Table 4 Safety analysis of 3 dosage regimens of SPH3127 versus placebo
Placebo (n = 32) | SPH3127 50 mg (n = 30) | SPH3127 100 mg (n = 30) | SPH3127 200 mg (n = 30) | |
|---|---|---|---|---|
AEs | 26 (81.25%) | 17 (56.67%) | 22 (73.33%) | 23 (76.67%) |
Important AEs | 1 (3.13%) | 2 (6.67%) | 1 (3.33%) | 1 (3.33%) |
CTCAE ≥ 3 | 1 (3.13%) | 2 (6.67%) | 1 (3.33%) | 1 (3.33%) |
AEs leading to discontinuation | 0 (0.00%) | 2 (6.67%) | 0 (0.00%) | 1 (3.33%) |
SAE | 0 (0.00%) | 0 (0.00%) | 1 (3.33%) | 0 (0.00%) |
AEs (or probably) related to the treatment | 5 (15.63%) | 3 (10.00%) | 6 (20.00%) | 7 (23.33%) |
Elevated BP | 0 (0.00%) | 1 (3.33%) | 0 (0.00%) | 2 (6.67%) |
Elevated ALT | 0 (0.00%) | 0 (0.00%) | 1 (3.33%) | 1 (3.33%) |
Urine protein | 1 (3.13%) | 0 (0.00%) | 0 (0.00%) | 0 (0.00%) |
Elevated eosinophils | 0 (0.00%) | 0 (0.00%) | 1 (3.33%) | 0 (0.00%) |
Elevated AST | 0 (0.00%) | 0 (0.00%) | 1 (3.33%) | 0 (0.00%) |
Elevated triglyceride | 0 (0.00%) | 0 (0.00%) | 1 (3.33%) | 0 (0.00%) |
Decreased serum phosphate | 1 (3.13%) | 0 (0.00%) | 0 (0.00%) | 0 (0.00%) |
Elevated uric acid | 0 (0.00%) | 0 (0.00%) | 1 (3.33%) | 0 (0.00%) |
Dizziness | 2 (6.25%) | 0 (0.00%) | 1 (3.33%) | 1 (3.33%) |
Headache | 1 (3.13%) | 0 (0.00%) | 0 (0.00%) | 1 (3.33%) |
Bradycardia | 0 (0.00%) | 0 (0.00%) | 1 (3.33%) | 0 (0.00%) |
