TriangleNCT02387996 · OUTCOME
Duration of Response (DOR)
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 14 months)
What was measured
DOR is defined as the time from first confirmed response, complete response (CR) or partial response (PR) to the date of the first documented tumor progression as determined using RECIST 1.1 criteria or death due to any cause, whichever occurs first. Participants who start subsequent therapy without a prior reported progression will be censored at the last evaluable tumor assessments prior to initiation of the subsequent anticancer therapy. Participants who die without a reported prior progression will be considered to have progressed on the date of their death. Participants who neither progress nor die will be censored on the date of their last evaluable tumor assessment.
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 | 52 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Nivolumab 3 mg/kg | NA | Not reported | 7.43 | NA | Median and upper limit not calculated due to insufficient number of events. |
Complete source fields
- classes
- categories
- measurements
- comment
- Median and upper limit not calculated due to insufficient number of events.
- group Id
- OG000
- lower Limit
- 7.43
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 52
- units
- Participants
- description
- DOR is defined as the time from first confirmed response, complete response (CR) or partial response (PR) to the date of the first documented tumor progression as determined using RECIST 1.1 criteria or death due to any cause, whichever occurs first. Participants who start subsequent therapy without a prior reported progression will be censored at the last evaluable tumor assessments prior to initiation of the subsequent anticancer therapy. Participants who die without a reported prior progression will be considered to have progressed on the date of their death. Participants who neither progress nor die will be censored on the date of their last evaluable tumor assessment.
- 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 14 months)
- title
- Duration of Response (DOR)
- type
- PRIMARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice