TriangleNCT02428192 · OUTCOME
Rate of Progression-free Survival (Cohort A)
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
- Time from start of treatment to time of progression or death, whichever occurs first, assessed at 12 weeks
What was measured
A null hypothesis of 20% and an alternative hypothesis of 40% at 12 weeks will be investigated. Patients lost to follow-up or deaths within 12 weeks will be counted as failures. The overall power for overall progression-free rate at 12 weeks is 87%, using the exact binomial distribution. The operating characteristics of this design are calculated using a one-sided exact test with 10% type I error.
Analysis population: Progression is defined as using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Groups in this outcome
Cohort A (Nivolumab - Closed to Accrual on 21-Oct-2015)
Patients receive nivolumab IV over approximately 60 minutes once every 2 weeks for up to 46 doses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV
| Group | Source count |
|---|---|
| Cohort A (Nivolumab - Closed to Accrual on 21-Oct-2015) | 12 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A (Nivolumab - Closed to Accrual on 21-Oct-2015) | 1.8 | Not reported | 0.8 | NA | The upper limit for the confidence interval on median PFS is unknown because the upper confidence limit for the PFS curve never reached 0.50 hence no upper limit for the median PFS exists. |
Complete source fields
- classes
- categories
- measurements
- comment
- The upper limit for the confidence interval on median PFS is unknown because the upper confidence limit for the PFS curve never reached 0.50 hence no upper limit for the median PFS exists.
- group Id
- OG000
- lower Limit
- 0.8
- upper Limit
- NA
- value
- 1.8
- denoms
- counts
- group Id
- OG000
- value
- 12
- units
- Participants
- description
- A null hypothesis of 20% and an alternative hypothesis of 40% at 12 weeks will be investigated. Patients lost to follow-up or deaths within 12 weeks will be counted as failures. The overall power for overall progression-free rate at 12 weeks is 87%, using the exact binomial distribution. The operating characteristics of this design are calculated using a one-sided exact test with 10% type I error.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive nivolumab IV over approximately 60 minutes once every 2 weeks for up to 46 doses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV
- id
- OG000
- title
- Cohort A (Nivolumab - Closed to Accrual on 21-Oct-2015)
- param Type
- MEDIAN
- population Description
- Progression is defined as using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
- reporting Status
- POSTED
- time Frame
- Time from start of treatment to time of progression or death, whichever occurs first, assessed at 12 weeks
- title
- Rate of Progression-free Survival (Cohort A)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice