TABLE 5.
Adverse Events
| Event | Events, n (events per patient) | p, Preventive vs Conventional | ||||
|---|---|---|---|---|---|---|
| Preventive Treatment, n = 25 | Conventional Treatment, n = 29 | Patient with no EA and No Seizures, n = 7 | Patients with Seizures prior to EA, n = 22 | Patients with Discordant EEG Analysis or Who Dropped Out before Treatment Allocation, n = 11 | ||
| All adverse events | 20 (0.80) | 36 (1.24) | 2 (0.29) | 40 (1.82) | 5 (0.45) | 0.153 |
| Serious adverse events | 11 (0.44) | 23 (0.79) | 0 | 37 (1.68) | 1 (0.09) | 0.132 |
| All serious adverse events | ||||||
| Death | 0 | 1 (0.03) a | 0 | 0 | 0 | 1 |
| Status epilepticus | 2 (0.08) | 7 (0.24) | 0 | 20 (0.9) | 1 (0.09) | 0.12 |
| Febrile seizures | 2 (0.08) | 5 (0.17) | 0 | 2 (0.09) | 0 | 0.22 |
| Surgery due to epilepsy | 1 (0.04) | 1 (0.03) | 0 | 11 (0.5) | 0 | 1 |
| Upper respiratory tract infection | 2 (0.08) | 4 (0.14) | 1 (0.14) | 3 (0.14) | 0 | 0.503 |
| Pneumonia | 2 (0.08) | 2 (0.07) | 0 | 1 (0.04) | 0 | 0.878 |
| Renal failure | 0 | 1 (0.03) | 0 | 0 | 0 | 1 |
| Surgery due to kidney tumors | 1 (0.04) | 1 (0.03) | 0 | 0 | 0 | 1 |
| Surgery due to cardiac tumors | 1 (0.04) | 1 (0.03) | 0 | 0 | 0 | 1 |
| Nonserious adverse events reported twice or more | ||||||
| Upper respiratory tract infection | 2 (0.08) | 2 (0.07) | 0 | 2 (0.09) | 2 (0.18) | 0.878 |
| Cardiac arrhythmia | 3 (0.12) | 4 (0.14) | 1 (0.14) | 2 (0.09) | 1 (0.09) | 0.846 |
| Feeding problems | 1 (0.04) | 1 (0.03) | 0 | 1 (0.04) | 0 | 1 |
| Anemia | 0 | 1 (0.03) | 0 | 0 | 1 (0.09) | 1 |
| Constipation | 0 | 2 (0.07) | 0 | 1 (0.04) | 0 | 0.494 |
| Influenza | 1 (0.04) | 2 (0.07) | 0 | 0 | 0 | 0.646 |
| Skin hyperkeratosis | 1 (0.04) | 1 (0.03) | 0 | 0 | 0 | 1 |
| Growth of SEGA | 1 (0.04) | 0 | 0 | 1 (0.04) | 0 | 0.463 |
Analysis includes the patients who dropped out from the study (n = 8) and patients with discordant EEG assessments (n = 7). Patients receiving preventive treatment were pooled from RCT and OLT. Patients receiving conventional treatment were pooled from RCT and OLT.
a
Due to cardiac arrest during epilepsy surgery.
EA = epileptiform activity; EEG = electroencephalogram; OLT = open‐label trial; RCT = randomized controlled trial; SEGA = subependymal giant cell astrocytoma.