TriangleNCT03962543 · OUTCOME
Change From Baseline in Localized Strength (Medical Research Council (MRC) Scale Grading) at Cycle 13.
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- units on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline and Cycle 13 (1 cycle = 28 days), up to 12 months
What was measured
If motor dysfunction or weakness is evident, strength of the affected muscle groups will be measured by dynamometer and assessed by a muscle grading scale. Medical Research Council (MRC) Scale grading (0-5) must be conducted in accordance with the study reference manual. MRC Grading is assessed on a scale of 0 to 5, with 0 representing no movement being observed, and 5 representing the muscle contracting normally against full resistance. 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 MRC Grade visit score is calculated for each participant separately, and these scores are then averaged.
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) | 0.3 | 0.35 | Not reported | Not reported | Not reported |
| Treatment Phase - Adult Cohort Mirdametinib (PD-0325901) | 0.3 | 0.46 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.35
- value
- 0.3
- group Id
- OG001
- spread
- 0.46
- value
- 0.3
- denoms
- counts
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 23
- units
- Participants
- description
- If motor dysfunction or weakness is evident, strength of the affected muscle groups will be measured by dynamometer and assessed by a muscle grading scale. Medical Research Council (MRC) Scale grading (0-5) must be conducted in accordance with the study reference manual. MRC Grading is assessed on a scale of 0 to 5, with 0 representing no movement being observed, and 5 representing the muscle contracting normally against full resistance. 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 MRC Grade visit score is calculated for each participant separately, and these scores are then averaged.
- 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 (Medical Research Council (MRC) Scale Grading) at Cycle 13.
- type
- OTHER_PRE_SPECIFIED
- unit Of Measure
- units on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice