NCT05949632 · OUTCOME
Part 1: 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 335 days
What was measured
DOR was defined as the time from the first CR or PR until disease progression by investigator assessment per RECIST v1.1 or death from any cause, whichever occurred earlier. 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. Only participants with a CR or PR were analyzed.
Groups in this outcome
INCB099280 400 mg BID Plus Axitinib 5 mg BID
Participants received INCB099280 400 milligrams (mg) twice daily (BID) and axitinib 5 mg BID in consecutive 21-day cycles for up to 2 years as long as they were receiving benefit and did not meet any criteria for study withdrawal.
| Group | Source count |
|---|---|
| INCB099280 400 mg BID Plus Axitinib 5 mg BID | 1 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| INCB099280 400 mg BID Plus Axitinib 5 mg BID | 8.0 | Not reported | NA | NA | The confidence interval cannot be calculated for a single participant. |
Complete source fields
- classes
- categories
- measurements
- comment
- The confidence interval cannot be calculated for a single participant.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- 8.0
- denoms
- counts
- group Id
- OG000
- value
- 1
- units
- Participants
- description
- DOR was defined as the time from the first CR or PR until disease progression by investigator assessment per RECIST v1.1 or death from any cause, whichever occurred earlier. 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 INCB099280 400 milligrams (mg) twice daily (BID) and axitinib 5 mg BID in consecutive 21-day cycles for up to 2 years as long as they were receiving benefit and did not meet any criteria for study withdrawal.
- id
- OG000
- title
- INCB099280 400 mg BID Plus Axitinib 5 mg BID
- param Type
- MEDIAN
- population Description
- Full Analysis Set. Only participants with a CR or PR were analyzed.
- reporting Status
- POSTED
- time Frame
- up to 335 days
- title
- Part 1: Duration of Response (DOR)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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