Table 3 Frequently reported AEs in the elderly population.
AEs | Cases (rebamipide) | ROR (95% CI) vs. all A02Bs | ROR (95% CI) vs. H2RAs | ROR (95% CI) vs. PPIs | Median time to events |
|---|---|---|---|---|---|
Dyspepsia/indigestion/GI distress | 391 | 2.24 (2.00, 2.52) | 2.49 (2.17, 2.85) | 2.11 (1.83, 2.43) | 4 days |
Somnolence | 274 | 2.23 (1.94, 2.56) | 1.76 (1.51, 2.05) | 2.78 (2.30, 3.35) | 3 days |
Dry mouth | 209 | 3.97 (3.30, 4.76) | 10.26 (7.52, 14.01) | 2.06 (1.69, 2.52) | 4 days |
Face edema | 90 | 3.04 (2.32, 3.97) | 4.25 (3.00, 6.02) | 2.02 (1.49, 2.75) | 3 days |
Abnormal temperature sensation /hot flashes | 55 | 2.44 (1.75, 3.39) | 2.12 (1.47, 3.06) | 2.36 (1.56, 3.57) | 2 days |
Generalized edema | 52 | 2.85 (2.01, 4.04) | 5.57 (3.36, 9.23) | 1.55 (1.06, 2.27) | 6 days |
Flatulence | 41 | 2.15 (1.48, 3.13) | 3.06 (1.91, 4.89) | 1.66 (1.07, 2.57) | 4 days |
Malaise/feeling queasy | 36 | 2.22 (1.49, 3.32) | 2.06 (1.31, 3.24) | 2.37 (1.42, 3.97) | 4 days |
Purpura/petechia | 22 | 2.14 (1.29, 3.58) | 2.58 (1.40, 4.76) | 1.44 (0.81, 2.57)† | 5 days |
Thirst | 18 | 4.71 (2.41, 9.23) | 10.04 (3.40, 29.65) | 2.58 (1.22, 5.46) | 9 days |
Periorbital edema | 16 | 2.68 (1.43, 5.01) | 2.54 (1.24, 5.21) | 2.29 (1.07, 4.94) | 3 days |
