Phase 2: DRM04-HH02 (N = 105) | Phase 3 Pooled: ATMOS-1 & ATMOS-2 | |||
---|---|---|---|---|
Age 9–15 Years (N = 32) | Age ≥ 16 Years (N = 665) | |||
ASDD Item 2 (Week 4 Average) | HDSS, mean (SD) | |||
Grade 1 | 0.9 ± 1.2 (n = 35) | 2.0 ± 0.6 (n = 5) | 1.1 ± 1.6 (n = 208) | |
Grade ≥ 3 | 5.3 ± 1.4 (n = 14) | 6.8 ± 1.86 (n = 13) | 6.5 ± 2.1 (n = 154) | |
p-value | < 0.001 | < 0.001 | < 0.001 | |
Sweat Production,a mean (SD) | ||||
1st Quartile | 1.8 ± 1.7 (n = 19) | 4.1 ± 3.2 (n = 3) | 2.6 ± 2.6 (n = 166) | |
4th Quartile | 3.4 ± 2.0 (n = 20) | 6.3 ± 1.9 (n = 15) | 4.2 ± 2.8 (n = 168) | |
p-value | 0.009 | 0.125 | < 0.001 | |
DLQI/C-DLQI, mean (SD) | ||||
No to moderate impact | N/A | 4.4 ± 2.5 (n = 27) | 2.9 ± 2.5 (n = 571) | |
Very large to extremely large impact | N/A | 9.8 (n = 1) | 7.3 ± 2.4 (n = 7) | |
p-value | N/A | N/Ab | < 0.001 | |
ASDD Item 3 (Week 4 Average) | HDSS, mean (SD) | |||
Grade 1 | 0.2 ± 0.4 (n = 35) | N/A | 0.2 ± 0.3 (n = 182) | |
Grade ≥ 3 | 1.5 ± 0.7 (n = 14) | N/A | 2.1 ± 1.0 (n = 114) | |
p-value | < 0.001 | N/A | < 0.001 | |
Sweat Production,a mean (SD) | ||||
1st Quartile | 0.5 ± 0.6 (n = 19) | N/A | 0.7 ± 0.8 (n = 146) | |
4th Quartile | 1.0 ± 0.7 (n = 20) | N/A | 1.2 ± 1.0 (n = 134) | |
p -value | 0.026 | N/A | < 0.001 | |
DLQI/C-DLQI, mean (SD) | ||||
No to moderate impact | N/A | N/A | 0.8 ± 0.9 (n = 508) | |
Very large to extremely large impact | N/A | N/A | 3.0 ± 1.0 (n = 5) | |
p -value | N/A | N/A | < 0.001 | |
ASDD Item 4 (Week 4 Average) | HDSS, mean (SD) | |||
Grade 1 | 0.2 ± 0.3 (n = 35) | N/A | 0.2 ± 0.3 (n = 182) | |
Grade ≥ 3 | 1.7 ± 0.7 (n = 14) | N/A | 2.3 ± 1.0 (n = 114) | |
p -value | < 0.001 | N/A | < 0.001 | |
Sweat Production,a mean (SD) | ||||
1st Quartile | 0.5 ± 0.5 (n = 19) | N/A | 0.8 ± 0.8 (n = 146) | |
4th Quartile | 1.2 ± 0.7 (n = 20) | N/A | 1.3 ± 1.0 (n = 134) | |
p -value | 0.002 | N/A | < 0.001 | |
DLQI/C-DLQI, mean (SD) | ||||
No to moderate impact | N/A | N/A | 0.9 ± 0.9 (n = 508) | |
Very large to extremely large impact | N/A | N/A | 3.0 ± 1.1 (n = 5) | |
p -value | N/A | N/A | < 0.001 |