TriangleNCT01668784 · OUTCOME
Investigator-assessed Objective Response Rate (ORR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- from randomization up to disease progression or death (approximately up to 105 Months)
What was measured
ORR is defined as Percentage of participants with a best response of complete response (CR) or partial response (PR) divided by number of randomized participants. 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. Tumor assessments began at 8 weeks following randomization and continued every 8 weeks for the first year, then every 12 weeks thereafter until disease progression or death. CIs used Clopper and Pearson.
Analysis population: All randomized participants; any participants that was randomized to any treatment group in the study.
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 | 410 |
| Everolimus | 411 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Nivolumab | 25.9 | Not reported | 21.7 | 30.4 | Not reported |
| Everolimus | 6.1 | Not reported | 4.0 | 8.8 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 21.7
- upper Limit
- 30.4
- value
- 25.9
- group Id
- OG001
- lower Limit
- 4.0
- upper Limit
- 8.8
- value
- 6.1
- denoms
- counts
- group Id
- OG000
- value
- 410
- group Id
- OG001
- value
- 411
- units
- Participants
- description
- ORR is defined as Percentage of participants with a best response of complete response (CR) or partial response (PR) divided by number of randomized participants. 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. Tumor assessments began at 8 weeks following randomization and continued every 8 weeks for the first year, then every 12 weeks thereafter until disease progression or death. CIs used Clopper and Pearson.
- 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
- NUMBER
- population Description
- All randomized participants; any participants that was randomized to any treatment group in the study.
- reporting Status
- POSTED
- time Frame
- from randomization up to disease progression or death (approximately up to 105 Months)
- title
- Investigator-assessed Objective Response Rate (ORR)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice