Comparison · NCT04209855-sae
Mirvetuximab Soravtansine vs Investigator's Choice (IC) Chemotherapy: serious adverse events
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: serious adverse events. Trial comparisons, record NCT04209855-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04209855-sae
On this page
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 | 0.273 | 0.219 | 0.335 | wilson | |
| Risk in group 2 | 0.323 | 0.265 | 0.386 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0499 | -0.133 | 0.0343 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.846 | 0.637 | 1.12 | log | |
| Odds ratio, group 1 over group 2 | 0.788 | 0.526 | 1.18 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Mirvetuximab Soravtansine than on Investigator's Choice (IC) Chemotherapy | 20 | 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. | 62 | 227 | EG000 |
| 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. | 73 | 226 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- 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.
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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT04209855-sae