Table 3.
Control (n-=53) | Treatment (n=57) | ||||
---|---|---|---|---|---|
Adverse Event | N | Percent | N | Percent | p-value* |
Grade 1 | 45 | 85 | 52 | 91 | |
Grade 2 | 20 | 38 | 26 | 46 | |
Grade 3 | 5 | 9 | 5 | 9 | |
Gastrointestinal | |||||
Abdominal Cramps/Pain | 11 | 21 | 22 | 39 | 0.060 |
Constipation | 5 | 9 | 13 | 23 | 0.073 |
Diarrhea | 14 | 26 | 20 | 35 | 0.410 |
Nausea | 7 | 13 | 17 | 30 | 0.040 |
Heartburn | 3 | 6 | 6 | 11 | 0.492 |
Gas | 24 | 45 | 17 | 30 | 0.116 |
Vomiting | 3 | 6 | 5 | 9 | 0.718 |
Mood Change | |||||
Mood alteration negative | 2 | 4 | 5 | 9 | 0.440 |
Mood alteration positive | 1 | 2 | 2 | 4 | 1.000 |
Insomnia | 7 | 13 | 8 | 14 | 1.000 |
Fatigue | 9 | 17 | 14 | 25 | 0.358 |
Headache | 12 | 23 | 13 | 23 | 1.000 |
Pain | 8 | 15 | 6 | 11 | 0.572 |
Increased urination | 10 | 19 | 13 | 23 | 0.646 |
Dry mouth | 10 | 19 | 11 | 19 | 1.000 |
Patients who had ≥ 1 Serious Adverse Events | 3 | 6 | 5 | 9 | 0.718 |
Serious Adverse Events | 4 | 8 | 7 | 12 | 0.530 |
Left Leg Vascular Claudication | Abdominal Discomfort | ||||
Hepatocellular Carcinoma | Pneumonia | ||||
Left Thigh Abscess | Small Bowel Inflammation | ||||
Abdominal Cellulitis | Portal Hypertension | ||||
Abdominal Pain | |||||
Nephrotic Syndrome | |||||
Non-ST Elevated MI |
Includes subjects with at least one follow-up visit after randomization. Rows are not mutually exclusive.
The p-value of Fisher’s exact test