Table 2.
Adverse Effects Reported in Safety Group Analysis (n=13)
| Adverse effectsa | Frequency, n (%) | Severity, mean (SD) |
|---|---|---|
| Any | 13 (100) | 1.17 (0.49) |
| Diarrhea | 11 (84.6) | 1.24 (0.68) |
| Somnolence | 9 (69.2) | 1.10 (0.31) |
| Fatigue | 8 (61.5) | 1.17 (0.22) |
| Weight gain | 4 (30.8) | 1.17 (0.33) |
| Abdominal pain | 3 (23.1) | 1 (0) |
| Dizziness | 3 (23.1) | 1 (0) |
| Weight loss, nausea, anorexia, increased appetite, headacheb | 2 (15.4) | N=6 (46.2%) 1.29 (0.37) |
| Vomiting, flatulence, gastroesophageal reflux disease, allergic reaction, spasm, fever, weaknessb | 1 (7.7) | N=6 (46.2%) 1.13 (0.27) |
a
Adverse effects terminology and severity is as per the Common Terminology Criteria for Adverse Events. Regarding severity, 1=mild, 2=moderate, 3=severe.
b
Individually each of the miscellaneous conditions occurs in only one or two patients, but when pooled for calculating the severity, 6 patients experience at least one.