Table 2.
Serious adverse events and other adverse events by treatment
| Event | ACTH 80U/1.73 m2, n=28a | ACTH 40U/1.73 m2, n=3 | No Relapse-Preventing Treatment, n=16 |
|---|---|---|---|
| Hospitalization, n (%) | 5 (18) | 0 | 2 (13) |
| AKI | 0 | 0 | 1 (6) |
| Edema | 2 (7) | 0 | 0 |
| Edema with GI complaints | 2 (7) | 0 | 0 |
| Edema with respiratory complaints | 1 (4) | 0 | 1 (6%) |
| Hypertension | 1 (4) | 0 | 0 |
| Other adverse events, n (%) | |||
| Infections | 1 (4) | 1 (33) | 1 (6) |
| Behavioral changes | 7 (25) | 0 | 0 |
| Sleep disturbances | 5 (18) | 0 | 1 (6) |
| Elevated BP | 1 (4) | 0 | 0 |
| Cushingoid symptoms/striae/acne | 5 (18) | 0 | 2 (13) |
| Hyperglycemia, >200 mg/dl | 0 | 0 | 0 |
| Injection site irritation | 7 (25) | 0 | N/A |
| Skin hyperpigmentation | 0 | 0 | 0 |
| Increased appetite | 9 (32) | 0 | 2 (13) |
ACTH, adrenocorticotropic hormone; GI, gastrointestinal; N/A, not applicable.
a
ACTH treatment participants include both those initially randomized to ACTH treatment and those who crossed over to ACTH treatment.