Table 3.
Number of patients experiencing treatment-emergent adverse events during weeks 0–54, by dose at onset of the event
| Patients experiencing adverse event at given dose [n (%)] | ||||
|---|---|---|---|---|
| Lanreotide Autogel dose | Total (n = 107)a | |||
| 60 mg (n = 46)a | 90 mg (n = 66)a | 120 mg (n = 74)a | ||
| Any AE | 33 (72) | 47 (71) | 67 (91) | 98 (92) |
| Any gastrointestinal AE | 16 (35) | 28 (42) | 46 (62) | 72 (67) |
| Most commonly reported AEs | ||||
| Diarrhoea | 10 (22) | 19 (29) | 35 (47) | 51 (48) |
| Cholelithiasis | 8 (17) | 9 (14) | 18 (24) | 32 (30) |
| Abdominal pain | 5 (11) | 9 (14) | 11 (15) | 23 (21) |
| Bradycardia | 7 (15) | 5 (8) | 4 (5) | 15 (14) |
| Arthralgia | 3 (7) | 8 (12) | 4 (5) | 14 (13) |
| Anaemia | 3 (7) | 6 (9) | 4 (5) | 13 (12) |
| Alopecia | 5 (11) | 3 (5) | 7 (9) | 13 (12) |
| Injection-site mass | 2 (4) | 2 (3) | 8 (11) | 11 (10) |
| Flatulence | 2 (4) | 3 (5) | 7 (9) | 11 (10) |
| Nausea | 3 (7) | 2 (3) | 6 (8) | 11 (10) |
Data are number (%) of patients. AE, adverse event
aThe number of patients in the ‘total’ column is the total number of patients in the study; the number of patients in the three other columns is the number of patients who received the given dose of Lan-Autogel at any time during the study. Thus, a single patient could be included in more than one column