TriangleNCT04209855 · STUDY IN CONTEXT
A Study of Mirvetuximab Soravtansine vs. Investigator's Choice (IC) of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
Read the full study record and all posted results →
Linked outcomes
PFS was defined as the time from randomization until progressive disease (PD) or death whichever occurred first. PD: At least a 20% increase in the sum of the longest diameters (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 millimeters (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.
ORR was defined as percentage of participants with a confirmed 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 \<10 mm. PR: At least 30% decrease in the sum of the longest diameters (SoD) of target lesions, taking as reference the baseline SoD.
Overall survival was defined as the time from the date of first dose until the date of death from any cause, estimated using the Kaplan-Meier method.
The EORTC QLQ-OV28 is specific for ovarian cancer and consists of 28 items assessing abdominal/gastrointestinal symptoms (6 items), peripheral neuropathy (2 items), other chemotherapy side effects (5 items), hormonal symptoms (2 items), body image (2 items), attitudes to disease/treatment (3 items), sexuality (4 items) and 4 other single items. Each scale was scored from 0 to 100 with higher scores on the symptom scales indicating greater symptom burden. Higher scores represent a higher ("better") level of functioning. Presented here are the number of participants achieving at least 15 point absolute improvement at Week 8 or Week 9 in the abdominal/GI scale of the EORTC QLQ-OV28.
An adverse event (AE) was defined as any untoward medical occurrence that developed or worsened in severity during the conduct of a clinical study and did not necessarily have a causal relationship to study drug. TEAEs were defined as AEs with an onset date on or after the first dose of study drug, and within 30 days of the last dose of study drug or prior to the start of a new anticancer treatment, whichever occurred first. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
DOR was defined as the time from the date of the first response (CR or PR), until the date of PD or death from any cause, whichever occurred first. DOR for participants who have not progressed or died at the time of analysis are censored at the date of their last tumor assessment. 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 have demonstrated an absolute increase of at least 5 mm. DOR was estimated using the Kaplan-Meier method.
Reported safety
Quality of life and patient-reported measures
EORTC QLQ · Number of Participants Achieving at Least 15 Point Absolute Improvement in the Abdominal/Gastrointestinal (GI) Scale of European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module 28 (QLQ-OV28)
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT04209855
- qol key
- qol-0003
- source section id
- NCT04209855-om-0003
- source outcome index
- 3
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Number of Participants Achieving at Least 15 Point Absolute Improvement in the Abdominal/Gastrointestinal (GI) Scale of European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module 28 (QLQ-OV28)
- measure definition
- The EORTC QLQ-OV28 is specific for ovarian cancer and consists of 28 items assessing abdominal/gastrointestinal symptoms (6 items), peripheral neuropathy (2 items), other chemotherapy side effects (5 items), hormonal symptoms (2 items), body image (2 items), attitudes to disease/treatment (3 items), sexuality (4 items) and 4 other single items. Each scale was scored from 0 to 100 with higher scores on the symptom scales indicating greater symptom burden. Higher scores represent a higher ("better") level of functioning. Presented here are the number of participants achieving at least 15 point absolute improvement at Week 8 or Week 9 in the abdominal/GI scale of the EORTC QLQ-OV28.
- time frame
- Baseline and Week 8 or 9
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- The ITT population included all participants randomized to the study, regardless of whether or not participants received study treatment (MIRV or IC Chemo). Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT04209855
- trial label
- A Study of Mirvetuximab Soravtansine vs. Investigator's Choice (IC) of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- regulator-cited
- discovery note
- Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
- outcome Count
- 6
- harms Count
- 2
- qol Count
- 1
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT04209855
- outcome key
- om-0000
- source section id
- NCT04209855-om-0000
- source outcome index
- 0
- endpoint
- Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
- endpoint definition
- PFS was defined as the time from randomization until progressive disease (PD) or death whichever occurred first. PD: At least a 20% increase in the sum of the longest diameters (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 millimeters (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.
- time origin
- From randomization until PD or death, whichever occurred first (up to approximately 36 months)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The ITT population included all participants randomized to the study, regardless of whether or not participants received study treatment (MIRV or IC Chemo).
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT04209855
- outcome key
- om-0001
- source section id
- NCT04209855-om-0001
- source outcome index
- 1
- endpoint
- Objective Response Rate (ORR), as Assessed by the Investigator Using RECIST v1.1
- endpoint definition
- ORR was defined as percentage of participants with a confirmed 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 \<10 mm. PR: At least 30% decrease in the sum of the longest diameters (SoD) of target lesions, taking as reference the baseline SoD.
- time origin
- Up to approximately 36 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The ITT population included all participants randomized to the study, regardless of whether or not participants received study treatment (MIRV or IC Chemo).
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT04209855
- outcome key
- om-0002
- source section id
- NCT04209855-om-0002
- source outcome index
- 2
- endpoint
- Overall Survival Assessed by the Investigator Using RECIST v1.1
- endpoint definition
- Overall survival was defined as the time from the date of first dose until the date of death from any cause, estimated using the Kaplan-Meier method.
- time origin
- Up to approximately 45 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The ITT population included all participants randomized to the study, regardless of whether or not participants received study treatment (MIRV or IC Chemo).
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT04209855
- outcome key
- om-0003
- source section id
- NCT04209855-om-0003
- source outcome index
- 3
- endpoint
- Number of Participants Achieving at Least 15 Point Absolute Improvement in the Abdominal/Gastrointestinal (GI) Scale of European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module 28 (QLQ-OV28)
- endpoint definition
- The EORTC QLQ-OV28 is specific for ovarian cancer and consists of 28 items assessing abdominal/gastrointestinal symptoms (6 items), peripheral neuropathy (2 items), other chemotherapy side effects (5 items), hormonal symptoms (2 items), body image (2 items), attitudes to disease/treatment (3 items), sexuality (4 items) and 4 other single items. Each scale was scored from 0 to 100 with higher scores on the symptom scales indicating greater symptom burden. Higher scores represent a higher ("better") level of functioning. Presented here are the number of participants achieving at least 15 point absolute improvement at Week 8 or Week 9 in the abdominal/GI scale of the EORTC QLQ-OV28.
- time origin
- Baseline and Week 8 or 9
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The ITT population included all participants randomized to the study, regardless of whether or not participants received study treatment (MIRV or IC Chemo). Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT04209855
- outcome key
- om-0004
- source section id
- NCT04209855-om-0004
- source outcome index
- 4
- endpoint
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)
- endpoint definition
- An adverse event (AE) was defined as any untoward medical occurrence that developed or worsened in severity during the conduct of a clinical study and did not necessarily have a causal relationship to study drug. TEAEs were defined as AEs with an onset date on or after the first dose of study drug, and within 30 days of the last dose of study drug or prior to the start of a new anticancer treatment, whichever occurred first. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
- time origin
- Up to approximately 37 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The Safety Population included all participants who received at least one dose of study treatment.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT04209855
- outcome key
- om-0005
- source section id
- NCT04209855-om-0005
- source outcome index
- 5
- endpoint
- Duration of Response (DOR) as Assessed by the Investigator Using RECIST v1.1
- endpoint definition
- DOR was defined as the time from the date of the first response (CR or PR), until the date of PD or death from any cause, whichever occurred first. DOR for participants who have not progressed or died at the time of analysis are censored at the date of their last tumor assessment. 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 have demonstrated an absolute increase of at least 5 mm. DOR was estimated using the Kaplan-Meier method.
- time origin
- Up to approximately 34 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The ITT population included all participants randomized to the study, regardless of whether or not participants received study treatment (MIRV or IC Chemo). Here, "Overall number of participants analyzed" is the number of evaluable participants for this outcome measure who had CR or PR.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT04209855
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Mirvetuximab Soravtansine
- regimen
- Participants randomized to single-agent MIRV at 6 mg/kg AIBW administered IV on Day 1 of Q3W.
- analyzed count
- 227
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04209855-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT04209855
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Investigator's Choice (IC) Chemotherapy
- regimen
- 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.
- analyzed count
- 226
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04209855-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT04209855
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Mirvetuximab Soravtansine
- regimen
- Participants randomized to single-agent MIRV at 6 mg/kg AIBW administered IV on Day 1 of Q3W.
- analyzed count
- 227
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04209855-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT04209855
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Investigator's Choice (IC) Chemotherapy
- regimen
- 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.
- analyzed count
- 226
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04209855-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT04209855
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Mirvetuximab Soravtansine
- regimen
- Participants randomized to single-agent MIRV at 6 mg/kg AIBW administered IV on Day 1 of Q3W.
- analyzed count
- 227
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04209855-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT04209855
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Investigator's Choice (IC) Chemotherapy
- regimen
- 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.
- analyzed count
- 226
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04209855-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT04209855
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Mirvetuximab Soravtansine
- regimen
- Participants randomized to single-agent MIRV at 6 mg/kg AIBW administered IV on Day 1 of Q3W.
- analyzed count
- 162
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04209855-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT04209855
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Investigator's Choice (IC) Chemotherapy
- regimen
- 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.
- analyzed count
- 150
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04209855-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT04209855
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Mirvetuximab Soravtansine
- regimen
- Participants randomized to single-agent MIRV at 6 mg/kg AIBW administered IV on Day 1 of Q3W.
- analyzed count
- 218
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04209855-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT04209855
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Investigator's Choice (IC) Chemotherapy
- regimen
- 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.
- analyzed count
- 207
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04209855-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT04209855
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Mirvetuximab Soravtansine
- regimen
- Participants randomized to single-agent MIRV at 6 mg/kg AIBW administered IV on Day 1 of Q3W.
- analyzed count
- 95
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04209855-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT04209855
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Investigator's Choice (IC) Chemotherapy
- regimen
- 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.
- analyzed count
- 36
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04209855-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT04209855
- harm key
- EG000
- source section id
- NCT04209855-ae
- event group key
- EG000
- event group label
- Mirvetuximab Soravtansine
- serious affected
- 62
- serious at risk
- 227
- other affected
- 212
- other at risk
- 227
- frequency threshold
- 5
- collection period
- 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.
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT04209855
- harm key
- EG001
- source section id
- NCT04209855-ae
- event group key
- EG001
- event group label
- Investigator's Choice (IC) Chemotherapy
- serious affected
- 73
- serious at risk
- 226
- other affected
- 196
- other at risk
- 226
- frequency threshold
- 5
- collection period
- 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.
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT04209855
- qol key
- qol-0003
- source section id
- NCT04209855-om-0003
- source outcome index
- 3
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Number of Participants Achieving at Least 15 Point Absolute Improvement in the Abdominal/Gastrointestinal (GI) Scale of European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module 28 (QLQ-OV28)
- measure definition
- The EORTC QLQ-OV28 is specific for ovarian cancer and consists of 28 items assessing abdominal/gastrointestinal symptoms (6 items), peripheral neuropathy (2 items), other chemotherapy side effects (5 items), hormonal symptoms (2 items), body image (2 items), attitudes to disease/treatment (3 items), sexuality (4 items) and 4 other single items. Each scale was scored from 0 to 100 with higher scores on the symptom scales indicating greater symptom burden. Higher scores represent a higher ("better") level of functioning. Presented here are the number of participants achieving at least 15 point absolute improvement at Week 8 or Week 9 in the abdominal/GI scale of the EORTC QLQ-OV28.
- time frame
- Baseline and Week 8 or 9
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- The ITT population included all participants randomized to the study, regardless of whether or not participants received study treatment (MIRV or IC Chemo). Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- setting source links
Preserved source evidence · Not medical advice