TriangleNCT03580655 · OUTCOME
Mean Change From Baseline in AdvSM-SAF Skin and Gastrointestinal Domain Scores at Month 10
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Score on a Scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline, Month 10
What was measured
The AdvSM-SAF is a 10-item questionnaire that assesses symptoms and functional domains specific to AdvSM. 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.
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 | Source count |
|---|---|
| Avapritinib | 93 |
Reported measurements
Skin Domain
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Avapritinib | -2.52 | 5.362 | Not reported | Not reported | Not reported |
Gastrointestinal Domain
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Avapritinib | -2.81 | 5.172 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 5.362
- value
- -2.52
- title
- Skin Domain
- categories
- measurements
- group Id
- OG000
- spread
- 5.172
- value
- -2.81
- title
- Gastrointestinal Domain
- denoms
- counts
- group Id
- OG000
- value
- 93
- units
- Participants
- description
- The AdvSM-SAF is a 10-item questionnaire that assesses symptoms and functional domains specific to AdvSM. 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.
- dispersion Type
- Standard Deviation
- groups
- description
- Avapritinib was administered once daily as an immediate-release tablet, orally, in 28-day cycles.
- id
- OG000
- title
- Avapritinib
- param Type
- MEAN
- population Description
- Safety Population: all participants who received ≥1 dose of avapritinib. Here, 'Number Analyzed' signifies those participants evaluable for this outcome measure at the specified timepoint.
- reporting Status
- POSTED
- time Frame
- Baseline, Month 10
- title
- Mean Change From Baseline in AdvSM-SAF Skin and Gastrointestinal Domain Scores at Month 10
- type
- SECONDARY
- unit Of Measure
- Score on a Scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice