Table 4 Overall summary of patients with an adverse event
Adverse events | Placebo (n = 87) | Pentoxifylline (n = 87) |
|---|---|---|
Overall summary of patients with an AE, n (%) | Â | Â |
 One or more AE, n (%) | 20 (23.0) | 27 (31.0) |
 One or more drug-related AE, n (%) | 12 (13.8) | 23 (26.4) |
AE leading to discontinuation | 5 (5.7) | 13 (14.9) |
Patients with AEs of ≥3 % in any group, n (%) |  |  |
 Dyspepsia | 1 (1.1) | 7 (8.0) |
 Nausea/vomiting | 2 (2.3) | 5 (5.7) |
 Gastric reflux | 3 (3.4) | 5 (5.7) |
 Diarrhea | 0 (0.0) | 2 (2.3) |
 Constipation | 0 (0.0) | 1 (1.1) |
 Headache | 1 (1.1) | 3 (3.4) |