NCT05059262 · OUTCOME
Change From Baseline in EuroQoL Visual Analogue Scale (EQ-VAS) at Week 25
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- LEAST_SQUARES_MEAN
- Unit
- score on a scale
- Interval / dispersion
- Standard Error
- Time frame
- Baseline to Week 25 (Cycle 7, Day 1)
What was measured
The EQ-VAS is a standardized tool for measuring overall health. EQ-VAS recorded the participant's self-rated health on a vertical VAS scale ranging from a minimum of 0 (worst imaginable health state) to a maximum of 100 (best imaginable health state). Higher scores indicated better health state.
Analysis population: The ITT Set consisted of participants who were randomized to a study treatment regimen. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure at the specified time point.
Groups in this outcome
Vimseltinib
Participants received 30 mg BIW vimseltinib for 24 weeks.
Placebo
Participants received matching placebo BIW for 24 weeks.
| Group | Source count |
|---|---|
| Vimseltinib | 64 |
| Placebo | 30 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Vimseltinib | 13.5 | 2.35 | Not reported | Not reported | Not reported |
| Placebo | 6.1 | 2.85 | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- 1.4
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 13.4
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0155
- p Value Comment
- Model included treatment+visit+treatment by visit interaction+stratification factor for region (U.S. versus non-U.S.) and tumor location (lower limb/all other) based on IRT+VAS baseline value.
- param Type
- LS Mean Difference
- param Value
- 7.4
- statistical Method
- Mixed model repeated measures
Complete source fields
- analyses
- ci Lower Limit
- 1.4
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 13.4
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0155
- p Value Comment
- Model included treatment+visit+treatment by visit interaction+stratification factor for region (U.S. versus non-U.S.) and tumor location (lower limb/all other) based on IRT+VAS baseline value.
- param Type
- LS Mean Difference
- param Value
- 7.4
- statistical Method
- Mixed model repeated measures
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 2.35
- value
- 13.5
- group Id
- OG001
- spread
- 2.85
- value
- 6.1
- denoms
- counts
- group Id
- OG000
- value
- 64
- group Id
- OG001
- value
- 30
- units
- Participants
- description
- The EQ-VAS is a standardized tool for measuring overall health. EQ-VAS recorded the participant's self-rated health on a vertical VAS scale ranging from a minimum of 0 (worst imaginable health state) to a maximum of 100 (best imaginable health state). Higher scores indicated better health state.
- dispersion Type
- Standard Error
- groups
- description
- Participants received 30 mg BIW vimseltinib for 24 weeks.
- id
- OG000
- title
- Vimseltinib
- description
- Participants received matching placebo BIW for 24 weeks.
- id
- OG001
- title
- Placebo
- param Type
- LEAST_SQUARES_MEAN
- population Description
- The ITT Set consisted of participants who were randomized to a study treatment regimen. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure at the specified time point.
- reporting Status
- POSTED
- time Frame
- Baseline to Week 25 (Cycle 7, Day 1)
- title
- Change From Baseline in EuroQoL Visual Analogue Scale (EQ-VAS) at Week 25
- type
- SECONDARY
- unit Of Measure
- score on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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