Table 3.
AEs (≥ 2 patients) regardless of study drug relationship reported during the extension phase (n = 16) and AEs of special interest reported during the entire study (n = 19)
| All grades n |
Grade ≥ 3 n |
|
|---|---|---|
| AEs regardless of study drug relationship | ||
| Adrenal insufficiency | 7 | 1 |
| Arthralgia | 6 | 0 |
| Headache | 6 | 1 |
| Diarrhea | 5 | 0 |
| Abdominal pain | 4 | 1 |
| Urinary tract infection | 4 | 0 |
| Arthropod bite | 3 | 0 |
| Blood testosterone increased | 3 | 0 |
| Edema peripheral | 3 | 0 |
| Fatigue | 3 | 0 |
| Hypertension | 3 | 3 |
| Lipase increased | 3 | 1 |
| Vertigo | 3 | 0 |
| Asthenia | 2 | 0 |
| Blood corticotropin increased | 2 | 0 |
| Blood pressure increased | 2 | 0 |
| Dizziness | 2 | 0 |
| Gastroenteritis | 2 | 1 |
| Hypokalemia | 2 | 0 |
| Influenza | 2 | 0 |
| Insomnia | 2 | 0 |
| Iron deficiency anemia | 2 | 0 |
| Musculoskeletal pain | 2 | 0 |
| Nasopharyngitis | 2 | 0 |
| Non-cardiac chest pain | 2 | 1 |
| Pain in extremity | 2 | 0 |
| Pituitary-dependent Cushing’s syndrome | 2 | 2 |
| Upper respiratory tract infection | 2 | 0 |
| Vomiting | 2 | 0 |
| Vulvovaginal mycotic infection | 2 | 0 |
| Weight decreased | 2 | 1 |
| Weight increased | 2 | 0 |
| AEs of special interest | ||
| Related to accumulation of adrenal hormone precursors | 12 | 4 |
| Related to hypocortisolism | 11 | 2 |
| Related to arrhythmogenic potential | 1 | 0 |
| Related to QT prolongation | 1 | 0 |
A patient with multiple severity grades for an AE is only counted under the maximum grade. Pituitary-dependent Cushing’s syndrome was the preferred term used by investigators to report events of worsening or uncontrolled Cushing’s syndrome