TriangleNCT03570749 · OUTCOME
Percentage of Participants Achieving ClinRO Measure for Eyelash (EL) Hair Loss 0 or 1 With ≥ 2-point Improvement From Baseline (Among Participants With ClinRO Measure for EL 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 measure for EL hair loss is comprised of 4 category response options: 0 = The EL form a continuous line along the eyelids on both eyes; 1 = There are minimal gaps and the EL are evenly spaced along the eyelids on both eyes; 2 = There are significant gaps along the eyelids or the EL are not evenly spaced along the eyelids; 3 = No notable EL.
Analysis population: All randomized phase 3 participants with baseline ClinRO measure for EL 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 | 96 |
| 2 mg Baricitinib Phase 3 | 111 |
| 4 mg Baricitinib Phase 3 | 167 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo Phase 3 | 3.1 | Not reported | 1.1 | 8.8 | Not reported |
| 2 mg Baricitinib Phase 3 | 13.5 | Not reported | 8.4 | 21.1 | Not reported |
| 4 mg Baricitinib Phase 3 | 33.5 | Not reported | 26.8 | 41.0 | Not reported |
Source statistical analyses
- ci Lower Limit
- 1.41
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 15.27
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.012
- param Type
- Odds Ratio (OR)
- param Value
- 4.63
- statistical Method
- Regression, Logistic
- ci Lower Limit
- 4.73
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 43.93
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.001
- param Type
- Odds Ratio (OR)
- param Value
- 14.42
- statistical Method
- Regression, Logistic
Complete source fields
- analyses
- ci Lower Limit
- 1.41
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 15.27
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.012
- param Type
- Odds Ratio (OR)
- param Value
- 4.63
- statistical Method
- Regression, Logistic
- ci Lower Limit
- 4.73
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 43.93
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.001
- param Type
- Odds Ratio (OR)
- param Value
- 14.42
- statistical Method
- Regression, Logistic
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.1
- upper Limit
- 8.8
- value
- 3.1
- group Id
- OG001
- lower Limit
- 8.4
- upper Limit
- 21.1
- value
- 13.5
- group Id
- OG002
- lower Limit
- 26.8
- upper Limit
- 41.0
- value
- 33.5
- denoms
- counts
- group Id
- OG000
- value
- 96
- group Id
- OG001
- value
- 111
- group Id
- OG002
- value
- 167
- units
- Participants
- description
- ClinRO measure for EL hair loss is comprised of 4 category response options: 0 = The EL form a continuous line along the eyelids on both eyes; 1 = There are minimal gaps and the EL are evenly spaced along the eyelids on both eyes; 2 = There are significant gaps along the eyelids or the EL are not evenly spaced along the eyelids; 3 = No notable EL.
- 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 EL 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 ClinRO Measure for Eyelash (EL) Hair Loss 0 or 1 With ≥ 2-point Improvement From Baseline (Among Participants With ClinRO Measure for EL 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