TriangleNCT04209855 · OUTCOME
Duration of Response (DOR) as Assessed by the Investigator Using RECIST v1.1
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to approximately 34 months
What was measured
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.
Analysis 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 evaluable participants for this outcome measure who had CR or PR.
Groups in this outcome
Mirvetuximab Soravtansine
Participants randomized to single-agent MIRV at 6 mg/kg AIBW administered IV on Day 1 of Q3W.
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.
| Group | Source count |
|---|---|
| Mirvetuximab Soravtansine | 95 |
| Investigator's Choice (IC) Chemotherapy | 36 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Mirvetuximab Soravtansine | 6.93 | Not reported | 5.78 | 8.84 | Not reported |
| Investigator's Choice (IC) Chemotherapy | 4.44 | Not reported | 4.17 | 5.75 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.78
- upper Limit
- 8.84
- value
- 6.93
- group Id
- OG001
- lower Limit
- 4.17
- upper Limit
- 5.75
- value
- 4.44
- denoms
- counts
- group Id
- OG000
- value
- 95
- group Id
- OG001
- value
- 36
- units
- Participants
- description
- 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.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants randomized to single-agent MIRV at 6 mg/kg AIBW administered IV on Day 1 of Q3W.
- id
- OG000
- title
- Mirvetuximab Soravtansine
- 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
- OG001
- title
- Investigator's Choice (IC) Chemotherapy
- param Type
- MEDIAN
- population Description
- 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.
- reporting Status
- POSTED
- time Frame
- Up to approximately 34 months
- title
- Duration of Response (DOR) as Assessed by the Investigator Using RECIST v1.1
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice