Table 7.
Onset and duration of hypoesthesia and paresthesia related AEs.
| TTX Dosage | |||||
|---|---|---|---|---|---|
| AE | 7.5 µg BID (N = 25) |
15 µg BID (N = 24) |
30 µg QD (N = 25) |
30 µg BID (N = 26) |
Placebo (N = 25) |
| Hypoesthesia, n | 3 | 1 | 7 | 1 | 0 |
| Median Onset (h:mm) | 0:10 | 1:38 | 0:07 | 0:16 | |
| (Range) | (0:05–0:25) | (1:38–1:38) | (0:02–3:12) | (0:16–0:16) | |
| Median Duration (h:mm) | 0:40 | 0:12 | 3:00 | 1:10 | |
| (Range) | (0:35–0:40) | (0:12–0:12) | (2:30–22:10) | (1:10–1:10) | |
| Hypoesthesia Oral, n | 46 | 38 | 25 | 25 | 4 |
| Median Onset (h:mm) | 0:21 | 0:27 | 0:19 | 0:15 | 0:07 |
| (Range) | (0:00–3:35) | (0:07–7:03) | (0:00–1:30) | (0:05–6:25) | (0:02–1:27) |
| Median Duration (h:mm) | 0:39 | 1:15 | 2:51 | 1:30 | 4:22 |
| (Range) | (0:05–53:50) | (0:05–5:15) | (0:10–12:44) | (0:15–73:30) | (0:10–55:45) |
| Paresthesia, n | 21 | 14 | 12 | 12 | 9 |
| Median Onset (h:mm) | 0:30 | 0:34 | 0:21 | 0:16 | 0:26 |
| (Range) | (0:00–6:37) | (0:00–3:05) | (0:04–1:13) | (0:00–2:56) | (0:08–3:26) |
| Median Duration (h:mm) | 1:43 | 0:27 | 0:50 | 1:45 | 0:36 |
| (Range) | (0:03–48:00) | (0:01–59:35) | (0:10–5:28) | (0:05–12:00) | (0:15–4:00) |
| Paresthesia Oral, n | 21 | 28 | 23 | 55 | 8 |
| Median Onset (h:mm) | 0:19 | 0:22 | 0:24 | 0:44 | 0:10 |
| (Range) | (0:05–0:51) | (0:00–14:34) | (0:00–3:18) | (0:00–17:50) | (0:08–0:23) |
| Median Duration (h:mm) | 0:22 | 0:39 | 0:40 | 1:09 | 0:32 |
| (Range) | (0:04–3:30) | (0:02–3:20) | (0:01–11:00) | (0:01–4:52) | (0:10–2:40) |
AE: adverse event; TTX: Tetrodotoxin; BID: twice daily; QD: once daily; n: number of events; h: hours; mm: minutes. Hypoesthesia oral includes AEs of hypoesthesia oral, hypoesthesia facial, pharyngeal hypoesthesia and hypoesthesia teeth.