NCT03580655 · OUTCOME

Mean Change From Baseline in AdvSM-SAF Individual Symptom Scores (Episodes) 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: Number of Episodes
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. Two symptoms (vomiting and diarrhea) are scored for number of episodes. 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

Group	Source count
Avapritinib	93

Reported measurements

Vomiting

Values in Number of Episodes · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avapritinib	0.31	2.642	Not reported	Not reported	Not reported

Diarrhea

Values in Number of Episodes · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Avapritinib	-0.30	2.302	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
2.642
value
0.31
title
Vomiting
categories
measurements
group Id
OG000
spread
2.302
value
-0.30
title
Diarrhea

denoms

counts
group Id
OG000
value
93
units
Participants

description

dispersion Type

Standard Deviation

groups

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 (Episodes) at Month 10

type

SECONDARY

unit Of Measure

Number of Episodes

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

Preserved source evidence · Not medical advice