Table 2.
Incidence and duration of TEAEs occurring in ≥ 5% of participants during the OLOTTP and SDP (safety population)a,b
| TEAE Term | SXB alone (n = 52) | SXB + other anticataplectics (n = 23) | Other anticataplectics (n = 36) | Anticataplectic-treatment naive (n = 90) | ||||
|---|---|---|---|---|---|---|---|---|
| Number of events | Median duration of events (range), d | Number of events | Median duration of events (range), d | Number of events | Median duration of events (range), d | Number of events | Median duration of events (range), d | |
| Headache | 18 | 1 (1–112) | 3 | 1 (1–1) | 14 | 1 (1–94) | 36 | 1 (1–147) |
| Nausea | 2 | 34 (14–54) | 1 | 54 (54–54) | 9 | 3 (1–16) | 19 | 9 (1–37) |
| Dizziness | 1 | 54 (54–54) | 1 | 4 (4–4) | 9 | 4 (1–29) | 15 | 10 (1–117) |
| Cataplexy | – | – | 12 | 9 (1–99) | 6 | 39 (12–50) | 3 | 1 (1–1) |
| Nasopharyngitis | 2 | 6 (4–8) | 1 | 10 (10–10) | 4 | 7 (4–8) | 6 | 4 (2–13) |
| Decreased appetite | – | – | 1 | 3 (3–3) | 2 | 68 (42–93) | 13 | 58 (2–358) |
| Influenza | 6 | 8 (3–14) | 3 | 12 (7–38) | 3 | 8 (7–39) | 4 | 6 (5–17) |
| Diarrhea | 4 | 41 (2–131) | – | – | – | – | 9 | 2 (1–64) |
| Vomiting | 1 | 2 (2–2) | – | – | 5 | 1 (1–2) | 5 | 1 (1–16) |
aTEAE duration was defined as time from TEAE start to end date (or end of SDP, if TEAE end date was unrecorded). bForty-three out of 520 (8%) TEAEs had a missing end date
OLOTTP open-label optimized treatment and titration period, SDP stable-dose period, SXB sodium oxybate, TEAE treatment-emergent adverse event