TriangleNCT02387996 · OUTCOME
Duration of Response (DOR) - Extended Collection
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 first confirmed response to the date of the first documented tumor progression or death due to any cause, whichever occurs first (up to approximately 32 months)
What was measured
DOR is the time from first confirmed response, complete (CR) or partial response (PR) to the date of the first tumor progression PER RECIST 1.1 criteria or death due to any cause, whichever occurs first. Participants without prior reported progression will be censored at the last evaluable tumor assessments prior to subsequent anticancer therapy. Participants who die without a reported prior progression will be considered on the date of their death. Participants who neither progress nor die will be censored on the date of their last evaluable tumor assessment. CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions. Note: This outcome measure represents an updated version of the primary endpoint to include additional data collection that has occurred after the primary completion date.
Analysis population: All responders-includes responders who had neither progressed nor initiated subsequent therapy at the time of analysis, and excludes responders censored prior to 12 weeks of the clinical data cutoff date (if this cutoff date is before week 48) or prior to 18 weeks of the clinical data cutoff date (if this cutoff date is after or on week 48)
Groups in this outcome
Nivolumab 3 mg/kg
Nivolumab 3 mg/kg was administered as a 60 minute IV infusion Q2W
| Group | Source count |
|---|---|
| Nivolumab 3 mg/kg | 56 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Nivolumab 3 mg/kg | 20.27 | Not reported | 11.50 | 31.31 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 11.50
- upper Limit
- 31.31
- value
- 20.27
- denoms
- counts
- group Id
- OG000
- value
- 56
- units
- Participants
- description
- DOR is the time from first confirmed response, complete (CR) or partial response (PR) to the date of the first tumor progression PER RECIST 1.1 criteria or death due to any cause, whichever occurs first. Participants without prior reported progression will be censored at the last evaluable tumor assessments prior to subsequent anticancer therapy. Participants who die without a reported prior progression will be considered on the date of their death. Participants who neither progress nor die will be censored on the date of their last evaluable tumor assessment. CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions. Note: This outcome measure represents an updated version of the primary endpoint to include additional data collection that has occurred after the primary completion date.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Nivolumab 3 mg/kg was administered as a 60 minute IV infusion Q2W
- id
- OG000
- title
- Nivolumab 3 mg/kg
- param Type
- MEDIAN
- population Description
- All responders-includes responders who had neither progressed nor initiated subsequent therapy at the time of analysis, and excludes responders censored prior to 12 weeks of the clinical data cutoff date (if this cutoff date is before week 48) or prior to 18 weeks of the clinical data cutoff date (if this cutoff date is after or on week 48)
- reporting Status
- POSTED
- time Frame
- From the first confirmed response to the date of the first documented tumor progression or death due to any cause, whichever occurs first (up to approximately 32 months)
- title
- Duration of Response (DOR) - Extended Collection
- type
- POST_HOC
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice