NCT04209855 · ADVERSE EVENTS

Adverse events

A Study of Mirvetuximab Soravtansine vs. Investigator's Choice (IC) of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha (FRα) Expression · Source last updated 2025-08-27

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 31.1 months and 29.7 months for Mirvetuximab Soravtansine and Investigator's Choice (IC) Chemotherapy, respectively.
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Mirvetuximab Soravtansine Participants randomized to single-agent MIRV at 6 mg/kg AIBW administered IV on Day 1 of Q3W.	62 / 227	212 / 227	162 / 227
Investigator's Choice (IC) Chemotherapy Participants randomized to IC chemotherapeutic agent calculated using BSA. Paclitaxel administered at 80 mg/m\^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 of a 4-week cycle; or topotecan administered at 4 mg/m\^2 over 30 minutes on Days 1, 8, and 15 of a 4-week cycle. Alternatively, topotecan could have been administered at 1.25 mg/m\^2 over 30 minutes on Days 1 to 5 of a 3-week cycle; or pegylated liposomal doxorubicin administered at 40 mg/m\^2 as a 1 mg/minute IV infusion on Day 1 of a 4-week cycle. After Cycle 1, if tolerated, pegylated liposomal doxorubicin could have been administered as a 1-hour infusion.	73 / 226	196 / 226	177 / 226

Group identifiers: EG000: Mirvetuximab Soravtansine · EG001: Investigator's Choice (IC) Chemotherapy

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
227
num Events
0
group Id
EG001
num Affected
1
num At Risk
226
num Events
1
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
227
num Events
0
group Id
EG001
num Affected
1
num At Risk
226
num Events
1
term
FEBRILE NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
227
num Events
0
group Id
EG001
num Affected
4
num At Risk
226
num Events
6
term
NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
227
num Events
0
group Id
EG001
num Affected
1
num At Risk
226
num Events
1
term
PANCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
3
num At Risk
227
num Events
5
group Id
EG001
num Affected
3
num At Risk
226
num Events
3
term
THROMBOCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
227
num Events
1
group Id
EG001
num Affected
0
num At Risk
226
num Events
0
term
CARDIOPULMONARY FAILURE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
227
num Events
0
group Id
EG001
num Affected
1
num At Risk
226
num Events
1
term
CORONARY ARTERY DISEASE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
227
num Events
1
group Id
EG001
num Affected
0
num At Risk
226
num Events
0
term
CORONARY ARTERY STENOSIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
227
num Events
1
group Id
EG001
num Affected
1
num At Risk
226
num Events
1
term
PERICARDIAL EFFUSION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
227
num Events
1
group Id
EG001
num Affected
0
num At Risk
226
num Events
0
term
KERATITIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
227
num Events
1
group Id
EG001
num Affected
0
num At Risk
226
num Events
0
term
KERATOPATHY
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
227
num Events
1
group Id
EG001
num Affected
0
num At Risk
226
num Events
0
term
RETINAL DETACHMENT

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
30
num At Risk
227
num Events
66
group Id
EG001
num Affected
79
num At Risk
226
num Events
212
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
3
num At Risk
227
num Events
3
group Id
EG001
num Affected
12
num At Risk
226
num Events
34
term
LEUKOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
27
num At Risk
227
num Events
49
group Id
EG001
num Affected
62
num At Risk
226
num Events
185
term
NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
16
num At Risk
227
num Events
20
group Id
EG001
num Affected
35
num At Risk
226
num Events
81
term
THROMBOCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
67
num At Risk
227
num Events
132
group Id
EG001
num Affected
28
num At Risk
226
num Events
31
term
CATARACT
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
73
num At Risk
227
num Events
149
group Id
EG001
num Affected
15
num At Risk
226
num Events
17
term
DRY EYE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
21
num At Risk
227
num Events
29
group Id
EG001
num Affected
1
num At Risk
226
num Events
2
term
EYE PAIN
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
78
num At Risk
227
num Events
211
group Id
EG001
num Affected
4
num At Risk
226
num Events
6
term
KERATOPATHY
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
46
num At Risk
227
num Events
73
group Id
EG001
num Affected
4
num At Risk
226
num Events
4
term
PHOTOPHOBIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
101
num At Risk
227
num Events
297
group Id
EG001
num Affected
12
num At Risk
226
num Events
14
term
VISION BLURRED
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
29
num At Risk
227
num Events
53
group Id
EG001
num Affected
0
num At Risk
226
num Events
0
term
VISUAL ACUITY REDUCED
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
17
num At Risk
227
num Events
23
group Id
EG001
num Affected
7
num At Risk
226
num Events
7
term
VITREOUS FLOATERS

Complete source fields

event Groups

deaths Num Affected
162
deaths Num At Risk
227
description
Participants randomized to single-agent MIRV at 6 mg/kg AIBW administered IV on Day 1 of Q3W.
id
EG000
other Num Affected
212
other Num At Risk
227
serious Num Affected
62
serious Num At Risk
227
title
Mirvetuximab Soravtansine
deaths Num Affected
177
deaths Num At Risk
226
description
Participants randomized to IC chemotherapeutic agent calculated using BSA. Paclitaxel administered at 80 mg/m\^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 of a 4-week cycle; or topotecan administered at 4 mg/m\^2 over 30 minutes on Days 1, 8, and 15 of a 4-week cycle. Alternatively, topotecan could have been administered at 1.25 mg/m\^2 over 30 minutes on Days 1 to 5 of a 3-week cycle; or pegylated liposomal doxorubicin administered at 40 mg/m\^2 as a 1 mg/minute IV infusion on Day 1 of a 4-week cycle. After Cycle 1, if tolerated, pegylated liposomal doxorubicin could have been administered as a 1-hour infusion.
id
EG001
other Num Affected
196
other Num At Risk
226
serious Num Affected
73
serious Num At Risk
226
title
Investigator's Choice (IC) Chemotherapy

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
30
num At Risk
227
num Events
66
group Id
EG001
num Affected
79
num At Risk
226
num Events
212
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
3
num At Risk
227
num Events
3
group Id
EG001
num Affected
12
num At Risk
226
num Events
34
term
LEUKOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
27
num At Risk
227
num Events
49
group Id
EG001
num Affected
62
num At Risk
226
num Events
185
term
NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
16
num At Risk
227
num Events
20
group Id
EG001
num Affected
35
num At Risk
226
num Events
81
term
THROMBOCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
67
num At Risk
227
num Events
132
group Id
EG001
num Affected
28
num At Risk
226
num Events
31
term
CATARACT
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
73
num At Risk
227
num Events
149
group Id
EG001
num Affected
15
num At Risk
226
num Events
17
term
DRY EYE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
21
num At Risk
227
num Events
29
group Id
EG001
num Affected
1
num At Risk
226
num Events
2
term
EYE PAIN
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
78
num At Risk
227
num Events
211
group Id
EG001
num Affected
4
num At Risk
226
num Events
6
term
KERATOPATHY
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
46
num At Risk
227
num Events
73
group Id
EG001
num Affected
4
num At Risk
226
num Events
4
term
PHOTOPHOBIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
101
num At Risk
227
num Events
297
group Id
EG001
num Affected
12
num At Risk
226
num Events
14
term
VISION BLURRED
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
29
num At Risk
227
num Events
53
group Id
EG001
num Affected
0
num At Risk
226
num Events
0
term
VISUAL ACUITY REDUCED
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
17
num At Risk
227
num Events
23
group Id
EG001
num Affected
7
num At Risk
226
num Events
7
term
VITREOUS FLOATERS

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
227
num Events
0
group Id
EG001
num Affected
1
num At Risk
226
num Events
1
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
227
num Events
0
group Id
EG001
num Affected
1
num At Risk
226
num Events
1
term
FEBRILE NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
227
num Events
0
group Id
EG001
num Affected
4
num At Risk
226
num Events
6
term
NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
227
num Events
0
group Id
EG001
num Affected
1
num At Risk
226
num Events
1
term
PANCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
3
num At Risk
227
num Events
5
group Id
EG001
num Affected
3
num At Risk
226
num Events
3
term
THROMBOCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
227
num Events
1
group Id
EG001
num Affected
0
num At Risk
226
num Events
0
term
CARDIOPULMONARY FAILURE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
227
num Events
0
group Id
EG001
num Affected
1
num At Risk
226
num Events
1
term
CORONARY ARTERY DISEASE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
227
num Events
1
group Id
EG001
num Affected
0
num At Risk
226
num Events
0
term
CORONARY ARTERY STENOSIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
227
num Events
1
group Id
EG001
num Affected
1
num At Risk
226
num Events
1
term
PERICARDIAL EFFUSION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
227
num Events
1
group Id
EG001
num Affected
0
num At Risk
226
num Events
0
term
KERATITIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
227
num Events
1
group Id
EG001
num Affected
0
num At Risk
226
num Events
0
term
KERATOPATHY
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
227
num Events
1
group Id
EG001
num Affected
0
num At Risk
226
num Events
0
term
RETINAL DETACHMENT

time Frame

All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 31.1 months and 29.7 months for Mirvetuximab Soravtansine and Investigator's Choice (IC) Chemotherapy, respectively.

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Preserved source evidence · Not medical advice