TriangleNCT01668784 · OUTCOME
Investigator-assessed Duration of 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
- 95% Confidence Interval
- Time frame
- From randomization to date of disease progression or death or censoring if no progression or death occurred (approximately 105 months)
What was measured
Duration of objective response is defined as the time from study start date to response, CR or partial response, PR) to the date of the first documented tumor progression as determined by the investigator (per RECIST 1.1 criteria or clinical) or death due to any cause, whichever occurred first. For participants who neither progress nor die, the duration of objective response were censored at the same time they were censored for the primary definition. 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. Based on Kaplan-Meier Estimates.
Analysis population: All randomized participants with a response; any participants that were 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 | 13.11 | Not reported | 9.26 | 19.75 | Not reported |
| Everolimus | 10.18 | Not reported | 5.39 | 18.73 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 9.26
- upper Limit
- 19.75
- value
- 13.11
- group Id
- OG001
- lower Limit
- 5.39
- upper Limit
- 18.73
- value
- 10.18
- denoms
- counts
- group Id
- OG000
- value
- 106
- group Id
- OG001
- value
- 25
- units
- Participants
- description
- Duration of objective response is defined as the time from study start date to response, CR or partial response, PR) to the date of the first documented tumor progression as determined by the investigator (per RECIST 1.1 criteria or clinical) or death due to any cause, whichever occurred first. For participants who neither progress nor die, the duration of objective response were censored at the same time they were censored for the primary definition. 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. Based on Kaplan-Meier Estimates.
- dispersion Type
- 95% Confidence Interval
- 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 were randomized to any treatment group in the study and that had a response.
- reporting Status
- POSTED
- time Frame
- From randomization to date of disease progression or death or censoring if no progression or death occurred (approximately 105 months)
- title
- Investigator-assessed Duration of Objective Response
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice