TABLE 4.
TEAE | Tegoprazan | Placebo | |||||||
---|---|---|---|---|---|---|---|---|---|
50 mg | 100 mg | ||||||||
(n = 108) | (n = 108) | (n = 107) | |||||||
n | (%) | [F] | n | (%) | [F] | n | (%) | [F] | |
Most frequently reported TEAEs by system organ class and preferred terma | |||||||||
Nervous system disorders | 2 | (1.9) | [2] | 6 | (5.6) | [6] | 3 | (2.8) | [5] |
Headache | 2 | (1.9) | [2] | 4 | (3.7) | [4] | 5 | (4.7) | [5] |
Infections and infestations | 4 | (3.7) | [4] | 5 | (4.6) | [5] | 6 | (5.6) | [6] |
Nasopharyngitis | 3 | (2.8) | [3] | 4 | (3.7) | [4] | 5 | (4.7) | [5] |
Most frequently reported drug‐related TEAEs by system organ class and preferred termb | |||||||||
Gastrointestinal disorders | 8 | (7.4) | [13] | 3 | (2.8) | [3] | 7 | (6.5) | [8] |
Nausea | 3 | (2.8) | [5] | 1 | (0.9) | [1] | 2 | (1.9) | [2] |
Infections and infestations | 1 | (0.9) | [1] | 2 | (1.9) | [2] | 3 | (2.8) | [3] |
Nasopharyngitis | 1 | (0.9) | [1] | 2 | (1.9) | [2] | 3 | (2.8) | [3] |
Nervous system disorders | 1 | (0.9) | [1] | 5 | (4.6) | [5] | 2 | (1.9) | [3] |
Headache | 1 | (0.9) | [1] | 5 | (4.6) | [5] | 2 | (1.9) | [3] |
Abbreviations: [F], Frequency of TEAEs; SAEs, serious adverse events.
≥4%.
≥2%.