Trial Outcomes & Findings for (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 (NCT NCT03580655)
NCT ID: NCT03580655
Last Updated: 2026-04-24
Results Overview
ORR was defined as the percentage of participants with a confirmed best response of complete remission (CR), complete remission with partial recovery of peripheral blood counts (CRh), partial remission (PR), or clinical improvement (CI) by mIWG-MRT-ECNM criteria. The mIWG-MRT-ECNM criteria were based on findings from bone marrow biopsy and aspirate, and peripheral blood smear; bone marrow cytogenetics; other extracutaneous tissue biopsies (when available); liver and spleen imaging; and other clinical and laboratory parameters.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
107 participants
Primary outcome timeframe
Baseline through Month 65
Results posted on
2026-04-24
Participant Flow
The Avapritinib group (N=107) includes all participants treated at a starting dose of 200 milligrams (mg) once daily (N=105) and 2 participants treated at a starting dose of 100 mg once daily. One participant was treated at a starting dose of 100 mg per previous protocol amendment, and 1 participant was treated at a starting dose of 100 mg per principal investigator decision.
Participant milestones
| Measure |
Avapritinib (100 mg)
Avapritinib was administered once daily as an immediate-release tablet, orally, in 28-day cycles.
|
Avapritinib (200 mg)
Avapritinib was administered once daily as an immediate-release tablet, orally, in 28-day cycles.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
105
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
2
|
105
|
|
Overall Study
Pure Pathologic Response-evaluable Population
|
2
|
105
|
|
Overall Study
Response-evaluable Population
|
2
|
81
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
105
|
Reasons for withdrawal
| Measure |
Avapritinib (100 mg)
Avapritinib was administered once daily as an immediate-release tablet, orally, in 28-day cycles.
|
Avapritinib (200 mg)
Avapritinib was administered once daily as an immediate-release tablet, orally, in 28-day cycles.
|
|---|---|---|
|
Overall Study
Disease Progression
|
0
|
1
|
|
Overall Study
Participant Non-compliance
|
0
|
2
|
|
Overall Study
Physician Decision
|
0
|
5
|
|
Overall Study
Intracranial Hemorrhage
|
0
|
1
|
|
Overall Study
Sponsor Decision
|
1
|
43
|
|
Overall Study
Withdrawal by Subject
|
0
|
19
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Death
|
1
|
33
|
Baseline Characteristics
(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
Baseline characteristics by cohort
| Measure |
Avapritinib
n=107 Participants
Avapritinib was administered once daily as an immediate-release tablet, orally, in 28-day cycles.
|
|---|---|
|
Age, Continuous
|
67.1 Years
STANDARD_DEVIATION 10.38 • n=2 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=2 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
91 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=2 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
White
|
91 Participants
n=2 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
15 Participants
n=2 Participants
|
PRIMARY outcome
Timeframe: Baseline through Month 65Population: Response-evaluable Population: all participants who received ≥1 dose of avapritinib, were deemed evaluable per mIWG-MRT-ECNM criteria at baseline as assessed by study steering committee review and had 1 of the following conditions: ≥2 complete postbaseline bone marrow assessments and had been on study for ≥6 cycles; had an end of study visit.
ORR was defined as the percentage of participants with a confirmed best response of complete remission (CR), complete remission with partial recovery of peripheral blood counts (CRh), partial remission (PR), or clinical improvement (CI) by mIWG-MRT-ECNM criteria. The mIWG-MRT-ECNM criteria were based on findings from bone marrow biopsy and aspirate, and peripheral blood smear; bone marrow cytogenetics; other extracutaneous tissue biopsies (when available); liver and spleen imaging; and other clinical and laboratory parameters.
Outcome measures
| Measure |
Avapritinib
n=83 Participants
Avapritinib was administered once daily as an immediate-release tablet, orally, in 28-day cycles.
|
|---|---|
|
Overall Response Rate (ORR) Based on Modified International Working Group-Myeloproliferative Neoplasms Research and Treatment and European Competence Network on Mastocytosis (mIWG-MRT-ECNM) Response Criteria
|
73.5 Percentage of Participants
Interval 62.7 to 82.6
|
SECONDARY outcome
Timeframe: Baseline up to Month 6 (Cycle 6, Day 1)Population: Safety Population: all participants who received ≥1 dose of avapritinib. Here, 'Number of Participants Analyzed' signifies those participants evaluable for this outcome measure at the specified timepoints.
The AdvSM-SAF is a 10-item questionnaire that assesses eight symptoms specific to AdvSM. All eight symptoms are scored on a scale of 0 (absence of symptoms) to 10 (more severe symptoms) (up to 80 points maximum). Each symptom contributes to the TSS equally. The TSS was generated based on average scores for each 7-day period. An increase in score from 0 (no symptoms) to 80 (worst symptoms represents a worse symptoms outcome. Participants completed the AdvSM-SAF daily using an electronic diary (eDiary). Each cycle is 28 days long.
Outcome measures
| Measure |
Avapritinib
n=92 Participants
Avapritinib was administered once daily as an immediate-release tablet, orally, in 28-day cycles.
|
|---|---|
|
Mean Change From Baseline in Advanced Systemic Mastocytosis-Symptom Assessment Form (AdvSM-SAF) Total Symptom Score (TTS)
|
-6.40 Score on a Scale
Standard Deviation 9.158
|
SECONDARY outcome
Timeframe: Baseline through Month 19Population: Response-evaluable Population: all participants who received ≥1 dose of avapritinib, were deemed evaluable per mIWG-MRT-ECNM criteria at baseline as assessed by local investigator and had 1 of the following conditions: ≥2 complete postbaseline bone marrow assessments and had been on study for ≥6 cycles; had an end of study visit. Here, 'Overall Number of Participants Analyzed' signifies those participants evaluable for this outcome measure.
ORR was defined as the percentage of participants with a confirmed best response of CR, CRh, PR, or CI by mIWG-MRT-ECNM criteria. The mIWG-MRT-ECNM criteria were based on findings from bone marrow biopsy and aspirate, and peripheral blood smear; bone marrow cytogenetics; other extracutaneous tissue biopsies (when available); liver and spleen imaging; and other clinical and laboratory parameters.
Outcome measures
| Measure |
Avapritinib
n=32 Participants
Avapritinib was administered once daily as an immediate-release tablet, orally, in 28-day cycles.
|
|---|---|
|
ORR Based on mIWG-MRT-ECNM Response Criteria as Assessed by Local Investigator
|
53.1 Percentage of Participants
Interval 34.7 to 70.9
|
SECONDARY outcome
Timeframe: Baseline through Month 65Population: Response-evaluable Population: all participants who received ≥1 dose of avapritinib, were deemed evaluable per mIWG-MRT-ECNM criteria at baseline as assessed by study steering committee review and had 1 of the following conditions: ≥2 complete postbaseline bone marrow assessments and had been on study for ≥6 cycles; had an end of study visit.
TTR was defined as the time from first dose to the time of initial evaluation of clinical improvement (CI) or better. Here, 'Overall Number of Participants Analyzed' signifies those participants with a confirmed best response of CR, CRh, PR, and CI by mIWG-MRT-ECNM criteria.
Outcome measures
| Measure |
Avapritinib
n=61 Participants
Avapritinib was administered once daily as an immediate-release tablet, orally, in 28-day cycles.
|
|---|---|
|
Time-to-Response (TTR)
|
2.30 Months
Interval 0.3 to 20.3
|
SECONDARY outcome
Timeframe: Baseline through Month 65Population: Response-evaluable Population: all participants who received ≥1 dose of avapritinib, were deemed evaluable per mIWG-MRT-ECNM criteria at baseline as assessed by study steering committee review and had 1 of the following conditions: ≥2 complete postbaseline bone marrow assessments and had been on study for ≥6 cycles; had an end of study visit.
DOR was defined as the time from initial documentation of a CI or better to the time of initial documentation of confirmed progressive disease (PD) or death due to any cause, whichever occurred first. For responders who had not progressed or died at the time of analysis, DOR was censored at the last response assessment that was stable disease (SD) or better. Here, 'Overall Number of Participants Analyzed' signifies those participants with a confirmed best response of CR, CRh, PR, and CI by mIWG-MRT-ECNM criteria.
Outcome measures
| Measure |
Avapritinib
n=61 Participants
Avapritinib was administered once daily as an immediate-release tablet, orally, in 28-day cycles.
|
|---|---|
|
Duration of Response (DOR)
|
57.8 Months
Interval 46.1 to
Values were non-estimable (insufficient number of participants with events).
|
SECONDARY outcome
Timeframe: Baseline through Month 65Population: Response-evaluable Population: all participants who received ≥1 dose of avapritinib, were deemed evaluable per mIWG-MRT-ECNM criteria at baseline as assessed by study steering committee review and had 1 of the following conditions: ≥2 complete postbaseline bone marrow assessments, and had been on study for ≥6 cycles; had an end of study visit.
PFS was defined as time from first dose to the time of initial documentation of confirmed PD or death due to any cause, whichever occurred first. Participants who had not progressed or died at the time of analysis were censored at the last response assessment that was SD or better.
Outcome measures
| Measure |
Avapritinib
n=83 Participants
Avapritinib was administered once daily as an immediate-release tablet, orally, in 28-day cycles.
|
|---|---|
|
Progression-free Survival (PFS)
|
51.3 Months
Interval 38.7 to
Values were non-estimable (insufficient number of participants with events).
|
SECONDARY outcome
Timeframe: Baseline through Month 65Population: Safety Population: all participants who received ≥1 dose of avapritinib.
OS was defined as time from first dose to the time of death due to any cause. Participants who were known to be alive or are lost to follow-up were censored at the last time point they were known to be alive.
Outcome measures
| Measure |
Avapritinib
n=107 Participants
Avapritinib was administered once daily as an immediate-release tablet, orally, in 28-day cycles.
|
|---|---|
|
Overall Survival (OS)
|
61.6 Months
Interval 60.0 to
Values were non-estimable (insufficient number of participants with events).
|
SECONDARY outcome
Timeframe: Baseline through Month 65Population: Pure Pathologic Response-evaluable Population: all participants who received ≥1 dose of avapritinib and had 1 of the following conditions: ≥2 complete postbaseline bone marrow assessments and had been on study for ≥6 cycles; had an end of study visit.
The objective response rate was defined as the number of participants with a confirmed best response of morphologic complete remission, morphologic complete remission with partial recovery of peripheral blood counts, or morphologic partial remission by pure pathologic response (PPR) criteria. The PPR criteria are a modification of the mIWG-MRT-ECNM criteria that define deep responses where direct measure of the disease burden determined the response and focus on objective changes (bone marrow mast cell burden, serum tryptase, and complete blood count).
Outcome measures
| Measure |
Avapritinib
n=107 Participants
Avapritinib was administered once daily as an immediate-release tablet, orally, in 28-day cycles.
|
|---|---|
|
Objective Response Rate
|
73.8 Percentage of Participants
Interval 64.4 to 81.9
|
SECONDARY outcome
Timeframe: Baseline through Month 65Population: Response-evaluable Population: all participants who received ≥1 dose of avapritinib, were deemed evaluable per mIWG-MRT-ECNM criteria at baseline as assessed by study steering committee review and had 1 of the following conditions: ≥2 complete postbaseline bone marrow assessments and had been on study for ≥6 cycles; had an end of study visit.
The clinical benefit rate was defined as the percentage of participants with a confirmed best response of CR, CRh, PR, CI, and SD by mIWG-MRT-ECNM criteria.
Outcome measures
| Measure |
Avapritinib
n=83 Participants
Avapritinib was administered once daily as an immediate-release tablet, orally, in 28-day cycles.
|
|---|---|
|
Clinical Benefit Rate
|
89.2 Percentage of Participants
Interval 80.4 to 94.9
|
SECONDARY outcome
Timeframe: Baseline up to Month 65Population: 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.
Bone marrow biopsies and aspirates and peripheral blood smears were obtained for systemic mastocytosis response assessment according to mIWG-MRT-ECNM criteria. Each cycle is 28 days long.
Outcome measures
| Measure |
Avapritinib
n=84 Participants
Avapritinib was administered once daily as an immediate-release tablet, orally, in 28-day cycles.
|
|---|---|
|
Percent Change From Baseline in Bone Marrow Mast Cells
Cycle 35, Day 1
|
-83.53 Percent Change
Standard Deviation 28.316
|
|
Percent Change From Baseline in Bone Marrow Mast Cells
Cycle 41, Day 1
|
-83.32 Percent Change
Standard Deviation 21.374
|
|
Percent Change From Baseline in Bone Marrow Mast Cells
Cycle 47, Day 1
|
-81.38 Percent Change
Standard Deviation 21.656
|
|
Percent Change From Baseline in Bone Marrow Mast Cells
Cycle 53, Day 1
|
-75.83 Percent Change
Standard Deviation 29.094
|
|
Percent Change From Baseline in Bone Marrow Mast Cells
Cycle 59, Day 1
|
-79.55 Percent Change
Standard Deviation 21.921
|
|
Percent Change From Baseline in Bone Marrow Mast Cells
Cycle 65, Day 1
|
-68.03 Percent Change
Standard Deviation 26.781
|
|
Percent Change From Baseline in Bone Marrow Mast Cells
Cycle 3, Day 1
|
-63.74 Percent Change
Standard Deviation 39.445
|
|
Percent Change From Baseline in Bone Marrow Mast Cells
Cycle 7, Day 1
|
-71.12 Percent Change
Standard Deviation 35.602
|
|
Percent Change From Baseline in Bone Marrow Mast Cells
Cycle 11, Day 1
|
-73.10 Percent Change
Standard Deviation 49.885
|
|
Percent Change From Baseline in Bone Marrow Mast Cells
Cycle 17, Day 1
|
-81.33 Percent Change
Standard Deviation 32.377
|
|
Percent Change From Baseline in Bone Marrow Mast Cells
Cycle 23, Day 1
|
-80.84 Percent Change
Standard Deviation 29.283
|
|
Percent Change From Baseline in Bone Marrow Mast Cells
Cycle 29, Day 1
|
-78.90 Percent Change
Standard Deviation 29.181
|
SECONDARY outcome
Timeframe: Baseline up to Month 65Population: 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.
Blood samples were collected to characterize the change in serum tryptase concentration during treatment with avapritinib. Each cycle is 28 days long.
Outcome measures
| Measure |
Avapritinib
n=98 Participants
Avapritinib was administered once daily as an immediate-release tablet, orally, in 28-day cycles.
|
|---|---|
|
Percent Change From Baseline in Serum Tryptase
Cycle 1, Day 15
|
-64.54 Percent Change
Standard Deviation 41.191
|
|
Percent Change From Baseline in Serum Tryptase
Cycle 2, Day 1
|
-68.54 Percent Change
Standard Deviation 42.091
|
|
Percent Change From Baseline in Serum Tryptase
Cycle 3, Day 1
|
-71.76 Percent Change
Standard Deviation 40.023
|
|
Percent Change From Baseline in Serum Tryptase
Cycle 7, Day 1
|
-75.18 Percent Change
Standard Deviation 45.822
|
|
Percent Change From Baseline in Serum Tryptase
Cycle 23, Day 1
|
-85.61 Percent Change
Standard Deviation 30.510
|
|
Percent Change From Baseline in Serum Tryptase
Cycle 29, Day 1
|
-83.50 Percent Change
Standard Deviation 40.716
|
|
Percent Change From Baseline in Serum Tryptase
Cycle 35, Day 1
|
-83.39 Percent Change
Standard Deviation 45.603
|
|
Percent Change From Baseline in Serum Tryptase
Cycle 41, Day 1
|
-90.64 Percent Change
Standard Deviation 14.206
|
|
Percent Change From Baseline in Serum Tryptase
Cycle 65, Day 1
|
-82.01 Percent Change
Standard Deviation 14.529
|
|
Percent Change From Baseline in Serum Tryptase
Cycle 11, Day 1
|
-78.69 Percent Change
Standard Deviation 36.038
|
|
Percent Change From Baseline in Serum Tryptase
Cycle 17, Day 1
|
-85.22 Percent Change
Standard Deviation 26.070
|
|
Percent Change From Baseline in Serum Tryptase
Cycle 47, Day 1
|
-90.64 Percent Change
Standard Deviation 12.581
|
|
Percent Change From Baseline in Serum Tryptase
Cycle 53, Day 1
|
-68.65 Percent Change
Standard Deviation 85.482
|
|
Percent Change From Baseline in Serum Tryptase
Cycle 59, Day 1
|
-92.23 Percent Change
Standard Deviation 6.8211
|
SECONDARY outcome
Timeframe: Baseline up to Month 65Population: 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.
Bone marrow aspirate and PB samples were collected to characterize the KIT D816V mutation allele fraction. Each cycle is 28 days long.
Outcome measures
| Measure |
Avapritinib
n=97 Participants
Avapritinib was administered once daily as an immediate-release tablet, orally, in 28-day cycles.
|
|---|---|
|
Percent Change From Baseline in V-kit Hardy-Zuckerman 4 Feline Sarcoma Viral Oncogene Homolog Aspartate 816 Valine (KIT D816V) Mutation Burden
Cycle 1, Day 15
|
-14.65 Percent Change
Standard Deviation 21.049
|
|
Percent Change From Baseline in V-kit Hardy-Zuckerman 4 Feline Sarcoma Viral Oncogene Homolog Aspartate 816 Valine (KIT D816V) Mutation Burden
Cycle 2, Day 1
|
-41.68 Percent Change
Standard Deviation 23.171
|
|
Percent Change From Baseline in V-kit Hardy-Zuckerman 4 Feline Sarcoma Viral Oncogene Homolog Aspartate 816 Valine (KIT D816V) Mutation Burden
Cycle 3, Day 1
|
-54.32 Percent Change
Standard Deviation 31.272
|
|
Percent Change From Baseline in V-kit Hardy-Zuckerman 4 Feline Sarcoma Viral Oncogene Homolog Aspartate 816 Valine (KIT D816V) Mutation Burden
Cycle 7, Day 1
|
-65.46 Percent Change
Standard Deviation 32.953
|
|
Percent Change From Baseline in V-kit Hardy-Zuckerman 4 Feline Sarcoma Viral Oncogene Homolog Aspartate 816 Valine (KIT D816V) Mutation Burden
Cycle 11, Day 1
|
-67.77 Percent Change
Standard Deviation 30.802
|
|
Percent Change From Baseline in V-kit Hardy-Zuckerman 4 Feline Sarcoma Viral Oncogene Homolog Aspartate 816 Valine (KIT D816V) Mutation Burden
Cycle 17, Day 1
|
-77.25 Percent Change
Standard Deviation 26.783
|
|
Percent Change From Baseline in V-kit Hardy-Zuckerman 4 Feline Sarcoma Viral Oncogene Homolog Aspartate 816 Valine (KIT D816V) Mutation Burden
Cycle 23, Day 1
|
-77.09 Percent Change
Standard Deviation 29.838
|
|
Percent Change From Baseline in V-kit Hardy-Zuckerman 4 Feline Sarcoma Viral Oncogene Homolog Aspartate 816 Valine (KIT D816V) Mutation Burden
Cycle 29, Day 1
|
-80.97 Percent Change
Standard Deviation 29.775
|
|
Percent Change From Baseline in V-kit Hardy-Zuckerman 4 Feline Sarcoma Viral Oncogene Homolog Aspartate 816 Valine (KIT D816V) Mutation Burden
Cycle 35, Day 1
|
-81.93 Percent Change
Standard Deviation 31.110
|
|
Percent Change From Baseline in V-kit Hardy-Zuckerman 4 Feline Sarcoma Viral Oncogene Homolog Aspartate 816 Valine (KIT D816V) Mutation Burden
Cycle 41, Day 1
|
-85.31 Percent Change
Standard Deviation 24.911
|
|
Percent Change From Baseline in V-kit Hardy-Zuckerman 4 Feline Sarcoma Viral Oncogene Homolog Aspartate 816 Valine (KIT D816V) Mutation Burden
Cycle 47, Day 1
|
-81.76 Percent Change
Standard Deviation 28.490
|
|
Percent Change From Baseline in V-kit Hardy-Zuckerman 4 Feline Sarcoma Viral Oncogene Homolog Aspartate 816 Valine (KIT D816V) Mutation Burden
Cycle 53, Day 1
|
-76.27 Percent Change
Standard Deviation 34.561
|
|
Percent Change From Baseline in V-kit Hardy-Zuckerman 4 Feline Sarcoma Viral Oncogene Homolog Aspartate 816 Valine (KIT D816V) Mutation Burden
Cycle 59, Day 1
|
-64.42 Percent Change
Standard Deviation 37.677
|
|
Percent Change From Baseline in V-kit Hardy-Zuckerman 4 Feline Sarcoma Viral Oncogene Homolog Aspartate 816 Valine (KIT D816V) Mutation Burden
Cycle 65, Day 1
|
-47.58 Percent Change
Standard Deviation 47.893
|
SECONDARY outcome
Timeframe: Baseline up to Month 65Population: 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.
Assessment of liver volume was performed using serial imaging with magnetic resonance imaging (MRI). Response was defined as resolution of palpable hepatomegaly (CR). Each cycle is 28 days long.
Outcome measures
| Measure |
Avapritinib
n=85 Participants
Avapritinib was administered once daily as an immediate-release tablet, orally, in 28-day cycles.
|
|---|---|
|
Percent Change From Baseline in Liver Volume by Imaging
Cycle 7, Day 1
|
-18.53 Percent Change
Standard Deviation 12.376
|
|
Percent Change From Baseline in Liver Volume by Imaging
Cycle 23, Day 1
|
-29.50 Percent Change
Standard Deviation 12.983
|
|
Percent Change From Baseline in Liver Volume by Imaging
Cycle 29, Day 1
|
-29.84 Percent Change
Standard Deviation 13.588
|
|
Percent Change From Baseline in Liver Volume by Imaging
Cycle 35, Day 1
|
-29.81 Percent Change
Standard Deviation 16.764
|
|
Percent Change From Baseline in Liver Volume by Imaging
Cycle 41, Day 1
|
-31.77 Percent Change
Standard Deviation 16.694
|
|
Percent Change From Baseline in Liver Volume by Imaging
Cycle 47, Day 1
|
-34.31 Percent Change
Standard Deviation 13.973
|
|
Percent Change From Baseline in Liver Volume by Imaging
Cycle 53, Day 1
|
-35.86 Percent Change
Standard Deviation 14.147
|
|
Percent Change From Baseline in Liver Volume by Imaging
Cycle 59, Day 1
|
-31.74 Percent Change
Standard Deviation 18.020
|
|
Percent Change From Baseline in Liver Volume by Imaging
Cycle 65, Day 1
|
-26.88 Percent Change
Standard Deviation 21.594
|
|
Percent Change From Baseline in Liver Volume by Imaging
Cycle 3, Day 1
|
-12.45 Percent Change
Standard Deviation 10.103
|
|
Percent Change From Baseline in Liver Volume by Imaging
Cycle 11, Day 1
|
-22.07 Percent Change
Standard Deviation 11.603
|
|
Percent Change From Baseline in Liver Volume by Imaging
Cycle 17, Day 1
|
-27.92 Percent Change
Standard Deviation 11.949
|
SECONDARY outcome
Timeframe: Baseline up to Month 65Population: 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.
Assessment of spleen volume was performed using serial imaging with MRI. Response was defined as ≥35% reduction in spleen volume (PR) or resolution of palpable splenomegaly (CR). Each cycle is 28 days long.
Outcome measures
| Measure |
Avapritinib
n=84 Participants
Avapritinib was administered once daily as an immediate-release tablet, orally, in 28-day cycles.
|
|---|---|
|
Percent Change From Baseline in Spleen Volume by Imaging
Cycle 3, Day 1
|
-28.47 Percent Change
Standard Deviation 26.817
|
|
Percent Change From Baseline in Spleen Volume by Imaging
Cycle 7, Day 1
|
-35.77 Percent Change
Standard Deviation 26.770
|
|
Percent Change From Baseline in Spleen Volume by Imaging
Cycle 11, Day 1
|
-38.71 Percent Change
Standard Deviation 28.700
|
|
Percent Change From Baseline in Spleen Volume by Imaging
Cycle 17, Day 1
|
-47.53 Percent Change
Standard Deviation 23.957
|
|
Percent Change From Baseline in Spleen Volume by Imaging
Cycle 23, Day 1
|
-44.89 Percent Change
Standard Deviation 24.377
|
|
Percent Change From Baseline in Spleen Volume by Imaging
Cycle 29, Day 1
|
-44.30 Percent Change
Standard Deviation 32.952
|
|
Percent Change From Baseline in Spleen Volume by Imaging
Cycle 35, Day 1
|
-45.00 Percent Change
Standard Deviation 32.274
|
|
Percent Change From Baseline in Spleen Volume by Imaging
Cycle 41, Day 1
|
-51.33 Percent Change
Standard Deviation 25.812
|
|
Percent Change From Baseline in Spleen Volume by Imaging
Cycle 47, Day 1
|
-52.45 Percent Change
Standard Deviation 24.580
|
|
Percent Change From Baseline in Spleen Volume by Imaging
Cycle 59, Day 1
|
-40.35 Percent Change
Standard Deviation 28.396
|
|
Percent Change From Baseline in Spleen Volume by Imaging
Cycle 65, Day 1
|
-40.27 Percent Change
Standard Deviation 11.884
|
|
Percent Change From Baseline in Spleen Volume by Imaging
Cycle 53, Day 1
|
-42.85 Percent Change
Standard Deviation 45.498
|
SECONDARY outcome
Timeframe: Baseline, Month 10Population: 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.
The AdvSM-SAF is a 10-item questionnaire that assesses symptoms and functional domains specific to AdvSM. Eight symptoms are scored on a scale of 0 to 10 for severity and 2 symptoms (vomiting and diarrhea) are scored for number of episodes. The skin domain is scored on a scale of 0-30, where 0 represents an absence of symptoms and 30 the most severe symptom experience. Similarly, the gastrointestinal domain is scored on a scale of 0-40, where 0 represents an absence of symptoms and 40 the most severe symptom experience. Skin and gastrointestinal domain scores were generated based on average scores for each 7-day period. An increase in score represents a worse symptoms outcome. Participants completed the AdvSM-SAF daily using an eDiary.
Outcome measures
| Measure |
Avapritinib
n=93 Participants
Avapritinib was administered once daily as an immediate-release tablet, orally, in 28-day cycles.
|
|---|---|
|
Mean Change From Baseline in AdvSM-SAF Skin and Gastrointestinal Domain Scores at Month 10
Skin Domain
|
-2.52 Score on a Scale
Standard Deviation 5.362
|
|
Mean Change From Baseline in AdvSM-SAF Skin and Gastrointestinal Domain Scores at Month 10
Gastrointestinal Domain
|
-2.81 Score on a Scale
Standard Deviation 5.172
|
SECONDARY outcome
Timeframe: Baseline, Month 10Population: 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.
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.
Outcome measures
| Measure |
Avapritinib
n=93 Participants
Avapritinib was administered once daily as an immediate-release tablet, orally, in 28-day cycles.
|
|---|---|
|
Mean Change From Baseline in AdvSM-SAF Individual Symptom Scores (Severity) at Month 10
Fatigue
|
-1.12 Score on a Scale
Standard Deviation 2.836
|
|
Mean Change From Baseline in AdvSM-SAF Individual Symptom Scores (Severity) at Month 10
Spots
|
-0.80 Score on a Scale
Standard Deviation 2.099
|
|
Mean Change From Baseline in AdvSM-SAF Individual Symptom Scores (Severity) at Month 10
Itching
|
-0.94 Score on a Scale
Standard Deviation 2.302
|
|
Mean Change From Baseline in AdvSM-SAF Individual Symptom Scores (Severity) at Month 10
Flushing
|
-0.78 Score on a Scale
Standard Deviation 2.351
|
|
Mean Change From Baseline in AdvSM-SAF Individual Symptom Scores (Severity) at Month 10
Abdominal Pain
|
-1.51 Score on a Scale
Standard Deviation 2.439
|
|
Mean Change From Baseline in AdvSM-SAF Individual Symptom Scores (Severity) at Month 10
Nausea
|
-0.75 Score on a Scale
Standard Deviation 1.723
|
|
Mean Change From Baseline in AdvSM-SAF Individual Symptom Scores (Severity) at Month 10
Vomiting
|
-0.03 Score on a Scale
Standard Deviation 1.004
|
|
Mean Change From Baseline in AdvSM-SAF Individual Symptom Scores (Severity) at Month 10
Diarrhea
|
-0.53 Score on a Scale
Standard Deviation 1.970
|
SECONDARY outcome
Timeframe: Baseline, Month 10Population: 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.
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.
Outcome measures
| Measure |
Avapritinib
n=93 Participants
Avapritinib was administered once daily as an immediate-release tablet, orally, in 28-day cycles.
|
|---|---|
|
Mean Change From Baseline in AdvSM-SAF Individual Symptom Scores (Episodes) at Month 10
Vomiting
|
0.31 Number of Episodes
Standard Deviation 2.642
|
|
Mean Change From Baseline in AdvSM-SAF Individual Symptom Scores (Episodes) at Month 10
Diarrhea
|
-0.30 Number of Episodes
Standard Deviation 2.302
|
SECONDARY outcome
Timeframe: 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)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.
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.
Outcome measures
| Measure |
Avapritinib
n=87 Participants
Avapritinib was administered once daily as an immediate-release tablet, orally, in 28-day cycles.
|
|---|---|
|
Change From Baseline in Patient's Global Impression of Symptom Severity (PGIS)
Cycle 2, Day 1
|
-0.9 Score on a Scale
Standard Deviation 1.24
|
|
Change From Baseline in Patient's Global Impression of Symptom Severity (PGIS)
Cycle 3, Day 1
|
-1.0 Score on a Scale
Standard Deviation 1.20
|
|
Change From Baseline in Patient's Global Impression of Symptom Severity (PGIS)
Cycle 5, Day 1
|
-1.0 Score on a Scale
Standard Deviation 1.32
|
|
Change From Baseline in Patient's Global Impression of Symptom Severity (PGIS)
Cycle 7, Day 1
|
-1.1 Score on a Scale
Standard Deviation 1.46
|
|
Change From Baseline in Patient's Global Impression of Symptom Severity (PGIS)
Cycle 9, Day 1
|
-1.3 Score on a Scale
Standard Deviation 1.50
|
|
Change From Baseline in Patient's Global Impression of Symptom Severity (PGIS)
Cycle 11, Day 1
|
-1.3 Score on a Scale
Standard Deviation 1.36
|
|
Change From Baseline in Patient's Global Impression of Symptom Severity (PGIS)
Cycle 14, Day 1
|
-1.4 Score on a Scale
Standard Deviation 1.65
|
|
Change From Baseline in Patient's Global Impression of Symptom Severity (PGIS)
Cycle 17, Day 1
|
-1.5 Score on a Scale
Standard Deviation 1.41
|
|
Change From Baseline in Patient's Global Impression of Symptom Severity (PGIS)
Cycle 1, Day 15
|
-0.7 Score on a Scale
Standard Deviation 1.23
|
SECONDARY outcome
Timeframe: 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)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.
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.
Outcome measures
| Measure |
Avapritinib
n=87 Participants
Avapritinib was administered once daily as an immediate-release tablet, orally, in 28-day cycles.
|
|---|---|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Cycle 17, Day 1
|
21.49 Score on a Scale
Standard Deviation 29.207
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Cycle 1, Day 15
|
14.66 Score on a Scale
Standard Deviation 23.397
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Cycle 2, Day 1
|
14.33 Score on a Scale
Standard Deviation 24.855
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Cycle 3, Day 1
|
15.00 Score on a Scale
Standard Deviation 28.516
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Cycle 5, Day 1
|
14.04 Score on a Scale
Standard Deviation 30.042
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Cycle 7, Day 1
|
15.85 Score on a Scale
Standard Deviation 30.575
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Cycle 9, Day 1
|
17.95 Score on a Scale
Standard Deviation 29.801
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Cycle 11, Day 1
|
18.78 Score on a Scale
Standard Deviation 28.179
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Cycle 14, Day 1
|
22.32 Score on a Scale
Standard Deviation 31.346
|
SECONDARY outcome
Timeframe: Baseline through Month 65Population: Safety Population: all participants who received ≥1 dose of avapritinib.
A TEAE was defined as any adverse events that occurred between the first dose of a study drug through 30 days after the last dose of any study drug. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Outcome measures
| Measure |
Avapritinib
n=107 Participants
Avapritinib was administered once daily as an immediate-release tablet, orally, in 28-day cycles.
|
|---|---|
|
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE)
|
107 Participants
|
SECONDARY outcome
Timeframe: Day 1 of Cycle 1 (1 hour postdose) (28 days/cycle)Population: Pharmacokinetic Population: all participants who received ≥1 dose of avapritinib and had had \>3 post-dose concentrations collected.
Blood samples were collected at specified timepoints. Results reported as nanograms/milliliter (ng/mL).
Outcome measures
| Measure |
Avapritinib
n=1 Participants
Avapritinib was administered once daily as an immediate-release tablet, orally, in 28-day cycles.
|
|---|---|
|
Maximum Plasma Concentration (Cmax) of a Single Dose of Avapritinib
|
191 ng/mL
Interval 191.0 to 191.0
|
SECONDARY outcome
Timeframe: Baseline, Month 10Population: Safety Population: all participants who received ≥1 dose of avapritinib.
The change in baseline for AdvSM-SAF TSS was correlated with the change in baseline for serum tryptase. Spearman correlation coefficients were performed with corresponding scatter plots on change from baseline.
Outcome measures
| Measure |
Avapritinib
n=107 Participants
Avapritinib was administered once daily as an immediate-release tablet, orally, in 28-day cycles.
|
|---|---|
|
Correlation Between TSS and Serum Tryptase
|
0.1043 Spearman Coefficient
|
Adverse Events
Avapritinib (100 mg)
Serious events: 2 serious events
Other events: 2 other events
Deaths: 1 deaths
Avapritinib (200 mg)
Serious events: 67 serious events
Other events: 104 other events
Deaths: 33 deaths
Serious adverse events
| Measure |
Avapritinib (100 mg)
n=2 participants at risk
Avapritinib was administered once daily as an immediate-release tablet, orally, in 28-day cycles.
|
Avapritinib (200 mg)
n=107 participants at risk；n=105 participants at risk
Avapritinib was administered once daily as an immediate-release tablet, orally, in 28-day cycles.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/2 • Day 1 through Month 65
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.
|
2.9%
3/105 • Number of events 3 • Day 1 through Month 65
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.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/2 • Day 1 through Month 65
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.
|
1.9%
2/105 • Number of events 2 • Day 1 through Month 65
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.
|
|
Blood and lymphatic system disorders
Haemorrhagic diathesis
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 2 • Day 1 through Month 65
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.
|
|
Blood and lymphatic system disorders
Mast cell activation syndrome
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 3 • Day 1 through Month 65
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.
|
|
Cardiac disorders
Cardiac failure
|
50.0%
1/2 • Number of events 3 • Day 1 through Month 65
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.
|
2.9%
3/105 • Number of events 5 • Day 1 through Month 65
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.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Cardiac disorders
Coronary artery dissection
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
50.0%
1/2 • Number of events 3 • Day 1 through Month 65
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.
|
2.9%
3/105 • Number of events 3 • Day 1 through Month 65
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.
|
|
Gastrointestinal disorders
Ascites
|
50.0%
1/2 • Number of events 1 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/2 • Day 1 through Month 65
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.
|
1.9%
2/105 • Number of events 2 • Day 1 through Month 65
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.
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.00%
0/2 • Day 1 through Month 65
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.
|
1.9%
2/105 • Number of events 4 • Day 1 through Month 65
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.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/2 • Day 1 through Month 65
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.
|
1.9%
2/105 • Number of events 2 • Day 1 through Month 65
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.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 2 • Day 1 through Month 65
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.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 2 • Day 1 through Month 65
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.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 3 • Day 1 through Month 65
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.
|
|
Gastrointestinal disorders
Lymphangiectasia intestinal
|
50.0%
1/2 • Number of events 1 • Day 1 through Month 65
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.
|
0.00%
0/105 • Day 1 through Month 65
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.
|
|
Gastrointestinal disorders
Pancreatic fistula
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
General disorders
Disease progression
|
0.00%
0/2 • Day 1 through Month 65
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.
|
1.9%
2/105 • Number of events 3 • Day 1 through Month 65
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.
|
|
General disorders
Pyrexia
|
0.00%
0/2 • Day 1 through Month 65
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.
|
1.9%
2/105 • Number of events 3 • Day 1 through Month 65
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.
|
|
General disorders
General physical health deterioration
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
General disorders
Oedema
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
General disorders
Oedema peripheral
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Hepatobiliary disorders
Acute cholecystitis necrotic
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Hepatobiliary disorders
Budd-Chiari syndrome
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Infections and infestations
COVID-19
|
0.00%
0/2 • Day 1 through Month 65
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.
|
3.8%
4/105 • Number of events 5 • Day 1 through Month 65
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.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/2 • Day 1 through Month 65
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.
|
3.8%
4/105 • Number of events 5 • Day 1 through Month 65
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.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/2 • Day 1 through Month 65
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.
|
2.9%
3/105 • Number of events 3 • Day 1 through Month 65
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.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/2 • Day 1 through Month 65
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.
|
2.9%
3/105 • Number of events 4 • Day 1 through Month 65
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.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/2 • Day 1 through Month 65
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.
|
2.9%
3/105 • Number of events 4 • Day 1 through Month 65
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.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/2 • Day 1 through Month 65
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.
|
1.9%
2/105 • Number of events 2 • Day 1 through Month 65
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.
|
|
Infections and infestations
Diverticulitis intestinal perforated
|
0.00%
0/2 • Day 1 through Month 65
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.
|
1.9%
2/105 • Number of events 2 • Day 1 through Month 65
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.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/2 • Day 1 through Month 65
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.
|
1.9%
2/105 • Number of events 2 • Day 1 through Month 65
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.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/2 • Day 1 through Month 65
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.
|
1.9%
2/105 • Number of events 2 • Day 1 through Month 65
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.
|
|
Infections and infestations
Infection
|
0.00%
0/2 • Day 1 through Month 65
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.
|
1.9%
2/105 • Number of events 2 • Day 1 through Month 65
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.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/2 • Day 1 through Month 65
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.
|
1.9%
2/105 • Number of events 2 • Day 1 through Month 65
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.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/2 • Day 1 through Month 65
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.
|
1.9%
2/105 • Number of events 2 • Day 1 through Month 65
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.
|
|
Infections and infestations
Sepsis
|
0.00%
0/2 • Day 1 through Month 65
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.
|
1.9%
2/105 • Number of events 2 • Day 1 through Month 65
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.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/2 • Day 1 through Month 65
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.
|
1.9%
2/105 • Number of events 4 • Day 1 through Month 65
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.
|
|
Infections and infestations
Appendiceal abscess
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 4 • Day 1 through Month 65
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.
|
|
Infections and infestations
Cystitis
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Infections and infestations
Device related infection
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Infections and infestations
Endocarditis
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 2 • Day 1 through Month 65
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.
|
|
Infections and infestations
Fournier's gangrene
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 2 • Day 1 through Month 65
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.
|
|
Infections and infestations
Gastroenteritis astroviral
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Infections and infestations
Groin abscess
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Infections and infestations
Herpes zoster
|
50.0%
1/2 • Number of events 1 • Day 1 through Month 65
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.
|
0.00%
0/105 • Day 1 through Month 65
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.
|
|
Infections and infestations
Intervertebral discitis
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Infections and infestations
Otitis media
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Infections and infestations
Parapharyngeal space infection
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Infections and infestations
Paraspinal abscess
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Infections and infestations
Septic endocarditis
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Infections and infestations
Septic shock
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Infections and infestations
Spontaneous bacterial peritonitis
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Infections and infestations
Stoma site cellulitis
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Infections and infestations
Submandibular abscess
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 2 • Day 1 through Month 65
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.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.00%
0/2 • Day 1 through Month 65
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.
|
1.9%
2/105 • Number of events 2 • Day 1 through Month 65
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.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/2 • Day 1 through Month 65
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.
|
1.9%
2/105 • Number of events 3 • Day 1 through Month 65
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.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/2 • Day 1 through Month 65
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.
|
1.9%
2/105 • Number of events 2 • Day 1 through Month 65
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.
|
|
Injury, poisoning and procedural complications
Cystitis radiation
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Injury, poisoning and procedural complications
Post procedural hypotension
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Injury, poisoning and procedural complications
Radiation proctitis
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Metabolism and nutrition disorders
Intervertebral disc protrusion
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/2 • Day 1 through Month 65
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.
|
1.9%
2/105 • Number of events 2 • Day 1 through Month 65
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Angiosarcoma
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 2 • Day 1 through Month 65
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/2 • Day 1 through Month 65
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.
|
3.8%
4/105 • Number of events 4 • Day 1 through Month 65
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.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/2 • Day 1 through Month 65
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.
|
1.9%
2/105 • Number of events 2 • Day 1 through Month 65
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.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/2 • Day 1 through Month 65
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.
|
1.9%
2/105 • Number of events 2 • Day 1 through Month 65
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.
|
|
Nervous system disorders
Dementia
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Nervous system disorders
Migraine
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Nervous system disorders
Seizure
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 2 • Day 1 through Month 65
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.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/2 • Day 1 through Month 65
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.
|
3.8%
4/105 • Number of events 4 • Day 1 through Month 65
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.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/2 • Day 1 through Month 65
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.
|
2.9%
3/105 • Number of events 5 • Day 1 through Month 65
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.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/2 • Day 1 through Month 65
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.
|
2.9%
3/105 • Number of events 3 • Day 1 through Month 65
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.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/2 • Day 1 through Month 65
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.
|
1.9%
2/105 • Number of events 2 • Day 1 through Month 65
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.
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Renal and urinary disorders
Obstructive nephropathy
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial haemorrhage
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 2 • Day 1 through Month 65
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Respiratory, thoracic and mediastinal disorders
Thoracic haemorrhage
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Vascular disorders
Angiodysplasia
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Vascular disorders
Embolism
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
|
Vascular disorders
Lymphangiectasia
|
50.0%
1/2 • Number of events 1 • Day 1 through Month 65
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.
|
0.00%
0/105 • Day 1 through Month 65
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.
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/2 • Day 1 through Month 65
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.
|
0.95%
1/105 • Number of events 1 • Day 1 through Month 65
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.
|
Other adverse events
| Measure |
Avapritinib (100 mg)
n=2 participants at risk
Avapritinib was administered once daily as an immediate-release tablet, orally, in 28-day cycles.
|
Avapritinib (200 mg)
n=107 participants at risk；n=105 participants at risk
Avapritinib was administered once daily as an immediate-release tablet, orally, in 28-day cycles.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
100.0%
2/2 • Number of events 2 • Day 1 through Month 65
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.
|
50.5%
54/107 • Number of events 203 • Day 1 through Month 65
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.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/2 • Day 1 through Month 65
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.
|
44.9%
48/107 • Number of events 282 • Day 1 through Month 65
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.
|
|
Blood and lymphatic system disorders
Neutropenia
|
50.0%
1/2 • Number of events 6 • Day 1 through Month 65
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.
|
22.4%
24/107 • Number of events 125 • Day 1 through Month 65
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.
|
|
Blood and lymphatic system disorders
Leukopenia
|
50.0%
1/2 • Number of events 4 • Day 1 through Month 65
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.
|
7.5%
8/107 • Number of events 28 • Day 1 through Month 65
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.
|
|
Eye disorders
Periorbital oedema
|
50.0%
1/2 • Number of events 1 • Day 1 through Month 65
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.
|
42.1%
45/107 • Number of events 78 • Day 1 through Month 65
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.
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/2 • Day 1 through Month 65
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.
|
13.1%
14/107 • Number of events 15 • Day 1 through Month 65
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.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/2 • Day 1 through Month 65
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.
|
7.5%
8/107 • Number of events 9 • Day 1 through Month 65
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.
|
|
Gastrointestinal disorders
Diarrhoea
|
100.0%
2/2 • Number of events 2 • Day 1 through Month 65
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.
|
33.6%
36/107 • Number of events 60 • Day 1 through Month 65
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.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • Day 1 through Month 65
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.
|
27.1%
29/107 • Number of events 36 • Day 1 through Month 65
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.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
1/2 • Number of events 1 • Day 1 through Month 65
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.
|
22.4%
24/107 • Number of events 29 • Day 1 through Month 65
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.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/2 • Day 1 through Month 65
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.
|
15.0%
16/107 • Number of events 22 • Day 1 through Month 65
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.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/2 • Day 1 through Month 65
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.
|
15.0%
16/107 • Number of events 20 • Day 1 through Month 65
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.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/2 • Day 1 through Month 65
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.
|
8.4%
9/107 • Number of events 10 • Day 1 through Month 65
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.
|
|
Gastrointestinal disorders
Ascites
|
50.0%
1/2 • Number of events 1 • Day 1 through Month 65
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.
|
5.6%
6/107 • Number of events 13 • Day 1 through Month 65
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.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/2 • Day 1 through Month 65
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.
|
5.6%
6/107 • Number of events 6 • Day 1 through Month 65
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.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
50.0%
1/2 • Number of events 1 • Day 1 through Month 65
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.
|
4.7%
5/107 • Number of events 9 • Day 1 through Month 65
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.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/2 • Day 1 through Month 65
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.
|
5.6%
6/107 • Number of events 6 • Day 1 through Month 65
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.
|
|
General disorders
Oedema peripheral
|
50.0%
1/2 • Number of events 1 • Day 1 through Month 65
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.
|
44.9%
48/107 • Number of events 72 • Day 1 through Month 65
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.
|
|
General disorders
Fatigue
|
100.0%
2/2 • Number of events 2 • Day 1 through Month 65
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.
|
20.6%
22/107 • Number of events 31 • Day 1 through Month 65
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.
|
|
General disorders
Face oedema
|
0.00%
0/2 • Day 1 through Month 65
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.
|
16.8%
18/107 • Number of events 19 • Day 1 through Month 65
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.
|
|
General disorders
Asthenia
|
0.00%
0/2 • Day 1 through Month 65
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.
|
12.1%
13/107 • Number of events 27 • Day 1 through Month 65
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.
|
|
General disorders
Pyrexia
|
50.0%
1/2 • Number of events 1 • Day 1 through Month 65
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.
|
7.5%
8/107 • Number of events 10 • Day 1 through Month 65
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.
|
|
General disorders
Swelling face
|
0.00%
0/2 • Day 1 through Month 65
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.
|
6.5%
7/107 • Number of events 9 • Day 1 through Month 65
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.
|
|
General disorders
Oedema
|
0.00%
0/2 • Day 1 through Month 65
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.
|
5.6%
6/107 • Number of events 6 • Day 1 through Month 65
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.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
50.0%
1/2 • Number of events 1 • Day 1 through Month 65
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.
|
5.6%
6/107 • Number of events 9 • Day 1 through Month 65
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.
|
|
Infections and infestations
COVID-19
|
50.0%
1/2 • Number of events 1 • Day 1 through Month 65
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.
|
17.8%
19/107 • Number of events 22 • Day 1 through Month 65
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.
|
|
Infections and infestations
Urinary tract infection
|
50.0%
1/2 • Number of events 3 • Day 1 through Month 65
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.
|
12.1%
13/107 • Number of events 30 • Day 1 through Month 65
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.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/2 • Day 1 through Month 65
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.
|
6.5%
7/107 • Number of events 8 • Day 1 through Month 65
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.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/2 • Day 1 through Month 65
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.
|
5.6%
6/107 • Number of events 7 • Day 1 through Month 65
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.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/2 • Day 1 through Month 65
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.
|
9.3%
10/107 • Number of events 11 • Day 1 through Month 65
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.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/2 • Day 1 through Month 65
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.
|
15.9%
17/107 • Number of events 22 • Day 1 through Month 65
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.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/2 • Day 1 through Month 65
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.
|
15.0%
16/107 • Number of events 19 • Day 1 through Month 65
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.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/2 • Day 1 through Month 65
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.
|
14.0%
15/107 • Number of events 38 • Day 1 through Month 65
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.
|
|
Investigations
Weight increased
|
0.00%
0/2 • Day 1 through Month 65
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.
|
14.0%
15/107 • Number of events 29 • Day 1 through Month 65
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.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/2 • Day 1 through Month 65
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.
|
13.1%
14/107 • Number of events 85 • Day 1 through Month 65
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.
|
|
Investigations
Platelet count decreased
|
0.00%
0/2 • Day 1 through Month 65
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.
|
15.9%
17/107 • Number of events 82 • Day 1 through Month 65
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.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/2 • Day 1 through Month 65
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.
|
11.2%
12/107 • Number of events 57 • Day 1 through Month 65
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.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/2 • Day 1 through Month 65
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.
|
9.3%
10/107 • Number of events 15 • Day 1 through Month 65
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.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/2 • Day 1 through Month 65
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.
|
8.4%
9/107 • Number of events 16 • Day 1 through Month 65
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.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/2 • Day 1 through Month 65
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.
|
7.5%
8/107 • Number of events 9 • Day 1 through Month 65
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.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/2 • Day 1 through Month 65
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.
|
7.5%
8/107 • Number of events 8 • Day 1 through Month 65
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.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/2 • Day 1 through Month 65
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.
|
13.1%
14/107 • Number of events 19 • Day 1 through Month 65
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.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/2 • Day 1 through Month 65
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.
|
8.4%
9/107 • Number of events 11 • Day 1 through Month 65
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.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/2 • Day 1 through Month 65
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.
|
7.5%
8/107 • Number of events 13 • Day 1 through Month 65
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.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/2 • Day 1 through Month 65
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.
|
6.5%
7/107 • Number of events 10 • Day 1 through Month 65
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.
|
|
Metabolism and nutrition disorders
Folate deficiency
|
0.00%
0/2 • Day 1 through Month 65
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.
|
5.6%
6/107 • Number of events 7 • Day 1 through Month 65
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.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/2 • Day 1 through Month 65
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.
|
5.6%
6/107 • Number of events 8 • Day 1 through Month 65
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.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
50.0%
1/2 • Number of events 1 • Day 1 through Month 65
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.
|
25.2%
27/107 • Number of events 44 • Day 1 through Month 65
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.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
50.0%
1/2 • Number of events 2 • Day 1 through Month 65
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.
|
12.1%
13/107 • Number of events 17 • Day 1 through Month 65
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.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
50.0%
1/2 • Number of events 1 • Day 1 through Month 65
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.
|
7.5%
8/107 • Number of events 8 • Day 1 through Month 65
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.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/2 • Day 1 through Month 65
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.
|
7.5%
8/107 • Number of events 9 • Day 1 through Month 65
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.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/2 • Day 1 through Month 65
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.
|
5.6%
6/107 • Number of events 6 • Day 1 through Month 65
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.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/2 • Day 1 through Month 65
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.
|
17.8%
19/107 • Number of events 31 • Day 1 through Month 65
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.
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • Day 1 through Month 65
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.
|
15.0%
16/107 • Number of events 23 • Day 1 through Month 65
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.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2 • Day 1 through Month 65
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.
|
12.1%
13/107 • Number of events 16 • Day 1 through Month 65
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.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/2 • Day 1 through Month 65
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.
|
9.3%
10/107 • Number of events 13 • Day 1 through Month 65
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.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/2 • Day 1 through Month 65
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.
|
9.3%
10/107 • Number of events 12 • Day 1 through Month 65
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.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/2 • Day 1 through Month 65
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.
|
7.5%
8/107 • Number of events 8 • Day 1 through Month 65
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.
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/2 • Day 1 through Month 65
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.
|
7.5%
8/107 • Number of events 9 • Day 1 through Month 65
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.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/2 • Day 1 through Month 65
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.
|
5.6%
6/107 • Number of events 7 • Day 1 through Month 65
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.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/2 • Day 1 through Month 65
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.
|
8.4%
9/107 • Number of events 9 • Day 1 through Month 65
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.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/2 • Day 1 through Month 65
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.
|
5.6%
6/107 • Number of events 8 • Day 1 through Month 65
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.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
50.0%
1/2 • Number of events 1 • Day 1 through Month 65
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.
|
17.8%
19/107 • Number of events 24 • Day 1 through Month 65
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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
50.0%
1/2 • Number of events 1 • Day 1 through Month 65
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.
|
10.3%
11/107 • Number of events 37 • Day 1 through Month 65
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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/2 • Day 1 through Month 65
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.
|
6.5%
7/107 • Number of events 10 • Day 1 through Month 65
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/2 • Day 1 through Month 65
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.
|
5.6%
6/107 • Number of events 6 • Day 1 through Month 65
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.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
50.0%
1/2 • Number of events 1 • Day 1 through Month 65
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.
|
16.8%
18/107 • Number of events 34 • Day 1 through Month 65
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.
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
0.00%
0/2 • Day 1 through Month 65
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.
|
16.8%
18/107 • Number of events 19 • Day 1 through Month 65
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.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/2 • Day 1 through Month 65
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.
|
16.8%
18/107 • Number of events 24 • Day 1 through Month 65
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.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/2 • Day 1 through Month 65
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.
|
11.2%
12/107 • Number of events 12 • Day 1 through Month 65
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.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
100.0%
2/2 • Number of events 2 • Day 1 through Month 65
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.
|
5.6%
6/107 • Number of events 6 • Day 1 through Month 65
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.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/2 • Day 1 through Month 65
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.
|
5.6%
6/107 • Number of events 6 • Day 1 through Month 65
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.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/2 • Day 1 through Month 65
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.
|
5.6%
6/107 • Number of events 6 • Day 1 through Month 65
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.
|
|
Vascular disorders
Hypertension
|
0.00%
0/2 • Day 1 through Month 65
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.
|
6.5%
7/107 • Number of events 16 • Day 1 through Month 65
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.
|
|
Vascular disorders
Flushing
|
0.00%
0/2 • Day 1 through Month 65
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.
|
5.6%
6/107 • Number of events 9 • Day 1 through Month 65
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.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
50.0%
1/2 • Number of events 1 • Day 1 through Month 65
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.
|
1.9%
2/107 • Number of events 2 • Day 1 through Month 65
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.
|
|
Blood and lymphatic system disorders
Cytopenia
|
50.0%
1/2 • Number of events 1 • Day 1 through Month 65
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.
|
0.00%
0/107 • Day 1 through Month 65
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.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
50.0%
1/2 • Number of events 6 • Day 1 through Month 65
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.
|
0.00%
0/107 • Day 1 through Month 65
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.
|
|
Blood and lymphatic system disorders
Neutrophilia
|
50.0%
1/2 • Number of events 1 • Day 1 through Month 65
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.
|
0.00%
0/107 • Day 1 through Month 65
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.
|
|
Eye disorders
Cataract
|
50.0%
1/2 • Number of events 1 • Day 1 through Month 65
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.
|
1.9%
2/107 • Number of events 2 • Day 1 through Month 65
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.
|
|
Gastrointestinal disorders
Toothache
|
50.0%
1/2 • Number of events 1 • Day 1 through Month 65
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.
|
1.9%
2/107 • Number of events 2 • Day 1 through Month 65
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.
|
|
Gastrointestinal disorders
Gastric polyps
|
50.0%
1/2 • Number of events 1 • Day 1 through Month 65
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.
|
0.00%
0/107 • Day 1 through Month 65
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.
|
|
Gastrointestinal disorders
Rectal tenesmus
|
50.0%
1/2 • Number of events 1 • Day 1 through Month 65
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.
|
0.00%
0/107 • Day 1 through Month 65
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.
|
|
Infections and infestations
Clostridium difficile colitis
|
50.0%
1/2 • Number of events 1 • Day 1 through Month 65
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.
|
0.00%
0/107 • Day 1 through Month 65
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.
|
|
Infections and infestations
Peritonitis
|
50.0%
1/2 • Number of events 1 • Day 1 through Month 65
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.
|
0.00%
0/107 • Day 1 through Month 65
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.
|
|
Nervous system disorders
Post herpetic neuralgia
|
50.0%
1/2 • Number of events 1 • Day 1 through Month 65
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.
|
0.93%
1/107 • Number of events 1 • Day 1 through Month 65
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.
|
|
Infections and infestations
Varicella zoster virus infection
|
50.0%
1/2 • Number of events 1 • Day 1 through Month 65
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.
|
0.00%
0/107 • Day 1 through Month 65
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.
|
|
Injury, poisoning and procedural complications
Immunisation reaction
|
50.0%
1/2 • Number of events 3 • Day 1 through Month 65
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.
|
0.00%
0/107 • Day 1 through Month 65
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.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
50.0%
1/2 • Number of events 2 • Day 1 through Month 65
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.
|
0.93%
1/107 • Number of events 1 • Day 1 through Month 65
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
50.0%
1/2 • Number of events 1 • Day 1 through Month 65
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.
|
1.9%
2/107 • Number of events 2 • Day 1 through Month 65
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
50.0%
1/2 • Number of events 1 • Day 1 through Month 65
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.
|
0.00%
0/107 • Day 1 through Month 65
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.
|
|
Nervous system disorders
Aphasia
|
50.0%
1/2 • Number of events 1 • Day 1 through Month 65
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.
|
2.8%
3/107 • Number of events 3 • Day 1 through Month 65
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.
|
|
Nervous system disorders
Polyneuropathy
|
50.0%
1/2 • Number of events 1 • Day 1 through Month 65
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.
|
1.9%
2/107 • Number of events 2 • Day 1 through Month 65
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.
|
|
Renal and urinary disorders
Haematuria
|
50.0%
1/2 • Number of events 1 • Day 1 through Month 65
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.
|
3.7%
4/107 • Number of events 8 • Day 1 through Month 65
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.
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Additional Information
Blueprint Medicines Medical Information
Blueprint Medicines
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Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee After (a) sponsor publication of the comprehensive multi-center clinical trial results; (b) sponsor notification that the multi-center clinical trial submission is no longer planned; or (c) the 18-month anniversary of the completion or early termination of the multi-center clinical trial, the PI (institution/investigator) may publish or publicly present the study data in accordance with the provisions set forth by the sponsor.
- Publication restrictions are in place
Restriction type: OTHER