NCT03899259 · OUTCOME
Time for Participants to Achieve SALT ≤ 20 at Week 36.
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Days
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Week 36
What was measured
The SALT uses a visual aid showing the division of the scalp hair into 4 areas with the top of the head constituting 40% of total surface, the posterior/back of head 24%, right side and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score, as developed by the National Alopecia Areata Foundation Working Committee. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account in the SALT scoring process. The SALT score will range from 0% to 100%, with lower score indicating better health outcomes. Kaplan-Meier method was used for analysis. Time for participants to achieve salt ≤ 20 at week 36 were reported in this outcome measure.
Analysis population: All randomized participants 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 | 156 |
| 2 mg Baricitinib | 156 |
| 4 mg Baricitinib | 234 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | NA | Not reported | NA | NA | Median and 95% confidence interval (CI) was not estimated due to insufficient number of participants with events. |
| 2 mg Baricitinib | NA | Not reported | NA | NA | Median and 95% confidence interval (CI) was not estimated due to insufficient number of participants with events. |
| 4 mg Baricitinib | NA | Not reported | NA | NA | Median and 95% confidence interval (CI) was not estimated due to insufficient number of participants with events. |
Complete source fields
- classes
- categories
- measurements
- comment
- Median and 95% confidence interval (CI) was not estimated due to insufficient number of participants with events.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Median and 95% confidence interval (CI) was not estimated due to insufficient number of participants with events.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Median and 95% confidence interval (CI) was not estimated due to insufficient number of participants with events.
- group Id
- OG002
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 156
- group Id
- OG001
- value
- 156
- group Id
- OG002
- value
- 234
- units
- Participants
- description
- The SALT uses a visual aid showing the division of the scalp hair into 4 areas with the top of the head constituting 40% of total surface, the posterior/back of head 24%, right side and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score, as developed by the National Alopecia Areata Foundation Working Committee. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account in the SALT scoring process. The SALT score will range from 0% to 100%, with lower score indicating better health outcomes. Kaplan-Meier method was used for analysis. Time for participants to achieve salt ≤ 20 at week 36 were reported in this outcome measure.
- 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
- MEDIAN
- population Description
- All randomized participants who had evaluable data for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Week 36
- title
- Time for Participants to Achieve SALT ≤ 20 at Week 36.
- type
- SECONDARY
- unit Of Measure
- Days
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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