Table 2.
Demographics and characteristics of the study population
Variable | Sonazoid group N = 218 | SonoVue group N = 206 | p-valuea |
---|---|---|---|
Age, mean ± SD | 54.5 ± 12.6 | 52.2 ± 13.8 | 0.07 |
Gender, n (%) | |||
Male | 137 (52.3%) | 125 (47.7%) | 0.65 |
Female | 81 (50.0%) | 81 (50.0%) | – |
Body Mass Index, mean ± SD (BMI, kg/m2) | 24.1 ± 3.5 | 23.8 ± 3.4 | 0.20 |
Any liver disease history, n (%) | 119 (54.6%) | 108 (52.4%) | 0.66 |
Hepatitis B | 36 (16.5%) | 30 (14.6%) | – |
Hepatitis C | 3 (1.4%) | 4 (1.9%) | – |
Primary or metastatic cancer | 34 (15.6%) | 27 (13.1%) | – |
Benign disease | 20 (9.2%) | 15 (7.3%) | – |
Cirrhosis | 7 (3.2%) | 2 (1.0%) | – |
Other | 19 (8.7%) | 30 (14.6) | – |
Efficacy population, n | 169 | 169 | – |
Target lesion reference diagnosisb, n (%) | – | ||
Malignant | |||
Hepatocellular carcinoma (HCC) | 65 (38%) | 61 (36%) | 0.28 |
Metastasis | 15 (9%) | 11 (7%) | – |
Other | 4 (2%) | 2 (1%) | – |
Benign | – | ||
Focal nodular hyperplasia (FNH) | 13 (8%) | 15 (9%) | – |
Haemangioma | 53 (31%) | 61 (36%) | – |
Other | 19 (11%) | 19 (11%) | – |
Some percentages do not add up to 100 due to rounding errors
SD standard deviation
aThe p-values are based on two-sample t-test for continuous variables and based on Chi-square test for categorical variables
bPercentages are based on number of patients in the efficacy population. The p-value is based on the comparison of dichotomized reference diagnosis (malignant vs benign) between the two groups