TriangleNCT03962543 · OUTCOME
Change From Baseline in Pain as Measured by the Numeric Rating Scale-11 (NRS-11) at Cycle 13.
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- LEAST_SQUARES_MEAN
- Unit
- units on a scale
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Baseline and Cycle 13 (1 cycle = 28 days), up to 12 months
What was measured
The NRS-11 is a self-reported 11-point numerical scale that assesses pain severity. Participants ≥ 8 years of age are asked to select a number from 0 (no pain) to 10 (worst pain you can imagine) that best describes their worst pain. The recall period is 24 hours. The change from baseline is modelled using a mixed-model for repeated measures.
Analysis population: The Full Analysis Set patients eligible for the instrument at baseline.
Groups in this outcome
Treatment Phase - Pediatric Cohort Mirdametinib (PD-0325901) - Self-Report
Patients 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 - Adult Cohort Mirdametinib (PD-0325901) - Self-Report
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) - Self-Report | 37 |
| Treatment Phase - Adult Cohort Mirdametinib (PD-0325901) - Self-Report | 58 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment Phase - Pediatric Cohort Mirdametinib (PD-0325901) - Self-Report | -0.79 | Not reported | -1.28 | -0.29 | Not reported |
| Treatment Phase - Adult Cohort Mirdametinib (PD-0325901) - Self-Report | -1.33 | Not reported | -1.83 | -0.84 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -1.28
- upper Limit
- -0.29
- value
- -0.79
- group Id
- OG001
- lower Limit
- -1.83
- upper Limit
- -0.84
- value
- -1.33
- denoms
- counts
- group Id
- OG000
- value
- 37
- group Id
- OG001
- value
- 58
- units
- Participants
- description
- The NRS-11 is a self-reported 11-point numerical scale that assesses pain severity. Participants ≥ 8 years of age are asked to select a number from 0 (no pain) to 10 (worst pain you can imagine) that best describes their worst pain. The recall period is 24 hours. The change from baseline is modelled using a mixed-model for repeated measures.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients 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 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) - Self-Report
- param Type
- LEAST_SQUARES_MEAN
- population Description
- The Full Analysis Set patients 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 Pain as Measured by the Numeric Rating Scale-11 (NRS-11) at Cycle 13.
- type
- SECONDARY
- unit Of Measure
- units on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice