TriangleNCT03962543 · OUTCOME
Change From Baseline in Pain as Measured by the Pain Interference Index (PII) 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 PII assesses relevant aspects of one's life, including pain interference with activities, spending time with family/friends, mood, sleep and attention. Participants ≥ 6 years of age complete a self-report, and parents/guardians of children aged 6-17 complete a parent proxy report. The recall period is 24 hours. The PII consists of 6 questions, each asking the responder to select one number from 0 to 6 that best describes how their/their proxy's pain has impacted various items over the past 24 hours with 0 representing "Not at all" and 6 representing "Completely". The mean of the completed items is taken as the PII score for a single assessment. The PII score presented each visit will be taken as the average of the PII scores over the 7 consecutive days up to and including visit day, with no transformation applied. 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 self-reported results aged 6 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 6 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 self-reported results aged 18 years 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 | 47 |
| Treatment Phase - Pediatric Cohort Mirdametinib (PD-0325901) - Parent Proxy | 47 |
| 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 | -0.46 | Not reported | -0.83 | -0.09 | Not reported |
| Treatment Phase - Pediatric Cohort Mirdametinib (PD-0325901) - Parent Proxy | -0.26 | Not reported | -0.49 | -0.03 | Not reported |
| Treatment Phase - Adult Cohort Mirdametinib (PD-0325901) - Self-Report | -0.70 | Not reported | -1.02 | -0.38 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -0.83
- upper Limit
- -0.09
- value
- -0.46
- group Id
- OG001
- lower Limit
- -0.49
- upper Limit
- -0.03
- value
- -0.26
- group Id
- OG002
- lower Limit
- -1.02
- upper Limit
- -0.38
- value
- -0.70
- denoms
- counts
- group Id
- OG000
- value
- 47
- group Id
- OG001
- value
- 47
- group Id
- OG002
- value
- 58
- units
- Participants
- description
- The PII assesses relevant aspects of one's life, including pain interference with activities, spending time with family/friends, mood, sleep and attention. Participants ≥ 6 years of age complete a self-report, and parents/guardians of children aged 6-17 complete a parent proxy report. The recall period is 24 hours. The PII consists of 6 questions, each asking the responder to select one number from 0 to 6 that best describes how their/their proxy's pain has impacted various items over the past 24 hours with 0 representing "Not at all" and 6 representing "Completely". The mean of the completed items is taken as the PII score for a single assessment. The PII score presented each visit will be taken as the average of the PII scores over the 7 consecutive days up to and including visit day, with no transformation applied. The change from baseline is modelled using a mixed-model for repeated measures.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients self-reported results aged 6 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 6 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
- description
- Patients self-reported results aged 18 years 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
- OG002
- 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 Pain Interference Index (PII) at Cycle 13.
- type
- SECONDARY
- unit Of Measure
- units on a scale
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Preserved source evidence · Not medical advice