Table 2.
An evaluation of the associations between AED choice and the outcome variables (clinical and/or electrographic seizures in the hospitalization period, in the first 7 days, and the risk of adverse drug events)
| Subgroup | Outcome measure | Crude analysis: number with outcome/total number with data available for analysis (%) |
Unadjusted OR of outcome in the levetiracetam arm compared to in the phenytoin arm | p value | Adjusted OR of outcome in the levetiracetam arm compared to in the phenytoin armb | p value | |
|---|---|---|---|---|---|---|---|
| Phenytoin arm [number experiencing outcome event/total number with data available for analysis (%)] | Levetiracetam arm [number experiencing outcome event/total number with data available for analysis (%)] | ||||||
|
| |||||||
| Complete dataset | Clinical or electrographic seizures during hospitalization (yes/no) [n (%) yes] | 21/123 (17.1) | 23/164 (14.0) | 0.79 | 0.478 | 1.00c | 0.919 |
| Clinical seizures during hospitalization (yes/no) [n (%) yes] | 21/123 (17.1) | 19/164 (11.6) | 0.64 | 0.184 | 1.00 | 0.979 | |
| Electrographic seizures during hospitalization (yes/no) [n (%) yes] | 1/23 (4.3) | 9/48 (18.8) | 5.08 | 0.151 | 1.18c | 0.130 | |
| Adverse drug events from AED (yes/no) [n (%) yes] | 26/122 (21.3) | 6/163a (3.7) | 0.14 | <0.001 | 0.83 | <0.001 | |
| Midline shift on initial CT head >0 mm | Clinical or electrographic seizures during hospitalization (yes/no) [n (%) yes] | 14/76 (18.4) | 16/78 (20.5) | 1.14 | 0.743 | 0.97c | 0.693 |
| Clinical seizures during hospitalization (yes/no) [n (%) yes] | 14/76 (18.4) | 12/78 (15.4) | 0.81 | 0.615 | 0.96 | 0.561 | |
| Electrographic seizures during hospitalization (yes/no) [n (%) yes] | 0/13 (0.0) | 8/30 (26.7) | Infinity | 0.082 | 1.34c | 0.028 | |
| Adverse drug events from AED (yes/no) [n (%) yes] | 16/75 (21.3) | 3/77 (3.9) | 0.15 | 0.001 | 0.84 | 0.001 | |
| Traumatic etiology and GCS ≤8 | Clinical or electrographic seizures during hospitalization (yes/no) [n (%) yes] | 2/13 (15.4) | 2/17 (11.8) | 0.73 | 1.000 | 0.94c | 0.676 |
| Clinical seizures during hospitalization (yes/no) [n (%) yes] | 2/13 (15.4) | 1/17 (5.9) | 0.34 | 0.565 | 0.91 | 0.407 | |
| Electrographic seizures during hospitalization (yes/no) [n (%) yes] | 0/3 (0.0) | 1/9 (11.1) | Infinity | 1.000 | 1.12c | 0.588 | |
| Adverse drug events from AED (yes/no) [n (%) yes] | 5/13 (38.5) | 1/17 (5.9) | 0.10 | 0.061 | 0.72 | 0.027 | |
| Clinical seizures in the first 7 days | 1/13 (7.7) | 0/17 (0.0) | 0.00 | 0.433 | 0.93 | 0.260 | |
Associations are listed for the complete dataset and for two subgroup analyses
a
Data on one patient not available
b
Odds ratios adjusted for all baseline characteristics that significantly differed between the two AED exposure arms within each subgroup
c
Odds ratio also adjusted for whether the subjects had EEG/LTM testing during hospitalization in addition to significantly different baseline characteristics