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. Author manuscript; available in PMC: 2016 Sep 1.
Published in final edited form as: Cancer Prev Res (Phila). 2015 Jun 30;8(9):864–872. doi: 10.1158/1940-6207.CAPR-15-0029

Table 3.

Number of patients with adverse events after randomization, by category

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