Table 1.
Overall | Intensive PK Study (n = 41) | ||||
---|---|---|---|---|---|
n = 76 | Group 0 (n = 17) | Group 1 (n = 9) | Group 2 (n = 13) | Group 3 (n = 2) | |
Variable | Value (median [IQR]/%) | - | - | - | - |
Age (median [IQR]) | 60 [50–70.5] | 60 [51–73] | 67 [48–75] | 60 [48–71] | 40 [17–40] |
Ethnicity: Caucasian (%) | 100% | - | - | - | - |
Sex: Male (n (%)) | 47 [60%] | 9 [53] | 7 [78] | 6 [60] | 1 [50] |
Albumin (g/L) | 43 [40–45] | 44 [39–46] | 44 [43–46] | 43 [42–45] | 45 [40–45] |
BMI | 24.5 [22.2-28.2] | 26 [22–31] | 20 [22–24] | 24 [23–30] | 23 [21–23] |
BSA | 1.7 [1.4–2.2] | 1.8 [1.5–2.3] | 1.6 [1.2–1.8] | 1.9 [1.7–2.2] | 1.2 [1–1.3] |
eGFR (mL/min) | 94.5 [77.3–116.2] | 86 [74–104] | 91 [79–126] | 100 [73–118] | 112 [90–113] |
AEs: yes | 1 | 1 [6%] | - | - | - |
Infection control: yes (n, (%)) | 36 [47%] | 10 [60] | 3 [30] | 10 [80] | 1 [50] |
Diabetes: yes (n, (%)) | 19 [25%] | 4 [23] | 1 [13] | 3 [23] | - |
Previous therapy: yes (n, (%)) | 73 [96%] | 17 [100] | 8 [89] | 13 [100] | 2 [100] |
N. therapy lines: 1 (n, (%));
2: (n, (%)); 3: (n, (%)) |
52 [75%]; 20 [26]; 1 [1] | 12 [67]; 5 [33] | 4 [50]; 4 [50] | 5 [40]; 8 [60] | 1 [50]; 1 [50] |
Length of therapy before DBV (days) | 14 [14–35] | 14 [14–56] | 35 [23–75] | 35 [28–105] | 35 [14–35] |
Reasons for DBV (n, (%)):
previous failure; consolidation; intolerance |
31 [41%]; 43 [56]; 2 [3] | 9 [53]; 8 [47] | 5 [55]; 4 [45] | 4 [30]; 7 [55]; 2 [15] | 1 [50]; 1 [50] |