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NCT03580655 · OUTCOME

Percent Change From Baseline in Liver Volume by Imaging

(PATHFINDER) Study to Evaluate Efficacy and Safety of Avapritinib (BLU-285), A Selective KIT Mutation-targeted Tyrosine Kinase Inhibitor, in Patients With Advanced Systemic Mastocytosis · Source last updated 2026-04-24

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

Measure
MEAN
Unit
Percent Change
Interval / dispersion
Standard Deviation
Time frame
Baseline up to Month 65

What was measured

Assessment of liver volume was performed using serial imaging with magnetic resonance imaging (MRI). Response was defined as resolution of palpable hepatomegaly (CR). Each cycle is 28 days long.

Analysis population: Safety Population: all participants who received ≥1 dose of avapritinib. Here, ' Number Analyzed' signifies those participants evaluable for this outcome measure at the specified timepoint.

Groups in this outcome

Avapritinib

Avapritinib was administered once daily as an immediate-release tablet, orally, in 28-day cycles.

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

Analysis denominator · Participants

GroupSource count
Avapritinib85

Reported measurements

Cycle 3, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib85
Values in Percent Change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-12.4510.103Not reportedNot reportedNot reported
Cycle 7, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib69
Values in Percent Change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-18.5312.376Not reportedNot reportedNot reported
Cycle 11, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib74
Values in Percent Change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-22.0711.603Not reportedNot reportedNot reported
Cycle 17, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib63
Values in Percent Change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-27.9211.949Not reportedNot reportedNot reported
Cycle 23, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib57
Values in Percent Change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-29.5012.983Not reportedNot reportedNot reported
Cycle 29, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib45
Values in Percent Change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-29.8413.588Not reportedNot reportedNot reported
Cycle 35, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib36
Values in Percent Change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-29.8116.764Not reportedNot reportedNot reported
Cycle 41, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib36
Values in Percent Change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-31.7716.694Not reportedNot reportedNot reported
Cycle 47, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib30
Values in Percent Change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-34.3113.973Not reportedNot reportedNot reported
Cycle 53, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib20
Values in Percent Change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-35.8614.147Not reportedNot reportedNot reported
Cycle 59, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib11
Values in Percent Change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-31.7418.020Not reportedNot reportedNot reported
Cycle 65, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib4
Values in Percent Change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-26.8821.594Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.103
        value
        -12.45
    denoms
    1. counts
      1. group Id
        OG000
        value
        85
      units
      Participants
    title
    Cycle 3, Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        12.376
        value
        -18.53
    denoms
    1. counts
      1. group Id
        OG000
        value
        69
      units
      Participants
    title
    Cycle 7, Day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        11.603
        value
        -22.07
    denoms
    1. counts
      1. group Id
        OG000
        value
        74
      units
      Participants
    title
    Cycle 11, Day 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        11.949
        value
        -27.92
    denoms
    1. counts
      1. group Id
        OG000
        value
        63
      units
      Participants
    title
    Cycle 17, Day 1
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        12.983
        value
        -29.50
    denoms
    1. counts
      1. group Id
        OG000
        value
        57
      units
      Participants
    title
    Cycle 23, Day 1
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.588
        value
        -29.84
    denoms
    1. counts
      1. group Id
        OG000
        value
        45
      units
      Participants
    title
    Cycle 29, Day 1
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.764
        value
        -29.81
    denoms
    1. counts
      1. group Id
        OG000
        value
        36
      units
      Participants
    title
    Cycle 35, Day 1
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.694
        value
        -31.77
    denoms
    1. counts
      1. group Id
        OG000
        value
        36
      units
      Participants
    title
    Cycle 41, Day 1
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.973
        value
        -34.31
    denoms
    1. counts
      1. group Id
        OG000
        value
        30
      units
      Participants
    title
    Cycle 47, Day 1
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        14.147
        value
        -35.86
    denoms
    1. counts
      1. group Id
        OG000
        value
        20
      units
      Participants
    title
    Cycle 53, Day 1
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        18.020
        value
        -31.74
    denoms
    1. counts
      1. group Id
        OG000
        value
        11
      units
      Participants
    title
    Cycle 59, Day 1
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.594
        value
        -26.88
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      units
      Participants
    title
    Cycle 65, Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      85
    units
    Participants
description
Assessment of liver volume was performed using serial imaging with magnetic resonance imaging (MRI). Response was defined as resolution of palpable hepatomegaly (CR). Each cycle is 28 days long.
dispersion Type
Standard Deviation
groups
  1. description
    Avapritinib was administered once daily as an immediate-release tablet, orally, in 28-day cycles.
    id
    OG000
    title
    Avapritinib
param Type
MEAN
population Description
Safety Population: all participants who received ≥1 dose of avapritinib. Here, ' Number Analyzed' signifies those participants evaluable for this outcome measure at the specified timepoint.
reporting Status
POSTED
time Frame
Baseline up to Month 65
title
Percent Change From Baseline in Liver Volume by Imaging
type
SECONDARY
unit Of Measure
Percent Change

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Preserved source evidence · Not medical advice