TriangleNCT03570749 · OUTCOME
Time for Participants to Achieve SALT ≤ 20 at Week 36 - Phase 3
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 phase 3 participants who had evaluable data for this outcome measure.
Groups in this outcome
Placebo Phase 3
Participants received two placebo tablets administered orally every day 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 every day QD, and one placebo tablet administered orally QD to maintain the blind.
| Group | Source count |
|---|---|
| Placebo Phase 3 | 189 |
| 2 mg Baricitinib Phase 3 | 184 |
| 4 mg Baricitinib Phase 3 | 281 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo Phase 3 | 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 Phase 3 | 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 Phase 3 | 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
- 189
- group Id
- OG001
- value
- 184
- group Id
- OG002
- value
- 281
- 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 administered orally every day 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 every day QD, and one placebo tablet administered orally QD to maintain the blind.
- id
- OG002
- title
- 4 mg Baricitinib Phase 3
- param Type
- MEDIAN
- population Description
- All randomized phase 3 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 - Phase 3
- type
- SECONDARY
- unit Of Measure
- Days
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice