Table 3.
Summary of AEs, safety population
| Part 1 (open-label period) | |
|---|---|
| AE | No. (%) of patients RCI (n = 259) |
| Any AEa | 98 (37.8) |
| Anemia | 5 (1.9) |
| Glycosylated hemoglobin increased | 4 (1.5) |
| Headache | 9 (3.5) |
| Hypertension | 4 (1.5) |
| Nasopharyngitis | 4 (1.5) |
| Nausea | 5 (1.9) |
| Pharyngitis | 7 (2.7) |
| Upper respiratory tract infection | 4 (1.5) |
| Urinary tract infection | 10 (3.9) |
| AE resulting in study drug withdrawal | 3 (1.2) |
| Serious AE | 3 (1.2) |
| Serious infectious event | 1 (0.4) |
| Opportunistic infections | |
| Herpes zoster | 1 (0.4) |
| Tuberculosis | 0 |
| Death | 0 |
| Part 2 (double-blind period) | ||
|---|---|---|
| AE | No. (%) of patients | |
| Placebo (n = 77) | RCI (n = 77) | |
| Any AEa | 31 (40.3) | 25 (32.5) |
| Anemia | 2 (2.6) | 2 (2.6) |
| Back pain | 0 | 2 (2.6) |
| Diarrhea | 3 (3.9) | 1 (1.3) |
| Dizziness | 1 (1.3) | 1 (1.3) |
| Gastritis | 2 (2.6) | 1 (1.3) |
| Glycosylated hemoglobin increasedb | 2 (2.6) | 1 (1.3) |
| Headache | 5 (6.5) | 5 (6.5) |
| Hyperglycemia | 2 (2.6) | 3 (3.9) |
| Hypertension | 0 | 3 (3.9) |
| Influenza | 1 (1.3) | 1 (1.3) |
| Nasopharyngitis | 2 (2.6) | 2 (2.6) |
| Rhinitis | 2 (2.6) | 0 |
| Upper respiratory tract infection | 3 (3.9) | 0 |
| Urinary tract infection | 3 (3.9) | 2 (2.6) |
| AE resulting in study drug withdrawal | 1 (1.3) | 0 |
| Serious AE | 0 | 0 |
| Serious infectious event | 0 | 0 |
| Opportunistic infections | ||
| Herpes zoster | 0 | 0 |
| Tuberculosis | 0 | 0 |
| Death | 0 | 0 |
AE adverse event, RCI repository corticotropin injection
aAEs reported in ≥ 1.5% of subjects in part 1 or in either group in part 2 are listed below
bRefers to glycosylated hemoglobin values > 6.5%