TriangleNCT05059262 · OUTCOME
Change From Baseline in the Worst Stiffness Numeric Rating Scale (NRS) Score 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 Worst Stiffness NRS is a single question that asks the participant to assess their worst stiffness in the last 24 hours. Participants rate their worst stiffness on a scale of 0 to 10, where 0 is "no stiffness" and 10 is "worst imaginable." Lower scores represented better level of stiffness.
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 | 63 |
| Placebo | 27 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Vimseltinib | -2.1 | 0.24 | Not reported | Not reported | Not reported |
| Placebo | -0.3 | 0.28 | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- -2.5
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -1.1
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- 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+Worst Stiffness NRS baseline value.
- param Type
- LS Mean Difference
- param Value
- -1.8
- statistical Method
- Mixed model repeated measures
Complete source fields
- analyses
- ci Lower Limit
- -2.5
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -1.1
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- 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+Worst Stiffness NRS baseline value.
- param Type
- LS Mean Difference
- param Value
- -1.8
- statistical Method
- Mixed model repeated measures
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.24
- value
- -2.1
- group Id
- OG001
- spread
- 0.28
- value
- -0.3
- denoms
- counts
- group Id
- OG000
- value
- 63
- group Id
- OG001
- value
- 27
- units
- Participants
- description
- The Worst Stiffness NRS is a single question that asks the participant to assess their worst stiffness in the last 24 hours. Participants rate their worst stiffness on a scale of 0 to 10, where 0 is "no stiffness" and 10 is "worst imaginable." Lower scores represented better level of stiffness.
- 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 the Worst Stiffness Numeric Rating Scale (NRS) Score 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