Table 8 Sensitivity analysis of the PWP-TT model (arm B)
From: Modelling seizure rates rather than time to an event within clinical trials of antiepileptic drugs
Variable | Hazard Ratio (95% CI) | |||
|---|---|---|---|---|
On randomised drug only | Recurrent tonic-clonic seizures only | On randomised drug only & recurrent tonic-clonic seizures only | ||
Gender | Female Male | 1.00 1.29 (1.22, 1.36) | 1.00 1.29 (1.19, 1.39) | 1.00 1.28 (1.14, 1.44) |
Febrile Seizure History | Absent Present | N/A | 1.00 0.82 (0.71, 0.95) | 1.00 1.33 (1.09, 1.63) |
First degree relative with epilepsy | Absent Present | 1.00 1.21 (1.14, 1.30) | N/A | 1.00 1.55 (1.37, 1.75) |
Treatment History | Treat. naïve Seizures Not SANAD AED | 1.00 0.81 (0.68, 0.97) 1.45 (1.31, 1.61) | 1.00 0.68 (0.53, 0.87) 1.08 (0.97, 1.21) | 1.00 1.09 (0.79, 1.50) 1.46 (1.24, 1.72) |
Neurological Insult | Absent Present | N/A | 1.00 1.17 (1.04, 1.31) | 1.00 0.79 (0.66, 0.93) |
EEG Result | Normal Epi. abnorm. N/S abnorm. Not indicated | 1.00 0.77 (0.64, 0.93) 0.75 (0.65, 0.85) 1.19 (1.11, 1.29) | 1.00 0.74 (0.63, 0.87) 0.61 (0.53, 0.70) 0.83 (0.76, 0.91) | 1.00 1.01 (0.75, 1.35) 0.65 (0.54, 0.80) 1.08 (0.95, 1.23) |
Age at randomisation (years) | ≤7 8–13 14–19 20–27 28–50 > 50 | 1.00 0.94 (0.93, 0.95) 0.89 (0.87, 0.91) 0.85 (0.82, 0.88) 0.80 (0.76, 0.84) 0.75 (0.71, 0.80) | 1.00 0.96 (0.94, 0.97) 0.92 (0.88, 0.95) 0.89 (0.84, 0.93) 0.85 (0.79, 0.91) 0.81 (0.74, 0.89) | 1.00 0.98 (0.95, 1.00) 0.96 (0.91, 1.01) 0.94 (0.88, 1.01) 0.92 (0.84, 1.01) 0.90 (0.80, 1.02) |
Annual rate seizures prior to randomisation | 1 1–2 2–6 > 6 | N/A | 1.00 0.99 (0.98, 1.00) 0.98 (0.96, 1.00) 0.96 (0.92, 0.99) | N/A |
Seizure type | Gen. TC Absence Myo./Abs + TC Unclass. TC Other | 1.00 1.14 (1.04, 1.26) 1.12 (1.03, 1.22) 1.00 (0.91, 1.11) 0.96 (0.85, 1.07) | 1.00 1.04 (0.84, 1.30) 1.43 (1.30, 1.57) 1.11 (1.00, 1.23) 1.45 (1.24, 1.70) | 1.00 0.88 (0.69, 1.12) 1.51 (1.32, 1.73) 1.02 (0.88, 1.18) 1.56 (1.25, 1.95) |
Treatment | Valproate Lamotrigine Topiramate | 1.00 1.26 (1.18, 1.34) 1.61 (1.50, 1.73) | 1.00 1.24 (1.14, 1.36) 1.29 (1.18, 1.42) | 1.00 1.57 (1.38, 1.79) 2.16 (1.88, 2.47) |