TABLE 2.
Adverse events.
| Placebo (N = 10) | SHR−1222 | ||||||
|---|---|---|---|---|---|---|---|
| 50 mg (N = 4) | 100 mg (N = 9) | 200 mg (N = 9) | 300 mg (N = 9) | 400 mg (N = 9) | All (N = 40) | ||
| Any adverse event | 10 (100.0) | 4 (100.0) | 9 (100.0) | 9 (100.0) | 9 (100.0) | 9 (100.0) | 40 (100.0) |
| Most common adverse events with a difference of at least 10% in incidence between SHR−1222 and placebo groups a | |||||||
| Blood calcium decreased | 2 (20.0) | 1 (25.0) | 0 | 5 (55.6) | 4 (44.4) | 5 (55.6) | 15 (37.5) |
| Blood urine present | 1 (10.0) | 1 (25.0) | 4 (44.4) | 3 (33.3) | 3 (33.3) | 0 | 11 (27.5) |
| Blood cholesterol increased | 0 | 2 (50.0) | 3 (33.3) | 1 (11.1) | 2 (22.2) | 1 (11.1) | 9 (22.5) |
| Blood triglycerides increased b | 4 (40.0) | 3 (75.0) | 2 (22.2) | 2 (22.2) | 0 | 1 (11.1) | 8 (20.0) |
| Electrocardiogram T wave abnormal | 0 | 0 | 1 (11.1) | 0 | 4 (44.4) | 1 (11.1) | 6 (15.0) |
| Urinary tract infection | 0 | 0 | 2 (22.2) | 1 (11.1) | 2 (22.2) | 1 (11.1) | 6 (15.0) |
| Blood phosphorus decreased b | 4 (40.0) | 0 | 0 | 3 (33.3) | 0 | 1 (11.1) | 4 (10.0) |
| Protein urine present b | 2 (20.0) | 0 | 1 (11.1) | 3 (33.3) | 0 | 0 | 4 (10.0) |
| Blood pressure diastolic increased | 0 | 0 | 0 | 1 (11.1) | 1 (11.1) | 2 (22.2) | 4 (10.0) |
| Bacterial test positive | 0 | 0 | 1 (11.1) | 2 (22.2) | 1 (11.1) | 0 | 4 (10.0) |
a
Adverse events that occurred in at least 2 subjects in either dose cohort of SHR−1222 group or placebo group and differed at least 10% in incidence between the SHR−1222 and placebo groups.
b
Incidences were higher in subjects who received placebo compared with SHR−1222.