Table 3. Participant demographics for those at risk of a seizure, or with a chance of achieving 12-month remission following a first breakthrough seizure, n (%) unless otherwise stated.
| Characteristic | Arm A (n = 332) | Arm B (n = 178) | Total (n = 510) |
|---|---|---|---|
| Male | 189 (57) | 101 (57) | 290 (57) |
| Febrile Seizure History | 19 (6) | 12 (7) | 31 (6) |
| Epilepsy in first degree relative | 29 (9) | 38 (21) | 67 (13) |
| Neurological insult | 50 (15) | 22 (12) | 72 (14) |
| Seizures | |||
| Simple/complex Partial + 2° generalised | 198 (60) | 6 (3) | 204 (40) |
| Simple or complex partial only | 88 (27) | 6 (23) | 94 (19) |
| Generalised tonic-clonic only | 7 (1) | 54 (30) | 61 (12) |
| Absence | 2 (1) | 19 (11) | 21 (4) |
| Myoclonic/absence + tonic- clonic seizures | 2 (10) | 44 (25) | 46 (9) |
| Tonic-clonic (uncertain if focal or generalised) | 30 (9) | 37 (21) | 67 (13) |
| Other | 5 (2) | 12 (7) | 17 (3) |
| Epilepsy type | |||
| Partial | 287 (86) | 12 (7) | 299 (59) |
| Generalised | 12 (4) | 125 (70) | 137 (27) |
| Unclassified | 33 (10) | 41 (23) | 74 (14) |
| EEG results | |||
| Normal | 140 (42) | 39 (22) | 179 (35) |
| Non-specific Abnormality | 53 (16) | 19 (11) | 72 (14) |
| Epileptiform Abnormality | 105 (32) | 116 (65) | 221 (43) |
| Not donea | 34 (10) | 4 (2) | 38 (8) |
| CT/MRI scan results | |||
| Normal | 186 (56) | 75 (42) | 261 (51) |
| Abnormal | 86 (26) | 12 (7) | 98 (19) |
| Not doneb | 60 (18) | 91 (51) | 151 (30) |
| Drugs attempted to achieve 12-month remission | |||
| One | 252 (76) | 136 (76) | 388 (76) |
| Two or more | 80 (24) | 42 (24) | 122 (24) |
| Number of tonic-clonic seizures ever until first breakthrough seizure, median (IQR) | 2 (0, 6) | 3 (2, 6) | 3 (1, 6) |
| Age at first breakthrough seizure (years), median (IQR) | 40.5 (24.1, 55.6) | 20.7 (15.1, 26.3) | 30.9 (19.0, 49.7) |
| Time to achieve 12-month remission from randomisation (years), median (IQR) | 1.2 (1.0, 1.9) | 1.2 (1.0, 1.8) | 1.2 (1.0, 1.8) |
| Breakthrough seizure treatment decision | |||
| No change to treatment plan | 189 (59) | 107 (63) | 296 (60) |
| Increase dosage | 124 (39) | 62 (36) | 186 (38) |
| Decrease dosage (or not specified) | 9 (2) | 2 (1) | 11 (2) |
aMost of these patients had focal epilepsy
bMost of these patients were aged < 20 years