Table 3.
Adverse events during the study.
| Total (n = 243) | CKD-495 75 mg (n = 54) | CKD-495 150 mg (n = 48) | Placebo (n = 48) | Stillen 60 mg (n = 48) | Rebamipide100 mg (n = 45) | p valuea | |
|---|---|---|---|---|---|---|---|
| n (%) [case] | n (%) [case] | n (%) [case] | n (%) [case] | n (%) [case] | n (%) [case] | ||
| Gastrointestinal disorders | 12 (4.94) [16] | 3 (5.56) [5] | 2 (4.17) [2] | 1 (2.08) [3] | 2 (4.17) [2] | 4 (8.89) [4] | 0.6742a |
| Gastrooesophageal reflux disease | 4 (1.65) [4] | — | 2 (4.17) [2] | — | 1 (2.08) [1] | 1 (2.22) [1] | 0.3779a |
| Diarrhea | 3 (1.23) [4] | 1 (1.85) [2] | — | 1 (2.08) [1] | — | 1 (2.22) [1] | 0.8420a |
| Dyspepsia | 3 (1.23) [3] | 1 (1.85) [1] | — | — | 1 (2.08) [1] | 1 (2.22) [1] | 0.8420a |
| Abdominal distension | 2 (0.82) [2] | 1 (1.85) [1] | — | 1 (2.08) [1] | — | — | 1.0000a |
| Erosive duodenitis | 1 (0.41) [1] | 1 (1.85) [1] | — | — | — | — | 1.0000a |
| Eructation | 1 (0.41) [1] | — | — | 1 (2.08) [1] | — | — | 0.7778a |
| Gastric ulcer | 1 (0.41) [1] | — | — | — | — | 1 (2.22) [1] | 0.1852a |
| General disorders and administration site conditions | 1 (0.41) [1] | — | 1 (2.08) [1] | — | — | — | 0.7778a |
| Chest discomfort | 1 (0.41) [1] | — | 1 (2.08) [1] | — | — | — | 0.7778a |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 (0.41) [1] | — | — | 1 (2.08) [1] | — | — | 0.7778a |
| Gastrointestinal submucosal tumour | 1 (0.41) [1] | — | — | 1 (2.08) [1] | — | — | 0.7778a |
| Nervous system disorders | 1 (0.41) [1] | — | 1 (2.08) [1] | — | — | — | 0.7778a |
| Dizziness | 1 (0.41) [1] | — | 1 (2.08) [1] | — | — | — | 0.7778a |
| Skin and subcutaneous tissue disorders | 1 (0.41) [1] | — | — | — | 1 (2.08) [1] | — | 0.7778a |
| Cold sweat | 1 (0.41) [1] | — | — | — | 1 (2.08) [1] | — | 0.7778a |
| Total | 16 (6.58) [20] | 3 (5.56) [5] | 4 (8.33) [4] | 2 (4.17) [4] | 3 (6.25) [3] | 4 (8.89) [4] | 0.8914a |
aFisher's exact test for comparison of proportions between the groups.