TriangleNCT03962543 · OUTCOME
Change From Baseline in Physical Function Status as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) at Cycle 13: Pediatric v2.0 Upper Extremities 8a.
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- T-score
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline and Cycle 13 (1 cycle = 28 days), up to 12 months
What was measured
PROMIS measures capability of physical functioning, with questions related to daily activities. Participants 8-17 years complete a self-report of physical function in the upper extremity or lower extremity (mobility), depending on the location of the PN. The recall period is 7 days. All PROMIS items are answered on a Likert scale with responses ranging from 1 to 5, with higher scores representing higher physical functioning in the upper extremities. The total raw score will be calculated as the sum of the individual item responses at a given visit (total raw scale range 8-40). The total raw scores for the measure will be converted to T-scores using the applicable score conversion table in the user manual and scoring instructions (PROMIS, 2023) ranging from 10 to 57 for self-report, and 13 to 55 for parent proxy with higher scores representing higher reported physical functioning and better outcomes. A T-score of 50 indicates the population mean with a standard deviation of 10.
Analysis population: The Full Analysis Set eligible for the instrument at baseline.
Groups in this outcome
Treatment Phase - Pediatric Cohort Mirdametinib (PD-0325901) - Self-Report
Patients self-reported results aged 8 to 17 years old at the time of informed consent. Mirdametinib (PD-0325901) capsule or dispersible tablet 2 mg/m\^2 (maximum dose of 4 mg) by mouth twice daily
Treatment Phase - Pediatric Cohort Mirdametinib (PD-0325901) - Parent Proxy
Patients parent proxy results aged 5 to 17 years old at the time of informed consent. Mirdametinib (PD-0325901) capsule or dispersible tablet 2 mg/m\^2 (maximum dose of 4 mg) by mouth twice daily
| Group | Source count |
|---|---|
| Treatment Phase - Pediatric Cohort Mirdametinib (PD-0325901) - Self-Report | 3 |
| Treatment Phase - Pediatric Cohort Mirdametinib (PD-0325901) - Parent Proxy | 4 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment Phase - Pediatric Cohort Mirdametinib (PD-0325901) - Self-Report | 11.5 | 3.54 | Not reported | Not reported | Not reported |
| Treatment Phase - Pediatric Cohort Mirdametinib (PD-0325901) - Parent Proxy | 9.5 | 3.54 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 3.54
- value
- 11.5
- group Id
- OG001
- spread
- 3.54
- value
- 9.5
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- units
- Participants
- description
- PROMIS measures capability of physical functioning, with questions related to daily activities. Participants 8-17 years complete a self-report of physical function in the upper extremity or lower extremity (mobility), depending on the location of the PN. The recall period is 7 days. All PROMIS items are answered on a Likert scale with responses ranging from 1 to 5, with higher scores representing higher physical functioning in the upper extremities. The total raw score will be calculated as the sum of the individual item responses at a given visit (total raw scale range 8-40). The total raw scores for the measure will be converted to T-scores using the applicable score conversion table in the user manual and scoring instructions (PROMIS, 2023) ranging from 10 to 57 for self-report, and 13 to 55 for parent proxy with higher scores representing higher reported physical functioning and better outcomes. A T-score of 50 indicates the population mean with a standard deviation of 10.
- dispersion Type
- Standard Deviation
- groups
- description
- Patients self-reported results aged 8 to 17 years old at the time of informed consent. Mirdametinib (PD-0325901) capsule or dispersible tablet 2 mg/m\^2 (maximum dose of 4 mg) by mouth twice daily
- id
- OG000
- title
- Treatment Phase - Pediatric Cohort Mirdametinib (PD-0325901) - Self-Report
- description
- Patients parent proxy results aged 5 to 17 years old at the time of informed consent. Mirdametinib (PD-0325901) capsule or dispersible tablet 2 mg/m\^2 (maximum dose of 4 mg) by mouth twice daily
- id
- OG001
- title
- Treatment Phase - Pediatric Cohort Mirdametinib (PD-0325901) - Parent Proxy
- param Type
- MEAN
- population Description
- The Full Analysis Set eligible for the instrument at baseline.
- reporting Status
- POSTED
- time Frame
- Baseline and Cycle 13 (1 cycle = 28 days), up to 12 months
- title
- Change From Baseline in Physical Function Status as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) at Cycle 13: Pediatric v2.0 Upper Extremities 8a.
- type
- OTHER_PRE_SPECIFIED
- unit Of Measure
- T-score
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice