Table 3.
Adverse Events Regardless of Study-Drug Relationship Reported in ≥10% of Patients in Either Treatment Group
| Pasireotide LAR, n = 178a |
Octreotide LAR, n = 180a |
|||
|---|---|---|---|---|
| All Grades, n (%) | Grade 3/4, n (%) | All Grades, n (%) | Grade 3/4, n (%) | |
| Diarrhea | 70 (39.3) | 1 (0.6) | 81 (45.0) | 4 (2.2) |
| Hyperglycemia | 51 (28.7) | 6 (3.4) | 15 (8.3) | 1 (0.6) |
| Cholelithiasis | 46 (25.8) | 1 (0.6) | 64 (35.6) | 2 (1.1) |
| Diabetes mellitus | 34 (19.1) | 9 (5.1) | 7 (3.9) | 0 |
| Headache | 33 (18.5) | 2 (1.1) | 46 (25.6) | 5 (2.8) |
| Abdominal pain | 32 (18.0) | 1 (0.6) | 40 (22.2) | 0 |
| Alopecia | 32 (18.0) | 0 | 35 (19.4) | 0 |
| Nasopharyngitis | 28 (15.7) | 0 | 28 (15.6) | 0 |
| Nausea | 24 (13.5) | 1 (0.6) | 39 (21.7) | 0 |
| Increased blood creatine phosphokinase | 23 (12.9) | 3 (1.7) | 21 (11.7) | 4 (2.2) |
| Abdominal distension | 21 (11.8) | 1 (0.6) | 21 (11.7) | 1 (0.6) |
| Arthralgia | 17 (9.6) | 1 (0.6) | 22 (12.2) | 1 (0.6) |
| Fatigue | 17 (9.6) | 1 (0.6) | 18 (10.0) | 0 |
| Dizziness | 17 (9.6) | 0 | 19 (10.6) | 0 |
| Back pain | 14 (7.9) | 0 | 20 (11.1) | 2 (1.1) |
a
Two patients randomized to the octreotide LAR treatment arm received pasireotide LAR in error. These 2 patients are included in the pasireotide LAR treatment arm for the purposes of the safety analysis.