TABLE 2.
Summary of adverse events.
| Term, n (%) | Placebo | SHR2285 | Total n = 52 | |||||
|---|---|---|---|---|---|---|---|---|
| A + B n = 7 | C n = 8 | Total n = 15 | A n = 12 | B n = 13 | C n = 12 | Total n = 37 | ||
| Epistaxis | 0 | 0 | 0 | 2 (16.7) | 0 | 0 | 2 (5.4) | 2 (3.8) |
| Gingival bleeding | 0 | 0 | 0 | 1 (8.3) | 1 (7.7) | 0 | 2 (5.4) | 2 (3.8) |
| Oral Ulcer | 1 (14.3) | 0 | 1 (6.7) | 1 (8.3) | 2 (15.4) | 0 | 3 (8.1) | 4 (7.7) |
| Scratch | 0 | 0 | 0 | 0 | 1 (7.7) | 0 | 1 (2.7) | 1 (1.9) |
| Subcutaneous hemorrhage | 0 | 2 (25.0) | 2 (13.3) | 1 (8.3) | 0 | 0 | 1 (2.7) | 3 (5.8) |
| Diarrhea | 0 | 0 | 0 | 0 | 2 (15.4) | 0 | 2 (5.4) | 2 (3.8) |
| Constipation | 0 | 0 | 0 | 0 | 1 (7.7) | 0 | 1 (2.7) | 1 (1.9) |
| Ecchymosis | 0 | 3 (37.5) | 3 (20.0) | 0 | 0 | 5 (41.7) | 5 (13.5) | 8 (15.4) |
| Rash | 0 | 0 | 0 | 0 | 0 | 1 (8.3) | 2 (2.7) | 1 (1.9) |
| URTI | 0 | 1 (12.5) | 1 (6.7) | 0 | 0 | 2 (16.7) | 2 (5.4) | 3 (5.8) |
| Abdominalburning sensation | 0 | 0 | 0 | 0 | 0 | 1 (8.3) | 1 (2.7) | 1 (1.9) |
| Decreased Hb | 0 | 1 (12.5) | 1 (6.7) | 2 (16.7) | 1 (7.7) | 0 | 3 (8.1) | 4 (7.7) |
| Increased WBC | 0 | 0 | 0 | 1 (8.3) | 0 | 0 | 1 (2.7) | 1 (1.9) |
| Increased N | 0 | 0 | 0 | 1 (8.3) | 0 | 0 | 1 (2.7) | 1 (1.9) |
| Increased M | 0 | 0 | 0 | 1 (8.3) | 0 | 0 | 1 (2.7) | 1 (1.9) |
| Fecal OB(+) | 1 (14.3) | 1 (12.5) | 2 (13.3) | 2 (16.7) | 0 | 0 | 2 (5.4) | 4 (7.7) |
| Urine OB(+) | 0 | 1 (12.5) | 1 (6.7) | 0 | 0 | 0 | 0 | 1 (1.9) |
| Elevated ALT | 0 | 0 | 0 | 0 | 1 (7.7) | 0 | 1 (2.7) | 1 (1.9) |
| Elevated TBil | 0 | 1 (12.5) | 1 (6.7) | 0 | 1 (7.7) | 0 | 1 (2.7) | 2 (3.8) |
| Elevated Ca | 0 | 0 | 0 | 0 | 1 (7.7) | 0 | 1 (2.7) | 1 (1.9) |
| Elevated TG | 2 (28.6) | 0 | 2 (13.3) | 5 (41.7) | 2 (15.4) | 3 (25.0) | 10 (27.0) | 12 (23.1) |
| Hypercholesterolemia | 0 | 0 | 0 | 0 | 1 (7.7) | 0 | 1 (2.7) | 1 (1.9) |
| Elevated UA | 2 (28.6) | 1 (12.5) | 3 (20.0) | 2 (16.7) | 1 (7.7) | 5 (41.7) | 8 (21.6) | 11 (21.2) |
| Elevated CK | 0 | 1 (12.5) | 1 (6.7) | 0 | 0 | 0 | 0 | 1 (1.9) |
| ECG T wave changes | 1 (14.3) | 3 (37.5) | 4 (26.7) | 2 (16.7) | 0 | 1 (8.3) | 3 (8.1) | 7 (13.5) |
| Prolonged QTc | 0 | 0 | 0 | 0 | 0 | 1 (8.3) | 1 (2.7) | 1 (1.9) |
URTI, upper respiratory tract infection; Hb, Hemoglobin; WBC, white blood cell count; N, neutrophil count; M, monocyte count; OB(+), occult blood positive; ALT, alanine aminotransferase; TBil, total bilirubin; Ca, blood calcium; TG, triglycerides; UA, serum uric acid; CK, creatine kinase; ECG, electrocardiogram; QTc, QTc interval of ECG. There were no serious adverse events during the entire study and no TEAEs, that led to treatment discontinuation or interruption.