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

Mean ± SD [median]

Floor and Ceiling Effects, Non-response Bias, N(%)

Axillary Sweating Severity (Item 2)

Baseline^a

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)

Baseline^a

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)

Baseline^a

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 r^c

0.21^f

0.01^d,e

0.22^d,e

Effect Size of Change (SD Baseline units)

−2.2

−2.0

− 2.4

Standardized Response Mean

−1.6

−0.70

−1.5