TABLE 3.
Summary of safety outcomes (safety analysis set)
| TEAE | Tegoprazan | Placebo | |||||||
|---|---|---|---|---|---|---|---|---|---|
| 50 mg | 100 mg | ||||||||
| (n = 108) | (n = 108) | (n = 107) | |||||||
| n | (%) | [F] | n | (%) | [F] | n | (%) | [F] | |
| TEAE | 21 | (19.4) | [29] | 24 | (22.2) | [32] | 22 | (20.6) | [37] |
| Related | 13 | (12.0) | [19] | 12 | (11.1) | [14] | 13 | (12.2) | [23] |
| Not related | 8 | (7.4) | [10] | 12 | (11.1) | [14] | 10 | (9.4) | [14] |
| Mild | 18 | (16.7) | [21] | 23 | (21.3) | [28] | 20 | (18.7) | [29] |
| Moderate | 4 | (3.7) | [8] | 3 | (2.8) | [4] | 6 | (5.6) | [8] |
| Severe | 0 | (0.0) | [0] | 0 | (0.0) | [0] | 0 | (0.0) | [0] |
| Leading to discontinuation | 0 | (0.0) | [0] | 2 | (1.9) | [2] | 1 | (1.985) | [2] |
| SAE | 0 | (0.0) | [0] | 1 | (0.9) | [1] | 1 | (0.9) | [1] |
| Related | 0 | (0.0) | [0] | 1 | (0.9) | [1] | 1 | (0.9) | [1] |
| Not related | 0 | (0.0) | [0] | 0 | (0.0) | [0] | 0 | (0.0) | [0] |
| Leading to discontinuation | 0 | (0.0) | [0] | 1 | (0.9) | [1] | 0 | (0.0) | [0] |
| Deaths | 0 | (0.0) | [0] | 0 | (0.0) | [0] | 0 | (0.0) | [0] |
Abbreviations: [F], Frequency of TEAEs; SAEs, serious adverse events; TEAEs, treatment‐emergent adverse events.