Table 3.
Most common drug-related AEs (occurring in ≥5% of patients) during the overall study period, by severity (all grades and grade 3/4).
| All patients, N = 123 | ||
|---|---|---|
| Adverse events | All grades, n (%) | Grade 3/4, n (%) |
| Any AE | 115 (93.5) | 29 (23.6) |
| Suspected to be drug related | 102 (82.9) | 12 (9.8) |
| Any SAE | 12 (9.8) | 10 (8.1) |
| Suspected to be drug related | 4 (3.3) | 4 (3.3) |
| Any AE leading to discontinuation | 4 (3.3) | 2 (1.6) |
| Suspected to be drug related | 3 (2.4) | 1 (0.8) |
| Deaths | 0 | 0 |
| Most common AEs suspected to be related to study drug (>5% based on all grades) | ||
| Hyperglycemia | 51 (41.5) | 4 (3.3) |
| Diabetes mellitus | 29 (23.6) | 5 (4.1) |
| Diarrhea | 14 (11.4) | 0 |
| Cholelithiasis | 11 (8.9) | 2 (1.6) |
| Abdominal pain | 10 (8.1) | 1 (0.8) |
| Alopecia | 9 (7.3) | 0 |
| Sinus bradycardia | 8 (6.5) | 0 |
n, number of patients; only AEs occurring on or after the start of study treatment and no more than 3 months (84 days) after the discontinuation of study treatment of pasireotide are reported. Patients with multiple severity grades for an AE are only counted under the maximum grade.