Table 7 Responder Estimates for ASDD Axillary Sweating Severity Item (Item 2): Anchor-Based Method (Phase 2 Data)
PGIC Response | Phase 2: DRM04-HH02 (N = 105) | Phase 3 Pooled: ATMOS-1 & ATMOS-2 (N = 697) | ||||||
|---|---|---|---|---|---|---|---|---|
n (%) | ASDD Axillary Sweating Severity (Average Weekly Change), mean ± SD [median] | n (%) | HDSS change score (Average Weekly Change), mean ± SD [median] | n (%) | ASDD Axillary Sweating Severity (Average Weekly Change), mean ± SD [median] | n (%) | HDSS change score (Average Weekly Change), mean ± SD [median] | |
1 = Much better | 50 (64.1) | − 5.1 ± 2.5 [− 5.5] | 45 | − 1.9 ± 0.80 [− 2.0] | 276 (39.6) | −5.7 ± 2.05 [− 5.7] | 276 (39.6) | − 2.0 ± 0.71 [− 2.0] |
2 = Moderately better | 11 (14.1) | − 3.8 ± 2.7 [− 3.4] | 10 | − 1.5 ± 0.71 [− 1.0] | 111 (15.9) | − 3.8 ± 2.28 [− 3.7] | 111 (15.9) | − 1.4 ± 0.66 [− 1.0] |
3 = A little better | 13 (16.7) | − 2.3 ± 1.2 [− 1.9] | 14 | − 0.6 ± 0.76 [0.0] | 119 (17.1) | − 2.3 ± 1.97 [− 1.9] | 119 (17.1) | − 0.9 ± 0.71 [− 1.0] |
4 = No difference | 4 (5.1) | − 1.7 ± 0.7 [− 1.9] | 3 | −0.3 ± 0.58 [0.0] | 82 (11.8) | −1.0 ± 1.69 [−0.6] | 82 (11.8) | −0.5 ± 0.74 [0.0] |
5 = A little worse | 0 | – | 0 | – | 11 (1.6) | 0.2 ± 1.54 [0.3] | 11 (1.6) | −0.4 ± 0.67 [0.0] |
6 = Moderately worse | 0 | – | 0 | – | 0 | – | 0 | – |
7 = Much worse | 0 | – | 0 | – | 0 | – | 0 | – |