TABLE 2.
Epilepsy Outcomes in the Randomized Controlled Trial and Open‐Label Trial Patients
| Outcome | Randomized Controlled Trial | Open‐Label Trial | Pooled Analysis | |||
|---|---|---|---|---|---|---|
| PTx (95% CI) | CTx (95% CI) | PTx (95% CI) | CTx (95% CI) | PTx (95% CI) | CTx (95% CI) | |
| Median time to clinical seizures, days a | 614 (364–Inf) | 124 (118–215) | 602 (463–Inf) | 124 (78–242) | 614 (474–Inf) | 124 (114–200) |
| Median time to first clinical or electrographic seizure, days a | 505 (230–Inf) | 124 (99–215) | 587 (390–Inf) | 124 (78–242) | 587 (397–Inf) | 124 (114–200) |
| Median time from EA to first seizure, b days a | 496 (274–Inf) | 103 (56–158) | 561 (389–Inf) | 36 (21–124) | 561 (435–Inf) | 61 (41–124) |
| Median age at treatment onset, days a | 77 (42–110) | 131 (102–222) | 116 (91–147) | 124 (81–249) | 96 (77–118) | 131 (102–201) |
| Median age at treatment onset for patients who received treatment, days c | 75 (44–112) | 142 (40–160) | 124 (97–160) | 111 (13–146) | 9996 (54–115) | 125 (51–149) |
| Median proportion of days with seizures c | 12% (8.9–33.3) | 54.3% (47.6–91.7) | 6.4% (5.14–14.8) | 37.6% (1.54–60.3) | 8.0% (6.65–15.8) | 43.5% (5.47–46.4) |
| Median BSID‐III Cognitive Scale c | 71.6 (60–90) | 69.7 (52.5–72.5) | 84.2 (75–100) | 80.8 (65–110) | 77.1 (64.5–82) | 73 (64.5–82) |
a
Medians and confidence intervals were obtained by using bootstrap technique for right‐censored data with Kaplan–Meier method.
b
Either electrographic seizure or clinical seizure, whichever was detected first.
c
Medians and basic 2‐sided nonparametric confidence intervals were obtained by bootstrap method.
BSID‐III = Bayley Scales of Infant Development, 3rd edition; CI = confidence interval; CTx = conventional treatment; EA = epileptiform activity; Inf = infinity; PTx = preventive treatment.