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NCT05059262 · OUTCOME

Change From Baseline in the Patient-reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) Score at Week 25

Study of Vimseltinib for Tenosynovial Giant Cell Tumor · Source last updated 2026-03-20

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

All participants were asked 15 questions from the PROMIS-PF item bank. The questions used one of two 5-point verbal rating scales: either 1 = "unable to do", 2 = "with much difficulty", 3 = "with some difficulty", 4 = "with a little difficulty", and 5 = "without any difficulty"; or 1 = "cannot do", 2 = "quite a lot", 3 = "somewhat", 4 = "very little", and 5 = "not at all." Total scores were converted to T-scores that ranged from 0 to 100, with higher scores representing less physical function interference and better health outcomes.

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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Vimseltinib63
Placebo30

Reported measurements

Source class 1
Values in score on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Vimseltinib4.60.96Not reportedNot reportedNot reported
Placebo1.30.88Not reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    1.4
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    5.2
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0007
    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+PROMIS-PF baseline value.
    param Type
    LS Mean Difference
    param Value
    3.3
    statistical Method
    Mixed model repeated measures
Complete source fields
analyses
  1. ci Lower Limit
    1.4
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    5.2
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0007
    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+PROMIS-PF baseline value.
    param Type
    LS Mean Difference
    param Value
    3.3
    statistical Method
    Mixed model repeated measures
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.96
        value
        4.6
      2. group Id
        OG001
        spread
        0.88
        value
        1.3
denoms
  1. counts
    1. group Id
      OG000
      value
      63
    2. group Id
      OG001
      value
      30
    units
    Participants
description
All participants were asked 15 questions from the PROMIS-PF item bank. The questions used one of two 5-point verbal rating scales: either 1 = "unable to do", 2 = "with much difficulty", 3 = "with some difficulty", 4 = "with a little difficulty", and 5 = "without any difficulty"; or 1 = "cannot do", 2 = "quite a lot", 3 = "somewhat", 4 = "very little", and 5 = "not at all." Total scores were converted to T-scores that ranged from 0 to 100, with higher scores representing less physical function interference and better health outcomes.
dispersion Type
Standard Error
groups
  1. description
    Participants received 30 mg BIW vimseltinib for 24 weeks.
    id
    OG000
    title
    Vimseltinib
  2. 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 Patient-reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) 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