NCT03580655 · ADVERSE EVENTS

Adverse events

(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.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: Day 1 through Month 65
Other-event reporting threshold: 5%

All reported safety data based upon the Safety Population: all participants who received ≥1 dose of avapritinib regardless of the starting avapritinib dose (N=107). All participants were treated with a starting dose of 200 mg with the exception of 2 participants who were treated with a starting dose of 100 mg.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Avapritinib (100 mg) Avapritinib was administered once daily as an immediate-release tablet, orally, in 28-day cycles.	2 / 2	2 / 2	1 / 2
Avapritinib (200 mg) Avapritinib was administered once daily as an immediate-release tablet, orally, in 28-day cycles.	67 / 105	104 / 107	33 / 105

Group identifiers: EG000: Avapritinib (100 mg) · EG001: Avapritinib (200 mg)

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
3
num At Risk
105
num Events
3
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
2
num At Risk
105
num Events
2
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
1
num At Risk
105
num Events
1
term
Haemorrhagic diathesis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
1
num At Risk
105
num Events
2
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
1
num At Risk
105
num Events
3
term
Mast cell activation syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
3
group Id
EG001
num Affected
3
num At Risk
105
num Events
5
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
1
num At Risk
105
num Events
1
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
1
num At Risk
105
num Events
1
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
1
num At Risk
105
num Events
1
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
1
num At Risk
105
num Events
1
term
Coronary artery dissection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
1
num At Risk
105
num Events
1
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
1
num At Risk
105
num Events
1
term
Vertigo

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
2
num At Risk
2
num Events
2
group Id
EG001
num Affected
54
num At Risk
107
num Events
203
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
48
num At Risk
107
num Events
282
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
6
group Id
EG001
num Affected
24
num At Risk
107
num Events
125
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
4
group Id
EG001
num Affected
8
num At Risk
107
num Events
28
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
1
group Id
EG001
num Affected
45
num At Risk
107
num Events
78
term
Periorbital oedema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
14
num At Risk
107
num Events
15
term
Eyelid oedema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
8
num At Risk
107
num Events
9
term
Lacrimation increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
2
num At Risk
2
num Events
2
group Id
EG001
num Affected
36
num At Risk
107
num Events
60
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
29
num At Risk
107
num Events
36
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
1
group Id
EG001
num Affected
24
num At Risk
107
num Events
29
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
16
num At Risk
107
num Events
22
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
16
num At Risk
107
num Events
20
term
Constipation

Complete source fields

description

event Groups

deaths Num Affected
1
deaths Num At Risk
2
description
Avapritinib was administered once daily as an immediate-release tablet, orally, in 28-day cycles.
id
EG000
other Num Affected
2
other Num At Risk
2
serious Num Affected
2
serious Num At Risk
2
title
Avapritinib (100 mg)
deaths Num Affected
33
deaths Num At Risk
105
description
Avapritinib was administered once daily as an immediate-release tablet, orally, in 28-day cycles.
id
EG001
other Num Affected
104
other Num At Risk
107
serious Num Affected
67
serious Num At Risk
105
title
Avapritinib (200 mg)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
2
num At Risk
2
num Events
2
group Id
EG001
num Affected
54
num At Risk
107
num Events
203
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
48
num At Risk
107
num Events
282
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
6
group Id
EG001
num Affected
24
num At Risk
107
num Events
125
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
4
group Id
EG001
num Affected
8
num At Risk
107
num Events
28
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
1
group Id
EG001
num Affected
45
num At Risk
107
num Events
78
term
Periorbital oedema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
14
num At Risk
107
num Events
15
term
Eyelid oedema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
8
num At Risk
107
num Events
9
term
Lacrimation increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
2
num At Risk
2
num Events
2
group Id
EG001
num Affected
36
num At Risk
107
num Events
60
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
29
num At Risk
107
num Events
36
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
1
group Id
EG001
num Affected
24
num At Risk
107
num Events
29
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
16
num At Risk
107
num Events
22
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
16
num At Risk
107
num Events
20
term
Constipation

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
3
num At Risk
105
num Events
3
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
2
num At Risk
105
num Events
2
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
1
num At Risk
105
num Events
1
term
Haemorrhagic diathesis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
1
num At Risk
105
num Events
2
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
1
num At Risk
105
num Events
3
term
Mast cell activation syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
3
group Id
EG001
num Affected
3
num At Risk
105
num Events
5
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
1
num At Risk
105
num Events
1
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
1
num At Risk
105
num Events
1
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
1
num At Risk
105
num Events
1
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
1
num At Risk
105
num Events
1
term
Coronary artery dissection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
1
num At Risk
105
num Events
1
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
1
num At Risk
105
num Events
1
term
Vertigo

time Frame

Day 1 through Month 65

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

Preserved source evidence · Not medical advice