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NCT03011372 · OUTCOME

Number of Participants With Any Treatment-emergent Adverse Event (TEAE)

A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement - (FIGHT-203) · Source last updated 2025-11-18

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 2543 days

What was measured

An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug.

Analysis population: Safety Population: all enrolled participants who received at least 1 dose of study drug

Groups in this outcome

Pemigatinib 13.5 mg

Pemigatinib 13.5 milligrams (mg) was self-administered once daily (QD) as oral tablets on an intermittent dosing (ID) schedule or continuous dosing (CD) schedule. Participants started pemigatinib 13.5 mg on the ID schedule (i.e., 2 weeks on/1 week off) as per the initial Protocol and on the CD schedule in 21-day cycles following a Protocol amendment.

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

Analysis denominator · Participants

GroupSource count
Pemigatinib 13.5 mg47

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pemigatinib 13.5 mg47Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        47
denoms
  1. counts
    1. group Id
      OG000
      value
      47
    units
    Participants
description
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug.
groups
  1. description
    Pemigatinib 13.5 milligrams (mg) was self-administered once daily (QD) as oral tablets on an intermittent dosing (ID) schedule or continuous dosing (CD) schedule. Participants started pemigatinib 13.5 mg on the ID schedule (i.e., 2 weeks on/1 week off) as per the initial Protocol and on the CD schedule in 21-day cycles following a Protocol amendment.
    id
    OG000
    title
    Pemigatinib 13.5 mg
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety Population: all enrolled participants who received at least 1 dose of study drug
reporting Status
POSTED
time Frame
up to 2543 days
title
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Independent clinical review pending · Not medical advice