Table 2.
Frequency of Adverse Events
| Type of AE | Number of Patients With AEs | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| TTF (N = 11) | No TTF (N = 4) | Total (N = 15) | |||||||
| n | % | 95% CI | n | % | 95% CI | n | % | 95% CI | |
| Neurological | |||||||||
| Headache | 9 | 81.8 | 48–98 | 0 | 9 | 60.0 | 32–84 | ||
| Speech disturbances | 3 | 27.3 | 6.0–61 | 1 | 25.0 | 0.6–81 | 4 | 26.7 | 7.8–55 |
| Seizure | 5 | 45.5 | 17–77 | 0 | 5 | 33.3 | 12–62 | ||
| Paresis | 1 | 9.1 | 0.2–41 | 3 | 75.0 | 19–99 | 4 | 26.7 | 7.8–55 |
| Visual disturbances | 2 | 18.2 | 2.3–52 | 0 | 2 | 13.3 | 1.7–41 | ||
| Neglect | 1 | 9.1 | 0.2–41 | 0 | 1 | 6.7 | 0.2–32 | ||
| Memory disturbances | 1 | 9.1 | 0.2–41 | 0 | 1 | 6.7 | 0.2–32 | ||
| Regional | |||||||||
| Skin rash | 6 | 54.5 | 23–83 | 0 | 6 | 40.0 | 16–68 | ||
| Scalp ulceration | 2 | 18.2 | 2.3–52 | 0 | 2 | 13.3 | 1.7–41 | ||
| Surgical wound infection | 1 | 9.1 | 2.3–52 | 1 | 25.0 | 0.6–81 | 2 | 13.3 | 1.7–41 |
| Surgical wound rupture | 2 | 18.2 | 6.0–61 | 1 | 25.0 | 0.6–81 | 3 | 20.0 | 4.3–48 |
| Shoulder pain | 2 | 18.2 | 2.3–52 | 1 | 25.0 | 0.6–81 | 3 | 20.0 | 4.3–48 |
| Axillary abscess | 1 | 9.1 | 0.2–41 | 0 | 1 | 6.7 | 0.2–32 | ||
| Systemic | |||||||||
| Fatigue | 4 | 36.4 | 11–69 | 2 | 50.0 | 6.8–93 | 6 | 40.0 | 16–68 |
| Nausea | 3 | 27.3 | 6.0–61 | 3 | 75.0 | 19–99 | 6 | 40.0 | 16–68 |
| Fever | 3 | 27.3 | 6.0–61 | 2 | 50.0 | 6.8–93 | 5 | 33.3 | 12–62 |
| Diarrhea | 3 | 27.3 | 6.0–61 | 0 | 3 | 20.0 | 4.3–48 | ||
| Constipation | 2 | 18.2 | 2.3–52 | 0 | 2 | 13.3 | 1.7–41 | ||
| Abdominal pain | 2 | 18.2 | 2.3–52 | 0 | 2 | 13.3 | 1.7–41 | ||
| Dehydration | 1 | 9.1 | 0.2–41 | 0 | 1 | 6.7 | 0.2–32 | ||
| Deep vein thrombosis | 1 | 9.1 | 0.2–41 | 0 | 1 | 6.7 | 0.2–32 | ||
| Corticosteroid withdrawal syndrome | 1 | 9.1 | 0.2–41 | 0 | 1 | 6.7 | 0.2–32 | ||
| Abnormal ECG | 1 | 9.1 | 0.2–41 | 0 | 1 | 6.7 | 0.2–32 | ||
The table shows the numbers and frequencies of patients experiencing the observed AEs. A patient is registered as having an AE, if the AE occurred at least once, regardless of severity. All observed AEs were of grades 1–3. Patients are separated into those treated with TTFields (left column) and those not treated with TTFields (middle column). The right column shows results for all patients collectively. Supplementary Tables S4 and S5 list a breakdown of the AE data into grades and causalities, respectively.