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. 2023 Sep 22;64:102238. doi: 10.1016/j.eclinm.2023.102238

Table 3.

Treatment-related adverse events that occurred in ≥20% of participants in the safety population.

All patients (n = 30)
200 mg cohort (n = 15)
300 mg cohort (n = 15)
All grades Grade 3–4 All grades Grade 3–4 All grades Grade 3–4
Any events 29 (97%) 22 (73%) 14 (93%) 9 (60%) 15 (100%) 13 (87%)
Rash 25 (83%) 15 (50%) 11 (73%) 6 (40%) 14 (93%) 9 (60%)
Diarrhea 21 (70%) 4 (13%) 9 (60%) 1 (7%) 12 (80%) 3 (20%)
Increased alanine aminotransferas 20 (67%) 2 (7%) 9 (60%) 1 (7%) 11 (73%) 1 (7%)
Increased aspartate aminotransferase 19 (63%) 1 (3%) 10 (67%) 1 (7%) 9 (60%) 0
Itch 18 (60%) 0 8 (53%) 0 10 (67%) 0
Increased conjugated bilirubin 16 (53%) 0 7 (47%) 0 9 (60%) 0
Xerosis cutis 16 (53%) 0 8 (53%) 0 8 (53%) 0
Paronychia 15 (50%) 1 (3%) 5 (33%) 0 10 (67%) 1 (7%)
Increased γ-glutamyltransferase 11 (37%) 3 (10%) 6 (40%) 2 (13%) 5 (33%) 1 (7%)
Mouth ulcer 10 (33%) 2 (7%) 2 (13%) 0 8 (53%) 2 (13%)
Increased blood bilirubin 10 (33%) 0 4 (27%) 0 6 (40%) 0
Cutaneous fissure 9 (30%) 1 (3%) 2 (13%) 0 7 (47%) 1 (7%)
Anorexia 9 (30%) 0 3 (20%) 0 6 (40%) 0
Eyelash growth 8 (27%) 0 4 (27%) 0 4 (27%) 0
Increased alkaline phosphatase 8 (27%) 0 6 (40%) 0 2 (13%) 0
Increased serum creatinine 7 (23%) 0 5 (33%) 0 2 (13%) 0
Nausea 6 (20%) 1 (3%) 1 (7%) 0 5 (33%) 1 (7%)
Skin exfoliation 6 (20%) 0 3 (20%) 0 3 (20%) 0
Extended QT interval of electrocardiogram 5 (17%) 0 4 (27%) 0 1 (7%) 0
Abdominal discomfort 4 (13%) 0 1 (7%) 0 3 (20%) 0
Conjunctivitis 4 (13%) 0 0 0 4 (27%) 0
Oral mucositis 4 (13%) 0 3 (20%) 0 1 (7%) 0
Alopecia 4 (13%) 0 1 (7%) 0 3 (20%) 0

Data are n (%). Treatment-related adverse events were assessed by investigators.

QT = time interval between the start of the Q wave and end of the T wave in the electrical cycle of the heart.