TABLE 3.
AESIs and incidence by everolimus blood levels and number of concomitant AEDs at baseline and by follow-up year.
| Category | Baseline N = 150 | FU1 N = 171 | FU2 N = 164 | FU3 N = 112 | FU4 N = 71 | FU5 N = 22 | FU6 N = 8 |
|---|---|---|---|---|---|---|---|
| Patients on treatment with everolimus, n (%) | |||||||
| No AESI | 101 (67.3) | 114 (66.7) | 116 (70.7) | 77 (68.8) | 50 (70.4) | 8 (36.4) | 4 (50.0) |
| AESI present | 49 (32.7) | 57 (33.3) | 48 (29.3) | 35 (31.3) | 21 (29.6) | 14 (63.6) | 4 (50.0) |
| AESI suspected to be everolimus-related | 37 (24.7) | 38 (22.2) | 35 (21.3) | 20 (17.9) | 11 (15.5) | 8 (36.4) | 2 (25.0) |
| Patients who experienced AESI during everolimus treatment by everolimus blood level, n (%) | |||||||
| <5 ng/ml | 22 (14.7) | 28 (16.4) | 22 (13.4) | 12 (10.7) | 5 (7.0) | 3 (13.6) | 2 (25.0) |
| 5–15 ng/ml | 23 (15.3) | 25 (14.6) | 16 (9.8) | 14 (12.5) | 12 (16.9) | 5 (22.7) | 2 (25.0) |
| >15 ng/ml | 1 (0.7) | 3 (1.8) | 3 (1.8) | 3 (2.7) | 2 (2.8) | 0 | 2 (25.0) |
| Patients who experienced AESI during everolimus treatment by number of concomitant AEDs, n (%) | |||||||
| With concomitant a use of any AEDs | 24 (16.0) | 25 (14.6) | 23 (14.0) | 20 (17.9) | 13 (18.3) | 11 (50.0) | 4 (50.0) |
| With concomitant use of ≥2 AEDs | 16 (10.7) | 16 (9.4) | 16 (9.8) | 8 (7.1) | 8 (11.3) | 8 (36.4) | 3 (37.5) |
| With concomitant use of ≥3 AEDs | 6 (4.0) | 9 (5.3) | 8 (4.9) | 3 (2.7) | 5 (7.0) | 5 (22.7) | 2 (25.0) |
| With concomitant use of ≥4 AEDs | 2 (1.3) | 3 (1.8) | 3 (1.8) | 1 (0.9) | 2 (2.8) | 3 (13.6) | 1 (12.5) |
AEDs, antiepileptic drugs; AESIs, adverse events of special interest; FU, follow-up; FUP, follow-up period.
a
Concomitant use of AED was defined as the use of AED taken between the start date and the stop date of AESI.
An event was mapped into baseline/FUP k if its start date was prior to the baseline date/baseline date + 12 × k months and its stop date was on or after the baseline date/baseline date + 12 × k months or the event was ongoing, where k = 1, 2, 3, 4, 5, 6.