TriangleNCT05949632 · OUTCOME
Part 1: Disease Control
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
- up to 335 days
What was measured
Disease control was defined as the percentage of participants with a BOR of CR, PR, or stable disease (SD) by investigator assessment per RECIST v1.1. 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. SD: no change in target lesions to qualify for CR, PR, or PD.
Analysis population: Full Analysis Set. Confidence intervals were calculated using the Clopper-Pearson method. In order to have a best overall response of SD, overall response must have met the SD criteria at least once after a minimum of 5 weeks from the start of treatment.
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 | 5 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| INCB099280 400 mg BID Plus Axitinib 5 mg BID | 80.0 | Not reported | 28.4 | 99.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 28.4
- upper Limit
- 99.5
- value
- 80.0
- denoms
- counts
- group Id
- OG000
- value
- 5
- units
- Participants
- description
- Disease control was defined as the percentage of participants with a BOR of CR, PR, or stable disease (SD) by investigator assessment per RECIST v1.1. 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. SD: no change in target lesions to qualify for CR, PR, or PD.
- 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
- NUMBER
- population Description
- Full Analysis Set. Confidence intervals were calculated using the Clopper-Pearson method. In order to have a best overall response of SD, overall response must have met the SD criteria at least once after a minimum of 5 weeks from the start of treatment.
- reporting Status
- POSTED
- time Frame
- up to 335 days
- title
- Part 1: Disease Control
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice