TriangleNCT04697628 · OUTCOME
Duration of Response (DOR) by Investigator Assessment
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
- From the date of first documented response of CR or PR to the first documented PD or death from any cause, whichever occurred first (maximum up to 25 months)
What was measured
DOR was defined as the time from the date of the first confirmed objective response (CR or PR that was subsequently confirmed) to the date of the first documented PD per RECIST v1.1 or death from any cause, whichever occurred first. CR was defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. PR was defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD: at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Analysis population: ITT analysis set included all randomized participants. Participants were included in the treatment group assigned at randomization regardless of any actual treatment received. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Only participants who achieved a confirmed CR or PR based on investigator assessment were included in the analysis.
Groups in this outcome
Tisotumab Vedotin
Participants with rCC/mCC were administered tisotumab vedotin 2.0 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once every 3 weeks (Q3W).
Chemotherapy
Participants with rCC/mCC were treated with investigator's choice of chemotherapy which included either topotecan 1 or 1.25 milligram per meter square \[mg/m\^2\] IV on Days 1 to 5, every 21 days or vinorelbine 30 mg/m\^2 IV on Days 1 and 8, every 21 days or gemcitabine 1000 mg/m\^2 IV on Days 1 and 8, every 21 days or irinotecan 100 or 125 mg/m\^2 IV weekly for 28 days, every 42 days or pemetrexed 500 mg/m\^2 on Day 1, every 21 days.
| Group | Source count |
|---|---|
| Tisotumab Vedotin | 45 |
| Chemotherapy | 13 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Tisotumab Vedotin | 5.3 | Not reported | 4.2 | 8.3 | Not reported |
| Chemotherapy | 5.7 | Not reported | 2.8 | NA | Upper limit of 95% CI could not be estimated due to insufficient number of participants with event. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.2
- upper Limit
- 8.3
- value
- 5.3
- comment
- Upper limit of 95% CI could not be estimated due to insufficient number of participants with event.
- group Id
- OG001
- lower Limit
- 2.8
- upper Limit
- NA
- value
- 5.7
- denoms
- counts
- group Id
- OG000
- value
- 45
- group Id
- OG001
- value
- 13
- units
- Participants
- description
- DOR was defined as the time from the date of the first confirmed objective response (CR or PR that was subsequently confirmed) to the date of the first documented PD per RECIST v1.1 or death from any cause, whichever occurred first. CR was defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. PR was defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD: at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with rCC/mCC were administered tisotumab vedotin 2.0 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once every 3 weeks (Q3W).
- id
- OG000
- title
- Tisotumab Vedotin
- description
- Participants with rCC/mCC were treated with investigator's choice of chemotherapy which included either topotecan 1 or 1.25 milligram per meter square \[mg/m\^2\] IV on Days 1 to 5, every 21 days or vinorelbine 30 mg/m\^2 IV on Days 1 and 8, every 21 days or gemcitabine 1000 mg/m\^2 IV on Days 1 and 8, every 21 days or irinotecan 100 or 125 mg/m\^2 IV weekly for 28 days, every 42 days or pemetrexed 500 mg/m\^2 on Day 1, every 21 days.
- id
- OG001
- title
- Chemotherapy
- param Type
- MEDIAN
- population Description
- ITT analysis set included all randomized participants. Participants were included in the treatment group assigned at randomization regardless of any actual treatment received. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Only participants who achieved a confirmed CR or PR based on investigator assessment were included in the analysis.
- reporting Status
- POSTED
- time Frame
- From the date of first documented response of CR or PR to the first documented PD or death from any cause, whichever occurred first (maximum up to 25 months)
- title
- Duration of Response (DOR) by Investigator Assessment
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice