{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"9"},{"groupId":"OG005","value":"18"},{"groupId":"OG006","value":"7"},{"groupId":"OG007","value":"5"},{"groupId":"OG008","value":"5"},{"groupId":"OG009","value":"4"},{"groupId":"OG010","value":"9"},{"groupId":"OG011","value":"7"},{"groupId":"OG012","value":"46"},{"groupId":"OG013","value":"24"},{"groupId":"OG014","value":"27"},{"groupId":"OG015","value":"40"}]}],"title":"Any TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"5"},{"groupId":"OG006","value":"1"},{"groupId":"OG007","value":"2"},{"groupId":"OG008","value":"2"},{"groupId":"OG009","value":"3"},{"groupId":"OG010","value":"4"},{"groupId":"OG011","value":"4"},{"groupId":"OG012","value":"18"},{"groupId":"OG013","value":"11"},{"groupId":"OG014","value":"9"},{"groupId":"OG015","value":"17"}]}],"title":"SAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"8"},{"groupId":"OG006","value":"1"},{"groupId":"OG007","value":"3"},{"groupId":"OG008","value":"2"},{"groupId":"OG009","value":"3"},{"groupId":"OG010","value":"4"},{"groupId":"OG011","value":"4"},{"groupId":"OG012","value":"24"},{"groupId":"OG013","value":"12"},{"groupId":"OG014","value":"14"},{"groupId":"OG015","value":"24"}]}],"title":"Grade >=3 TEAEs"}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"9"},{"groupId":"OG005","value":"18"},{"groupId":"OG006","value":"7"},{"groupId":"OG007","value":"5"},{"groupId":"OG008","value":"5"},{"groupId":"OG009","value":"4"},{"groupId":"OG010","value":"9"},{"groupId":"OG011","value":"7"},{"groupId":"OG012","value":"46"},{"groupId":"OG013","value":"24"},{"groupId":"OG014","value":"27"},{"groupId":"OG015","value":"40"}],"units":"Participants"}],"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.","groups":[{"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":"OG000","title":"Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 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":"OG001","title":"Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 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":"OG002","title":"Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 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":"OG003","title":"Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 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":"OG004","title":"Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 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":"OG005","title":"Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 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":"OG006","title":"Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 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":"OG007","title":"Dose Escalation: Schedule A (Mirvetuximab Soravtansine 7.0 mg/kg Q3W)"},{"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":"OG008","title":"Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.1 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":"OG009","title":"Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.8 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":"OG010","title":"Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.0 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":"OG011","title":"Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.5 mg/kg Weekly)"},{"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":"OG012","title":"Dose Expansion: Cohort 1 (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":"OG013","title":"Dose Expansion: Cohort 2 (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":"OG014","title":"Dose Expansion: Cohort 3 (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":"OG015","title":"Dose Expansion: Cohort 5 (Mirvetuximab Soravtansine Q3W)"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Safety population included all participants who were enrolled and received at least 1 dose of study drug.","reportingStatus":"POSTED","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)","title":"Number of Participants With TEAEs","type":"SECONDARY","unitOfMeasure":"Participants"}