Table 5.
Overview of treatment-emergent adverse events [Safety Set]
| BUS 4 mg, N = 286 | BUF 2 mg, N = 291 | Total N = 577 | ||||
|---|---|---|---|---|---|---|
| n [%] | m | n [%] | m | n [%] | m | |
| Any TEAE | 141 [49.3] | 231 | 119 [40.9] | 212 | 260 [45.1] | 443 |
| SAEs | 2 [0.7] | 4 | 3 [1.0] | 3 | 5 [0.9] | 7 |
| ADRs | 79 [27.6] | 94 | 52 [17.9] | 63 | 131 [22.7] | 157 |
| Most common TEAEsa | ||||||
| Cortisol decreased | 69 [24.1] | 71 | 39 [13.4] | 40 | 108 [18.7] | 111 |
| Lipase increased | 5 [1.7] | 5 | 8 [2.7] | 8 | 13 [2.3] | 13 |
| ALT increased | 5 [1.7] | 5 | 9 [3.1] | 9 | 14 [2.4] | 14 |
| Nasopharyngitis | 6 [2.1] | 7 | 10 [3.4] | 11 | 16 [2.8] | 18 |
| Colitis ulcerative | 12 [4.2] | 12 | 9 [3.1] | 9 | 21 [3.6] | 21 |
| Adrenal insufficiency | 3 [1.0] | 3 | 0 [0.0] | 0 | 3 [0.5] | 3 |
| Anorectal discomfort | 0 [0.0] | 0 | 3 [1.0] | 3 | 3 [0.5] | 3 |
| Nausea | 0 [0.0] | 0 | 3 [1.0] | 3 | 3 [0.5] | 3 |
| Headache | 19 [6.6] | 29 | 17 [5.8] | 27 | 36 [6.2] | 56 |
| Leukocytosis | 4 [1.4] | 4 | 1 [0.3] | 1 | 5 [0.9] | 5 |
| Dyspepsia | 5 [1.7] | 5 | 0 [0.0] | 0 | 5 [0.9] | 5 |
| GGT increased | 3 [1.0] | 3 | 3 [1.0] | 3 | 6 [1.0] | 6 |
| Abdominal pain | 3 [1.0] | 5 | 4 [1.4] | 5 | 7 [1.2] | 10 |
| Blood ALP increased | 2 [0.7] | 2 | 5 [1.7] | 5 | 7 [1.2] | 7 |
| Hypertension | 4 [1.4] | 4 | 3 [1.0] | 3 | 7 [1.2] | 7 |
| Anaemia | 4 [1.4] | 4 | 4 [1.4] | 4 | 8 [1.4] | 8 |
| Hyperkalaemia | 5 [1.7] | 5 | 3 [1.0] | 3 | 8 [1.4] | 8 |
| AST increased | 3 [1.0] | 3 | 6 [2.1] | 6 | 9 [1.6] | 9 |
ADR, adverse drug reaction; m, number of events; N, number of patients; n, number of patients reporting adverse events; ALT, alanine aminotransferase; ALP, alkaline phosphatase; AST, aspartate aminotransferase; GGT, γ-glutamyltransferase; TEAE, treatment-emergent adverse event; SAE, serious adverse event; ADR, adverse drug reaction.
≥1% of patients.