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. 2021 Aug 28;11(5):1717–1732. doi: 10.1007/s13555-021-00591-z

Table 2.

Incidence of treatment-emergent adverse events (safety population)

TEAEs, n (%) Clobetasol propionate 0.025% cream Clobetasol propionate 0.05% cream
(N = 30)
Formulation 5 (N = 29) Formulation 13 (N = 29)
Total Treatment related Probably related Total Treatment related Probably related Total Treatment related Probably related
Patients with at least 1 TEAE 13 (44.8) 0 12 (41.4) 15 (50.0) 0 10 (34.5) 15 (50.0) 0 11 (36.7)
TEAEs in > 3% of patients 0 0 0 0 0 0 2 (6.7) 0 0
 Pain 0 0 0 0 0 0 1 (3.3) 0 0
 Pyrexia 0 0 0 0 0 0 1 (3.3) 0 0
 Gastroenteritis 0 0 0 0 0 0 1 (3.3) 0 0
 Nasopharyngitis 0 0 0 0 0 0 2 (6.7) 0 0
 Tinea cruris 0 0 0 0 0 0 1 (3.3) 0 0
 Blood cortisol decrease 13 (44.8) 0 12 (41.4) 11 (37.9) 0 10 (34.5) 11 (36.7) 0 11 (36.7)
 Cough 0 0 0 0 0 0 2 (6.7) 0 0
 Pruritus 1 (3.4) 0 0 0 0 0 1 (3.3) 0 0
 Telangiectasia 0 0 0 0 0 0 1 (3.3) 0 1 (3.3)
Mild Moderate Severe Mild Moderate Severe Mild Moderate Severe
Proportion of patients with mild, moderate, and severe
 Patients with at least 1 TEAE 11 (37.9) 2 (6.9) 1 (3.4) 7 (24.1) 3 (10.3) 1 (3.4) 9 (30.0) 6 (20.0) 3 (10.0)
 Pain 0 0 0 0 0 0 0 0 1 (3.3)
 Pyrexia 0 0 0 0 0 0 1 (3.3) 0 0
 Gastroenteritis 0 0 0 0 0 0 1 (3.3) 0 0
 Nasopharyngitis 0 0 0 0 0 0 0 2 (6.7) 0
 Tinea cruris 0 0 0 0 0 0 1 (3.3) 0 0
 Blood cortisol decrease 10 (34.5) 2 (6.9) 1 (3.4) 7 (24.1) 3 (10.3) 1 (3.4) 6 (20.0) 4 (13.3) 1 (3.3)
 Hyperglycemia 1 (3.4) 0 0 0 0 0 0 0 0
 Cough 0 0 0 0 0 0 2 (6.7) 0 0
 Pruritus 1 (3.4) 0 0 0 0 0 0 0 1 (3.3)
 Telangiectasia 0 0 0 0 0 0 1 (3.3) 0 0

TEAEs treatment-emergent adverse events.