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Table 4 ASDD/ASDD-C Measurement Properties Evaluated in Phase 2 and Phase 3 Trials

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

Measurement Property   Phase 2:
DRM04-HH02 (N = 105)
Phase 3 Pool:
ATMOS-1 & ATMOS-2
Age 9–15 Years (N = 32) Age ≥ 16 Years (N = 665)
Mean ± SD [median]
Floor and Ceiling Effects, Non-response Bias, N(%)
Axillary Sweating Severity (Item 2) Baselinea 6.8 ± 1.9 [7.0] 6.8 ± 2.5 [7.0] 7.2 ± 1.6 [7.4]
Minimum (0) 3 (2.9%) 0 (0%) 1 (0.2%)
Maximum (10) 9 (8.6%) 6 (18.8%) 83 (12.5%)
Impact (Item 3) Baselinea 2.2 ± 0.9 [2.2] N/A 2.4 ± 0.9 [2.3]
Minimum (0) 12 (11.4%) 31 (4.7%)
Maximum (4) 10 (9.5%) 105 (15.8%)
Bothersomeness (Item 4) Baselinea 2.3 ± 0.9 [2.3] N/A 2.6 ± 0.9 [2.6]
Minimum (0) 11 (10.5%) 13 (2.0%)
Maximum (4) 15 (14.3%) 145 (21.8%)
Test-Retest Reliability, ICC Axillary Sweating Severity (Item 2) Week 4 –
Week 3
0.91 0.92 0.94
Impact (Item 3) Week 4 –
Week 3
0.89 N/A 0.90
Bothersomeness (Item 4) Week 4 –
Week 3
0.88 N/A 0.89
Item 2 Responsiveness   Week 4 –
Baseline
   
Sweat Production,b rc    0.21f 0.01d,e 0.22d,e
Effect Size of Change (SD Baseline units)    −2.2 −2.0 − 2.4
Standardized Response Mean    −1.6 −0.70 −1.5
  1. ASDD Axillary Sweating Daily Diary, ICC Intraclass correlation, SD Standard deviation
  2. a For subjects with Week 4 scores
  3. b Measured gravimetrically
  4. c Based on the change from Baseline to Week 4 in ASDD Item 2 scores and sweat production
  5. d Spearman correlation coefficient
  6. e Based on the change from Baseline to Week 4 in ASDD Item 2 scores and the natural logarithm of sweat production
  7. f Pearson correlation coefficient
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