TriangleNCT02387996 · OUTCOME
Time to Response (TTR) - 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
- Full Range
- Time frame
- From first dosing date to the date of the first confirmed response (up to approximately 14 months)
What was measured
TTR is defined as the time from first dosing date to the date of the first confirmed complete response (CR) or partial response (PR), as assessed by the Blinded Independent Review Committee (BIRC). Complete response 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. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. 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 | 1.97 | Not reported | 1.6 | 13.8 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.6
- upper Limit
- 13.8
- value
- 1.97
- denoms
- counts
- group Id
- OG000
- value
- 56
- units
- Participants
- description
- TTR is defined as the time from first dosing date to the date of the first confirmed complete response (CR) or partial response (PR), as assessed by the Blinded Independent Review Committee (BIRC). Complete response 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. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. 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
- Full Range
- 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 first dosing date to the date of the first confirmed response (up to approximately 14 months)
- title
- Time to Response (TTR) - Extended Collection
- type
- POST_HOC
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice