Table 3.
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