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Table 7 Responder Estimates for ASDD Axillary Sweating Severity Item (Item 2): Anchor-Based Method (Phase 2 Data)

From: Development and validation of the Axillary Sweating Daily Diary: a patient-reported outcome measure to assess axillary sweating severity

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
  1. Bold text represents the preferred threshold for meaningful response consistent with FDA guidance (“moderately better”)
  2. ASDD Axillary Sweating Daily Diary, PGIC Patient Global Impression of Change, SD Standard deviation
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