Carboplatin 45 mg/m2', 'description': 'Guadecitabine 45 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles. Due to dose limiting toxicities, the guadecitabine dose for this group was reduced from 45 mg/m2 to 30 mg/m2 after Cycle 1 for 4 of 6 participants and the carboplatin dose was reduced for 2 of 6 participants.'}], 'classes': [{'title': 'Guadecitabine', 'categories': [{'measurements': [{'value': '96.2', 'spread': '78.3', 'groupId': 'OG000'}, {'value': '109', 'spread': '70.8', 'groupId': 'OG001'}]}]}, {'title': 'Decitabine', 'categories': [{'measurements': [{'value': '22.6', 'spread': '13.3', 'groupId': 'OG000'}, {'value': '26.3', 'spread': '14.5', 'groupId': 'OG001'}]}]}, {'title': 'Carboplatin', 'categories': [{'measurements': [{'value': '19600', 'spread': '5650', 'groupId': 'OG000'}, {'value': '21900', 'spread': '13800', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose and up to 8 hours post-dose on Cycle 1 Day 1 for guadecitabine and decitabine and Day 8 for carboplatin (28 day cycles)', 'description': 'Time to maximum plasma concentration for guadecitabine, decitabine and carboplatin', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) population included participants for which sufficient data were available to calculate PK parameters.'}, {'type': 'SECONDARY', 'title': 'Stage 1: Pharmacokinetic Parameter Tmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1: Guadecitabine+Carboplatin 30 mg/m2', 'description': 'Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.'}, {'id': 'OG001', 'title': 'Stage 1: Guadecitabine+Carboplatin 45 mg/m2', 'description': 'Guadecitabine 45 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles. Due to dose limiting toxicities, the guadecitabine dose for this group was reduced from 45 mg/m2 to 30 mg/m2 after Cycle 1 for 4 of 6 participants and the carboplatin dose was reduced for 2 of 6 participants.'}], 'classes': [{'title': 'Guadecitabine', 'categories': [{'measurements': [{'value': '1.42', 'groupId': 'OG000', 'lowerLimit': '0.25', 'upperLimit': '6.00'}, {'value': '1.98', 'groupId': 'OG001', 'lowerLimit': '1.50', 'upperLimit': '7.25'}]}]}, {'title': 'Decitabine', 'categories': [{'measurements': [{'value': '1.98', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '6.00'}, {'value': '3.95', 'groupId': 'OG001', 'lowerLimit': '1.67', 'upperLimit': '7.25'}]}]}, {'title': 'Carboplatin', 'categories': [{'measurements': [{'value': '1.03', 'groupId': 'OG000', 'lowerLimit': '0.48', 'upperLimit': '1.20'}, {'value': '1.05', 'groupId': 'OG001', 'lowerLimit': '0.48', 'upperLimit': '1.20'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose and up to 8 hours post-dose on Cycle 1 Day 1 for guadecitabine and decitabine and Day 8 for carboplatin (28 day cycles)', 'description': 'Time to last measurable concentration for guadecitabine, decitabine and carboplatin', 'unitOfMeasure': 'Hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) population included participants for which sufficient data were available to calculate PK parameters.'}, {'type': 'SECONDARY', 'title': 'Stage 1: Pharmacokinetic Parameter AUC0-8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1: Guadecitabine+Carboplatin 30 mg/m2', 'description': 'Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.'}, {'id': 'OG001', 'title': 'Stage 1: Guadecitabine+Carboplatin 45 mg/m2', 'description': 'Guadecitabine 45 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles. Due to dose limiting toxicities, the guadecitabine dose for this group was reduced from 45 mg/m2 to 30 mg/m2 after Cycle 1 for 4 of 6 participants and the carboplatin dose was reduced for 2 of 6 participants.'}], 'classes': [{'title': 'Guadecitabine', 'categories': [{'measurements': [{'value': '239', 'spread': '136', 'groupId': 'OG000'}, {'value': '416', 'spread': '217', 'groupId': 'OG001'}]}]}, {'title': 'Decitabine', 'categories': [{'measurements': [{'value': '71.1', 'spread': '26.6', 'groupId': 'OG000'}, {'value': '129', 'spread': '17.9', 'groupId': 'OG001'}]}]}, {'title': 'Carboplatin', 'categories': [{'measurements': [{'value': '51200', 'spread': '12100', 'groupId': 'OG000'}, {'value': '41900', 'spread': '31700', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose and up to 8 hours post-dose on Cycle 1 Day 1 for guadecitabine and decitabine and Day 8 for carboplatin (28 day cycles)', 'description': 'Area under the concentration-time curve from 0 to 8 hours (AUC0-8) for guadecitabine, decitabine and carboplatin', 'unitOfMeasure': 'Hours*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) population included participants for which sufficient data were available to calculate PK parameters.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Stage 1: Guadecitabine+Carboplatin 30 mg/m2', 'description': 'Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.'}, {'id': 'FG001', 'title': 'Stage 1: Guadecitabine+Carboplatin 45 mg/m2', 'description': 'Guadecitabine 45 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles. Due to dose limiting toxicities, the guadecitabine dose for this group was reduced from 45 mg/m2 to 30 mg/m2 after Cycle 1 for 4 of 6 participants and the carboplatin dose was reduced for 2 of 6 participants.'}, {'id': 'FG002', 'title': 'Stage 2: Guadecitabine+Carboplatin 30 mg/m2', 'description': 'Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.'}, {'id': 'FG003', 'title': 'Stage 2: Treatment Choice', 'description': "Treatment was selected at the investigator's discretion and administered based on recommended dosing for topotecan (3.5-4.0 mg/m2/wk administered on Days 1, 8, and 15 via IV infusion); pegylated liposomal doxorubicin (PLD) (40-50 mg/m2 administered on Day 1 via IV infusion), paclitaxel (60-80 mg/m2/wk administered on Days 1, 8, 15, and 22 via IV infusion), or gemcitabine (800-1000 mg/m2 administered on Days 1, 8, and 15 via IV infusion). Participants initially randomized to TC were able to cross over to receive 30 mg/m2 G+C due to disease progression."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '51'}, {'groupId': 'FG003', 'numSubjects': '49'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '51'}, {'groupId': 'FG003', 'numSubjects': '22'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '43'}, {'groupId': 'FG003', 'numSubjects': '18'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Database lock', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'A total of 124 participants were enrolled in the study and 120 were treated at 20 study centers, with 12 in the United States, 5 in the United Kingdom, and 3 in Canada. The enrollment period was 10 December 2012 (first participant dosed) to 12 May 2014 (last participant first dose).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}, {'value': '120', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Stage 1: Guadecitabine+Carboplatin 30 mg/m2', 'description': 'Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.'}, {'id': 'BG001', 'title': 'Stage 1: Guadecitabine+Carboplatin 45 mg/m2', 'description': 'Guadecitabine 45 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles. Due to dose limiting toxicities, the guadecitabine dose for this group was reduced from 45 mg/m2 to 30 mg/m2 after Cycle 1 for 4 of 6 participants and the carboplatin dose was reduced for 2 of 6 participants.'}, {'id': 'BG002', 'title': 'Stage 2: Guadecitabine+Carboplatin 30 mg/m2', 'description': 'Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.'}, {'id': 'BG003', 'title': 'Stage 2: Treatment Choice', 'description': "Treatment was selected at the investigator's discretion and administered based on recommended dosing for topotecan (3.5-4.0 mg/m2/wk administered on Days 1, 8, and 15 via IV infusion); PLD (40-50 mg/m2 administered on Day 1 via IV infusion), paclitaxel (60-80 mg/m2/wk administered on Days 1, 8, 15, and 22 via IV infusion), or gemcitabine (800-1000 mg/m2 administered on Days 1, 8, and 15 via IV infusion. Participants initially randomized to TC were able to cross over to receive 30 mg/m2 G+C due to disease progression."}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.99', 'spread': '9.47', 'groupId': 'BG000'}, {'value': '56.79', 'spread': '13.20', 'groupId': 'BG001'}, {'value': '61.96', 'spread': '9.17', 'groupId': 'BG002'}, {'value': '62.09', 'spread': '9.62', 'groupId': 'BG003'}, {'value': '61.29', 'spread': '9.62', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}, {'value': '120', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}, {'value': '114', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}, {'value': '100', 'groupId': 'BG004'}]}, {'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'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Includes all treated participants'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'dispFirstSubmitDate': '2018-01-15', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-31', 'studyFirstSubmitDate': '2012-09-26', 'dispFirstSubmitQcDate': '2018-01-15', 'resultsFirstSubmitDate': '2021-04-30', 'studyFirstSubmitQcDate': '2012-09-27', 'dispFirstPostDateStruct': {'date': '2018-01-18', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-04-30', 'studyFirstPostDateStruct': {'date': '2012-09-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stage 1: Dose Limiting Toxicities', 'timeFrame': 'Up to 12 months', 'description': 'Number of participants with dose limiting toxicities (DLTs) in Stage 1'}, {'measure': 'Stage 2: Progression Free Survival', 'timeFrame': 'Up to 24 months', 'description': 'Progression free survival (PFS) time was defined as the time interval from the date of the first dose of study medication until the earlier of disease progression or death. Participants were treated with their assigned treatment \\[guadecitabine+carboplatin (G+C) or treatment choice (TC)\\] until disease progression or unacceptable treatment-related toxicity occurred.'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate', 'timeFrame': 'Up to 24 months', 'description': 'The objective response rate (ORR) was defined as the proportion of participants who experienced an objective response (best overall response of complete response/full response or partial response, which was confirmed by a subsequent assessment at least 28 days later). Response categories were determined based on RECIST v1.1 criteria, or on modified Rustin (CA-125) criteria if response assessment could not be made using RECIST criteria.'}, {'measure': 'Progression Free Survival at 6 Months', 'timeFrame': '6 months', 'description': 'Progression free survival rate at 6 months is the proportion of participants who were alive and did not have disease progression at 6 months after start of treatment.'}, {'measure': 'Clinical Benefit Rate', 'timeFrame': 'Up to 24 months', 'description': 'Clinical benefit rate (CBR) was defined as the proportion of subjects who experienced a best overall response of complete response/full response or partial response (confirmed by a subsequent assessment at least 28 days later), or documented stable disease for at least 3 months after the first dose. Response categories were determined based on RECIST v1.1 criteria, then based on modified Rustin (CA-125) criteria if assessment could not be made using RECIST criteria.'}, {'measure': 'CA-125 Levels', 'timeFrame': 'Up to 24 months', 'description': 'Percentage of participants with CA-125 reduction by ≥ 50% from baseline'}, {'measure': 'Duration of Response', 'timeFrame': 'Up to 24 months', 'description': 'Duration of response is defined as the time between the date of the first documentation of complete response/full response or partial response, and the date of disease progression or date of death due to any cause, or the last adequate tumor assessment prior to the start of subsequent anti-cancer therapy including crossing over to G+C from TC arm, whichever occurred earlier. Only participants who responded were included in the duration of response calculation.'}, {'measure': 'Overall Survival', 'timeFrame': 'Up to 24 months', 'description': 'Overall survival was defined as the number of days from the day the participant was administered the first dose of study treatment to the date of death (regardless of cause). Survival time was censored on the last date the participant was known to be alive or lost to follow-up before reaching the event of death; in the TC group, time was censored at the date of crossover.'}, {'measure': 'Stage 1: Pharmacokinetic Parameter Cmax', 'timeFrame': 'Pre-dose and up to 8 hours post-dose on Cycle 1 Day 1 for guadecitabine and decitabine and Day 8 for carboplatin (28 day cycles)', 'description': 'Time to maximum plasma concentration for guadecitabine, decitabine and carboplatin'}, {'measure': 'Stage 1: Pharmacokinetic Parameter Tmax', 'timeFrame': 'Pre-dose and up to 8 hours post-dose on Cycle 1 Day 1 for guadecitabine and decitabine and Day 8 for carboplatin (28 day cycles)', 'description': 'Time to last measurable concentration for guadecitabine, decitabine and carboplatin'}, {'measure': 'Stage 1: Pharmacokinetic Parameter AUC0-8', 'timeFrame': 'Pre-dose and up to 8 hours post-dose on Cycle 1 Day 1 for guadecitabine and decitabine and Day 8 for carboplatin (28 day cycles)', 'description': 'Area under the concentration-time curve from 0 to 8 hours (AUC0-8) for guadecitabine, decitabine and carboplatin'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ovarian Cancer'], 'conditions': ['Ovarian Cancer']}, 'referencesModule': {'references': [{'pmid': '33289590', 'type': 'DERIVED', 'citation': 'Cardenas H, Fang F, Jiang G, Perkins SM, Zhang C, Emerson RE, Hutchins G, Keer HN, Liu Y, Matei D, Nephew K. Methylomic Signatures of High Grade Serous Ovarian Cancer. Epigenetics. 2021 Nov;16(11):1201-1216. doi: 10.1080/15592294.2020.1853402. Epub 2020 Dec 8.'}, {'pmid': '31831561', 'type': 'DERIVED', 'citation': 'Oza AM, Matulonis UA, Alvarez Secord A, Nemunaitis J, Roman LD, Blagden SP, Banerjee S, McGuire WP, Ghamande S, Birrer MJ, Fleming GF, Markham MJ, Hirte HW, Provencher DM, Basu B, Kristeleit R, Armstrong DK, Schwartz B, Braly P, Hall GD, Nephew KP, Jueliger S, Oganesian A, Naim S, Hao Y, Keer H, Azab M, Matei D. A Randomized Phase II Trial of Epigenetic Priming with Guadecitabine and Carboplatin in Platinum-resistant, Recurrent Ovarian Cancer. Clin Cancer Res. 2020 Mar 1;26(5):1009-1016. doi: 10.1158/1078-0432.CCR-19-1638. Epub 2019 Dec 12.'}]}, 'descriptionModule': {'briefSummary': 'A 2-part, Phase 2 controlled, open-label, randomized study in participants with platinum-resistant recurrent ovarian cancer. In Part 1, participants received SGI-110 and carboplatin. The optimum dose of SGI-110 (guadecitabine) was identified in Part 1 based on safety and efficacy. In Part 2, participants were randomized to receive the dose identified in Part 1 plus carboplatin or one of four treatment of choice at the discretion of the investigator. The treatment of choice consisted of topotecan, pegylated liposomal doxorubicin, paclitaxel or gemcitabine.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Participants who are women 18 years of age or older.\n2. Participants who have histologically or cytologically confirmed recurrent high-grade serous epithelial ovarian cancer (Grade 2 or 3), primary peritoneal carcinomatosis or fallopian tube cancer.\n3. Participants who have platinum-resistant disease (defined as having relapsed within 6 months of her last platinum-containing regimen). There is no limit on the number of prior treatment regimens in Part 1. In Part 2, participants may have had no more than 3 prior cytotoxic treatment regimens, excluding adjuvant or maintenance therapy.\n4. Participants must have had prior paclitaxel treatment.\n5. Participants who have measurable disease according to RECIST v1.1 or detectable disease.\n6. Participants with ECOG performance status of 0 or 1.\n7. Participants with acceptable organ function.\n8. Participants must be at least 3 weeks from last chemotherapy.\n\nExclusion Criteria:\n\n1. Participants who have hypersensitivity to SGI-110 and/or carboplatin or other components of these drug products.\n2. Participants who have received prior therapy with any hypomethylating agents.\n3. Participants who are refractory to platinum treatment i.e., progressed while on platinum treatment.\n4. Participants with abnormal left ventricular ejection fraction.\n5. Participants with Grade 2 or greater neuropathy.\n6. Participants with known brain metastases.\n7. Participants with known history of HIV, HCV or HBV.'}, 'identificationModule': {'nctId': 'NCT01696032', 'acronym': 'SGI-110', 'briefTitle': 'SGI-110 in Combination With Carboplatin in Ovarian Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astex Pharmaceuticals, Inc.'}, 'officialTitle': 'A Randomized, Controlled, Open-Label, Phase 2 Trial of SGI-110 and Carboplatin in Subjects With Platinum-Resistant Recurrent Ovarian Cancer', 'orgStudyIdInfo': {'id': 'SGI-110-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SGI-110 + Carboplatin', 'description': 'Stage 1 was a safety lead-in stage with a dose escalation design. Participants were evaluated with the combination of SGI-110 (guadecitabine) plus carboplatin (G+C), given as 28-day treatment cycles: guadecitabine administered subcutaneous (SC) daily on Days 1-5, at a starting dose of 45 mg/m2/day in Cohort 1, followed by carboplatin intravenous (IV) based on a targeted dose of area under the curve (AUC) 5 on Day 8. After dose limiting toxicities were noted, guadecitabine dose was reduced to 30 mg/m2/day for subsequent cycles for 4 participants. Cohort 2 received 30 mg/m2/day guadecitabine and carboplatin IV AUC 4.', 'interventionNames': ['Drug: SGI-110', 'Drug: Carboplatin']}, {'type': 'EXPERIMENTAL', 'label': 'SGI-110 + Carboplatin or TC', 'description': 'Stage 2 was an open-label, randomized, controlled trial. Eligible participants were randomly assigned in a 1:1 ratio to receive either (1) G+C combination treatment in 28-day cycles at 30 mg/m2 SC once daily on Days 1-5 and carboplatin IV AUC 4 on Day 8, or (2) treatment of choice (TC) of topotecan, pegylated liposomal doxorubicin (PLD), paclitaxel, or gemcitabine based on recommended dosing in 28-day cycles; participants initially randomized to TC were able to cross over to receive 30 mg/m2 G+C due to disease progression.', 'interventionNames': ['Drug: SGI-110', 'Drug: Treatment of Choice (topotecan, pegylated liposomal doxorubicin, paclitaxel, or gemcitabine)', 'Drug: Carboplatin']}], 'interventions': [{'name': 'SGI-110', 'type': 'DRUG', 'otherNames': ['guadecitabine'], 'armGroupLabels': ['SGI-110 + Carboplatin', 'SGI-110 + Carboplatin or TC']}, {'name': 'Treatment of Choice (topotecan, pegylated liposomal doxorubicin, paclitaxel, or gemcitabine)', 'type': 'DRUG', 'description': 'Investigator chose to treat with either topotecan, pegylated liposomal doxorubicin, paclitaxel, or gemcitabine', 'armGroupLabels': ['SGI-110 + Carboplatin or TC']}, {'name': 'Carboplatin', 'type': 'DRUG', 'armGroupLabels': ['SGI-110 + Carboplatin', 'SGI-110 + Carboplatin or TC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Norris Comprehensive Cancer Center- University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida Shands Cancer Center', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Georgia Health Sciences University', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Melvin and Bren Simon Cancer Center- Indiana University', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '70433', 'city': 'Covington', 'state': 'Louisiana', 'country': 'United States', 'facility': "Women's Cancer Care", 'geoPoint': {'lat': 30.47549, 'lon': -90.10042}}, {'zip': '21231', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Kimmel Cancer Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '11718', 'city': 'Brightwaters', 'state': 'New York', 'country': 'United States', 'facility': 'Island Gynecologic Oncology', 'geoPoint': {'lat': 40.72093, 'lon': -73.26734}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Cancer Institute- Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '45267', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati Cancer Institute', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '75201', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Mary Crowley Medical Research Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '22042', 'city': 'Falls Church', 'state': 'Virginia', 'country': 'United States', 'facility': 'Inova Fairfax Hospital', 'geoPoint': {'lat': 38.88233, 'lon': -77.17109}}, {'zip': 'T2N 4N2', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Tom Baker Cancer Centre', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'L8V 5C2', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Juravinski Cancer Centre', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Princess Margaret Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H2L 4M1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CHUM Gynecologie-Oncologie, Notre Dame Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'BS2 8ED', 'city': 'Bristol', 'country': 'United Kingdom', 'facility': 'Bristol Heamatology and Oncology Centre', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'zip': 'LS9 7TF', 'city': 'Leeds', 'country': 'United Kingdom', 'facility': 'St. James Univesity Hospital - St. James Institute of Oncology', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'zip': 'EC1V 4AD', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Cambridge University Hospitals NHS Foundation and Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'NW1 2PG', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Univesity College Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'W12 0NN', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Imperial College Health Care NHS Trust-Garry Weston Centre', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'HA6 2RN', 'city': 'Middlesex', 'country': 'United Kingdom', 'facility': 'Mount Vernon Cancer Centre', 'geoPoint': {'lat': 51.53174, 'lon': -0.26856}}, {'zip': 'SM2 5PT', 'city': 'Sutton', 'country': 'United Kingdom', 'facility': 'Royal Marsden Foundation Trust', 'geoPoint': {'lat': 51.35, 'lon': -0.2}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astex Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}