TriangleNCT01668784 · OUTCOME
Investigator-assessed Time to Objective Response
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
- Randomization to date of first response (approximately 105 months)
What was measured
Time to objective response is defined as the time from randomization to first response (complete response, CR or partial response, PR). 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, the baseline sum diameters used as reference.
Analysis population: All randomized participants with a response; any participants that was randomized to any treatment group in the study and that had a response.
Groups in this outcome
Nivolumab
Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
Everolimus
Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
| Group | Source count |
|---|---|
| Nivolumab | 106 |
| Everolimus | 25 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Nivolumab | 3.55 | Not reported | 1.4 | 24.8 | Not reported |
| Everolimus | 3.71 | Not reported | 1.5 | 68.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.4
- upper Limit
- 24.8
- value
- 3.55
- group Id
- OG001
- lower Limit
- 1.5
- upper Limit
- 68.9
- value
- 3.71
- denoms
- counts
- group Id
- OG000
- value
- 106
- group Id
- OG001
- value
- 25
- units
- Participants
- description
- Time to objective response is defined as the time from randomization to first response (complete response, CR or partial response, PR). 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, the baseline sum diameters used as reference.
- dispersion Type
- Full Range
- groups
- description
- Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
- id
- OG000
- title
- Nivolumab
- description
- Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
- id
- OG001
- title
- Everolimus
- param Type
- MEDIAN
- population Description
- All randomized participants with a response; any participants that was randomized to any treatment group in the study and that had a response.
- reporting Status
- POSTED
- time Frame
- Randomization to date of first response (approximately 105 months)
- title
- Investigator-assessed Time to Objective Response
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice