From: Modelling seizure rates rather than time to an event within clinical trials of antiepileptic drugs
Variable | Hazard Ratio (95% CI) | Negative Binomial: Rate of seizures | |||
---|---|---|---|---|---|
PWP-CP: Rate of recurrent seizures | Cox PH: First seizure | Cox PH: 12-month remission | |||
Gender | Female Male | 1.00 0.94 (0.89, 1.00) | 1.00 0.84 (0.75,0.94) | 1.00 1.22 (1.07, 1.38) | 1.00 0.72 (0.59, 0.89) |
Febrile Seizure History | Absent Present | 1.00 1.06 (0.93, 1.20) | N/A | N/A | N/A |
First degree relative with epilepsy | Absent Present | 1.00 0.88 (0.80, 0.97) | N/A | N/A | N/A |
Treatment History | Treatment naïve Seizures after remission Taking non-SANAD AEDs | 1.00 0.92 (0.70, 1.22) 1.04 (0.96, 1.11) | 1.00 1.02 (0.70, 1.47) 1.59 (1.37, 1.85) | 1.00 0.87 (0.58, 1.30) 0.52 (0.43, 0.63) | 1.00 0.99 (0.52,2.15) 1.86 (1.14, 2.51) |
Neurological Insult | Absent Present | 1.00 1.07 (0.98, 1.17) | 1.00 1.20 (1.01, 1.42) | 1.00 0.78 (0.63, 0.97) | N/A |
EEG Result | Normal Epileptiform abnormality Non-specific abnormality Not clinically indicated | 1.00 1.01 (0.94, 1.09) 1.01 (0.93, 1.11) 0.95 (0.85, 1.07) | N/A | N/A | 1.00 1.24 (0.86, 1.82) 0.69 (0.51, 0.94) 0.95 (0.73, 1.23) |
CT or MRI Result | Normal Abnormal Not clinically indicated | 1.00 1.10 (1.02, 1.18) 0.93 (0.85, 1.02) | N/A | 1.00 0.89 (0.77, 1.04) 1.16 (0.97, 1.38) | N/A |
Focal site of onset | Temporal Not localised Frontal Other Unclassified | 1.00 0.98 (0.91, 1.05) 0.84 (0.73, 0.96) 0.83 (0.71, 0.96) 0.50 (0.29, 0.86) | N/A | 1.00 0.93 (0.80, 1.07) 1.18 (0.91, 1.54) 1.26 (0.97, 1.65) 1.33 (1.07, 1.65) | N/A |
Age at randomisation (years) | ≤10 11–24 25–36 37–49 50–70 ≥71 | N/A | 1.00 0.99 (0.99, 1.00) 0.99 (0.98, 0.99) 0.98 (0.97, 0.99) 0.97 (0.96, 0.99) 0.97 (0.95, 0.99) | 1.00 1.01 (1.00, 1.01) 1.01 (1.00, 1.02) 1.02 (1.01, 1.03) 1.03 (1.01, 1.04) 1.03 (1.01, 1.05) | 1.00 0.91 (0.86, 0.96) 0.81 (0.71, 0.92) 0.71 (059, 0.87) 0.61 (0.45, 0.82) 0.51 (0.34, 0.76) |
Annual rate seizures prior to randomisation | ≤1 1–4 4–10 10–25 25–175 ≥175 | 1.00 0.98 (0.96, 0.99) 0.96 (0.94, 0.99) 0.95 (0.92, 0.98) 0.93 (0.88, 0.97) 0.89 (0.83, 0.96) | 1.00 1.15 (1.12, 1.18) 1.26 (1.21, 1.32) 1.37 (1.30, 1.45) 1.61 (1.48, 1.75) 2.06 (1.82, 2.34) | 1.00 0.86 (0.83, 0.90) 0.75 (0.69, 0.81) 0.60 (0.52, 0.69) 0.52 (0.43, 0.63) 0.45 (0.36, 0.56) | N/A |
Seizure type | Simple or complex partial Simple or complex partial with generalised tonic-clonic Uncertain | 1.00 1.09 (1.02, 1.17) 1.91 (1.15, 3.17) | 1.00 0.93 (0.81, 1.05) 0.67 (0.54, 0.84) | N/A | 1.00 0.75 (0.59, 0.95) 1.19 (0.26, 15.42) |
Treatment | Carbamazepine Gabapentin Lamotrigine Oxcarbazepine Topiramate | 1.00 0.97 (0.88, 1.06) 0.98 (0.89, 1.08) 0.92 (0.82, 1.02) 1.06 (0.97, 1.17) | 1.00 1.42 (1.20, 1.68) 1.26 (1.07, 1.50) 1.11 (0.90, 1.36) 1.08 (0.91, 1.28) | 1.00 0.73 (0.60, 0.87) 0.89 (0.74, 1.06) 0.98 (0.79, 1.22) 0.82 (0.68, 0.99) | 1.00 1.41 (1.03, 1.93) 1.02 (0.74, 1.39) 0.80 (0.56, 1.17) 1.13 (0.83, 1.53) |
Intercept | N/A | N/A | N/A | −2.17 (−2.62, −1.71) |