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NCT03580655 · OUTCOME

Change From Baseline in Patient's Global Impression of Symptom Severity (PGIS)

(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

The PGIS is a single-item scale that assesses a participant's perception of disease symptoms at a point in time. Scores range from 0 to 4 points, with higher values representing worse symptom outcomes. It is widely used to evaluate a participant's overall sense of whether a treatment has been beneficial. 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
Avapritinib-0.71.23Not reportedNot reportedNot reported
Cycle 2, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib82
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-0.91.24Not reportedNot reportedNot reported
Cycle 3, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib85
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-1.01.20Not reportedNot reportedNot reported
Cycle 5, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib73
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-1.01.32Not reportedNot reportedNot reported
Cycle 7, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib71
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-1.11.46Not reportedNot reportedNot reported
Cycle 9, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib65
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-1.31.50Not reportedNot reportedNot reported
Cycle 11, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib67
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-1.31.36Not reportedNot reportedNot reported
Cycle 14, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib56
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-1.41.65Not reportedNot reportedNot reported
Cycle 17, Day 1

Analysis denominator · Participants

GroupSource count
Avapritinib56
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-1.51.41Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.23
        value
        -0.7
    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
        1.24
        value
        -0.9
    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
        1.20
        value
        -1.0
    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
        1.32
        value
        -1.0
    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
        1.46
        value
        -1.1
    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
        1.50
        value
        -1.3
    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
        1.36
        value
        -1.3
    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
        1.65
        value
        -1.4
    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
        1.41
        value
        -1.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        56
      units
      Participants
    title
    Cycle 17, Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      87
    units
    Participants
description
The PGIS is a single-item scale that assesses a participant's perception of disease symptoms at a point in time. Scores range from 0 to 4 points, with higher values representing worse symptom outcomes. It is widely used to evaluate a participant's overall sense of whether a treatment has been beneficial. 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 Patient's Global Impression of Symptom Severity (PGIS)
type
SECONDARY
unit Of Measure
Score on a Scale

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

Preserved source evidence · Not medical advice