Table 3.
Most common AEs (>10 % in either treatment arm) reported during the 26-month study period, regardless of relationship to study drug
| Pasireotide LAR (N = 178a) | Octreotide LAR (N = 180a) | |||
|---|---|---|---|---|
| All grades | Grade 3/4 | All grades | Grade 3/4 | |
| n (%) | n (%) | n (%) | n (%) | |
| Diarrhea | 71 (39.9) | 1 (0.6) | 81 (45.0) | 5 (2.8) |
| Hyperglycemia | 55 (30.9) | 6 (3.4) | 18 (10.0) | 1 (0.6) |
| Cholelithiasis | 54 (30.3) | 2 (1.1) | 71 (39.4) | 3 (1.7) |
| Headache | 40 (22.5) | 2 (1.1) | 49 (27.2) | 5 (2.8) |
| Diabetes mellitus | 38 (21.3) | 9 (5.1) | 8 (4.4) | 0 |
| Alopecia | 34 (19.1) | 0 | 36 (20.0) | 0 |
| Abdominal pain | 33 (18.5) | 1 (0.6) | 44 (24.4) | 0 |
| Nasopharyngitis | 31 (17.4) | 0 | 29 (16.1) | 0 |
| Nausea | 27 (15.2) | 1 (0.6) | 41 (22.8) | 0 |
| Increased blood creatine phosphokinase | 25 (14.0) | 6 (3.4) | 24 (13.3) | 4 (2.2) |
| Arthralgia | 21 (11.8) | 1 (0.6) | 25 (13.9) | 1 (0.6) |
| Back pain | 21 (11.8) | 0 | 22 (12.2) | 2 (1.1) |
| Abdominal distension | 21 (11.8) | 1 (0.6) | 22 (12.2) | 1 (0.6) |
| Dizziness | 21 (11.8) | 0 | 20 (11.1) | 0 |
| Fatigue | 19 (10.7) | 1 (0.6) | 21 (11.7) | 0 |
| Hypertension | 18 (10.1) | 2 (1.1) | 16 (8.9) | 4 (2.2) |
| Constipation | 10 (5.6) | 0 | 19 (10.6) | 0 |
AEs are presented in overall descending order for the pasireotide LAR arm, starting with the most frequent
aTwo patients randomized to the octreotide LAR treatment arm received pasireotide LAR in error. These two patients are included in the pasireotide LAR treatment arm for the purposes of the safety analysis