Table 1.
Baseline demographic and seizure characteristics
| Levetiracetam (n=152) | Phenytoin (n=134) | ||
|---|---|---|---|
| Sex | |||
| Male | 75 (49%) | 72 (54%) | |
| Female | 77 (51%) | 62 (46%) | |
| Age | |||
| 6 months to <2 years | 65 (43%) | 53 (40%) | |
| 2–11 years | 81 (53%) | 74 (55%) | |
| 12–17 years | 6 (4%) | 7 (5%) | |
| Median (IQR), years | 2·7 (1·3–5·9) | 2·7 (1·6–5·6) | |
| Range, years | 0·6–16·1 | 0·6–17·9 | |
| Weight | |||
| <12 kg | 52 (34%) | 42 (31%) | |
| 12–36 kg | 86 (57%) | 80 (60%) | |
| >36 kg | 14 (9%) | 12 (9%) | |
| Median (IQR) | 12·1 (10·0–19·0) | 12·0 (10·0–18·0) | |
| Range | 7·5–70·0 | 6·0–66·0 | |
| Participant's first seizure | 69 (45%) | 49 (37%) | |
| Presenting seizure type | |||
| Generalised tonic-clonic | 107 (70%) | 105 (78%) | |
| Generalised clonic | 12 (8%) | 7 (5%) | |
| Focal clonic | 33 (22%) | 22 (16%) | |
| Seizure cause* | |||
| Febrile convulsion | 63 (41%) | 58 (43%) | |
| Seizure (pre-existing epilepsy) | 46 (30%) | 46 (34%) | |
| First afebrile seizure | 16 (11%) | 12 (9%) | |
| CNS infection | 6 (4%) | 7 (5%) | |
| Intracranial vascular event (bleed or stroke) | 2 (1%) | 2 (1%) | |
| Traumatic brain injury | 0 | 0 | |
| Substance misuse | 1 (<1%) | 0 | |
| Indeterminate | 10 (7%) | 7 (5%) | |
| Other | 27 (18%) | 26 (19%) | |
| Maintenance antiepilepsy drugs at presentation*† | |||
| Levetiracetam | 29 (19%) | 26 (19%) | |
| Sodium valproate | 16 (11%) | 19 (14%) | |
| Carbamazepine | 12 (8%) | 10 (7%) | |
| Clobazam | 9 (6%) | 9 (7%) | |
| Topiramate | 4 (3%) | 8 (6%) | |
| Phenytoin | 0 | 1 (<1%) | |
| Other | 11 (7%) | 18 (13%) | |
Data are n (%), median (IQR), or range.
*
Categories not mutually exclusive.
†
Includes participants with an established diagnosis of epilepsy who were reciving antiepilepsy drugs at the time of random allocation to treatment.