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Table 2 PWP-TT, Cox and negative binomial models for participants in arm A of SANAD

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)

  1. N/A – variable not included in multivariable model