Summary of TEAEs and treatment-related AEs over 52 weeks*
| Parameter | Placebo/RCI (n=11) | RCI/RCI (n=25) |
| Any TEAE | 11 (100) | 23 (92.0) |
| Any severe TEAE† | 3 (27.3) | 2 (8.0) |
| Any treatment-related AE‡ | 6 (54.5) | 14 (56.0) |
| Any TEAE leading to study discontinuation | 3 (27.3) | 6 (24.0) |
| Any serious TEAE | 4 (36.4) | 4 (16.0) |
| Any TEAE resulting in death | 0 | 1 (4.0) |
Data reported as n (%).
*AEs classified into System Organ Class and preferred terms using the Medical Dictionary for Regulatory Activities, V.15.1.
†AEs were considered severe if the severity of an event was missing.
‡AEs were considered treatment related if the relationship to study medication was possibly related, probably related, definitely related or missing.
AE, adverse event; RCI, repository corticotropin injection; TEAE, treatment-emergent adverse event.