TriangleNCT03962543 · OUTCOME
Change From Baseline in Localized Strength (Dynamometer) at Cycle 13.
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- lbs
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline and Cycle 13 (1 cycle = 28 days), up to 12 months
What was measured
Assessment of strength will be conducted only in the area affected by the target tumor. Measurements will be obtained using Medical Research Council (MRC) grading followed by quantitative assessments using the sponsor provided MicroFET2 dynamometer. Dynamometer assessment (in lbs) must be conducted in accordance with the study reference manual. For each participant, the sum of the dynamometer scores for the muscle groups tested will be taken as an overall score for each visit with higher scores indicating better localized strength. To assess the change from baseline at a visit, a participant will need assessments in which all the following categories, as assessed at baseline, match at that visit: side affected, position during assessment (sitting/supine/lateral decubitus), muscle group assessed. The change from baseline in localized strength measured by the sum of the dynamometer scores for the muscle groups tested will be assessed at Cycle 13.
Analysis population: The Full Analysis Set patients eligible for this instrument at baseline.
Groups in this outcome
Treatment Phase - Pediatric Cohort Mirdametinib (PD-0325901)
Patients aged 2 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 - Adult Cohort Mirdametinib (PD-0325901)
Patients aged 18 and above 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) | 15 |
| Treatment Phase - Adult Cohort Mirdametinib (PD-0325901) | 23 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment Phase - Pediatric Cohort Mirdametinib (PD-0325901) | 18.8 | 31.93 | Not reported | Not reported | Not reported |
| Treatment Phase - Adult Cohort Mirdametinib (PD-0325901) | 68.5 | 130.33 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 31.93
- value
- 18.8
- group Id
- OG001
- spread
- 130.33
- value
- 68.5
- denoms
- counts
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 23
- units
- Participants
- description
- Assessment of strength will be conducted only in the area affected by the target tumor. Measurements will be obtained using Medical Research Council (MRC) grading followed by quantitative assessments using the sponsor provided MicroFET2 dynamometer. Dynamometer assessment (in lbs) must be conducted in accordance with the study reference manual. For each participant, the sum of the dynamometer scores for the muscle groups tested will be taken as an overall score for each visit with higher scores indicating better localized strength. To assess the change from baseline at a visit, a participant will need assessments in which all the following categories, as assessed at baseline, match at that visit: side affected, position during assessment (sitting/supine/lateral decubitus), muscle group assessed. The change from baseline in localized strength measured by the sum of the dynamometer scores for the muscle groups tested will be assessed at Cycle 13.
- dispersion Type
- Standard Deviation
- groups
- description
- Patients aged 2 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)
- description
- Patients aged 18 and above 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 - Adult Cohort Mirdametinib (PD-0325901)
- param Type
- MEAN
- population Description
- The Full Analysis Set patients eligible for this 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 Localized Strength (Dynamometer) at Cycle 13.
- type
- OTHER_PRE_SPECIFIED
- unit Of Measure
- lbs
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice