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. 2021 Aug 9;22(6):877–889. doi: 10.1007/s40257-021-00627-2

Table 3.

Summary of adverse events (safety set)

SHR0302 4 mg [n = 35] SHR0302 8 mg [n = 35] Placebo [n = 35]
No. of cases (%) No. of events No. of cases (%) No. of events No. of cases (%) No. of events
All AEs 21 (60.0) 43 24 (68.6) 62 18 (51.4) 33
AEs during screening 0 0 0 0 0 0
TEAEs 21 (60.0) 43 24 (68.6) 62 18 (51.4) 33
Moderate/severe TEAE 3 (8.6) 4 0 0 1 (2.9) 4
Serious TEAE 2 (5.7) 2 1 (2.9) 1 0 0
TEAE leading to death 0 0 0 0 0 0
TEAE affecting the administration of the study drug 3 (8.6) 3 2 (5.7) 2 1 (2.9) 1
TEAE resulting in study withdrawal 3 (8.6) 3 1 (2.9) 1 1 (2.9) 1
Preferred term, frequency ≥5% in any group
Tri-iodothyronine free increased 2 (5.7) 1 (2.9) 4 (11.4)
Transaminases increased 2 (5.7) 1 (2.9) 3 (8.6)
Blood creatine phosphokinase increased 1 (2.9) 2 (5.7) 0
Blood pressure increased 0 2 (5.7) 0
Weight decreased 0 0 2 (5.7)
Upper respiratory tract infection 2 (5.7) 1 (2.9) 0
Folliculitis 0 2 (5.7) 0
Urinary tract infection 0 2 (5.7) 0
Hyperlipidemia 3 (8.6) 2 (5.7) 0
Hyperuricemia 2 (5.7) 3 (8.6) 0
Hypertriglyceridemia 2 (5.7) 1 (2.9) 1 (2.9)
Hypercholesterolemia 0 2 (5.7) 1 (2.9)
Headache 0 2 (5.7) 0
Atopic dermatitis 2 (5.7) 1 (2.9) 0
Leukocytosis 3 (8.6) 0 0

AEs adverse events, TEAEs treatment-emergent adverse events