Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-25 @ 9:11 PM
Study NCT ID:
NCT01609556
Status:
COMPLETED
Last Update Posted:
2021-02-17
First Post:
2012-05-30
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Mirvetuximab Soravtansine in Adults With Ovarian Cancer and Other Folate Receptor 1 (FOLR1)-Positive Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000607289', 'term': 'mirvetuximab soravtansine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@immunogen.com', 'phone': '781-895-0600', 'title': 'CMO, ImmunoGen', 'organization': 'ImmunoGen, Inc'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose of study drug up to 28 days after last dose of study drug (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)', 'description': 'Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data was only collected and reported by combined groups for the dose-escalation phase and not by individual doses.', 'eventGroups': [{'id': 'EG000', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 0.15 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 2, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 0.5 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 1.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 3.3 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 5.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 18, 'seriousNumAtRisk': 18, 'deathsNumAffected': 1, 'seriousNumAffected': 5}, {'id': 'EG006', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 6.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG007', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 7.0 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 7.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG008', 'title': 'Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.1 mg/kg Weekly)', 'description': 'Participants received mirvetuximab soravtansine 1.1 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG009', 'title': 'Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.8 mg/kg Weekly)', 'description': 'Participants received mirvetuximab soravtansine 1.8 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG010', 'title': 'Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.0 mg/kg Weekly)', 'description': 'Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'deathsNumAffected': 1, 'seriousNumAffected': 4}, {'id': 'EG011', 'title': 'Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.5 mg/kg Weekly)', 'description': 'Participants received mirvetuximab soravtansine 2.5 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG012', 'title': 'Dose Expansion: Cohort 1 (Mirvetuximab Soravtansine Q3W)', 'description': 'Participants with EOC, primary peritoneal cancer, or fallopian tube cancer resistant to platinum-based therapy received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.', 'otherNumAtRisk': 46, 'deathsNumAtRisk': 46, 'otherNumAffected': 45, 'seriousNumAtRisk': 46, 'deathsNumAffected': 4, 'seriousNumAffected': 18}, {'id': 'EG013', 'title': 'Dose Expansion: Cohort 2 (Mirvetuximab Soravtansine Q3W)', 'description': 'Participants with FOLR1-positive uterine cancer (that was advanced or recurrent and had received at least 1 platinum-based regimen, and no more than 5 prior systemic treatment regimens for EC) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 24, 'seriousNumAtRisk': 24, 'deathsNumAffected': 4, 'seriousNumAffected': 11}, {'id': 'EG014', 'title': 'Dose Expansion: Cohort 3 (Mirvetuximab Soravtansine Q3W)', 'description': 'Participants with biopsy-accessible relapsed or refractory ovarian cancer, primary peritoneal cancer, or fallopian tube cancer received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 27, 'seriousNumAtRisk': 27, 'deathsNumAffected': 1, 'seriousNumAffected': 9}, {'id': 'EG015', 'title': 'Dose Expansion: Cohort 5 (Mirvetuximab Soravtansine Q3W)', 'description': 'Participants with EOC primary peritoneal cancer or fallopian tube cancer (that had relapsed following platinum-based therapy, excluding those participants with primary platinum refractory disease or low grade or clear cell ovarian cancer) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 40, 'seriousNumAtRisk': 40, 'deathsNumAffected': 4, 'seriousNumAffected': 17}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 7}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 5}, {'groupId': 'EG011', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG012', 'numAtRisk': 46, 'numAffected': 24}, {'groupId': 'EG013', 'numAtRisk': 24, 'numAffected': 8}, {'groupId': 'EG014', 'numAtRisk': 27, 'numAffected': 10}, {'groupId': 'EG015', 'numAtRisk': 40, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 6}, {'groupId': 'EG011', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG012', 'numAtRisk': 46, 'numAffected': 19}, {'groupId': 'EG013', 'numAtRisk': 24, 'numAffected': 10}, {'groupId': 'EG014', 'numAtRisk': 27, 'numAffected': 9}, {'groupId': 'EG015', 'numAtRisk': 40, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG011', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 46, 'numAffected': 4}, {'groupId': 'EG013', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG014', 'numAtRisk': 27, 'numAffected': 4}, {'groupId': 'EG015', 'numAtRisk': 40, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG011', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 46, 'numAffected': 15}, {'groupId': 'EG013', 'numAtRisk': 24, 'numAffected': 5}, {'groupId': 'EG014', 'numAtRisk': 27, 'numAffected': 6}, {'groupId': 'EG015', 'numAtRisk': 40, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 46, 'numAffected': 9}, {'groupId': 'EG013', 'numAtRisk': 24, 'numAffected': 7}, {'groupId': 'EG014', 'numAtRisk': 27, 'numAffected': 8}, {'groupId': 'EG015', 'numAtRisk': 40, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 40, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 40, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Gingival bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 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'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 46, 'numAffected': 3}, {'groupId': 'EG013', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 46, 'numAffected': 2}, {'groupId': 'EG013', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Metastases to meninges', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Spinal fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pulmonary fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Dose-Escalation Phase: Maximum Tolerated Dose (MTD) of Mirvetuximab Soravtansine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine Q3W)', 'description': 'Participants received mirvetuximab soravtansine IV infusion on Day 1 of every 21-day (Q3W) cycle. Dose escalation started at 0.15 mg/kg and proceeded through 7.0 mg/kg. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG001', 'title': 'Dose Escalation: Schedule B (Mirvetuximab Soravtansine Weekly)', 'description': 'Participants received mirvetuximab soravtansine IV infusion on Days 1, 8, and 15 of every 28-day cycle. Dose escalation started at 1.1 mg/kg and proceeded through 2.5 mg/kg. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.0', 'groupId': 'OG000'}, {'value': '2.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Cycle 1 (21 days)', 'description': 'MTD was defined as the highest dose at which 1 or fewer among 6 participants or less than or equal to (\\<=) 33 percent (%) experienced a dose-limiting toxicity (DLT) (calculated based on adjusted ideal body weight \\[AIBW\\]). AIBW was calculated as ideal body weight (IBW) + 0.4 \\* (actual weight - IBW), where IBW for men was 0.9 \\* height in centimeters (cm) - 88 and IBW for women was 0.9 \\* height in cm - 92. DLT was defined as a treatment-emergent adverse event (TEAE) or abnormal laboratory value related to study treatment (that is, assessed as unrelated to disease, intercurrent illness, or concomitant medications), including those TEAEs and abnormal laboratory values that resulted in a failure to meet the criteria for re-treatment.', 'unitOfMeasure': 'mg/kg', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who were enrolled and received at least 1 dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Dose-Escalation Phase: Recommended Phase 2 Dose (RP2D) of Mirvetuximab Soravtansine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine Q3W)', 'description': 'Participants received mirvetuximab soravtansine IV infusion on Day 1 of every 21-day (Q3W) cycle. Dose escalation started at 0.15 mg/kg and proceeded through 7.0 mg/kg. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Cycle 1 (21 days)', 'description': 'RP2D was determined by MTD. MTD was defined as the highest dose at which 1 or fewer among 6 participants or \\<=33% experienced a DLT. DLT was defined as a TEAE or abnormal laboratory value related to study treatment (that is, assessed as unrelated to disease, intercurrent illness, or concomitant medications), including those TEAEs and abnormal laboratory values that resulted in a failure to meet the criteria for re-treatment. Available clinical data indicated that the MTD defined for the Q3W schedule was equal to the RP2D.', 'unitOfMeasure': 'mg/kg', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who were enrolled and received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '9', 'groupId': 'OG010'}, {'value': '7', 'groupId': 'OG011'}, {'value': '46', 'groupId': 'OG012'}, {'value': '24', 'groupId': 'OG013'}, {'value': '27', 'groupId': 'OG014'}, {'value': '40', 'groupId': 'OG015'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 0.15 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG001', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 0.5 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG002', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 1.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG003', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG004', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 3.3 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG005', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 5.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG006', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 6.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG007', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 7.0 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 7.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG008', 'title': 'Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.1 mg/kg Weekly)', 'description': 'Participants received mirvetuximab soravtansine 1.1 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG009', 'title': 'Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.8 mg/kg Weekly)', 'description': 'Participants received mirvetuximab soravtansine 1.8 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG010', 'title': 'Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.0 mg/kg Weekly)', 'description': 'Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG011', 'title': 'Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.5 mg/kg Weekly)', 'description': 'Participants received mirvetuximab soravtansine 2.5 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG012', 'title': 'Dose Expansion: Cohort 1 (Mirvetuximab Soravtansine Q3W)', 'description': 'Participants with EOC, primary peritoneal cancer, or fallopian tube cancer resistant to platinum-based therapy received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG013', 'title': 'Dose Expansion: Cohort 2 (Mirvetuximab Soravtansine Q3W)', 'description': 'Participants with FOLR1-positive uterine cancer (that was advanced or recurrent and had received at least 1 platinum-based regimen, and no more than 5 prior systemic treatment regimens for EC) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG014', 'title': 'Dose Expansion: Cohort 3 (Mirvetuximab Soravtansine Q3W)', 'description': 'Participants with biopsy-accessible relapsed or refractory ovarian cancer, primary peritoneal cancer, or fallopian tube cancer received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG015', 'title': 'Dose Expansion: Cohort 5 (Mirvetuximab Soravtansine Q3W)', 'description': 'Participants with EOC primary peritoneal cancer or fallopian tube cancer (that had relapsed following platinum-based therapy, excluding those participants with primary platinum refractory disease or low grade or clear cell ovarian cancer) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}], 'classes': [{'title': 'Any TEAE', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '9', 'groupId': 'OG010'}, {'value': '7', 'groupId': 'OG011'}, {'value': '46', 'groupId': 'OG012'}, {'value': '24', 'groupId': 'OG013'}, {'value': '27', 'groupId': 'OG014'}, {'value': '40', 'groupId': 'OG015'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}, {'value': '18', 'groupId': 'OG012'}, {'value': '11', 'groupId': 'OG013'}, {'value': '9', 'groupId': 'OG014'}, {'value': '17', 'groupId': 'OG015'}]}]}, {'title': 'Grade >=3 TEAEs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}, {'value': '24', 'groupId': 'OG012'}, {'value': '12', 'groupId': 'OG013'}, {'value': '14', 'groupId': 'OG014'}, {'value': '24', 'groupId': 'OG015'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study drug up to 28 days after last dose of study drug (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)', 'description': 'An adverse event (AE) was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to study drug. Severity was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03 on following scale: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening, Grade 5=death. Serious AEs include death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as any AE that emerged on or after the first dose, and within 28 days of the last dose.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who were enrolled and received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Shift From Baseline Grade <=2 in Clinical Laboratory Parameters to Grade 3 or Grade 4 on Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '9', 'groupId': 'OG010'}, {'value': '7', 'groupId': 'OG011'}, {'value': '46', 'groupId': 'OG012'}, {'value': '24', 'groupId': 'OG013'}, {'value': '27', 'groupId': 'OG014'}, {'value': '40', 'groupId': 'OG015'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 0.15 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG001', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 0.5 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG002', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 1.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG003', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG004', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 3.3 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG005', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 5.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG006', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 6.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG007', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 7.0 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 7.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG008', 'title': 'Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.1 mg/kg Weekly)', 'description': 'Participants received mirvetuximab soravtansine 1.1 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG009', 'title': 'Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.8 mg/kg Weekly)', 'description': 'Participants received mirvetuximab soravtansine 1.8 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG010', 'title': 'Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.0 mg/kg Weekly)', 'description': 'Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG011', 'title': 'Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.5 mg/kg Weekly)', 'description': 'Participants received mirvetuximab soravtansine 2.5 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG012', 'title': 'Dose Expansion: Cohort 1 (Mirvetuximab Soravtansine Q3W)', 'description': 'Participants with EOC, primary peritoneal cancer, or fallopian tube cancer resistant to platinum-based therapy received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG013', 'title': 'Dose Expansion: Cohort 2 (Mirvetuximab Soravtansine Q3W)', 'description': 'Participants with FOLR1-positive uterine cancer (that was advanced or recurrent and had received at least 1 platinum-based regimen, and no more than 5 prior systemic treatment regimens for EC) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG014', 'title': 'Dose Expansion: Cohort 3 (Mirvetuximab Soravtansine Q3W)', 'description': 'Participants with biopsy-accessible relapsed or refractory ovarian cancer, primary peritoneal cancer, or fallopian tube cancer received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG015', 'title': 'Dose Expansion: Cohort 5 (Mirvetuximab Soravtansine Q3W)', 'description': 'Participants with EOC primary peritoneal cancer or fallopian tube cancer (that had relapsed following platinum-based therapy, excluding those participants with primary platinum refractory disease or low grade or clear cell ovarian cancer) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}], 'classes': [{'title': 'Glucose: Grade 0 to Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}]}]}, {'title': 'Magnesium: Grade 2 to Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}]}]}, {'title': 'PTT: Grade 2 to Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}]}]}, {'title': 'Lymphocytes: Grade 0 to Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '1', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}]}]}, {'title': 'Lymphocytes: Grade 2 to Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '1', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '1', 'groupId': 'OG015'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study drug up to 28 days after last dose of study drug (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)', 'description': 'Laboratory parameters included serum chemistry (alanine aminotransferase \\[ALT\\]/serum glutamic pyruvic transaminase \\[SGPT\\], aspartate aminotransferase \\[AST\\]/serum glutamic oxaloacetic transaminase \\[SGOT\\], albumin, alkaline phosphatase, bilirubin, calcium, creatinine, glucose, magnesium, phosphorous, potassium, sodium), hematology (hemoglobin, lymphocytes, neutrophils, platelets, white blood cells) and coagulation (international normalized ratio \\[INR\\], partial thromboplastin time \\[PTT\\]). Clinically significant laboratory values were defined as per NCI CTCAE v.03 Grade 3 or higher. A grading (severity) scale was provided with grades ranging from 0 (none), 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening or disabling), to 5 (death). Only participants who shifted from a baseline value of Grade \\<=2 to a post-baseline Grade 3/4 on-treatment, are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who were enrolled and received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Abnormalities in Physical Examination Findings and Vital Signs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '9', 'groupId': 'OG010'}, {'value': '7', 'groupId': 'OG011'}, {'value': '46', 'groupId': 'OG012'}, {'value': '24', 'groupId': 'OG013'}, {'value': '27', 'groupId': 'OG014'}, {'value': '40', 'groupId': 'OG015'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 0.15 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG001', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 0.5 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG002', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 1.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG003', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG004', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 3.3 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG005', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 5.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG006', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 6.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG007', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 7.0 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 7.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG008', 'title': 'Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.1 mg/kg Weekly)', 'description': 'Participants received mirvetuximab soravtansine 1.1 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG009', 'title': 'Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.8 mg/kg Weekly)', 'description': 'Participants received mirvetuximab soravtansine 1.8 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG010', 'title': 'Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.0 mg/kg Weekly)', 'description': 'Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG011', 'title': 'Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.5 mg/kg Weekly)', 'description': 'Participants received mirvetuximab soravtansine 2.5 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG012', 'title': 'Dose Expansion: Cohort 1 (Mirvetuximab Soravtansine Q3W)', 'description': 'Participants with EOC, primary peritoneal cancer, or fallopian tube cancer resistant to platinum-based therapy received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG013', 'title': 'Dose Expansion: Cohort 2 (Mirvetuximab Soravtansine Q3W)', 'description': 'Participants with FOLR1-positive uterine cancer (that was advanced or recurrent and had received at least 1 platinum-based regimen, and no more than 5 prior systemic treatment regimens for EC) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG014', 'title': 'Dose Expansion: Cohort 3 (Mirvetuximab Soravtansine Q3W)', 'description': 'Participants with biopsy-accessible relapsed or refractory ovarian cancer, primary peritoneal cancer, or fallopian tube cancer received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG015', 'title': 'Dose Expansion: Cohort 5 (Mirvetuximab Soravtansine Q3W)', 'description': 'Participants with EOC primary peritoneal cancer or fallopian tube cancer (that had relapsed following platinum-based therapy, excluding those participants with primary platinum refractory disease or low grade or clear cell ovarian cancer) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study drug up to 28 days after last dose of study drug (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)', 'description': 'Physical examination included assessments of general appearance, skin, head (eyes, ears, nose, and throat), neck, lungs, heart, abdomen, back, lymph nodes, extremities, and neurological system. Vital signs included assessment of blood pressure, pulse rate, respiratory rate and body temperature.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who were enrolled and received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '9', 'groupId': 'OG010'}, {'value': '7', 'groupId': 'OG011'}, {'value': '46', 'groupId': 'OG012'}, {'value': '24', 'groupId': 'OG013'}, {'value': '27', 'groupId': 'OG014'}, {'value': '40', 'groupId': 'OG015'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 0.15 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG001', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 0.5 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG002', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 1.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG003', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG004', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 3.3 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG005', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 5.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG006', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 6.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG007', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 7.0 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 7.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG008', 'title': 'Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.1 mg/kg Weekly)', 'description': 'Participants received mirvetuximab soravtansine 1.1 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG009', 'title': 'Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.8 mg/kg Weekly)', 'description': 'Participants received mirvetuximab soravtansine 1.8 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG010', 'title': 'Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.0 mg/kg Weekly)', 'description': 'Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG011', 'title': 'Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.5 mg/kg Weekly)', 'description': 'Participants received mirvetuximab soravtansine 2.5 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG012', 'title': 'Dose Expansion: Cohort 1 (Mirvetuximab Soravtansine Q3W)', 'description': 'Participants with EOC, primary peritoneal cancer, or fallopian tube cancer resistant to platinum-based therapy received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG013', 'title': 'Dose Expansion: Cohort 2 (Mirvetuximab Soravtansine Q3W)', 'description': 'Participants with FOLR1-positive uterine cancer (that was advanced or recurrent and had received at least 1 platinum-based regimen, and no more than 5 prior systemic treatment regimens for EC) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG014', 'title': 'Dose Expansion: Cohort 3 (Mirvetuximab Soravtansine Q3W)', 'description': 'Participants with biopsy-accessible relapsed or refractory ovarian cancer, primary peritoneal cancer, or fallopian tube cancer received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG015', 'title': 'Dose Expansion: Cohort 5 (Mirvetuximab Soravtansine Q3W)', 'description': 'Participants with EOC primary peritoneal cancer or fallopian tube cancer (that had relapsed following platinum-based therapy, excluding those participants with primary platinum refractory disease or low grade or clear cell ovarian cancer) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}, {'value': '1', 'groupId': 'OG013'}, {'value': '1', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to end of treatment (EOT) (up to maximum 124 weeks)', 'description': 'Standard ECGs were performed in triplicate at 2- to 5-minute intervals during the study. A single ECG was performed at the end of treatment visit and as clinically indicated.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who were enrolled and received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent Ocular AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '9', 'groupId': 'OG010'}, {'value': '7', 'groupId': 'OG011'}, {'value': '46', 'groupId': 'OG012'}, {'value': '24', 'groupId': 'OG013'}, {'value': '27', 'groupId': 'OG014'}, {'value': '40', 'groupId': 'OG015'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 0.15 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG001', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 0.5 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG002', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 1.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG003', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG004', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 3.3 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG005', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 5.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG006', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 6.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG007', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 7.0 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 7.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG008', 'title': 'Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.1 mg/kg Weekly)', 'description': 'Participants received mirvetuximab soravtansine 1.1 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG009', 'title': 'Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.8 mg/kg Weekly)', 'description': 'Participants received mirvetuximab soravtansine 1.8 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG010', 'title': 'Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.0 mg/kg Weekly)', 'description': 'Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG011', 'title': 'Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.5 mg/kg Weekly)', 'description': 'Participants received mirvetuximab soravtansine 2.5 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG012', 'title': 'Dose Expansion: Cohort 1 (Mirvetuximab Soravtansine Q3W)', 'description': 'Participants with EOC, primary peritoneal cancer, or fallopian tube cancer resistant to platinum-based therapy received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG013', 'title': 'Dose Expansion: Cohort 2 (Mirvetuximab Soravtansine Q3W)', 'description': 'Participants with FOLR1-positive uterine cancer (that was advanced or recurrent and had received at least 1 platinum-based regimen, and no more than 5 prior systemic treatment regimens for EC) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG014', 'title': 'Dose Expansion: Cohort 3 (Mirvetuximab Soravtansine Q3W)', 'description': 'Participants with biopsy-accessible relapsed or refractory ovarian cancer, primary peritoneal cancer, or fallopian tube cancer received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG015', 'title': 'Dose Expansion: Cohort 5 (Mirvetuximab Soravtansine Q3W)', 'description': 'Participants with EOC primary peritoneal cancer or fallopian tube cancer (that had relapsed following platinum-based therapy, excluding those participants with primary platinum refractory disease or low grade or clear cell ovarian cancer) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}, {'value': '24', 'groupId': 'OG012'}, {'value': '9', 'groupId': 'OG013'}, {'value': '14', 'groupId': 'OG014'}, {'value': '18', 'groupId': 'OG015'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study drug up to 28 days after last dose of study drug (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)', 'description': 'Ocular AEs included keratopathy and blurred vision. An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to study drug. TEAEs were defined as any AE that emerged on or after the first dose, and within 28 days of the last dose.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who were enrolled and received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Plasma Concentration (Cmax) of Mirvetuximab Soravtansine and Total M9346A Antibody at RP2D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mirvetuximab Soravtansine 6.0 mg/kg AIBW', 'description': 'Participants received mirvetuximab soravtansine 6.0 mg/kg (calculated based on AIBW) on Day 1 of Cycle 1 and Cycle 3.'}], 'classes': [{'title': 'Mirvetuximab soravtansine at Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '146.9', 'spread': '30.14', 'groupId': 'OG000'}]}]}, {'title': 'Mirvetuximab soravtansine at Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '154.6', 'spread': '33.08', 'groupId': 'OG000'}]}]}, {'title': 'Total M9346A antibody at Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '149.2', 'spread': '33.74', 'groupId': 'OG000'}]}]}, {'title': 'Total M9346A antibody at Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '170.4', 'spread': '40.55', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1, 3: Day 1 (pre-infusion; within 10 minutes [min] of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion)', 'description': 'Pharmacokinetic (PK) parameters were calculated using standard non-compartmental methods. PK analysis of mirvetuximab soravtansine and total M9346A antibody is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.', 'unitOfMeasure': 'micrograms per milliliter (mcg/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PK Population included all participants who received at least 1 infusion of mirvetuximab soravtansine and had evaluable PK data. 'Overall number of participants analyzed' = participants who received mirvetuximab soravtansine at 6 mg/kg AIBW. 'Number analyzed' = participants evaluable for this outcome for specified categories."}, {'type': 'SECONDARY', 'title': 'Cmax of Free DM4 and S-Methyl DM4 at RP2D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mirvetuximab Soravtansine 6.0 mg/kg AIBW', 'description': 'Participants received mirvetuximab soravtansine 6.0 mg/kg (calculated based on AIBW) on Day 1 of Cycle 1 and Cycle 3.'}], 'classes': [{'title': 'DM4 at Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.014', 'spread': '3.119', 'groupId': 'OG000'}]}]}, {'title': 'DM4 at Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.016', 'spread': '2.389', 'groupId': 'OG000'}]}]}, {'title': 'S-methyl DM4 at Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12.43', 'spread': '12.39', 'groupId': 'OG000'}]}]}, {'title': 'S-methyl DM4 at Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.974', 'spread': '5.485', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1, 3: Day 1 (pre-infusion; within 10 min of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion)', 'description': "PK parameters were calculated using standard non-compartmental methods. PK analysis of free N2'-\\[4-\\[(3-carboxypropyl)dithio\\]-4-methyl-1-oxo-2-sulfopentyl\\]-N2'-deacetylmaytansine (DM4) and S-methyl DM4 is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.", 'unitOfMeasure': 'nanograms per milliliter (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PK Population included all participants who received at least 1 infusion of mirvetuximab soravtansine and had evaluable PK data. 'Overall number of participants analyzed' = participants who received mirvetuximab soravtansine at 6 mg/kg AIBW. 'Number analyzed' = participants evaluable for this outcome for specified categories."}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) of Mirvetuximab Soravtansine and Total M9346A Antibody at RP2D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mirvetuximab Soravtansine 6.0 mg/kg AIBW', 'description': 'Participants received mirvetuximab soravtansine 6.0 mg/kg (calculated based on AIBW) on Day 1 of Cycle 1 and Cycle 3.'}], 'classes': [{'title': 'Mirvetuximab soravtansine at Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17.39', 'spread': '4.341', 'groupId': 'OG000'}]}]}, {'title': 'Mirvetuximab soravtansine at Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20.40', 'spread': '5.144', 'groupId': 'OG000'}]}]}, {'title': 'Total M9346A antibody at Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '24.00', 'spread': '7.316', 'groupId': 'OG000'}]}]}, {'title': 'Total M9346A antibody at Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '37.27', 'spread': '12.54', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1, 3: Day 1 (pre-infusion; within 10 min of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion)', 'description': 'PK parameters were calculated using standard non-compartmental methods. PK analysis of mirvetuximab soravtansine and total M9346A antibody is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.', 'unitOfMeasure': 'hours*milligrams/milliliter (hr*mg/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PK Population included all participants who received at least 1 infusion of mirvetuximab soravtansine and had evaluable PK data. 'Overall number of participants analyzed' = participants who received mirvetuximab soravtansine at 6 mg/kg AIBW. 'Number analyzed' = participants evaluable for this outcome for specified categories."}, {'type': 'SECONDARY', 'title': 'AUC0-inf of Free DM4 and S-Methyl DM4 at RP2D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mirvetuximab Soravtansine 6.0 mg/kg AIBW', 'description': 'Participants received mirvetuximab soravtansine 6.0 mg/kg (calculated based on AIBW) on Day 1 of Cycle 1 and Cycle 3.'}], 'classes': [{'title': 'DM4 at Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '292.9', 'spread': '129.2', 'groupId': 'OG000'}]}]}, {'title': 'DM4 at Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '290.6', 'spread': '98.52', 'groupId': 'OG000'}]}]}, {'title': 'S-methyl DM4 at Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2656', 'spread': '2722', 'groupId': 'OG000'}]}]}, {'title': 'S-methyl DM4 at Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1928', 'spread': '1108', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1, 3: Day 1 (pre-infusion; within 10 min of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion)', 'description': 'PK parameters were calculated using standard non-compartmental methods. PK analysis of free DM4 and S-methyl DM4 is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.', 'unitOfMeasure': 'hours*nanograms/milliliter (hr*ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PK Population included all participants who received at least 1 infusion of mirvetuximab soravtansine and had evaluable PK data. 'Overall number of participants analyzed' = participants who received mirvetuximab soravtansine at 6 mg/kg AIBW. 'Number analyzed' = participants evaluable for this outcome for specified categories."}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration-Versus Time Curve From Time of Dose Until Tlast (AUClast) of Mirvetuximab Soravtansine and Total M9346A Antibody at RP2D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mirvetuximab Soravtansine 6.0 mg/kg AIBW', 'description': 'Participants received mirvetuximab soravtansine 6.0 mg/kg (calculated based on AIBW) on Day 1 of Cycle 1 and Cycle 3.'}], 'classes': [{'title': 'Mirvetuximab soravtansine at Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16.44', 'spread': '4.177', 'groupId': 'OG000'}]}]}, {'title': 'Mirvetuximab soravtansine at Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18.91', 'spread': '4.940', 'groupId': 'OG000'}]}]}, {'title': 'Total M9346A antibody at Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20.27', 'spread': '5.903', 'groupId': 'OG000'}]}]}, {'title': 'Total M9346A antibody at Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '29.29', 'spread': '9.613', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1, 3: Day 1 (pre-infusion; within 10 min of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion)', 'description': 'PK parameters were calculated using standard non-compartmental methods. PK analysis of mirvetuximab soravtansine and total M9346A antibody is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.', 'unitOfMeasure': 'hr*mg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PK Population included all participants who received at least 1 infusion of mirvetuximab soravtansine and had evaluable PK data. 'Overall number of participants analyzed' = participants who received mirvetuximab soravtansine at 6 mg/kg AIBW. 'Number analyzed' = participants evaluable for this outcome for specified categories."}, {'type': 'SECONDARY', 'title': 'AUClast of Free DM4 and S-Methyl DM4 at RP2D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mirvetuximab Soravtansine 6.0 mg/kg AIBW', 'description': 'Participants received mirvetuximab soravtansine 6.0 mg/kg (calculated based on AIBW) on Day 1 of Cycle 1 and Cycle 3.'}], 'classes': [{'title': 'DM4 at Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '246.0', 'spread': '133.3', 'groupId': 'OG000'}]}]}, {'title': 'DM4 at Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '270.1', 'spread': '95.62', 'groupId': 'OG000'}]}]}, {'title': 'S-methyl DM4 at Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2485', 'spread': '2536', 'groupId': 'OG000'}]}]}, {'title': 'S-methyl DM4 at Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1806', 'spread': '1046', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1, 3: Day 1 (pre-infusion; within 10 min of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion)', 'description': 'PK parameters were calculated using standard non-compartmental methods. PK analysis of free DM4 and S-methyl DM4 is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.', 'unitOfMeasure': 'hr*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PK Population included all participants who received at least 1 infusion of mirvetuximab soravtansine and had evaluable PK data. 'Overall number of participants analyzed' = participants who received mirvetuximab soravtansine at 6 mg/kg AIBW. 'Number analyzed' = participants evaluable for this outcome for specified categories."}, {'type': 'SECONDARY', 'title': 'Terminal Half-Life (t1/2) of Mirvetuximab Soravtansine,Total M9346A Antibody, DM4, and S-Methyl DM4 at RP2D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mirvetuximab Soravtansine 6.0 mg/kg AIBW', 'description': 'Participants received mirvetuximab soravtansine 6.0 mg/kg (calculated based on AIBW) on Day 1 of Cycle 1 and Cycle 3.'}], 'classes': [{'title': 'Mirvetuximab soravtansine at Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '119.4', 'spread': '22.58', 'groupId': 'OG000'}]}]}, {'title': 'Mirvetuximab soravtansine at Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '127.8', 'spread': '34.11', 'groupId': 'OG000'}]}]}, {'title': 'Total M9346A antibody at Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '186.7', 'spread': '54.04', 'groupId': 'OG000'}]}]}, {'title': 'Total M9346A antibody at Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '218.8', 'spread': '71.46', 'groupId': 'OG000'}]}]}, {'title': 'DM4 at Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '73.80', 'spread': '28.99', 'groupId': 'OG000'}]}]}, {'title': 'DM4 at Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '80.62', 'spread': '26.12', 'groupId': 'OG000'}]}]}, {'title': 'S-methyl DM4 at Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '122.2', 'spread': '25.23', 'groupId': 'OG000'}]}]}, {'title': 'S-methyl DM4 at Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '130.4', 'spread': '23.47', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1, 3: Day 1 (pre-infusion; within 10 min of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion)', 'description': 'PK parameters were calculated using standard non-compartmental methods. PK analysis of mirvetuximab soravtansine, total M9346A antibody, DM4, and S-methyl DM4 is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PK Population included all participants who received at least 1 infusion of mirvetuximab soravtansine and had evaluable PK data. 'Overall number of participants analyzed' = participants who received mirvetuximab soravtansine at 6 mg/kg AIBW. 'Number analyzed' = participants evaluable for this outcome for specified categories."}, {'type': 'SECONDARY', 'title': 'Clearance (CL) of Mirvetuximab Soravtansine and Total M9346A Antibody at RP2D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mirvetuximab Soravtansine 6.0 mg/kg AIBW', 'description': 'Participants received mirvetuximab soravtansine 6.0 mg/kg (calculated based on AIBW) on Day 1 of Cycle 1 and Cycle 3.'}], 'classes': [{'title': 'Mirvetuximab soravtansine at Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '22.20', 'spread': '6.476', 'groupId': 'OG000'}]}]}, {'title': 'Mirvetuximab soravtansine at Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19.80', 'spread': '4.953', 'groupId': 'OG000'}]}]}, {'title': 'Total M9346A antibody at Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16.89', 'spread': '7.155', 'groupId': 'OG000'}]}]}, {'title': 'Total M9346A antibody at Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13.26', 'spread': '4.956', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1, 3: Day 1 (pre-infusion; within 10 min of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion)', 'description': 'PK parameters were calculated using standard non-compartmental methods. PK analysis of mirvetuximab soravtansine and total M9346A antibody is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.', 'unitOfMeasure': 'milliliters per hour (mL/hr)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PK Population included all participants who received at least 1 infusion of mirvetuximab soravtansine and had evaluable PK data. 'Overall number of participants analyzed' = participants who received mirvetuximab soravtansine at 6 mg/kg AIBW. 'Number analyzed' = participants evaluable for this outcome for specified categories."}, {'type': 'SECONDARY', 'title': 'CL of DM4 and S-Methyl DM4 at RP2D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mirvetuximab Soravtansine 6.0 mg/kg AIBW', 'description': 'Participants received mirvetuximab soravtansine 6.0 mg/kg (calculated based on AIBW) on Day 1 of Cycle 1 and Cycle 3.'}], 'classes': [{'title': 'DM4 at Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1421', 'spread': '560.2', 'groupId': 'OG000'}]}]}, {'title': 'DM4 at Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1338', 'spread': '438.8', 'groupId': 'OG000'}]}]}, {'title': 'S-methyl DM4 at Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '218.9', 'spread': '128.5', 'groupId': 'OG000'}]}]}, {'title': 'S-methyl DM4 at Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '258.4', 'spread': '173.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1, 3: Day 1 (pre-infusion; within 10 min of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion)', 'description': 'PK parameters were calculated using standard non-compartmental methods. PK analysis of DM4 and S-methyl DM4 is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.', 'unitOfMeasure': 'Liters per hour (L/hr)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PK Population included all participants who received at least 1 infusion of mirvetuximab soravtansine and had evaluable PK data. 'Overall number of participants analyzed' = participants who received mirvetuximab soravtansine at 6 mg/kg AIBW. 'Number analyzed' = participants evaluable for this outcome for specified categories."}, {'type': 'SECONDARY', 'title': 'Time to Reach Maximum Observed Concentration (Tmax) of Mirvetuximab Soravtansine, Free DM4, S-Methyl DM4, and Total M9346A Antibody at RP2D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mirvetuximab Soravtansine 6.0 mg/kg AIBW', 'description': 'Participants received mirvetuximab soravtansine 6.0 mg/kg (calculated based on AIBW) on Day 1 of Cycle 1 and Cycle 3.'}], 'classes': [{'title': 'Mirvetuximab soravtansine at Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.80', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '24'}]}]}, {'title': 'Mirvetuximab soravtansine at Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.20', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '47'}]}]}, {'title': 'Total M9346A antibody at Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.60', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '53'}]}]}, {'title': 'Total M9346A antibody at Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.20', 'groupId': 'OG000', 'lowerLimit': '0.93', 'upperLimit': '170'}]}]}, {'title': 'DM4 at Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.80', 'groupId': 'OG000', 'lowerLimit': '1.7', 'upperLimit': '500'}]}]}, {'title': 'DM4 at Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.00', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '670'}]}]}, {'title': 'S-methyl DM4 at Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '49.0', 'groupId': 'OG000', 'lowerLimit': '5.8', 'upperLimit': '500'}]}]}, {'title': 'S-methyl DM4 at Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '23.0', 'groupId': 'OG000', 'lowerLimit': '4.5', 'upperLimit': '670'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1, 3: Day 1 (pre-infusion; within 10 min of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion)', 'description': 'PK parameters were calculated using standard non-compartmental methods. PK analysis of mirvetuximab soravtansine, free DM4, S-methyl DM4, and total M9346A antibody is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': "PK Population included all participants who received at least 1 infusion of mirvetuximab soravtansine and had evaluable PK data. 'Overall number of participants analyzed' = participants who received mirvetuximab soravtansine at 6 mg/kg AIBW. 'Number analyzed' = participants evaluable for this outcome for specified categories."}, {'type': 'SECONDARY', 'title': 'Volume of Distribution at Steady State (Vss) of Mirvetuximab Soravtansine Free DM4, S-Methyl DM4, and Total M9346A Antibody at RP2D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mirvetuximab Soravtansine 6.0 mg/kg AIBW', 'description': 'Participants received mirvetuximab soravtansine 6.0 mg/kg (calculated based on AIBW) on Day 1 of Cycle 1 and Cycle 3.'}], 'classes': [{'title': 'Mirvetuximab soravtansine at Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.198', 'spread': '0.7422', 'groupId': 'OG000'}]}]}, {'title': 'Mirvetuximab soravtansine at Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.172', 'spread': '1.022', 'groupId': 'OG000'}]}]}, {'title': 'Total M9346A antibody at Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.744', 'spread': '0.9183', 'groupId': 'OG000'}]}]}, {'title': 'Total M9346A antibody at Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.671', 'spread': '1.185', 'groupId': 'OG000'}]}]}, {'title': 'DM4 at Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '107400', 'spread': '38770', 'groupId': 'OG000'}]}]}, {'title': 'DM4 at Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '114300', 'spread': '48740', 'groupId': 'OG000'}]}]}, {'title': 'S-methyl DM4 at Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '41590', 'spread': '27890', 'groupId': 'OG000'}]}]}, {'title': 'S-methyl DM4 at Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '47520', 'spread': '40440', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1, 3: Day 1 (pre-infusion; within 10 min of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion)', 'description': 'PK parameters were calculated using standard non-compartmental methods. PK analysis of mirvetuximab soravtansine, free DM4, S-methyl DM4, and total M9346A antibody is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PK Population included all participants who received at least 1 infusion of mirvetuximab soravtansine and had evaluable PK data. 'Overall number of participants analyzed' = participants who received mirvetuximab soravtansine at 6 mg/kg AIBW. 'Number analyzed' = participants evaluable for this outcome for specified categories."}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR): Percentage of Participants With Objective Response as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine Q3W)', 'description': "Participants received mirvetuximab soravtansine IV infusion on Day 1 of every 21-day (Q3W) cycle. Dose escalation started at 0.15 mg/kg and proceeded through 7.0 mg/kg. Doses calculated initially based on participant's TBW; then from protocol amendment 5 onwards, calculated based on AIBW. The doses evaluated during dose escalation for Schedule A, TBW were: 0.15 mg/kg (n=2); 0.5 mg/kg; 1.0 mg/kg, and 2.0 mg/kg (n=1, in each); 3.3 mg/kg (n=9); 5.0 mg/kg (n=11); and 7.0 mg/kg (n=5). The doses evaluated during dose escalation for Schedule A, AIBW were: 5.0 mg/kg (n=7); and 6 mg/kg (n=7). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study."}, {'id': 'OG001', 'title': 'Dose Escalation: Schedule B (Mirvetuximab Soravtansine Weekly)', 'description': 'Participants received mirvetuximab soravtansine IV infusion on Days 1, 8, and 15 of every 28-day cycle. Dose escalation started at 1.1 mg/kg and proceeded through 2.5 mg/kg (calculated based on AIBW). The doses evaluated during dose escalation for Schedule B, AIBW were: 1.1 mg/kg (n=5); 1.8 mg/kg (n=4), 2.0 mg/kg (n=9); and 2.5 mg/kg (n=7). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG002', 'title': 'Dose Expansion:EOC Participants(Mirvetuximab Soravtansine Q3W)', 'description': 'Participants with EOC received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle (calculated based on AIBW). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG003', 'title': 'Dose Expansion: EC Participants(Mirvetuximab Soravtansine Q3W)', 'description': 'Participants with EC received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle (calculated based on AIBW). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '15.8'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '2.7', 'upperLimit': '32.4'}, {'value': '30', 'groupId': 'OG002', 'lowerLimit': '21.8', 'upperLimit': '39.4'}, {'value': '8', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '27.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose of study drug until first BOR of CR or PR (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)', 'description': 'ORR was defined as percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). CR: Disappearance of all target or non-target lesions. All pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\\<) 10 millimeters (mm). PR: At least 30 percent (%) decrease in the sum of the longest diameters (SoD) of target lesions, taking as reference the baseline SoD.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy-evaluable population included participants who had radiographic assessment at baseline, received at least 1 dose of study drug, and had at least 1 post-dose tumor assessment or died or clinically progressed within 105 days of last dose. Data was only collected and reported combined for dose-escalation phase and not by individual doses.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR) as Assessed by RECIST v1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine Q3W)', 'description': "Participants received mirvetuximab soravtansine IV infusion on Day 1 of every 21-day (Q3W) cycle. Dose escalation started at 0.15 mg/kg and proceeded through 7.0 mg/kg. Doses calculated initially based on participant's TBW; then from protocol amendment 5 onwards, calculated based on AIBW. The doses evaluated during dose escalation for Schedule A, TBW were: 0.15 mg/kg (n=2); 0.5 mg/kg; 1.0 mg/kg, and 2.0 mg/kg (n=1, in each); 3.3 mg/kg (n=9); 5.0 mg/kg (n=11); and 7.0 mg/kg (n=5). The doses evaluated during dose escalation for Schedule A, AIBW were: 5.0 mg/kg (n=7); and 6 mg/kg (n=7). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study."}, {'id': 'OG001', 'title': 'Dose Escalation: Schedule B (Mirvetuximab Soravtansine Weekly)', 'description': 'Participants received mirvetuximab soravtansine IV infusion on Days 1, 8, and 15 of every 28-day cycle. Dose escalation started at 1.1 mg/kg and proceeded through 2.5 mg/kg (calculated based on AIBW). The doses evaluated during dose escalation for Schedule B, AIBW were: 1.1 mg/kg (n=5); 1.8 mg/kg (n=4), 2.0 mg/kg (n=9); and 2.5 mg/kg (n=7). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG002', 'title': 'Dose Expansion:EOC Participants(Mirvetuximab Soravtansine Q3W)', 'description': 'Participants with EOC received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle (calculated based on AIBW). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG003', 'title': 'Dose Expansion: EC Participants(Mirvetuximab Soravtansine Q3W)', 'description': 'Participants with EC received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle (calculated based on AIBW). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.3', 'groupId': 'OG000', 'lowerLimit': '18.4', 'upperLimit': '24.1'}, {'value': '60.2', 'groupId': 'OG001', 'lowerLimit': '44.3', 'upperLimit': '76.1'}, {'value': '19.3', 'groupId': 'OG002', 'lowerLimit': '18.0', 'upperLimit': '34.0'}, {'value': '28.6', 'comment': 'Due to smaller number of events, 95% CI could not be calculated.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of first response (CR or PR) until the date of PD (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)', 'description': 'DOR was defined as the time from the date of the first response (CR or PR), whichever was recorded first, until the date of progressive disease (PD). PD: At least a 20% increase in the SoD of target lesion, taken as reference the smallest (nadir) SoD since and including baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase. DOR was only defined for participants who had a BOR of CR or PR using the method of Kaplan-Meier.', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Efficacy-evaluable population included participants who had radiographic assessment at baseline, received at least 1 dose of study drug, and had at least 1 post-dose tumor assessment or died or clinically progressed within 105 days of last dose. 'Overall number of participants analyzed'=participants who had a BOR of CR or PR. Data by group only."}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival (PFS) as Assessed by RECIST v1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine Q3W)', 'description': "Participants received mirvetuximab soravtansine IV infusion on Day 1 of every 21-day (Q3W) cycle. Dose escalation started at 0.15 mg/kg and proceeded through 7.0 mg/kg. Doses calculated initially based on participant's TBW; then from protocol amendment 5 onwards, calculated based on AIBW. The doses evaluated during dose escalation for Schedule A, TBW were: 0.15 mg/kg (n=2); 0.5 mg/kg; 1.0 mg/kg, and 2.0 mg/kg (n=1, in each); 3.3 mg/kg (n=9); 5.0 mg/kg (n=11); and 7.0 mg/kg (n=5). The doses evaluated during dose escalation for Schedule A, AIBW were: 5.0 mg/kg (n=7); and 6 mg/kg (n=7). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study."}, {'id': 'OG001', 'title': 'Dose Escalation: Schedule B (Mirvetuximab Soravtansine Weekly)', 'description': 'Participants received mirvetuximab soravtansine IV infusion on Days 1, 8, and 15 of every 28-day cycle. Dose escalation started at 1.1 mg/kg and proceeded through 2.5 mg/kg (calculated based on AIBW). The doses evaluated during dose escalation for Schedule B, AIBW were: 1.1 mg/kg (n=5); 1.8 mg/kg (n=4), 2.0 mg/kg (n=9); and 2.5 mg/kg (n=7). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG002', 'title': 'Dose Expansion:EOC Participants(Mirvetuximab Soravtansine Q3W)', 'description': 'Participants with EOC received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle (calculated based on AIBW). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG003', 'title': 'Dose Expansion: EC Participants(Mirvetuximab Soravtansine Q3W)', 'description': 'Participants with EC received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle (calculated based on AIBW). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '3.3'}, {'value': '3.9', 'groupId': 'OG001', 'lowerLimit': '1.8', 'upperLimit': '11.1'}, {'value': '4.3', 'groupId': 'OG002', 'lowerLimit': '3.9', 'upperLimit': '5.4'}, {'value': '2.8', 'groupId': 'OG003', 'lowerLimit': '1.2', 'upperLimit': '4.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose of study drug until PD or death whichever occurred first (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)', 'description': 'PFS was defined as the time from initiation of study drug until PD or death whichever occurred first, estimated using the Kaplan-Meier method. PD: At least a 20% increase in the SoD of target lesion, taken as reference the smallest (nadir) SoD since and including baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of non-target lesions and appearance of new lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy-evaluable population included participants who had radiographic assessment at baseline, received at least 1 dose of study drug, and had at least 1 post-dose tumor assessment or died or clinically progressed within 105 days of last dose. Data was only collected and reported combined for dose-escalation phase and not by individual doses.'}, {'type': 'SECONDARY', 'title': 'Time to Progression (TTP) as Assessed by RECIST v1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine Q3W)', 'description': "Participants received mirvetuximab soravtansine IV infusion on Day 1 of every 21-day (Q3W) cycle. Dose escalation started at 0.15 mg/kg and proceeded through 7.0 mg/kg. Doses calculated initially based on participant's TBW; then from protocol amendment 5 onwards, calculated based on AIBW. The doses evaluated during dose escalation for Schedule A, TBW were: 0.15 mg/kg (n=2); 0.5 mg/kg; 1.0 mg/kg, and 2.0 mg/kg (n=1, in each); 3.3 mg/kg (n=9); 5.0 mg/kg (n=11); and 7.0 mg/kg (n=5). The doses evaluated during dose escalation for Schedule A, AIBW were: 5.0 mg/kg (n=7); and 6 mg/kg (n=7). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study."}, {'id': 'OG001', 'title': 'Dose Escalation: Schedule B (Mirvetuximab Soravtansine Weekly)', 'description': 'Participants received mirvetuximab soravtansine IV infusion on Days 1, 8, and 15 of every 28-day cycle. Dose escalation started at 1.1 mg/kg and proceeded through 2.5 mg/kg (calculated based on AIBW). The doses evaluated during dose escalation for Schedule B, AIBW were: 1.1 mg/kg (n=5); 1.8 mg/kg (n=4), 2.0 mg/kg (n=9); and 2.5 mg/kg (n=7). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG002', 'title': 'Dose Expansion:EOC Participants(Mirvetuximab Soravtansine Q3W)', 'description': 'Participants with EOC received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle (calculated based on AIBW). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG003', 'title': 'Dose Expansion: EC Participants(Mirvetuximab Soravtansine Q3W)', 'description': 'Participants with EC received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle (calculated based on AIBW). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '3.3'}, {'value': '3.9', 'groupId': 'OG001', 'lowerLimit': '1.8', 'upperLimit': '11.1'}, {'value': '4.4', 'groupId': 'OG002', 'lowerLimit': '4.0', 'upperLimit': '5.6'}, {'value': '2.8', 'groupId': 'OG003', 'lowerLimit': '1.2', 'upperLimit': '6.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose of study drug until PD (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)', 'description': 'TTP was defined as the time from initiation of study drug until PD, estimated using the method of Kaplan-Meier. PD: At least a 20% increase in the SoD of target lesion, taken as reference the smallest (nadir) SoD since and including baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of non-target lesions and appearance of new lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy-evaluable population included participants who had radiographic assessment at baseline, received at least 1 dose of study drug, and had at least 1 post-dose tumor assessment or died or clinically progressed within 105 days of last dose. Data was only collected and reported combined for dose-escalation phase and not by individual doses.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Anti-Drug Antibodies (ADA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '9', 'groupId': 'OG010'}, {'value': '7', 'groupId': 'OG011'}, {'value': '46', 'groupId': 'OG012'}, {'value': '24', 'groupId': 'OG013'}, {'value': '27', 'groupId': 'OG014'}, {'value': '40', 'groupId': 'OG015'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 0.15 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG001', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 0.5 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG002', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 1.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG003', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG004', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 3.3 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG005', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 5.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG006', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 6.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG007', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 7.0 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 7.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG008', 'title': 'Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.1 mg/kg Weekly)', 'description': 'Participants received mirvetuximab soravtansine 1.1 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG009', 'title': 'Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.8 mg/kg Weekly)', 'description': 'Participants received mirvetuximab soravtansine 1.8 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG010', 'title': 'Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.0 mg/kg Weekly)', 'description': 'Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG011', 'title': 'Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.5 mg/kg Weekly)', 'description': 'Participants received mirvetuximab soravtansine 2.5 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG012', 'title': 'Dose Expansion: Cohort 1 (Mirvetuximab Soravtansine Q3W)', 'description': 'Participants with EOC, primary peritoneal cancer, or fallopian tube cancer resistant to platinum-based therapy received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG013', 'title': 'Dose Expansion: Cohort 2 (Mirvetuximab Soravtansine Q3W)', 'description': 'Participants with FOLR1-positive uterine cancer (that was advanced or recurrent and had received at least 1 platinum-based regimen, and no more than 5 prior systemic treatment regimens for EC) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG014', 'title': 'Dose Expansion: Cohort 3 (Mirvetuximab Soravtansine Q3W)', 'description': 'Participants with biopsy-accessible relapsed or refractory ovarian cancer, primary peritoneal cancer, or fallopian tube cancer received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG015', 'title': 'Dose Expansion: Cohort 5 (Mirvetuximab Soravtansine Q3W)', 'description': 'Participants with EOC primary peritoneal cancer or fallopian tube cancer (that had relapsed following platinum-based therapy, excluding those participants with primary platinum refractory disease or low grade or clear cell ovarian cancer) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '7', 'groupId': 'OG013'}, {'value': '2', 'groupId': 'OG014'}, {'value': '2', 'groupId': 'OG015'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to follow-up visit (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)', 'description': 'During the conduct of the study, a single immunogenicity assay was developed to concurrently detect human antibodies against all components of mirvetuximab soravtansine, including the humanized anti-FOLR1 antibody, the cleavable disulfide linker, and the cytotoxic maytansinoid, DM4. Therefore, immunogenicity results were reported as ADA titers, and did not distinguish between human anti-drug or anti-human titers.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Immunogenicity population included all participants who received at least 1 infusion of mirvetuximab soravtansine and had evaluable immunogenicity data.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Gynecologic Cancer Intergroup (GCIG) CA-125 Criteria Clinical Responses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '5', 'groupId': 'OG011'}, {'value': '31', 'groupId': 'OG012'}, {'value': '12', 'groupId': 'OG013'}, {'value': '20', 'groupId': 'OG014'}, {'value': '26', 'groupId': 'OG015'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 0.15 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG001', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 0.5 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG002', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 1.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG003', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG004', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 3.3 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG005', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 5.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG006', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 6.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG007', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 7.0 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 7.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG008', 'title': 'Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.1 mg/kg Weekly)', 'description': 'Participants received mirvetuximab soravtansine 1.1 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG009', 'title': 'Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.8 mg/kg Weekly)', 'description': 'Participants received mirvetuximab soravtansine 1.8 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG010', 'title': 'Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.0 mg/kg Weekly)', 'description': 'Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG011', 'title': 'Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.5 mg/kg Weekly)', 'description': 'Participants received mirvetuximab soravtansine 2.5 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG012', 'title': 'Dose Expansion: Cohort 1 (Mirvetuximab Soravtansine Q3W)', 'description': 'Participants with EOC, primary peritoneal cancer, or fallopian tube cancer resistant to platinum-based therapy received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG013', 'title': 'Dose Expansion: Cohort 2 (Mirvetuximab Soravtansine Q3W)', 'description': 'Participants with FOLR1-positive uterine cancer (that was advanced or recurrent and had received at least 1 platinum-based regimen, and no more than 5 prior systemic treatment regimens for EC) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG014', 'title': 'Dose Expansion: Cohort 3 (Mirvetuximab Soravtansine Q3W)', 'description': 'Participants with biopsy-accessible relapsed or refractory ovarian cancer, primary peritoneal cancer, or fallopian tube cancer received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'OG015', 'title': 'Dose Expansion: Cohort 5 (Mirvetuximab Soravtansine Q3W)', 'description': 'Participants with EOC primary peritoneal cancer or fallopian tube cancer (that had relapsed following platinum-based therapy, excluding those participants with primary platinum refractory disease or low grade or clear cell ovarian cancer) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '23', 'groupId': 'OG012'}, {'value': '4', 'groupId': 'OG013'}, {'value': '11', 'groupId': 'OG014'}, {'value': '17', 'groupId': 'OG015'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study drug until CA-125 response (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)', 'description': 'CA-125 response was defined as at least 50% reduction in CA-125 levels from baseline. The date of response corresponded to the date when the CA 125 level was first reduced by 50%.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'CA-125 evaluable population included participants who had a baseline CA-125 value greater than or equal to (\\>=) 2 \\* upper limit of normal (ULN), received at least 1 dose of study drug, and had at least 1 post-dose CA-125 assessment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 0.15 milligrams (mg)/kilogram (kg) intravenous (IV) infusion on Day 1 of every 21-day (every 3 weeks \\[Q3W\\]) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'FG001', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 0.5 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'FG002', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 1.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'FG003', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'FG004', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 3.3 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'FG005', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 5.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'FG006', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 6.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'FG007', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 7.0 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 7.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'FG008', 'title': 'Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.1 mg/kg Weekly)', 'description': 'Participants received mirvetuximab soravtansine 1.1 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'FG009', 'title': 'Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.8 mg/kg Weekly)', 'description': 'Participants received mirvetuximab soravtansine 1.8 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'FG010', 'title': 'Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.0 mg/kg Weekly)', 'description': 'Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'FG011', 'title': 'Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.5 mg/kg Weekly)', 'description': 'Participants received mirvetuximab soravtansine 2.5 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'FG012', 'title': 'Dose Expansion: Cohort 1 (Mirvetuximab Soravtansine Q3W)', 'description': 'Participants with EOC, primary peritoneal cancer, or fallopian tube cancer resistant to platinum-based therapy received mirvetuximab soravtansine 6.0 mg/kg (maximum tolerated dose \\[MTD\\]) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'FG013', 'title': 'Dose Expansion: Cohort 2 (Mirvetuximab Soravtansine Q3W)', 'description': 'Participants with folate receptor 1 (FOLR1)-positive uterine cancer (that was advanced or recurrent and had received at least 1 platinum-based regimen, and no more than 5 prior systemic treatment regimens for EC) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'FG014', 'title': 'Dose Expansion: Cohort 3 (Mirvetuximab Soravtansine Q3W)', 'description': 'Participants with biopsy-accessible relapsed or refractory ovarian cancer, primary peritoneal cancer, or fallopian tube cancer received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'FG015', 'title': 'Dose Expansion: Cohort 5 (Mirvetuximab Soravtansine Q3W)', 'description': 'Participants with EOC primary peritoneal cancer or fallopian tube cancer (that had relapsed following platinum-based therapy, excluding those participants with primary platinum refractory disease or low grade or clear cell ovarian cancer) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}], 'periods': [{'title': 'Dose Escalation: Maximum 101.3 Weeks', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '18'}, {'groupId': 'FG006', 'numSubjects': '7'}, {'groupId': 'FG007', 'numSubjects': '5'}, {'groupId': 'FG008', 'numSubjects': '5'}, {'groupId': 'FG009', 'numSubjects': '4'}, {'groupId': 'FG010', 'numSubjects': '9'}, {'groupId': 'FG011', 'numSubjects': '7'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '18'}, {'groupId': 'FG006', 'numSubjects': '7'}, {'groupId': 'FG007', 'numSubjects': '5'}, {'groupId': 'FG008', 'numSubjects': '5'}, {'groupId': 'FG009', 'numSubjects': '4'}, {'groupId': 'FG010', 'numSubjects': '9'}, {'groupId': 'FG011', 'numSubjects': '7'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '18'}, {'groupId': 'FG006', 'numSubjects': '7'}, {'groupId': 'FG007', 'numSubjects': '5'}, {'groupId': 'FG008', 'numSubjects': '5'}, {'groupId': 'FG009', 'numSubjects': '4'}, {'groupId': 'FG010', 'numSubjects': '9'}, {'groupId': 'FG011', 'numSubjects': '7'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '1'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}]}, {'type': 'Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '13'}, {'groupId': 'FG006', 'numSubjects': '5'}, {'groupId': 'FG007', 'numSubjects': '4'}, {'groupId': 'FG008', 'numSubjects': '3'}, {'groupId': 'FG009', 'numSubjects': '3'}, {'groupId': 'FG010', 'numSubjects': '6'}, {'groupId': 'FG011', 'numSubjects': '3'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}]}, {'type': 'Clinical Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '2'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}]}, {'type': 'Began New Anticancer Therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '1'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}]}, {'type': 'Investigator Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}]}]}, {'title': 'Dose Expansion: Maximum 124 Weeks', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '46'}, {'groupId': 'FG013', 'numSubjects': '24'}, {'groupId': 'FG014', 'numSubjects': '27'}, {'groupId': 'FG015', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '46'}, {'groupId': 'FG013', 'numSubjects': '24'}, {'groupId': 'FG014', 'numSubjects': '27'}, {'groupId': 'FG015', 'numSubjects': '40'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '4'}, {'groupId': 'FG013', 'numSubjects': '2'}, {'groupId': 'FG014', 'numSubjects': '2'}, {'groupId': 'FG015', 'numSubjects': '2'}]}, {'type': 'Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '32'}, {'groupId': 'FG013', 'numSubjects': '13'}, {'groupId': 'FG014', 'numSubjects': '20'}, {'groupId': 'FG015', 'numSubjects': '27'}]}, {'type': 'Clinical Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '3'}, {'groupId': 'FG013', 'numSubjects': '3'}, {'groupId': 'FG014', 'numSubjects': '3'}, {'groupId': 'FG015', 'numSubjects': '2'}]}, {'type': 'Began New Anticancer Therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '1'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '1'}, {'groupId': 'FG013', 'numSubjects': '4'}, {'groupId': 'FG014', 'numSubjects': '2'}, {'groupId': 'FG015', 'numSubjects': '5'}]}, {'type': 'Investigator Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '4'}, {'groupId': 'FG013', 'numSubjects': '2'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '3'}]}, {'type': 'Other Than Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '1'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "A total of 206 participants were enrolled in this study, of whom 69 participants (44 to receive Schedule A and 25 to receive Schedule B treatment) were entered in dose-escalation phase and 137 participants (113 with epithelial ovarian cancer \\[EOC\\] and 24 with endometrial cancer \\[EC\\]) were entered in dose-expansion phase. Doses calculated initially based on participant's total body weight (TBW); then from protocol amendment 5 onwards, calculated based on adjusted ideal body weight (AIBW).", 'preAssignmentDetails': 'Dose expansion Cohort 4 was planned to enroll relapsed/refractory non-small cell lung cancer (NSCLC) adenocarcinoma or bronchoalveolar carcinoma (BAC) but no participants were enrolled due to a company decision to focus on endometrial and ovarian carcinoma for the initial investigation.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '18', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}, {'value': '4', 'groupId': 'BG009'}, {'value': '9', 'groupId': 'BG010'}, {'value': '7', 'groupId': 'BG011'}, {'value': '46', 'groupId': 'BG012'}, {'value': '24', 'groupId': 'BG013'}, {'value': '27', 'groupId': 'BG014'}, {'value': '40', 'groupId': 'BG015'}, {'value': '206', 'groupId': 'BG016'}]}], 'groups': [{'id': 'BG000', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 0.15 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'BG001', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 0.5 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'BG002', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 1.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'BG003', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'BG004', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 3.3 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'BG005', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 5.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'BG006', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 6.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'BG007', 'title': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine 7.0 mg/kg Q3W)', 'description': 'Participants received mirvetuximab soravtansine 7.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'BG008', 'title': 'Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.1 mg/kg Weekly)', 'description': 'Participants received mirvetuximab soravtansine 1.1 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'BG009', 'title': 'Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.8 mg/kg Weekly)', 'description': 'Participants received mirvetuximab soravtansine 1.8 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'BG010', 'title': 'Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.0 mg/kg Weekly)', 'description': 'Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'BG011', 'title': 'Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.5 mg/kg Weekly)', 'description': 'Participants received mirvetuximab soravtansine 2.5 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'BG012', 'title': 'Dose Expansion: Cohort 1 (Mirvetuximab Soravtansine Q3W)', 'description': 'Participants with EOC, primary peritoneal cancer, or fallopian tube cancer resistant to platinum-based therapy received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'BG013', 'title': 'Dose Expansion: Cohort 2 (Mirvetuximab Soravtansine Q3W)', 'description': 'Participants with FOLR1-positive uterine cancer (that was advanced or recurrent and had received at least 1 platinum-based regimen, and no more than 5 prior systemic treatment regimens for EC) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'BG014', 'title': 'Dose Expansion: Cohort 3 (Mirvetuximab Soravtansine Q3W)', 'description': 'Participants with biopsy-accessible relapsed or refractory ovarian cancer, primary peritoneal cancer, or fallopian tube cancer received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'BG015', 'title': 'Dose Expansion: Cohort 5 (Mirvetuximab Soravtansine Q3W)', 'description': 'Participants with EOC primary peritoneal cancer or fallopian tube cancer (that had relapsed following platinum-based therapy, excluding those participants with primary platinum refractory disease or low grade or clear cell ovarian cancer) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.'}, {'id': 'BG016', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'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'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}, {'value': '5', 'groupId': 'BG010'}, {'value': '5', 'groupId': 'BG011'}, {'value': '25', 'groupId': 'BG012'}, {'value': '10', 'groupId': 'BG013'}, {'value': '17', 'groupId': 'BG014'}, {'value': '30', 'groupId': 'BG015'}, {'value': '122', 'groupId': 'BG016'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}, {'value': '4', 'groupId': 'BG010'}, {'value': '2', 'groupId': 'BG011'}, {'value': '21', 'groupId': 'BG012'}, {'value': '14', 'groupId': 'BG013'}, {'value': '10', 'groupId': 'BG014'}, {'value': '10', 'groupId': 'BG015'}, {'value': '84', 'groupId': 'BG016'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '16', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '4', 'groupId': 'BG008'}, {'value': '4', 'groupId': 'BG009'}, {'value': '9', 'groupId': 'BG010'}, {'value': '7', 'groupId': 'BG011'}, {'value': '46', 'groupId': 'BG012'}, {'value': '24', 'groupId': 'BG013'}, {'value': '27', 'groupId': 'BG014'}, {'value': '40', 'groupId': 'BG015'}, {'value': '200', 'groupId': 'BG016'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '6', 'groupId': 'BG016'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'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': '2', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '4', 'groupId': 'BG016'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '16', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '4', 'groupId': 'BG008'}, {'value': '4', 'groupId': 'BG009'}, {'value': '9', 'groupId': 'BG010'}, {'value': '6', 'groupId': 'BG011'}, {'value': '44', 'groupId': 'BG012'}, {'value': '23', 'groupId': 'BG013'}, {'value': '26', 'groupId': 'BG014'}, {'value': '33', 'groupId': 'BG015'}, {'value': '189', 'groupId': 'BG016'}]}, {'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'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '2', 'groupId': 'BG012'}, {'value': '1', 'groupId': 'BG013'}, {'value': '1', 'groupId': 'BG014'}, {'value': '7', 'groupId': 'BG015'}, {'value': '13', 'groupId': 'BG016'}]}]}], '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'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '2', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '2', 'groupId': 'BG016'}]}, {'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': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '2', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '2', 'groupId': 'BG014'}, {'value': '3', 'groupId': 'BG015'}, {'value': '8', 'groupId': 'BG016'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '2', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '1', 'groupId': 'BG015'}, {'value': '5', 'groupId': 'BG016'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '18', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}, {'value': '4', 'groupId': 'BG009'}, {'value': '9', 'groupId': 'BG010'}, {'value': '5', 'groupId': 'BG011'}, {'value': '41', 'groupId': 'BG012'}, {'value': '23', 'groupId': 'BG013'}, {'value': '25', 'groupId': 'BG014'}, {'value': '34', 'groupId': 'BG015'}, {'value': '187', 'groupId': 'BG016'}]}, {'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'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}]}, {'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'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '1', 'groupId': 'BG012'}, {'value': '1', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '2', 'groupId': 'BG015'}, {'value': '4', 'groupId': 'BG016'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety population included all participants who were enrolled and received at least 1 dose of study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-09-02', 'size': 1552937, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-01-20T11:51', 'hasProtocol': True}, {'date': '2018-02-01', 'size': 857158, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-01-20T11:51', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 206}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2018-03-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-27', 'studyFirstSubmitDate': '2012-05-30', 'resultsFirstSubmitDate': '2019-02-01', 'studyFirstSubmitQcDate': '2012-05-31', 'lastUpdatePostDateStruct': {'date': '2021-02-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-01-27', 'studyFirstPostDateStruct': {'date': '2012-06-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose-Escalation Phase: Maximum Tolerated Dose (MTD) of Mirvetuximab Soravtansine', 'timeFrame': 'Cycle 1 (21 days)', 'description': 'MTD was defined as the highest dose at which 1 or fewer among 6 participants or less than or equal to (\\<=) 33 percent (%) experienced a dose-limiting toxicity (DLT) (calculated based on adjusted ideal body weight \\[AIBW\\]). AIBW was calculated as ideal body weight (IBW) + 0.4 \\* (actual weight - IBW), where IBW for men was 0.9 \\* height in centimeters (cm) - 88 and IBW for women was 0.9 \\* height in cm - 92. DLT was defined as a treatment-emergent adverse event (TEAE) or abnormal laboratory value related to study treatment (that is, assessed as unrelated to disease, intercurrent illness, or concomitant medications), including those TEAEs and abnormal laboratory values that resulted in a failure to meet the criteria for re-treatment.'}, {'measure': 'Dose-Escalation Phase: Recommended Phase 2 Dose (RP2D) of Mirvetuximab Soravtansine', 'timeFrame': 'Cycle 1 (21 days)', 'description': 'RP2D was determined by MTD. MTD was defined as the highest dose at which 1 or fewer among 6 participants or \\<=33% experienced a DLT. DLT was defined as a TEAE or abnormal laboratory value related to study treatment (that is, assessed as unrelated to disease, intercurrent illness, or concomitant medications), including those TEAEs and abnormal laboratory values that resulted in a failure to meet the criteria for re-treatment. Available clinical data indicated that the MTD defined for the Q3W schedule was equal to the RP2D.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With TEAEs', 'timeFrame': 'From first dose of study drug up to 28 days after last dose of study drug (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)', 'description': 'An adverse event (AE) was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to study drug. Severity was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03 on following scale: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening, Grade 5=death. Serious AEs include death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as any AE that emerged on or after the first dose, and within 28 days of the last dose.'}, {'measure': 'Number of Participants With Shift From Baseline Grade <=2 in Clinical Laboratory Parameters to Grade 3 or Grade 4 on Study', 'timeFrame': 'From first dose of study drug up to 28 days after last dose of study drug (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)', 'description': 'Laboratory parameters included serum chemistry (alanine aminotransferase \\[ALT\\]/serum glutamic pyruvic transaminase \\[SGPT\\], aspartate aminotransferase \\[AST\\]/serum glutamic oxaloacetic transaminase \\[SGOT\\], albumin, alkaline phosphatase, bilirubin, calcium, creatinine, glucose, magnesium, phosphorous, potassium, sodium), hematology (hemoglobin, lymphocytes, neutrophils, platelets, white blood cells) and coagulation (international normalized ratio \\[INR\\], partial thromboplastin time \\[PTT\\]). Clinically significant laboratory values were defined as per NCI CTCAE v.03 Grade 3 or higher. A grading (severity) scale was provided with grades ranging from 0 (none), 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening or disabling), to 5 (death). Only participants who shifted from a baseline value of Grade \\<=2 to a post-baseline Grade 3/4 on-treatment, are reported.'}, {'measure': 'Number of Participants With Clinically Significant Abnormalities in Physical Examination Findings and Vital Signs', 'timeFrame': 'From first dose of study drug up to 28 days after last dose of study drug (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)', 'description': 'Physical examination included assessments of general appearance, skin, head (eyes, ears, nose, and throat), neck, lungs, heart, abdomen, back, lymph nodes, extremities, and neurological system. Vital signs included assessment of blood pressure, pulse rate, respiratory rate and body temperature.'}, {'measure': 'Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG)', 'timeFrame': 'Baseline up to end of treatment (EOT) (up to maximum 124 weeks)', 'description': 'Standard ECGs were performed in triplicate at 2- to 5-minute intervals during the study. A single ECG was performed at the end of treatment visit and as clinically indicated.'}, {'measure': 'Number of Participants With Treatment-Emergent Ocular AEs', 'timeFrame': 'From first dose of study drug up to 28 days after last dose of study drug (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)', 'description': 'Ocular AEs included keratopathy and blurred vision. An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to study drug. TEAEs were defined as any AE that emerged on or after the first dose, and within 28 days of the last dose.'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) of Mirvetuximab Soravtansine and Total M9346A Antibody at RP2D', 'timeFrame': 'Cycle 1, 3: Day 1 (pre-infusion; within 10 minutes [min] of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion)', 'description': 'Pharmacokinetic (PK) parameters were calculated using standard non-compartmental methods. PK analysis of mirvetuximab soravtansine and total M9346A antibody is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.'}, {'measure': 'Cmax of Free DM4 and S-Methyl DM4 at RP2D', 'timeFrame': 'Cycle 1, 3: Day 1 (pre-infusion; within 10 min of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion)', 'description': "PK parameters were calculated using standard non-compartmental methods. PK analysis of free N2'-\\[4-\\[(3-carboxypropyl)dithio\\]-4-methyl-1-oxo-2-sulfopentyl\\]-N2'-deacetylmaytansine (DM4) and S-methyl DM4 is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3."}, {'measure': 'Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) of Mirvetuximab Soravtansine and Total M9346A Antibody at RP2D', 'timeFrame': 'Cycle 1, 3: Day 1 (pre-infusion; within 10 min of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion)', 'description': 'PK parameters were calculated using standard non-compartmental methods. PK analysis of mirvetuximab soravtansine and total M9346A antibody is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.'}, {'measure': 'AUC0-inf of Free DM4 and S-Methyl DM4 at RP2D', 'timeFrame': 'Cycle 1, 3: Day 1 (pre-infusion; within 10 min of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion)', 'description': 'PK parameters were calculated using standard non-compartmental methods. PK analysis of free DM4 and S-methyl DM4 is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.'}, {'measure': 'Area Under the Plasma Concentration-Versus Time Curve From Time of Dose Until Tlast (AUClast) of Mirvetuximab Soravtansine and Total M9346A Antibody at RP2D', 'timeFrame': 'Cycle 1, 3: Day 1 (pre-infusion; within 10 min of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion)', 'description': 'PK parameters were calculated using standard non-compartmental methods. PK analysis of mirvetuximab soravtansine and total M9346A antibody is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.'}, {'measure': 'AUClast of Free DM4 and S-Methyl DM4 at RP2D', 'timeFrame': 'Cycle 1, 3: Day 1 (pre-infusion; within 10 min of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion)', 'description': 'PK parameters were calculated using standard non-compartmental methods. PK analysis of free DM4 and S-methyl DM4 is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.'}, {'measure': 'Terminal Half-Life (t1/2) of Mirvetuximab Soravtansine,Total M9346A Antibody, DM4, and S-Methyl DM4 at RP2D', 'timeFrame': 'Cycle 1, 3: Day 1 (pre-infusion; within 10 min of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion)', 'description': 'PK parameters were calculated using standard non-compartmental methods. PK analysis of mirvetuximab soravtansine, total M9346A antibody, DM4, and S-methyl DM4 is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.'}, {'measure': 'Clearance (CL) of Mirvetuximab Soravtansine and Total M9346A Antibody at RP2D', 'timeFrame': 'Cycle 1, 3: Day 1 (pre-infusion; within 10 min of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion)', 'description': 'PK parameters were calculated using standard non-compartmental methods. PK analysis of mirvetuximab soravtansine and total M9346A antibody is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.'}, {'measure': 'CL of DM4 and S-Methyl DM4 at RP2D', 'timeFrame': 'Cycle 1, 3: Day 1 (pre-infusion; within 10 min of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion)', 'description': 'PK parameters were calculated using standard non-compartmental methods. PK analysis of DM4 and S-methyl DM4 is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.'}, {'measure': 'Time to Reach Maximum Observed Concentration (Tmax) of Mirvetuximab Soravtansine, Free DM4, S-Methyl DM4, and Total M9346A Antibody at RP2D', 'timeFrame': 'Cycle 1, 3: Day 1 (pre-infusion; within 10 min of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion)', 'description': 'PK parameters were calculated using standard non-compartmental methods. PK analysis of mirvetuximab soravtansine, free DM4, S-methyl DM4, and total M9346A antibody is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.'}, {'measure': 'Volume of Distribution at Steady State (Vss) of Mirvetuximab Soravtansine Free DM4, S-Methyl DM4, and Total M9346A Antibody at RP2D', 'timeFrame': 'Cycle 1, 3: Day 1 (pre-infusion; within 10 min of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion)', 'description': 'PK parameters were calculated using standard non-compartmental methods. PK analysis of mirvetuximab soravtansine, free DM4, S-methyl DM4, and total M9346A antibody is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.'}, {'measure': 'Objective Response Rate (ORR): Percentage of Participants With Objective Response as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)', 'timeFrame': 'From first dose of study drug until first BOR of CR or PR (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)', 'description': 'ORR was defined as percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). CR: Disappearance of all target or non-target lesions. All pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\\<) 10 millimeters (mm). PR: At least 30 percent (%) decrease in the sum of the longest diameters (SoD) of target lesions, taking as reference the baseline SoD.'}, {'measure': 'Duration of Response (DOR) as Assessed by RECIST v1.1', 'timeFrame': 'From the date of first response (CR or PR) until the date of PD (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)', 'description': 'DOR was defined as the time from the date of the first response (CR or PR), whichever was recorded first, until the date of progressive disease (PD). PD: At least a 20% increase in the SoD of target lesion, taken as reference the smallest (nadir) SoD since and including baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase. DOR was only defined for participants who had a BOR of CR or PR using the method of Kaplan-Meier.'}, {'measure': 'Progression-Free Survival (PFS) as Assessed by RECIST v1.1', 'timeFrame': 'From first dose of study drug until PD or death whichever occurred first (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)', 'description': 'PFS was defined as the time from initiation of study drug until PD or death whichever occurred first, estimated using the Kaplan-Meier method. PD: At least a 20% increase in the SoD of target lesion, taken as reference the smallest (nadir) SoD since and including baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of non-target lesions and appearance of new lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.'}, {'measure': 'Time to Progression (TTP) as Assessed by RECIST v1.1', 'timeFrame': 'From first dose of study drug until PD (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)', 'description': 'TTP was defined as the time from initiation of study drug until PD, estimated using the method of Kaplan-Meier. PD: At least a 20% increase in the SoD of target lesion, taken as reference the smallest (nadir) SoD since and including baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of non-target lesions and appearance of new lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.'}, {'measure': 'Number of Participants With Anti-Drug Antibodies (ADA)', 'timeFrame': 'Baseline up to follow-up visit (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)', 'description': 'During the conduct of the study, a single immunogenicity assay was developed to concurrently detect human antibodies against all components of mirvetuximab soravtansine, including the humanized anti-FOLR1 antibody, the cleavable disulfide linker, and the cytotoxic maytansinoid, DM4. Therefore, immunogenicity results were reported as ADA titers, and did not distinguish between human anti-drug or anti-human titers.'}, {'measure': 'Number of Participants With Gynecologic Cancer Intergroup (GCIG) CA-125 Criteria Clinical Responses', 'timeFrame': 'From first dose of study drug until CA-125 response (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)', 'description': 'CA-125 response was defined as at least 50% reduction in CA-125 levels from baseline. The date of response corresponded to the date when the CA 125 level was first reduced by 50%.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['FOLR-1 solid tumors'], 'conditions': ['Tumors']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test mirvetuximab soravtansine (IMGN853) in participants with ovarian cancer and other FOLR-1 positive tumors.', 'detailedDescription': 'The study consists of a dose-escalation phase that will evaluate 2 dosing schedules (Schedule A and Schedule B) of mirvetuximab soravtansine and up to 5 dose-expansion groups at the maximum tolerated dose (MTD). The first 4 escalation cohorts will be single participant cohorts. Subsequent escalation cohorts will use a standard 3+3 design, with each cohort consisting of 3 or 4 to 6 participants. Data were collected and analysed for the escalation and expansion groups by dose schedule and not by individual dose.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\n* Participants with advanced solid tumor that is refractory to standard treatment, for which no standard treatment is available, or the participant refuses standard therapy.\n* Participants must be willing to provide an archival tumor tissue block or slides for biomarker analysis.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.\n* Time from prior therapy:\n\n 1. Systemic anti-neoplastic therapy: five half-lives or four weeks, whichever is shorter (6 weeks for prior nitrosoureas or mitomycin C).\n 2. Radiotherapy: wide-field radiotherapy (for example, greater than \\[\\>\\] 30 percent \\[%\\] of marrow-bearing bones) completed at least four weeks, or focal radiation completed at least two weeks, prior to starting study drug.\n* Participants must have recovered or stabilized from all therapy-related toxicities.\n* Major surgery (not including placement of vascular access device or tumor biopsies) must be completed four weeks prior to Day 1. Participants must have recovered or stabilized from the side effects prior to study treatment.\n* Participants must have adequate hematologic, liver and kidney function.\n* Participants with central nervous system (CNS) disease involvement are eligible if they have had brain metastases resected or have received radiation therapy ending at least 4 weeks prior to study day 1 and they meet all of the following criteria: Residual neurological symptoms less than or equal to (\\<=) Grade 1; No dexamethasone requirement; and Follow-up magnetic resonance imaging (MRI) shows no progression of treated lesions and no new lesions appearing.\n* Participants must be willing and able to sign the informed consent form, and to adhere to the study visit schedule and other protocol requirements.\n* Women of childbearing potential and men must agree to use effective contraceptive methods while on study and for at least twelve weeks after the last dose of study drug.\n* Women of childbearing potential must have a negative pregnancy test prior to the first dose of study treatment.\n\nExclusion Criteria\n\n* Grade \\>1 neuropathy.\n* Any active or chronic corneal disorder, including, but not limited to the following: Sjogren's syndrome, Fuch's corneal dystrophy (requiring treatment), history of corneal transplantation, active herpetic keratitis, and also active ocular conditions requiring ongoing treatment/monitoring such as wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, presence of papilledema, acquired monocular vision.\n* Serious concurrent illness, including, but not limited to the following:\n\n 1. Clinically relevant active infection including known active hepatitis B or C, Human Immunodeficiency Virus (HIV) infection, varicella-zoster virus (shingles) or cytomegalovirus infection or any other known concurrent infectious disease, requiring IV antibiotics within 2 weeks of study enrollment.\n 2. Significant cardiac disease such as recent myocardial infarction (\\<=6 months prior to Day 1), unstable angina pectoris, uncontrolled congestive heart failure (New York Heart Association \\>class II), uncontrolled hypertension (greater than or equal to \\[\\>=\\] Common Terminology Criteria for Adverse Events Version 4.03 \\[CTCAE v4.03\\] Grade 3), uncontrolled cardiac arrhythmias, severe aortic stenosis, or \\>=Grade 3 cardiac toxicity following prior chemotherapy.\n 3. History of multiple sclerosis or other demyelinating disease, Eaton-Lambert syndrome (para-neoplastic syndrome), history of hemorrhagic or ischemic stroke within the last six months, or alcoholic liver disease.\n 4. Previous clinical diagnosis of treatment-related pneumonitis.\n* Any other concomitant anti-cancer treatment such as immunotherapy, biotherapy, radiotherapy, chemotherapy, investigative therapy, or high-dose steroids; however, low dose steroids and Luteinizing Hormone Releasing Hormone (LHRH) at doses that have been stable for \\>=14 days are permitted for participants with prostate cancer.\n* Known hypersensitivity to previous monoclonal antibody therapy or maytansinoids.\n* Prior history of solid tumor malignancy within the last 3 years except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, in situ prostate cancer (participants must have shown no evidence of active disease for 2 years prior to enrollment).\n* Concomitant administration of folate-containing vitamins.\n* Participants who have received prior allogeneic or autologous bone marrow transplants.\n* Women of childbearing potential who are pregnant or breast feeding."}, 'identificationModule': {'nctId': 'NCT01609556', 'acronym': 'IMGN853-0401', 'briefTitle': 'First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Mirvetuximab Soravtansine in Adults With Ovarian Cancer and Other Folate Receptor 1 (FOLR1)-Positive Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'ImmunoGen, Inc.'}, 'officialTitle': 'A Phase 1, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IMGN853 in Adults With Ovarian Cancer and Other FOLR1-Positive Solid Tumors', 'orgStudyIdInfo': {'id': 'IMGN853-0401'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose Escalation: Schedule A (Mirvetuximab Soravtansine Q3W)', 'description': "Participants will receive mirvetuximab soravtansine intravenous (IV) infusion on Day 1 of every 21-day (every 3 weeks \\[Q3W\\]) cycle. Dose escalation for this group schedule will start at 0.15 milligrams per kilogram (mg/kg) and proceed through 7.0 mg/kg. Doses calculated initially based on participant's total body weight (TBW); then from protocol amendment 5 onwards, calculated based on adjusted ideal body weight (AIBW). Participants will continue to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever comes first, or until the sponsor terminate the study.", 'interventionNames': ['Drug: Mirvetuximab soravtansine']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Escalation: Schedule B (Mirvetuximab Soravtansine Weekly)', 'description': 'Participants will receive mirvetuximab soravtansine IV infusion on Days 1, 8, and 15 of every 28-day cycle. Dose escalation for this group schedule will start at 1.1 mg/kg (calculated based on AIBW) and proceed through 2.5 mg/kg. Participants will continue to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever comes first, or until the sponsor terminate the study.', 'interventionNames': ['Drug: Mirvetuximab soravtansine']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Expansion:EOC Participants(Mirvetuximab Soravtansine Q3W)', 'description': 'Participants with epithelial ovarian cancer (EOC) will receive mirvetuximab soravtansine 6.0 mg/kg (maximum tolerated dose \\[MTD\\]) IV infusion on Day 1 of every 21-day (Q3W) cycle (calculated based on AIBW). Participants will continue to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever comes first, or until the sponsor terminated the study.', 'interventionNames': ['Drug: Mirvetuximab soravtansine']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Expansion: EC Participants(Mirvetuximab Soravtansine Q3W)', 'description': 'Participants with endometrial cancer (EC) will receive mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle (calculated based on AIBW). Participants will continue to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever comes first, or until the sponsor terminate the study.', 'interventionNames': ['Drug: Mirvetuximab soravtansine']}], 'interventions': [{'name': 'Mirvetuximab soravtansine', 'type': 'DRUG', 'otherNames': ['IMGN853'], 'description': 'Mirvetuximab soravtansine IV infusion will be administered as per dose and schedule specified in the respective arms.', 'armGroupLabels': ['Dose Escalation: Schedule A (Mirvetuximab Soravtansine Q3W)', 'Dose Escalation: Schedule B (Mirvetuximab Soravtansine Weekly)', 'Dose Expansion: EC Participants(Mirvetuximab Soravtansine Q3W)', 'Dose Expansion:EOC Participants(Mirvetuximab Soravtansine Q3W)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66205', 'city': 'Fairway', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center Research Institute', 'geoPoint': {'lat': 39.02223, 'lon': -94.6319}}, {'zip': '02062', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Barbara Ann Karmanos Cancer Institute', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'University of Oklahoma Stephenson Cancer Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '19111', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Fox Chase Cancer Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Sarah Cannon Research Institute', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'CTRC at the University of Texas Health Science Center', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Princess Margaret Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H4A3J1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'McGill University Health Centre', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ImmunoGen, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}