TABLE 2.
Adverse events.
Placebo (n = 7) | 50 mg (n = 3) | 100 mg (n = 6) | 200 mg (n = 6) | 400 mg (n = 6) | All SHR2285 (n = 21) | |
---|---|---|---|---|---|---|
Adverse events of any cause, n (%) | 3 (42.9) | 1 (33.3) | 3 (50.0) | 4 (66.7) | 4 (66.7) | 12 (57.1) |
Biological | ||||||
Blood triglycerides increased | 2 (28.6) | 0 | 0 | 0 | 0 | 0 |
White blood cell count decreased | 0 | 0 | 1 (16.7) | 0 | 0 | 1 (4.8) |
Bilirubin conjugated increased | 0 | 0 | 2 (33.3) | 0 | 2 (33.3) | 4 (19.0) |
Occult blood positive | 0 | 0 | 0 | 3 (50.0) | 1 (16.7) | 4 (19.0) |
Blood bilirubin increased | 0 | 0 | 1 (16.7) | 0 | 2 (33.3) | 3 (14.3) |
Blood alkaline phosphatase increased | 0 | 0 | 0 | 0 | 1 (16.7) | 1 (4.8) |
Neutrophil count decreased | 0 | 0 | 2 (33.3) | 1 (16.7) | 0 | 3 (14.3) |
Clinical | ||||||
Pain in jaw | 0 | 0 | 0 | 0 | 1 (16.7) | 1 (4.8) |
Oropharyngeal pain | 0 | 0 | 0 | 0 | 1 (16.7) | 1 (4.8) |
Abdominal discomfort | 0 | 0 | 0 | 0 | 1 (16.7) | 1 (4.8) |
Diarrhea | 0 | 0 | 0 | 1 (16.7) | 0 | 1 (4.8) |
Ventricular extrasystoles | 0 | 1 (33.3) | 0 | 0 | 0 | 1 (4.8) |
Productive cough | 0 | 0 | 1 (16.7) | 0 | 0 | 1 (4.8) |
Musculoskeletal discomfort | 1 (14.3) | 0 | 0 | 0 | 0 | 0 |
Treatment-related adverse events, n(%) | 2 (28.6) | 0 | 2 (33.3) | 4 (66.7) | 5 (83.3) | 11 (52.4) |
Biological | ||||||
Blood triglycerides increased | 2 (28.6) | 0 | 0 | 0 | 0 | 0 |
White blood cell count decreased | 0 | 0 | 1 (16.7) | 0 | 0 | 1 (4.8) |
Bilirubin conjugated increased | 0 | 0 | 2 (33.3) | 0 | 2 (33.3) | 4 (19.0) |
Occult blood positive | 0 | 0 | 0 | 3 (50.0) | 1 (16.7) | 4 (19.0) |
Blood bilirubin increased | 0 | 0 | 1 (16.7) | 0 | 2 (33.3) | 3 (14.3) |
Blood alkaline phosphatase increased | 0 | 0 | 0 | 0 | 1 (16.7) | 1 (4.8) |
Neutrophil count decreased | 0 | 0 | 2 (33.3) | 1 (16.7) | 0 | 3 (14.3) |
Data are n (%). “Treatment-related” is defined as the relationship of an adverse event to the study drug being certain, probable, or possible.