Table 7.
Tumor Treating Fields therapy-related AEs in pediatric patients with brain tumors, by diagnosis.
| Preferred term, n (%) | Total events(n = 99) | Diagnosis | Patients (N = 81) | |
|---|---|---|---|---|
| Newly diagnosed (n = 41) | Recurrent (n = 40) | |||
| Patients with ≥ 1 related AE | – | 25 (61) | 17 (43) | 42 (52) |
| Skin reaction | 48 | 19 (46) | 10 (25) | 29 (36) |
| Electric sensation* | 14 | 4 (10) | 4 (10) | 8 (10) |
| Headache | 11 | 6 (15) | 4 (10) | 10 (12) |
| Heat sensation† | 11 | 6 (15) | 4 (10) | 10 (12) |
| Fatigue/malaise | 5 | 3 (7) | 2 (5) | 5 (6) |
| Medical device pain | 4 | 2 (5) | 1 (3) | 3 (4) |
| Medical device discomfort | 2 | 1 (2) | 1 (3) | 2 (2) |
| Alopecia | 1 | 1 (2) | 0 | 1 (1) |
| Insomnia | 1 | 1 (2) | 0 | 1 (1) |
| Medical device hyperhidrosis | 1 | 1 (2) | 0 | 1 (1) |
| Medical device ulcer | 1 | 1 (2) | 0 | 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.