Table 4.
Adverse events
| Adverse Event Type | Placebo, n=15 | Pasireotide Long-Acting Release, n=33 | P Value |
|---|---|---|---|
| Most frequently occurring adverse events | |||
| Hyperglycemia | 4 (27%) | 26 (79%) | <0.001b |
| Diarrhea | 8 (53%) | 17 (52%) | 0.91 |
| Dizziness | 3 (20%) | 10 (30%) | 0.46 |
| Pain abdomen | 1 (7%) | 11 (33%) | 0.05b |
| Fatigue | 3 (20%) | 13 (39%) | 0.19 |
| Diabetesa | 1/15 (7%) | 19/32 (59%) | 0.001b |
| Nausea | 3 (20%) | 9 (27%) | 0.59 |
| Bradycardia | 1 (7%) | 10 (30%) | 0.07 |
| Alopecia | 0 (0%) | 9 (27%) | 0.03b |
| Headache | 3 (20%) | 5 (15%) | 0.68 |
| Serious adverse event | 2 (13%) | 4 (12%) | 0.91 |
P values were derived using the chi-squared test.
a
We used standard definitions for diagnosis of diabetes: a fasting plasma glucose (no caloric intake ×8 hours) ≥126 on two occasions; hemoglobin A1C >6.5; or in a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose ≥200 mg/dl were equally appropriate for diagnostic testing. The numbers above are on the basis of the 47 patients without diabetes at baseline.
b
Denotes significance at the 0.05 α-level.