Table 2.
AEs (regardless of study drug relationship) occurring in ≥10% of the 162 patients who received pasireotide
| Preferred term | Overall population (N = 162) | Patients reaching month 60 (N = 16) | ||
|---|---|---|---|---|
| Grades 3/4 | All grades | Grades 3/4 | All grades | |
| n (%) | n (%) | n (%) | n (%) | |
| Diarrhoea | 5 (3.1) | 95 (58.6) | 0 | 7 (43.8) |
| Nausea | 4 (2.5) | 87 (53.7) | 2 (12.5) | 11 (68.8) |
| Hyperglycaemia | 21 (13.0) | 67 (41.4) | 2 (12.5) | 9 (56.3) |
| Cholelithiasis | 3 (1.9) | 53 (32.7) | 1 (6.3) | 8 (50.0) |
| Headache | 3 (1.9) | 50 (30.9) | 1 (6.3) | 7 (43.8) |
| Abdominal pain | 4 (2.5) | 41 (25.3) | 1 (6.3) | 8 (50.0) |
| Diabetes mellitus | 14 (8.6) | 36 (22.2) | 2 (12.5) | 8 (50.0) |
| Fatigue | 3 (1.9) | 36 (22.2) | 1 (6.3) | 8 (50.0) |
| Nasopharyngitis | 0 | 24 (14.8) | 0 | 6 (37.5) |
| Alopecia | 0 | 21 (13.0) | 0 | 3 (18.8) |
| Hypercholesterolaemia | 0 | 20 (12.3) | 0 | 4 (25.0) |
| Abdominal pain upper | 0 | 19 (11.7) | 0 | 6 (37.5) |
| Asthenia | 4 (2.5) | 19 (11.7) | 0 | 3 (18.8) |
| Dizziness | 2 (1.2) | 19 (11.7) | 0 | 3 (18.8) |
| ALT increased | 4 (2.5) | 18 (11.1) | 0 | 2 (12.5) |
| Gamma-glutamyltransferase increased | 6 (3.7) | 18 (11.1) | 0 | 2 (12.5) |
| HbA1c increased | 1 (0.6) | 18 (11.1) | 0 | 1 (6.3) |
| Hypertension | 0 | 18 (11.1) | 0 | 2 (12.5) |
| Hypoglycaemia | 3 (1.9) | 18 (11.1) | 0 | 3 (18.8) |
| Decreased appetite | 0 | 17 (10.5) | 0 | 2 (12.5) |
| Myalgia | 1 (0.6) | 17 (10.5) | 1 (6.3) | 8 (50.0) |
ALT alanine aminotransferase