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NCT02924376 · OUTCOME

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

Efficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Who Failed Previous Therapy - (FIGHT-202) · Source last updated 2025-08-14

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 1584 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 occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). A TEAE was defined as any adverse event either reported for the first time or the worsening of a pre-existing event after the first dose of study drug and within 30 days of the last dose of study drug.

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

Groups in this outcome

Cohort A: FGFR2 Rearrangements or Fusions

Participants with fibroblast growth factor (FGF) receptor 2 (FGFR2) rearrangements or fusions self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.

Cohort B: FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions

Participants with all other FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.

Cohort C: Negative for FGF/FGFR Alterations

Participants with no FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles (United States only). Pemigatinib was administered until documented disease progression or unacceptable toxicity.

Other

Participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.

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

Analysis denominator · Participants

GroupSource count
Cohort A: FGFR2 Rearrangements or Fusions108
Cohort B: FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions20
Cohort C: Negative for FGF/FGFR Alterations17
Other2

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A: FGFR2 Rearrangements or Fusions108Not reportedNot reportedNot reportedNot reported
Cohort B: FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions20Not reportedNot reportedNot reportedNot reported
Cohort C: Negative for FGF/FGFR Alterations17Not reportedNot reportedNot reportedNot reported
Other2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        108
      2. group Id
        OG001
        value
        20
      3. group Id
        OG002
        value
        17
      4. group Id
        OG003
        value
        2
denoms
  1. counts
    1. group Id
      OG000
      value
      108
    2. group Id
      OG001
      value
      20
    3. group Id
      OG002
      value
      17
    4. group Id
      OG003
      value
      2
    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 occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). A TEAE was defined as any adverse event either reported for the first time or the worsening of a pre-existing event after the first dose of study drug and within 30 days of the last dose of study drug.
groups
  1. description
    Participants with fibroblast growth factor (FGF) receptor 2 (FGFR2) rearrangements or fusions self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
    id
    OG000
    title
    Cohort A: FGFR2 Rearrangements or Fusions
  2. description
    Participants with all other FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
    id
    OG001
    title
    Cohort B: FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions
  3. description
    Participants with no FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles (United States only). Pemigatinib was administered until documented disease progression or unacceptable toxicity.
    id
    OG002
    title
    Cohort C: Negative for FGF/FGFR Alterations
  4. description
    Participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
    id
    OG003
    title
    Other
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety Population: all enrolled participants who received at least 1 dose of pemigatinib
reporting Status
POSTED
time Frame
up to 1584 days
title
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice