Comparison · NCT04209855-a40a7323
Mirvetuximab Soravtansine vs Investigator's Choice (IC) Chemotherapy: 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)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Mirvetuximab Soravtansine vs Investigator's Choice (IC) Chemotherapy: 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). Trial comparisons, record NCT04209855-a40a7323. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04209855-a40a7323
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.21 | 0.154 | 0.279 | wilson | |
| Risk in group 2 | 0.153 | 0.104 | 0.22 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0565 | -0.03 | 0.141 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.37 | 0.847 | 2.21 | log | |
| Odds ratio, group 1 over group 2 | 1.47 | 0.818 | 2.63 | log | |
| Number needed to treat, for one more participant with the outcome on Mirvetuximab Soravtansine than on Investigator's Choice (IC) Chemotherapy | 17.7 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Mirvetuximab Soravtansine | Participants randomized to single-agent MIRV at 6 mg/kg AIBW administered IV on Day 1 of Q3W. | 34 | 162 | OG000 |
| Group 2 | 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. | 23 | 150 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- 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)
- Description
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
- Population
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.
Source ClinicalTrials.gov
Trial
- Title
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
- NCT number
- NCT04209855
- Phases
- PHASE3
- Conditions
- Epithelial Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer
- Interventions
- Mirvetuximab Soravtansine, Paclitaxel, Topotecan, Pegylated liposomal doxorubicin
- Lead sponsor
- AbbVie
- Results first posted
- 2024-08-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04209855?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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