TriangleNCT05949632 · OUTCOME
Part 2: Number of Participants With TEAEs Leading to a Dosing Modification (Treatment Interruption, Dose Reduction, and Permanent Discontinuation of Either Study Drug)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- Not reported
- Unit
- Not reported
- Interval / dispersion
- Not reported
- Time frame
- up to 2 years
What was measured
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE therefore could have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as an AE that was either reported for the first time or the worsening of a pre-existing event after the first dose of either study drug until 104 days after the last dose of study treatment or the start of new anticancer therapy.
Analysis population: Safety Population. Enrollment in this study was closed during Part 1 following the sponsor's decision to discontinue the INCB099280 development program for strategic reasons. There were no safety concerns that contributed to the decision. Part 2 of the study was not conducted.
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 | 0 |
Reported measurements
No numerical measurement classes were posted for this outcome. Missing is not zero.
Complete source fields
- denoms
- counts
- group Id
- OG000
- value
- 0
- units
- Participants
- description
- An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE therefore could have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as an AE that was either reported for the first time or the worsening of a pre-existing event after the first dose of either study drug until 104 days after the last dose of study treatment or the start of new anticancer therapy.
- 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
- population Description
- Safety Population. Enrollment in this study was closed during Part 1 following the sponsor's decision to discontinue the INCB099280 development program for strategic reasons. There were no safety concerns that contributed to the decision. Part 2 of the study was not conducted.
- reporting Status
- POSTED
- time Frame
- up to 2 years
- title
- Part 2: Number of Participants With TEAEs Leading to a Dosing Modification (Treatment Interruption, Dose Reduction, and Permanent Discontinuation of Either Study Drug)
- type
- SECONDARY
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice