Table 4 Frequency of adverse events in the three treatment groups.
Adverse event | OAC1W (n = 301), | OAC2W (n = 302), | OA (n = 305), |
---|---|---|---|
n (%) | n (%) | n (%) | |
Diarrhoea | 10 (3.3) | 10 (3.3) | 6 (2.0) |
Glossitis | 7 (2.3) | 10 (3.3) | 3 (1.0) |
Stomatitis | 4 (1.3) | 5 (1.7) | 2 (0.7) |
Abdominal pain | 2 (0.7) | 4 (1.3) | 2 (0.7) |
Allergic cutaneous reactions | 4 (1.3) | 2 (0.7) | 2 (0.7) |
Dry mouth/throat | 3 (1) | 3 (1.0) | 0 |
Tongue discoloration | 2 (0.7) | 1 (0.3) | 0 |
Nausea | 0 | 2 (0.7) | 2 (0.7) |
Vomiting | 0 | 1 (0.3) | 0 |
Headache | 2 (0.7) | 2 (0.7) | 2 (0.7) |
Monilia | 1 (0.3) | 1 (0.3) | 0 |
Herpes simplex labialis | 0 | 1 (0.3) | 1 (0.3) |
OA, omeprazole 20 mg twice daily and amoxicillin 1 g twice daily and placebo for 2 weeks; OAC1W, omeprazole 20 mg twice daily and amoxicillin 1 g twice daily and clarithromycin 500 mg twice daily for 1 week, then omeprazole 20 mg twice daily and placebo for 1 week; OAC2W, omeprazole 20 mg twice daily + amoxicillin 1 g twice daily and clarithromycin 500 g twice daily for 2 weeks.