TriangleNCT05059262 · OUTCOME
Percentage of Participants With Response at Week 25 Based on Brief Pain Inventory (BPI) Worst Pain NRS Score and Narcotic Analgesic Use
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Baseline to Week 25 (Cycle 7, Day 1)
What was measured
Participants reported responses to the BPI Worst Pain NRS. The BPI Worst Pain NRS ranged from 0 to 10, where 0 is "no pain" and 10 is "pain as bad as you can imagine." A responder was defined as a participant who: (i) experienced a decrease of at least 30% in the mean BPI Worst Pain NRS item and (ii) did not experience a 30% or greater increase in narcotic analgesic use.
Analysis population: The ITT Set consisted of participants who were randomized to a study treatment regimen.
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 | 83 |
| Placebo | 40 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Vimseltinib | 48.2 | Not reported | 37.1 | 59.4 | Not reported |
| Placebo | 22.5 | Not reported | 10.8 | 38.5 | Not reported |
Source statistical analyses
- ci Lower Limit
- 9.5
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 42.8
- estimate Comment
- Stratified Mantel-Haenszel with stratification factors based on IRT.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0056
- p Value Comment
- Stratified by tumor location (lower limb/all other) and region (U.S./non-U.S.) based on IRT.
- param Type
- Difference in responder rate
- param Value
- 26.2
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- ci Lower Limit
- 9.5
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 42.8
- estimate Comment
- Stratified Mantel-Haenszel with stratification factors based on IRT.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0056
- p Value Comment
- Stratified by tumor location (lower limb/all other) and region (U.S./non-U.S.) based on IRT.
- param Type
- Difference in responder rate
- param Value
- 26.2
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 37.1
- upper Limit
- 59.4
- value
- 48.2
- group Id
- OG001
- lower Limit
- 10.8
- upper Limit
- 38.5
- value
- 22.5
- denoms
- counts
- group Id
- OG000
- value
- 83
- group Id
- OG001
- value
- 40
- units
- Participants
- description
- Participants reported responses to the BPI Worst Pain NRS. The BPI Worst Pain NRS ranged from 0 to 10, where 0 is "no pain" and 10 is "pain as bad as you can imagine." A responder was defined as a participant who: (i) experienced a decrease of at least 30% in the mean BPI Worst Pain NRS item and (ii) did not experience a 30% or greater increase in narcotic analgesic use.
- dispersion Type
- 95% Confidence Interval
- 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
- NUMBER
- population Description
- The ITT Set consisted of participants who were randomized to a study treatment regimen.
- reporting Status
- POSTED
- time Frame
- Baseline to Week 25 (Cycle 7, Day 1)
- title
- Percentage of Participants With Response at Week 25 Based on Brief Pain Inventory (BPI) Worst Pain NRS Score and Narcotic Analgesic Use
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice