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.