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. 2021 Jul 6;54(4):402–411. doi: 10.1111/apt.16477

TABLE 4.

Summary of treatment‐emergent adverse events (TEAEs) and drug‐related TEAEs (safety analysis set)

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.

a

≥4%.

b

≥2%.