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NCT05949632 · OUTCOME

Part 1: Number of Participants With TEAEs Leading to a Dosing Modification (Treatment Interruption, Dose Reduction, and Permanent Discontinuation of Either Study Drug)

A Study of INCB099280 in Combination With Axitinib in Adults With Advanced Solid Tumors · Source last updated 2026-06-04

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
up to approximately 1 year

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

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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
INCB099280 400 mg BID Plus Axitinib 5 mg BID5

Reported measurements

TEAE leading to dose interruption of INCB099280
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
INCB099280 400 mg BID Plus Axitinib 5 mg BID5Not reportedNot reportedNot reportedNot reported
TEAE leading to discontinuation of INCB099280
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
INCB099280 400 mg BID Plus Axitinib 5 mg BID0Not reportedNot reportedNot reportedNot reported
TEAE leading to dose interruption of axitinib
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
INCB099280 400 mg BID Plus Axitinib 5 mg BID4Not reportedNot reportedNot reportedNot reported
TEAE leading to dose reduction of axitinib
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
INCB099280 400 mg BID Plus Axitinib 5 mg BID3Not reportedNot reportedNot reportedNot reported
TEAE leading to discontinuation of axitinib
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
INCB099280 400 mg BID Plus Axitinib 5 mg BID1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    TEAE leading to dose interruption of INCB099280
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    TEAE leading to discontinuation of INCB099280
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    TEAE leading to dose interruption of axitinib
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    TEAE leading to dose reduction of axitinib
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    TEAE leading to discontinuation of axitinib
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    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
  1. 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
COUNT_OF_PARTICIPANTS
population Description
Safety Population
reporting Status
POSTED
time Frame
up to approximately 1 year
title
Part 1: Number of Participants With TEAEs Leading to a Dosing Modification (Treatment Interruption, Dose Reduction, and Permanent Discontinuation of Either Study Drug)
type
PRIMARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice