NCT03899259 · OUTCOME
Percentage of Participants Achieving Clinician-Reported Outcome (ClinRO) Measure for Eyebrow (EB) Hair Loss 0 or 1 With ≥2-point Improvement From Baseline (Among Participants With ClinRO Measure for EB Hair Loss ≥2 at Baseline)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Week 36
What was measured
ClinRO is a clinician reported assessment which measures a participant's EB hair loss. It is comprised of 4 category response options: 0 = EB have full coverage and no areas of hair loss; 1 = There are minimal gaps in EB hair and distribution is even; 2 = There are significant gaps in EB hair or distribution is not even; 3 = No notable EB.
Analysis population: All randomized participants with baseline ClinRO measure for EB hair loss ≥ 2 and who had evaluable data for this outcome measure.
Groups in this outcome
Placebo
Participants received two placebo tablets matched to baricitinib, administered orally QD to maintain the blind.
2 mg Baricitinib
Participants received one 2 mg Baricitinib tablet administered orally QD and one placebo tablet administered orally QD to maintain the blind.
4 mg Baricitinib
Participants received one 4 mg Baricitinib tablet and one placebo tablet administered orally QD to maintain the blind.
| Group | Source count |
|---|---|
| Placebo | 112 |
| 2 mg Baricitinib | 104 |
| 4 mg Baricitinib | 161 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | 4.5 | Not reported | 1.9 | 10.0 | Not reported |
| 2 mg Baricitinib | 11.5 | Not reported | 6.7 | 19.1 | Not reported |
| 4 mg Baricitinib | 34.8 | Not reported | 27.9 | 42.4 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.91
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 7.24
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.076
- param Type
- Odds Ratio (OR)
- param Value
- 2.56
- statistical Method
- Regression, Logistic
- ci Lower Limit
- 4.12
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 25.77
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.001
- param Type
- Odds Ratio (OR)
- param Value
- 10.30
- statistical Method
- Regression, Logistic
Complete source fields
- analyses
- ci Lower Limit
- 0.91
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 7.24
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.076
- param Type
- Odds Ratio (OR)
- param Value
- 2.56
- statistical Method
- Regression, Logistic
- ci Lower Limit
- 4.12
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 25.77
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.001
- param Type
- Odds Ratio (OR)
- param Value
- 10.30
- statistical Method
- Regression, Logistic
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.9
- upper Limit
- 10.0
- value
- 4.5
- group Id
- OG001
- lower Limit
- 6.7
- upper Limit
- 19.1
- value
- 11.5
- group Id
- OG002
- lower Limit
- 27.9
- upper Limit
- 42.4
- value
- 34.8
- denoms
- counts
- group Id
- OG000
- value
- 112
- group Id
- OG001
- value
- 104
- group Id
- OG002
- value
- 161
- units
- Participants
- description
- ClinRO is a clinician reported assessment which measures a participant's EB hair loss. It is comprised of 4 category response options: 0 = EB have full coverage and no areas of hair loss; 1 = There are minimal gaps in EB hair and distribution is even; 2 = There are significant gaps in EB hair or distribution is not even; 3 = No notable EB.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received two placebo tablets matched to baricitinib, administered orally QD to maintain the blind.
- id
- OG000
- title
- Placebo
- description
- Participants received one 2 mg Baricitinib tablet administered orally QD and one placebo tablet administered orally QD to maintain the blind.
- id
- OG001
- title
- 2 mg Baricitinib
- description
- Participants received one 4 mg Baricitinib tablet and one placebo tablet administered orally QD to maintain the blind.
- id
- OG002
- title
- 4 mg Baricitinib
- param Type
- NUMBER
- population Description
- All randomized participants with baseline ClinRO measure for EB hair loss ≥ 2 and who had evaluable data for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Week 36
- title
- Percentage of Participants Achieving Clinician-Reported Outcome (ClinRO) Measure for Eyebrow (EB) Hair Loss 0 or 1 With ≥2-point Improvement From Baseline (Among Participants With ClinRO Measure for EB Hair Loss ≥2 at Baseline)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice
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