TriangleNCT03597295 · OUTCOME
Duration of Response (DOR)
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
- up to 18.2 months
What was measured
DOR was defined as the time from an initial objective response (CR or PR) per RECIST v1.1 until the first observation of documented disease progression (PD), as determined by ICR, or death due to any cause. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion.
Analysis population: Full Analysis Set. All participants with confirmed tumor responses (CR or PR) by ICR according to RECIST v1.1 were analyzed. The 95% confidence interval was calculated using the Brookmeyer and Crowley's method and Klein and Moeschberger's method with log-log transformation.
Groups in this outcome
Retifanlimab 500 mg
Participants received retifanlimab 500 milligrams (mg) intravenously every 4 weeks (Q4W).
| Group | Source count |
|---|---|
| Retifanlimab 500 mg | 13 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Retifanlimab 500 mg | 9.5 | Not reported | 4.4 | NA | The upper limit of the confidence interval was not estimable because too few participants had disease progression or died |
Complete source fields
- classes
- categories
- measurements
- comment
- The upper limit of the confidence interval was not estimable because too few participants had disease progression or died
- group Id
- OG000
- lower Limit
- 4.4
- upper Limit
- NA
- value
- 9.5
- denoms
- counts
- group Id
- OG000
- value
- 13
- units
- Participants
- description
- DOR was defined as the time from an initial objective response (CR or PR) per RECIST v1.1 until the first observation of documented disease progression (PD), as determined by ICR, or death due to any cause. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received retifanlimab 500 milligrams (mg) intravenously every 4 weeks (Q4W).
- id
- OG000
- title
- Retifanlimab 500 mg
- param Type
- MEDIAN
- population Description
- Full Analysis Set. All participants with confirmed tumor responses (CR or PR) by ICR according to RECIST v1.1 were analyzed. The 95% confidence interval was calculated using the Brookmeyer and Crowley's method and Klein and Moeschberger's method with log-log transformation.
- reporting Status
- POSTED
- time Frame
- up to 18.2 months
- title
- Duration of Response (DOR)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice