Adverse events | GC group (n=555) | AE/1000 PY N=1349 | Duration of GC therapy by the time of AEs (median, days) | Non-GC group (n=275) | AE/1000 PY N=452 |
---|---|---|---|---|---|
Hypertension | 4 (0.7) | 3.0 | 43 | 1 (0.4) | 2.2 |
Serious infections | 6 (1.0) | 4.4 | 230 | 2 (0.7) | 4.4 |
Peptic ulcer disease | 4 (0.9) | 3.0 | 691 | 4 (1.5) | 8.8 |
Sleep disorder, mood disturbances | 3 (0.5) | 2.2 | 264 | 1 (0.4) | 2.2 |
Diabetes | 1 (0.2) | 0.7 | 96 | 0 | 0 |
Symptom of weight gain | 6 (1.1) | 4.4 | 132 | 0 | 0 |
Puffy and rounded face | 9 (1.6) | 6.7 | 60 | 0 | 0 |
Dermatological AEs | 30 (5.4)* | 22.2 | 3 (1.0)* | 6.6 | |
Acne, bruisability | 17 (3.1) | 12.6 | 180 | 0 | 0 |
Cutaneous infection | 13 (2.3) | 9.6 | 365 | 3 (1.0) | 6.6 |
Fragility fracture | 0 | 0 | 1 (0.3) | 2.2 |
*p=0.003.
The incidence rates of AEs in the table are expressed as cumulative rate n (%) or events per 1000 PY.
AEs, adverse events; GC, glucocorticoid; PY, patient-years.