TriangleNCT01642004 · OUTCOME
Time To Response (TTR) in Months for All Confirmed Responders
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 the date of randomization to the date of the first confirmed response, up to approximately 12 months
What was measured
Time to Response (TTR) for participants demonstrating a response (either CR or PR) was defined as the time from the date of randomization to the date of the first confirmed response. CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters.
Analysis population: All confirmed responders (participants demonstrating CR or PR)
Groups in this outcome
Nivolumab
Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
Docetaxel
Docetaxel 75mg/m\^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.
| Group | Source count |
|---|---|
| Nivolumab | 27 |
| Docetaxel | 12 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Nivolumab | 2.23 | Not reported | 1.6 | 11.8 | Not reported |
| Docetaxel | 2.09 | Not reported | 1.8 | 9.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.6
- upper Limit
- 11.8
- value
- 2.23
- group Id
- OG001
- lower Limit
- 1.8
- upper Limit
- 9.5
- value
- 2.09
- denoms
- counts
- group Id
- OG000
- value
- 27
- group Id
- OG001
- value
- 12
- units
- Participants
- description
- Time to Response (TTR) for participants demonstrating a response (either CR or PR) was defined as the time from the date of randomization to the date of the first confirmed response. CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters.
- dispersion Type
- Full Range
- groups
- description
- Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
- id
- OG000
- title
- Nivolumab
- description
- Docetaxel 75mg/m\^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.
- id
- OG001
- title
- Docetaxel
- param Type
- MEDIAN
- population Description
- All confirmed responders (participants demonstrating CR or PR)
- reporting Status
- POSTED
- time Frame
- From the date of randomization to the date of the first confirmed response, up to approximately 12 months
- title
- Time To Response (TTR) in Months for All Confirmed Responders
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice