NCT03580655 · OUTCOME
Percent Change From Baseline in Liver Volume by Imaging
(PATHFINDER) Study to Evaluate Efficacy and Safety of Avapritinib (BLU-285), A Selective KIT Mutation-targeted Tyrosine Kinase Inhibitor, in Patients With Advanced Systemic Mastocytosis · Source last updated 2026-04-24
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Percent Change
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline up to Month 65
What was measured
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.
Analysis population: Safety Population: all participants who received ≥1 dose of avapritinib. Here, ' Number Analyzed' signifies those participants evaluable for this outcome measure at the specified timepoint.
Groups in this outcome
Avapritinib
Avapritinib was administered once daily as an immediate-release tablet, orally, in 28-day cycles.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Avapritinib | 85 |
|---|
Reported measurements
Cycle 3, Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Avapritinib | 85 |
|---|
Values in Percent Change · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Avapritinib | -12.45 | 10.103 | Not reported | Not reported | Not reported |
|---|
Cycle 7, Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Avapritinib | 69 |
|---|
Values in Percent Change · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Avapritinib | -18.53 | 12.376 | Not reported | Not reported | Not reported |
|---|
Cycle 11, Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Avapritinib | 74 |
|---|
Values in Percent Change · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Avapritinib | -22.07 | 11.603 | Not reported | Not reported | Not reported |
|---|
Cycle 17, Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Avapritinib | 63 |
|---|
Values in Percent Change · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Avapritinib | -27.92 | 11.949 | Not reported | Not reported | Not reported |
|---|
Cycle 23, Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Avapritinib | 57 |
|---|
Values in Percent Change · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Avapritinib | -29.50 | 12.983 | Not reported | Not reported | Not reported |
|---|
Cycle 29, Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Avapritinib | 45 |
|---|
Values in Percent Change · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Avapritinib | -29.84 | 13.588 | Not reported | Not reported | Not reported |
|---|
Cycle 35, Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Avapritinib | 36 |
|---|
Values in Percent Change · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Avapritinib | -29.81 | 16.764 | Not reported | Not reported | Not reported |
|---|
Cycle 41, Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Avapritinib | 36 |
|---|
Values in Percent Change · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Avapritinib | -31.77 | 16.694 | Not reported | Not reported | Not reported |
|---|
Cycle 47, Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Avapritinib | 30 |
|---|
Values in Percent Change · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Avapritinib | -34.31 | 13.973 | Not reported | Not reported | Not reported |
|---|
Cycle 53, Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Avapritinib | 20 |
|---|
Values in Percent Change · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Avapritinib | -35.86 | 14.147 | Not reported | Not reported | Not reported |
|---|
Cycle 59, Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Avapritinib | 11 |
|---|
Values in Percent Change · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Avapritinib | -31.74 | 18.020 | Not reported | Not reported | Not reported |
|---|
Cycle 65, Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Avapritinib | 4 |
|---|
Values in Percent Change · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Avapritinib | -26.88 | 21.594 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 10.103
- value
- -12.45
- title
- Cycle 3, Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 12.376
- value
- -18.53
- title
- Cycle 7, Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 11.603
- value
- -22.07
- title
- Cycle 11, Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 11.949
- value
- -27.92
- title
- Cycle 17, Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 12.983
- value
- -29.50
- title
- Cycle 23, Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 13.588
- value
- -29.84
- title
- Cycle 29, Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 16.764
- value
- -29.81
- title
- Cycle 35, Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 16.694
- value
- -31.77
- title
- Cycle 41, Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 13.973
- value
- -34.31
- title
- Cycle 47, Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 14.147
- value
- -35.86
- title
- Cycle 53, Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 18.020
- value
- -31.74
- title
- Cycle 59, Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 21.594
- value
- -26.88
- title
- Cycle 65, Day 1
- description
- 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.
- dispersion Type
- Standard Deviation
- groups
- description
- Avapritinib was administered once daily as an immediate-release tablet, orally, in 28-day cycles.
- id
- OG000
- title
- Avapritinib
- param Type
- MEAN
- population Description
- Safety Population: all participants who received ≥1 dose of avapritinib. Here, ' Number Analyzed' signifies those participants evaluable for this outcome measure at the specified timepoint.
- reporting Status
- POSTED
- time Frame
- Baseline up to Month 65
- title
- Percent Change From Baseline in Liver Volume by Imaging
- type
- SECONDARY
- unit Of Measure
- Percent Change
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Preserved source evidence · Not medical advice