Table 9 Safety assessment
0 W | 12 W | 24 W | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
SZF | Irbesartan | p value | SZF | Irbesartan | p value | SZF | Irbesartan | p value | ||
(n = xx) | (n = xx) | (n = xx) | (n = xx) | (n = xx) | (n = xx) | |||||
Hematology | Red blood cell | xx (xx) | xx (xx) | .xx | xx (xx) | xx (xx) | .xx | xx (xx) | xx (xx) | .xx |
White blood cell | xx (xx) | xx (xx) | .xx | xx (xx) | xx (xx) | .xx | xx (xx) | xx (xx) | .xx | |
Hemoglobin | xx (xx) | xx (xx) | .xx | xx (xx) | xx (xx) | .xx | xx (xx) | xx (xx) | .xx | |
Platelet | xx (xx) | xx (xx) | .xx | xx (xx) | xx (xx) | .xx | xx (xx) | xx (xx) | .xx | |
Urine test | Glucose | xx (xx) | xx (xx) | .xx | xx (xx) | xx (xx) | .xx | xx (xx) | xx (xx) | .xx |
Ketone | xx (xx) | xx (xx) | .xx | xx (xx) | xx (xx) | .xx | xx (xx) | xx (xx) | .xx | |
Occult blood | xx (xx) | xx (xx) | .xx | xx (xx) | xx (xx) | .xx | xx (xx) | xx (xx) | .xx | |
Erythrocytes | xx (xx) | xx (xx) | .xx | xx (xx) | xx (xx) | .xx | xx (xx) | xx (xx) | .xx | |
Leukocytes | xx (xx) | xx (xx) | .xx | xx (xx) | xx (xx) | .xx | xx (xx) | xx (xx) | .xx | |
Stool routine | Fecal leukocytes | xx (xx) | xx (xx) | .xx | xx (xx) | xx (xx) | .xx | xx (xx) | xx (xx) | .xx |
Feces occult blood | xx (xx) | xx (xx) | .xx | xx (xx) | xx (xx) | .xx | xx (xx) | xx (xx) | .xx | |
Liver function | ALT | xx (xx) | xx (xx) | .xx | xx (xx) | xx (xx) | .xx | xx (xx) | xx (xx) | .xx |
AST | xx (xx) | xx (xx) | .xx | xx (xx) | xx (xx) | .xx | xx (xx) | xx (xx) | .xx | |
ALP | xx (xx) | xx (xx) | .xx | xx (xx) | xx (xx) | .xx | xx (xx) | xx (xx) | .xx | |
GGT | xx (xx) | xx (xx) | .xx | xx (xx) | xx (xx) | .xx | xx (xx) | xx (xx) | .xx | |
TBIL | xx (xx) | xx (xx) | .xx | xx (xx) | xx (xx) | .xx | xx (xx) | xx (xx) | .xx | |
kidney function | UA | xx (xx) | xx (xx) | .xx | xx (xx) | xx (xx) | .xx | xx (xx) | xx (xx) | .xx |
β2-microglobulin | xx (xx) | xx (xx) | .xx | xx (xx) | xx (xx) | .xx | xx (xx) | xx (xx) | .xx | |
Serum albumin | xx (xx) | xx (xx) | .xx | xx (xx) | xx (xx) | .xx | xx (xx) | xx (xx) | .xx | |
Blood urea nitrogen | xx (xx) | xx (xx) | .xx | xx (xx) | xx (xx) | .xx | xx (xx) | xx (xx) | .xx | |
Electrocardiogram | xx (xx%) | xx (xx%) | .xx | xx (xx%) | xx (xx%) | .xx | xx (xx%) | xx (xx%) | .xx | |
Adverse events | Mild | xx (xx%) | xx (xx%) | .xx | xx (xx%) | xx (xx%) | .xx | xx (xx%) | xx (xx%) | .xx |
Moderate | xx (xx%) | xx (xx%) | .xx | xx (xx%) | xx (xx%) | .xx | xx (xx%) | xx (xx%) | .xx | |
Severe | xx (xx%) | xx (xx%) | .xx | xx (xx%) | xx (xx%) | .xx | xx (xx%) | xx (xx%) | .xx | |
Overall AEs | xx (xx%) | xx (xx%) | .xx | xx (xx%) | xx (xx%) | .xx | xx (xx%) | xx (xx%) | .xx | |