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NCT03580655 · OUTCOME

Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

(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
Score on a Scale
Interval / dispersion
Standard Deviation
Time frame
Baseline, Cycle 1, Day 15 and Day 1 of Cycle 2, Cycle 3, Cycle 5, Cycle 7, Cycle 9, Cycle 11, Cycle 14, and Cycle 17 (28 days/cycle)

What was measured

Quality of life was assessed using EORTC QLQ-C30, which is a 30-item questionnaire that includes 5 functional domains (physical, cognitive, role, emotional, and social) and a global health status scale. Twenty-eight questions are scored from 1 (not at all) to 4 (very much), while the other 2 are scored from 1 (very poor) to 7 (excellent). The calculated average is standardized using a linear transformation to a standardized scale of 0 to 100, with a decrease in score representing a decrease in quality of life. 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
Avapritinib87

Reported measurements

Cycle 1, Day 15

Analysis denominator · Participants

GroupSource count
Avapritinib87
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib14.6623.397Not reportedNot reportedNot reported
Cycle 2, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib82
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib14.3324.855Not reportedNot reportedNot reported
Cycle 3, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib85
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib15.0028.516Not reportedNot reportedNot reported
Cycle 5, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib73
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib14.0430.042Not reportedNot reportedNot reported
Cycle 7, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib71
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib15.8530.575Not reportedNot reportedNot reported
Cycle 9, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib65
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib17.9529.801Not reportedNot reportedNot reported
Cycle 11, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib67
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib18.7828.179Not reportedNot reportedNot reported
Cycle 14, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib56
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib22.3231.346Not reportedNot reportedNot reported
Cycle 17, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib57
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib21.4929.207Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.397
        value
        14.66
    denoms
    1. counts
      1. group Id
        OG000
        value
        87
      units
      Participants
    title
    Cycle 1, Day 15
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        24.855
        value
        14.33
    denoms
    1. counts
      1. group Id
        OG000
        value
        82
      units
      Participants
    title
    Cycle 2, Day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        28.516
        value
        15.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        85
      units
      Participants
    title
    Cycle 3, Day 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        30.042
        value
        14.04
    denoms
    1. counts
      1. group Id
        OG000
        value
        73
      units
      Participants
    title
    Cycle 5, Day 1
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        30.575
        value
        15.85
    denoms
    1. counts
      1. group Id
        OG000
        value
        71
      units
      Participants
    title
    Cycle 7, Day 1
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        29.801
        value
        17.95
    denoms
    1. counts
      1. group Id
        OG000
        value
        65
      units
      Participants
    title
    Cycle 9, Day 1
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        28.179
        value
        18.78
    denoms
    1. counts
      1. group Id
        OG000
        value
        67
      units
      Participants
    title
    Cycle 11, Day 1
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        31.346
        value
        22.32
    denoms
    1. counts
      1. group Id
        OG000
        value
        56
      units
      Participants
    title
    Cycle 14, Day 1
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        29.207
        value
        21.49
    denoms
    1. counts
      1. group Id
        OG000
        value
        57
      units
      Participants
    title
    Cycle 17, Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      87
    units
    Participants
description
Quality of life was assessed using EORTC QLQ-C30, which is a 30-item questionnaire that includes 5 functional domains (physical, cognitive, role, emotional, and social) and a global health status scale. Twenty-eight questions are scored from 1 (not at all) to 4 (very much), while the other 2 are scored from 1 (very poor) to 7 (excellent). The calculated average is standardized using a linear transformation to a standardized scale of 0 to 100, with a decrease in score representing a decrease in quality of life. 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, Cycle 1, Day 15 and Day 1 of Cycle 2, Cycle 3, Cycle 5, Cycle 7, Cycle 9, Cycle 11, Cycle 14, and Cycle 17 (28 days/cycle)
title
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
type
SECONDARY
unit Of Measure
Score on a Scale

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

Preserved source evidence · Not medical advice