Table 2.
Summary of adverse events by each part
| Treatment | |||||
|---|---|---|---|---|---|
| Part I | Part II | Total (N = 32) |
|||
| Monotherapy (N = 16) |
Triple therapy (N = 13) |
Dual therapy (N = 16) |
Triple therapy (N = 15) |
||
| Subjects with any adverse event | 5 (31.3) | 8 (61.5) | 5 (31.3) | 7 (46.7) | 20a (62.5) |
| Subjects with adverse drug reactions | – | 6 (46.2) | 2 (12.5) | 3 (20.0) | 9b (28.1) |
| System organ classa/preferred terma | |||||
| Gastrointestinal disorders | – | 5 (38.5) | 1 (6.3) | 1 (6.7) | 7 (21.9) |
| Abdominal discomfort | – | 1 (7.7) | – | 1 (6.7) | 2 (6.3) |
| Dyspepsia | – | 1 (7.7) | – | – | 1 (3.1) |
| Nausea | – | 1 (7.7) | 1 (6.3) | – | 2 (6.3) |
| Abdominal pain | – | 1 (7.7) | – | – | 1 (3.1) |
| Diarrhoea | – | 1 (7.7) | – | – | 1 (3.1) |
| Blood and lymphatic system disorders | – | 1 (7.7) | – | – | 1 (3.1) |
| Leukopenia | 1 (7.7) | – | – | 1 (3.1) | |
| Skin and subcutaneous tissue disorders | – | – | – | 3 (20.0) | 3 (9.4) |
| Pruritus | – | – | – | 2 (13.3) | 2 (6.3) |
| Rash | – | – | – | 1 (6.7) | 1 (3.1) |
| Metabolism and nutrition disorders | – | – | 1 (6.3) | 1 (6.7) | 1c (3.1) |
| Hypertriglyceridemia | – | – | 1 (6.3) | 1 (6.7) | 1c (3.1) |
Notes: Data are presented as the number (%) of subjects with adverse events or adverse drug reactions
Abbreviations: monotherapy, administration of ilaprazole 10 mg in period 1 of part 1; dual therapy, administration of clarithromycin 500 mg and amoxicillin 1000 mg in period 1 of part 2; triple therapy, administration of ilaprazole 10 mg, clarithromycin 500 mg, and amoxicillin 1000 mg in period 2 of both part 1 and part 2
aA total of 5 subjects showed adverse events in both treatment groups in each part
bTwo subjects developed adverse drug reactions in both treatment groups in the relevant part
cOne subject developed adverse drug reaction in both treatment groups in the relevant part