Table 4.
Everolimus dosage and exposure.
| Baseline | FU1 | FU2 | FU3 | FU4 | FU5 | |
|---|---|---|---|---|---|---|
| (N = 150) | (N = 171) | (N = 168) | (N = 153) | (N = 58) | (N = 33) | |
| Pharmaceutical formulation | ||||||
| Tablets | 143 (95.3) | 165 (96.5) | 162 (96.4) | 147 (96.1) | 56 (96.6) | 33 (100.0) |
| Dispersible tablets | 9 (6.0) | 9 (5.3) | 8 (4.8) | 10 (6.5) | 3 (5.2) | 0 |
| Dosage | ||||||
| 2 mg | 3 (2.0) | 3 (1.8) | 3 (1.8) | 3 (2.0) | 0 | 0 |
| 2.5 mg | 16 (10.7) | 13 (7.6) | 19 (11.3) | 17 (11.1) | 6 (10.3) | 2 (6.1) |
| 3 mg | 2 (1.3) | 3 (1.8) | 2 (1.2) | 2 (1.3) | 1 (1.7) | 0 |
| 5 mg | 118 (78.7) | 131 (76.6) | 128 (76.2) | 114 (74.5) | 43 (74.1) | 31 (93.9) |
| 10 mg | 17 (11.3) | 18 (10.5) | 16 (9.5) | 16 (10.5) | 4 (6.9) | 0 |
| Other | 34 (22.7) | 37 (21.6) | 25 (14.9) | 18 (11.8) | 6 (10.3) | 0 |
| Daily dose (mg) | ||||||
| Mean (SD) | 7.2 (3.11) | 7.3 (3.14) | 7.1 (3.28) | 7.4 (4.27) | 7.8 (3.40) | 8.3 (3.99) |
| Median (min–max) | 7.0 (1–20) | 7.5 (1–20) | 6.4 (0–20) | 5.8 (0–35) | 7.5 (3–15) | 7.5 (3–15) |
| Patients with dose changes | 53 (35.3) | 55 (32.2) | 52 (31.0) | 34 (22.2) | 19 (32.8) | 0 |
| Reductions | 14 (9.3) | 15 (8.8) | 24 (14.3) | 9 (5.9) | 3 (5.2) | 0 |
| Interruptions | 20 (13.3) | 31 (18.1) | 26 (15.5) | 22 (14.4) | 10 (17.2) | 0 |
| Increased | 44 (29.3) | 41 (24.0) | 34 (20.2) | 23 (15.0) | 17 (29.3) | 0 |
| Reasons for changes | ||||||
| Side effect | 21 (14.0) | 25 (14.6) | 22 (13.1) | 11 (7.2) | 2 (3.4) | 0 |
| Dosing error | 3 (2.0) | 1 (0.6) | 1 (0.6) | 0 | 0 | 0 |
| Lab test abnormality | 2 (1.3) | 4 (2.3) | 1 (0.6) | 0 | 0 | 0 |
| Concomitant medication affecting drug exposure | 1 (0.7) | 2 (1.2) | 0 | 0 | 0 | 0 |
| Other | 30 (20.0) | 30 (17.5) | 24 (14.3) | 20 (13.1) | 10 (17.2) | 0 |
FUP, follow-up; SD, standard deviation.