Table 2

Summary of TEAEs and treatment-related AEs over 52 weeks*

ParameterPlacebo/RCI (n=11)RCI/RCI (n=25)
Any TEAE11 (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 discontinuation3 (27.3)6 (24.0)
Any serious TEAE4 (36.4)4 (16.0)
Any TEAE resulting in death01 (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.