Table 2.
AEs (≥ 2 patients) regardless of study drug relationship reported during the core phase (n = 19)
| All grades n |
Grade ≥ 3 n |
|
|---|---|---|
| AEs regardless of study drug relationship | ||
| Blood corticotropin increased | 7 | 0 |
| Hormone level abnormal | 7 | 0 |
| Asthenia | 6 | 0 |
| Nausea | 6 | 0 |
| Fatigue | 4 | 0 |
| Headache | 4 | 0 |
| Nasopharyngitis | 4 | 0 |
| Acne | 3 | 0 |
| Blood creatinine phosphokinase increased | 3 | 1 |
| Blood testosterone increased | 3 | 0 |
| Diarrhea | 3 | 0 |
| Dizziness | 3 | 0 |
| Hypertrichosis | 3 | 0 |
| Malaise | 3 | 0 |
| Adrenal insufficiency | 2 | 1 |
| Anemia | 2 | 1 |
| Back pain | 2 | 0 |
| Depression | 2 | 1 |
| Hirsutism | 2 | 0 |
| Hypomagnesemia | 2 | 2 |
| Muscle spasms | 2 | 1 |
| Musculoskeletal stiffness | 2 | 0 |
| Pruritus | 2 | 0 |
| Rash | 2 | 0 |
| Toothache | 2 | 0 |
| Sinus bradycardia | 2 | 0 |
| Urinary tract infection | 2 | 0 |
| Vitamin D decreased | 2 | 0 |
A patient with multiple severity grades for an AE is only counted under the maximum grade