TriangleNCT03570749 · 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) - Phase 3
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 phase 3 participants with baseline ClinRO measure for EB Hair Loss ≥ 2 and who had evaluable data for this outcome measure. A Non-responder Imputation (NRI) was applied for participants with missing data at the timepoint due to discontinuation or other intercurrent events.
Groups in this outcome
Placebo Phase 3
Participants received two placebo tablets administered orally QD.
2 mg Baricitinib Phase 3
Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
4 mg Baricitinib Phase 3
Participants received one 4 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
| Group | Source count |
|---|---|
| Placebo Phase 3 | 124 |
| 2 mg Baricitinib Phase 3 | 136 |
| 4 mg Baricitinib Phase 3 | 188 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo Phase 3 | 3.2 | Not reported | 1.3 | 8.0 | Not reported |
| 2 mg Baricitinib Phase 3 | 19.1 | Not reported | 13.4 | 26.5 | Not reported |
| 4 mg Baricitinib Phase 3 | 31.4 | Not reported | 25.2 | 38.3 | Not reported |
Source statistical analyses
- ci Lower Limit
- 2.34
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 18.62
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.001
- param Type
- Odds Ratio (OR)
- param Value
- 6.60
- statistical Method
- Regression, Logistic
- ci Lower Limit
- 5.01
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 36.81
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.001
- param Type
- Odds Ratio (OR)
- param Value
- 13.58
- statistical Method
- Regression, Logistic
Complete source fields
- analyses
- ci Lower Limit
- 2.34
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 18.62
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.001
- param Type
- Odds Ratio (OR)
- param Value
- 6.60
- statistical Method
- Regression, Logistic
- ci Lower Limit
- 5.01
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 36.81
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.001
- param Type
- Odds Ratio (OR)
- param Value
- 13.58
- statistical Method
- Regression, Logistic
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.3
- upper Limit
- 8.0
- value
- 3.2
- group Id
- OG001
- lower Limit
- 13.4
- upper Limit
- 26.5
- value
- 19.1
- group Id
- OG002
- lower Limit
- 25.2
- upper Limit
- 38.3
- value
- 31.4
- denoms
- counts
- group Id
- OG000
- value
- 124
- group Id
- OG001
- value
- 136
- group Id
- OG002
- value
- 188
- 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 administered orally QD.
- id
- OG000
- title
- Placebo Phase 3
- 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 Phase 3
- description
- Participants received one 4 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
- id
- OG002
- title
- 4 mg Baricitinib Phase 3
- param Type
- NUMBER
- population Description
- All randomized phase 3 participants with baseline ClinRO measure for EB Hair Loss ≥ 2 and who had evaluable data for this outcome measure. A Non-responder Imputation (NRI) was applied for participants with missing data at the timepoint due to discontinuation or other intercurrent events.
- 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) - Phase 3
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice