TABLE 2.
Additional number of convulsive seizure‐free days and longest duration of convulsive seizure‐free days
| Study 1, N = 119 | Study 2, N = 87 | ||||
|---|---|---|---|---|---|
| FFA .7 mg/kg/day, n = 40 | FFA .2 mg/kg/day, n = 39 | Placebo, n = 40 | FFA .4 mg/kg/day, n = 43 | Placebo, n = 44 | |
| TTE analysis | |||||
| Patients who never reached baseline seizure count, n (%) | 24 (60) | 12 (31) | 5 (12) | 25 (58) | 1 (2) |
| Time to reach baseline seizure count from treatment start date, weeks, median | 13 | 10 | 7 | 13 | 5 |
| p a | <.001 | – | <.001 | – | |
| Longest duration of convulsive seizure‐free days | |||||
| Longest duration, days, median (range) | 25.0 (2–97) | 15.0 (3–106) | 9.5 (2–23) | 22.0 (3–105) | 13.0 (1–40) |
| Estimated median treatment difference from placebo, days (95% CI) | 15.5 (6–25) | 4.5 (0–9) | – | 8.5 (2.0–15.0) | – |
| p b | .0001 | .0352 | – | .004 | – |
| Number of convulsive seizure‐free days per 28 days, median (range) | 24.4 (1–28) | 20.9 (2–28) | 15.1 (1–26) | 24.4 (2–28) | 20.3 (0–26) |
| p b | .012 | .525 | – | .001 | – |
Abbreviations: CI, confidence interval; FFA, fenfluramine; TTE, time‐to‐event.
a
p values are versus placebo, calculated using log‐rank test.
b
p values are versus placebo, calculated using Wilcoxon rank sum test (95% CI).