TABLE 3.
Secondary Endpoints at 24 Months of Life
| Number (%) of Patients With | Randomized Controlled Trial | Open‐Label Trial | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| PTx | CTx | Estimated Difference (95% CI) | Estimated Odds Ratio (95% CI) | p a | PTx | CTx | Estimated Difference (95% CI) | Estimated Odds Ratio (95% CI) | p a | |
| Clinical seizures | 7 (54) | 11 (85) | −30.77 (−64.22, 2.68) | 0.23 (0.02, 1.74) | 0.202 | 6 (50) | 10 (77) | −33.33 (−68.62, 1.95) | 0.21 (0.02, 1.72) | 0.193 |
| Drug‐resistant epilepsy | 4 (31) | 10 (77) | −46.15 (−80.12, −12.18) | 0.15 (0.02, 0.98) | 0.047 | 3 (25) | 6 (50) | −25 (−62.42, 12.42) | 0.35 (0.04, 2.45) | 0.400 |
| Infantile spasms | 0 | 4 (31) | −30.77 (−55.86, −5.68) | 0 (0, 1.36) | 0.096 | 0 | 6 (50) | −46.15 (−73.25, −19.05) | 0 (0, 0.7) | 0.015 |
| Abnormal EEG | 11 (85) | 11 (85) | 0 (−27.74, 27.74) | 1 (0.06, 16.14) | 1.000 | 6 (50) | 8 (67) | 16.67 (−22.21, 55.55) | 1.94 (0.29, 14.3) | 0.680 |
| Hypsarrhythmia | 1 (8) | 1 (8) | 0 (−20.49, 20.49) | 1 (0.01, 84.9) | 1.000 | 1 (8) | 2 (15) | −7.05 (−32.14, 18.03) | 0.51 (0.01, 11.25) | 1.000 |
| Autism b | 4 (33) | 2 (16) | 16.67 (−17.33, 50.67) | 2.41 (0.26, 33.18) | 0.640 | 3 (25) | 2 (17) | 10 (−27.7, 47.7) | 1.67 (0.14, 25.6) | 1.000 |
| Neurodevelopmental delay c | 4 (33) | 6 (50) | −16.67 (−55.55, 22.21) | 0.51 (0.07, 3.4) | 0.680 | 2 (17) | 3 (25) | −10 (−47.7, 27.7) | 0.6 (0.04, 6.94) | 1.000 |
a
Fisher test.
b
High risk of autism according to Autistic Diagnostic Observation Schedule, 2nd edition score.
c
Bayley Scales of Infant Development, 3rd edition cognitive score < 70.
CI = confidence interval; CTx = conventional treatment; EEG = electroencephalogram; PTx = preventive treatment.