Table 1 Treatment-emergent adverse events
Adverse event system organ class/preferred term | Safety population (n = 30) | Severity |
|---|---|---|
n (%) E | ||
Total | ||
Overall study | 24 (80.0%) 68 | Mild, Moderate, Severe |
Related | ||
Overall study | 0 (0%) 0 | N/A |
Possibly related | ||
Overall study | 14 (46.7%) 21 | Mild, Moderate |
GI disorders | ||
Abdominal pain | 2 (6.7%) 2 | Mild |
Nausea | 2 (6.7%) 2 | Mild |
Diarrhea | 1 (3.3%) 2 | Mild, Moderate |
Abdominal discomfort | 1 (3.3%) 1 | Mild |
Abdominal tenderness | 1 (3.3%) 1 | Mild |
Dyspepsia | 1 (3.3%) 1 | Mild |
Rectal hemorrhage | 1 (3.3%) 1 | Mild |
Abdominal pain upper | 1 (3.3%) 1 | Moderate |
General disorders | ||
Pyrexia | 2 (6.7%) 2 | Mild |
Nervous system disorders | ||
Headache | 3 (10.0%) 3 | Mild |
Disturbance in attention | 1 (3.3%) 1 | Mild |
Psychiatric disorders | ||
Insomnia | 1 (3.3%) 1 | Moderate |
Anxiety | 1 (3.3%) 1 | Moderate |
Respiratory, thoracic and mediastinal disorders | ||
Epistaxis | 1 (3.3%) 1 | Mild |
Skin/subcutaneous tissue disorders | ||
Rash | 1 (3.3%) 1 | Moderate |
Not related | ||
Overall study | 21 (70.0%) 47 | Mild, Moderate, Severe |
