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NCT03011372 · OUTCOME

Duration of Response

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
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
up to 2513 days (120 21-day treatment cycles)

What was measured

Duration of response was defined as the time from the first assessment of complete response or partial response to the earlier of the date of first worsening assessment after response or death due to any cause.

Analysis population: Full Efficacy-Evaluable Population. Only participants with complete response or partial response were analyzed. Confidence intervals were calculated based on the exact method for binomial distribution.

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 mg45

Reported measurements

Investigator assessment

Analysis denominator · Participants

GroupSource count
Pemigatinib 13.5 mg35
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pemigatinib 13.5 mg53.29Not reported15.51NAThe upper limit of the confidence interval was not estimable because too few participants had events of loss of response (disease progression) or death.
CRC assessment

Analysis denominator · Participants

GroupSource count
Pemigatinib 13.5 mg34
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pemigatinib 13.5 mgNANot reported27.86NAThe median and the upper limit of the confidence interval were not estimable because too few participants had events of loss of response (disease progression) or death.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        The upper limit of the confidence interval was not estimable because too few participants had events of loss of response (disease progression) or death.
        group Id
        OG000
        lower Limit
        15.51
        upper Limit
        NA
        value
        53.29
    denoms
    1. counts
      1. group Id
        OG000
        value
        35
      units
      Participants
    title
    Investigator assessment
  2. categories
    1. measurements
      1. comment
        The median and the upper limit of the confidence interval were not estimable because too few participants had events of loss of response (disease progression) or death.
        group Id
        OG000
        lower Limit
        27.86
        upper Limit
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        34
      units
      Participants
    title
    CRC assessment
denoms
  1. counts
    1. group Id
      OG000
      value
      45
    units
    Participants
description
Duration of response was defined as the time from the first assessment of complete response or partial response to the earlier of the date of first worsening assessment after response or death due to any cause.
dispersion Type
95% Confidence Interval
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
MEDIAN
population Description
Full Efficacy-Evaluable Population. Only participants with complete response or partial response were analyzed. Confidence intervals were calculated based on the exact method for binomial distribution.
reporting Status
POSTED
time Frame
up to 2513 days (120 21-day treatment cycles)
title
Duration of Response
type
SECONDARY
unit Of Measure
months

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

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