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NCT03580655 · OUTCOME

Mean Change From Baseline in AdvSM-SAF Individual Symptom Scores (Severity) at Month 10

(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, Month 10

What was measured

The AdvSM-SAF is a 10-item questionnaire that assesses symptoms and functional domains specific to AdvSM. Individual symptom scores are generated based on average scores for each 7-day period. Eight symptoms are scored on a scale of 0 to 10 for severity. An increase in score represents a worse symptoms outcome. Participants completed the AdvSM-SAF daily using an eDiary.

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
Avapritinib93

Reported measurements

Fatigue
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-1.122.836Not reportedNot reportedNot reported
Spots
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-0.802.099Not reportedNot reportedNot reported
Itching
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-0.942.302Not reportedNot reportedNot reported
Flushing
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-0.782.351Not reportedNot reportedNot reported
Abdominal Pain
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-1.512.439Not reportedNot reportedNot reported
Nausea
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-0.751.723Not reportedNot reportedNot reported
Vomiting
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-0.031.004Not reportedNot reportedNot reported
Diarrhea
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-0.531.970Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.836
        value
        -1.12
    title
    Fatigue
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.099
        value
        -0.80
    title
    Spots
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.302
        value
        -0.94
    title
    Itching
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.351
        value
        -0.78
    title
    Flushing
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.439
        value
        -1.51
    title
    Abdominal Pain
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.723
        value
        -0.75
    title
    Nausea
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.004
        value
        -0.03
    title
    Vomiting
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.970
        value
        -0.53
    title
    Diarrhea
denoms
  1. counts
    1. group Id
      OG000
      value
      93
    units
    Participants
description
The AdvSM-SAF is a 10-item questionnaire that assesses symptoms and functional domains specific to AdvSM. Individual symptom scores are generated based on average scores for each 7-day period. Eight symptoms are scored on a scale of 0 to 10 for severity. An increase in score represents a worse symptoms outcome. Participants completed the AdvSM-SAF daily using an eDiary.
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, Month 10
title
Mean Change From Baseline in AdvSM-SAF Individual Symptom Scores (Severity) at Month 10
type
SECONDARY
unit Of Measure
Score on a Scale

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

Preserved source evidence · Not medical advice