Trial · NCT02631876
Results by group27
Each measurement the trial posted, group by group, in the words and numbers it posted.
1 to 20 of 27
Download this page as JSON| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-Free Survival (PFS), as Assessed by BIRC Per RECIST Version 1.1 in All Participants Randomized to the Study | Mirvetuximab Soravtansine | 4.14 | 95% Confidence Interval 3.75 to 4.53 | months | |
| Progression-Free Survival (PFS), as Assessed by BIRC Per RECIST Version 1.1 in All Participants Randomized to the Study | Investigator's Choice (IC) Chemotherapy | 4.44 | 95% Confidence Interval 2.83 to 5.59 | months | |
| PFS, as Assessed by BIRC Per RECIST Version 1.1 in Participants With High Folate Receptor Alpha Level (≥ 75% of Tumor Staining) | Mirvetuximab Soravtansine | 4.76 | 95% Confidence Interval 4.11 to 5.68 | months | |
| PFS, as Assessed by BIRC Per RECIST Version 1.1 in Participants With High Folate Receptor Alpha Level (≥ 75% of Tumor Staining) | Investigator's Choice (IC) Chemotherapy | 3.25 | 95% Confidence Interval 1.97 to 5.59 | months | |
| Objective Response Rate (ORR): Percentage of Participants With Objective Response, as Assessed by BIRC Per RECIST1.1 | Mirvetuximab Soravtansine | 22 | 95% Confidence Interval 17.2 to 27.9 | percentage of participants | |
| Objective Response Rate (ORR): Percentage of Participants With Objective Response, as Assessed by BIRC Per RECIST1.1 | Investigator's Choice (IC) Chemotherapy | 12 | 95% Confidence Interval 6.6 to 19.1 | percentage of participants | |
| Overall Survival (OS) | Mirvetuximab Soravtansine | 15.57 | 95% Confidence Interval 12.85 to 18.04 | months | |
| Overall Survival (OS) | Investigator's Choice (IC) Chemotherapy | 13.93 | 95% Confidence Interval 11.40 to 18.50 | months | |
| Number of Participants Achieving at Least a 15% (≥ 15-Point) Absolute Improvement From Baseline on the EORTC QLQ-OV28 Abdominal/Gastrointestinal (AB/GI) Symptom Subscale at Week 8/9 Assessment | Mirvetuximab Soravtansine | 45 | Participants | ||
| Number of Participants Achieving at Least a 15% (≥ 15-Point) Absolute Improvement From Baseline on the EORTC QLQ-OV28 Abdominal/Gastrointestinal (AB/GI) Symptom Subscale at Week 8/9 Assessment | Investigator's Choice (IC) Chemotherapy | 7 | Participants | ||
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Mirvetuximab Soravtansine | 242 | Participants | ||
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Investigator's Choice (IC) Chemotherapy | 107 | Participants | ||
| Gynecologic Cancer Intergroup (GCIG) CA-125 Response Rate: Percentage of Participants With GCIG CA-125 Confirmed Clinical Responses | Mirvetuximab Soravtansine | 51 | 95% Confidence Interval 44.1 to 58.3 | percentage of participants | |
| Gynecologic Cancer Intergroup (GCIG) CA-125 Response Rate: Percentage of Participants With GCIG CA-125 Confirmed Clinical Responses | Investigator's Choice (IC) Chemotherapy | 27 | 95% Confidence Interval 17.6 to 37.8 | percentage of participants | |
| PFS, as Assessed by Investigator Per RECIST Version 1.1 | Mirvetuximab Soravtansine | 4.27 | 95% Confidence Interval 4.11 to 5.06 | months | |
| PFS, as Assessed by Investigator Per RECIST Version 1.1 | Investigator's Choice (IC) Chemotherapy | 4.24 | 95% Confidence Interval 2.76 to 5.36 | months | |
| Duration of Response (DOR), as Assessed by BIRC Per RECIST v1.1 | Mirvetuximab Soravtansine | 5.65 | 95% Confidence Interval 4.17 to 8.51 | months | |
| Duration of Response (DOR), as Assessed by BIRC Per RECIST v1.1 | Investigator's Choice (IC) Chemotherapy | 7.26 | 95% Confidence Interval 4.14 to NA | months | |
| Area Under the Plasma Concentration-Versus Time Curve From Time of Dose Until Tlast (AUClast) of Mirvetuximab Soravtansine,Total M9346A Antibody, DM4, and S-methyl DM4 | Mirvetuximab Soravtansine | Mirvetuximab Soravtansine at Cycle 1 | 20.53 | Standard Deviation 10.31 | hours*milligrams/milliliter (hr*mg/mL) |
| Area Under the Plasma Concentration-Versus Time Curve From Time of Dose Until Tlast (AUClast) of Mirvetuximab Soravtansine,Total M9346A Antibody, DM4, and S-methyl DM4 | Mirvetuximab Soravtansine | Mirvetuximab Soravtansine at Cycle 3 | 22.40 | Standard Deviation 7.770 | hours*milligrams/milliliter (hr*mg/mL) |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT02631876/results