Table 3.

Number of patients with adverse events after randomization, by category

Control (n = 53)Treatment (n = 57)
n (%)n (%)Pa
Adverse event
 Grade 145 (85)52 (91)
 Grade 220 (38)26 (46)
 Grade 35 (9)5 (9)
Gastrointestinal
 Abdominal cramps/pain11 (21)22 (39)0.060
 Constipation5 (9)13 (23)0.073
 Diarrhea14 (26)20 (35)0.410
 Nausea7 (13)17 (30)0.040
 Heartburn3 (6)6 (11)0.492
 Gas24 (45)17 (30)0.116
 Vomiting3 (6)5 (9)0.718
Mood change
 Mood alteration negative2 (4)5 (9)0.440
 Mood alteration positive1 (2)2 (4)1.000
Insomnia7 (13)8 (14)1.000
Fatigue9 (17)14 (25)0.358
Headache12 (23)13 (23)1.000
Pain8 (15)6 (11)0.572
Increased urination10 (19)13 (23)0.646
Dry mouth10 (19)11 (19)1.000
Patients who had ≥1 serious adverse event3 (6)5 (9)0.718
Serious adverse events4 (8)7 (12)0.530
Left leg vascular claudicationAbdominal discomfort
HCCPneumonia
Left thigh abscessSmall bowel inflammation
Abdominal cellulitisPortal hypertension
Abdominal pain
Nephrotic syndrome
Non-ST elevated myocardial infarction

NOTE: Includes subjects with at least one follow-up visit after randomization. Rows are not mutually exclusive.

  • aThe P value of the Fisher exact test.