Table 6.
Tumor Treating Fields therapy-related AEs in pediatric patients with malignant brain tumors, by age.
| Preferred term, n (%) | Total events (n = 99) | Age subgroup | Patients (N = 81) | |
|---|---|---|---|---|
| Children (<13 years) (n = 40) | Adolescents (13–17 years) (n = 41) | |||
| Patients with ≥1 related AE | – | 19 (48) | 23 (56) | 42 (52) |
| Skin reaction | 48 | 14 (35) | 15 (37) | 29 (36) |
| Electric sensation* | 14 | 3 (8) | 5 (12) | 8 (10) |
| Headache | 11 | 2 (5) | 8 (20) | 10 (12) |
| Heat sensation† | 11 | 3 (8) | 7 (17) | 10 (12) |
| Fatigue/malaise | 5 | 3 (8) | 2 (5) | 5 (6) |
| Medical device pain | 4 | 2 (5) | 1 (2) | 3 (4) |
| Medical device discomfort | 2 | 0 | 2 (5) | 2 (2) |
| Alopecia | 1 | 0 | 1 (2) | 1 (1) |
| Medical device site hyperhidrosis | 1 | 1 (3) | 0 | 1 (1) |
| Medical device site ulcer | 1 | 1 (3) | 0 | 1 (1) |
| Insomnia | 0 | 1 (2) | 1 (1) | |
Brain tumors included: anaplastic astrocytoma, anaplastic ependymoma glioblastoma, atypical meningioma, high-grade glioma (not otherwise specified), and pleomorphic xantoastrocytoma.
*Beneath array tingling sensation; tingling.
†Beneath array warm sensation; warmth.
AE, adverse event.