TABLE 3.
TRAEs | IGA 2 (mild) | IGA 3,4 (moderate and severe) | Total | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Vehicle | Delgocitinib 0.25% ointment | Delgocitinib 0.5% ointment | Vehicle | Delgocitinib 0.25% ointment | Delgocitinib 0.5% ointment | Vehicle | Delgocitinib 0.25% ointment | Delgocitinib 0.5% ointment | ||||||||||
n | 13 | 13 | 14 | 22 | 21 | 20 | 35 | 34 | 34 | |||||||||
N (%) | e | N | e | N | e | N | e | N | e | N | e | N | e | N | e | N | e | N |
Total | 1 | 1 (7.7) | 1 | 1 (7.7) | 0 | 0 (0.0) | 1 | 1 (4.5) | 0 | 0 (0.0) | 1 | 1 (5.0) | 2 | 2 (5.7) | 1 | 1 (2.9) | 1 | 1 (2.9) |
Infections and infestations | 1 | 1 (7.7) | 1 | 1 (7.7) | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | 1 | 1 (5.0) | 1 | 1 (2.9) | 1 | 1 (2.9) | 1 | 1 (2.9) |
Impetigo | 1 | 1 (7.7) | 1 | 1 (7.7) | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | 1 | 1 (5.0) | 1 | 1 (2.9) | 1 | 1 (2.9) | 1 | 1 (2.9) |
Skin and subcutaneous tissue disorders | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | 1 | 1 (4.5) | 0 | 0 (0.0) | 0 | 0 (0.0) | 1 | 1 (2.9) | 0 | 0 (0.0) | 0 | 0 (0.0) |
Dermatitis contact | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | 1 | 1 (4.5) | 0 | 0 (0.0) | 0 | 0 (0.0) | 1 | 1 (2.9) | 0 | 0 (0.0) | 0 | 0 (0.0) |
Note: TRAEs coded according to MedDRA/J 19.1.
Abbreviations: IGA, investigator’s global assessment; e, number of events; N, number of patients.