TriangleNCT00886769 · OUTCOME
Change in Health-related Quality of Life (HRQoL)Over Time by Use of the Child Health Questionnaire - Parent Form (CHQ-PF50)
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
- Standard Error
- Time frame
- Over 4 week study period (Baseline, Day 15, Day 29)
What was measured
CHQ-PF50 measures HRQoL in children 5-18 years old from parent's perspective. Questionnaire completed by parent without input from patient. Total score ranges from 0-100. Increases in scores represent improved well-being in subjects as assessed by their parents. Mixed linear model on change from baseline in CHQ-PF50 score with treatment group, stratification factors, day of assessment and interaction between group and day as covariates. Covariance analysis used a repeated measures approach, so all timepoints over time were taken into account.
Analysis population: The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug. Observed cases only were analyzed.
Groups in this outcome
Canakinumab
Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients\>37.5 kg) received two sc injections.
Placebo
Patients received a single dose matching placebo of canakinumab on day 1.
| Group | Source count |
|---|---|
| Canakinumab | 28 |
| Placebo | 34 |
Reported measurements
CHQ-PF50 physical score
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Canakinumab | 16.9 | 3.46 | Not reported | Not reported | Not reported |
| Placebo | 4.9 | 3.97 | Not reported | Not reported | Not reported |
CHQ-PF50 psychosocial score
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Canakinumab | 6.2 | 2.15 | Not reported | Not reported | Not reported |
| Placebo | -1.1 | 2.49 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 3.46
- value
- 16.9
- group Id
- OG001
- spread
- 3.97
- value
- 4.9
- title
- CHQ-PF50 physical score
- categories
- measurements
- group Id
- OG000
- spread
- 2.15
- value
- 6.2
- group Id
- OG001
- spread
- 2.49
- value
- -1.1
- title
- CHQ-PF50 psychosocial score
- denoms
- counts
- group Id
- OG000
- value
- 28
- group Id
- OG001
- value
- 34
- units
- Participants
- description
- CHQ-PF50 measures HRQoL in children 5-18 years old from parent's perspective. Questionnaire completed by parent without input from patient. Total score ranges from 0-100. Increases in scores represent improved well-being in subjects as assessed by their parents. Mixed linear model on change from baseline in CHQ-PF50 score with treatment group, stratification factors, day of assessment and interaction between group and day as covariates. Covariance analysis used a repeated measures approach, so all timepoints over time were taken into account.
- dispersion Type
- Standard Error
- groups
- description
- Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients\>37.5 kg) received two sc injections.
- id
- OG000
- title
- Canakinumab
- description
- Patients received a single dose matching placebo of canakinumab on day 1.
- id
- OG001
- title
- Placebo
- param Type
- LEAST_SQUARES_MEAN
- population Description
- The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug. Observed cases only were analyzed.
- reporting Status
- POSTED
- time Frame
- Over 4 week study period (Baseline, Day 15, Day 29)
- title
- Change in Health-related Quality of Life (HRQoL)Over Time by Use of the Child Health Questionnaire - Parent Form (CHQ-PF50)
- type
- SECONDARY
- unit Of Measure
- units on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice