Table 6.
Adverse events.
| TTX Dosage | |||||
|---|---|---|---|---|---|
| 7.5 µg BID (N = 25) |
15 µg BID (N = 24) |
30 µg QD (N = 25) |
30 µg BID (N = 26) |
Placebo (N = 25) |
|
| Patients with ≥1 AE | 21 (84.0) | 22 (91.7) | 20 (80.0) | 24 (92.3) | 18 (72.0) |
| Common AEs, n (%) a | |||||
| Paresthesia oral | 4 (16.0) | 9 (37.5) | 10 (40.0) | 11 (42.3) | 3 (12.0) |
| Hypoesthesia oral | 5 (20.0) | 7 (29.2) | 6 (24.0) | 10 (38.5) | 3 (12.0) |
| Paresthesia | 5 (20.0) | 7 (29.2) | 5 (20.0) | 7 (26.9) | 6 (24.0) |
| Headache | 6 (24.0) | 3 (12.5) | 1 (4.0) | 9 (34.6) | 5 (20.0) |
| Dizziness | 3 (12.0) | 4 (16.7) | 3 (12.0) | 8 (30.8) | 5 (20.0) |
| Fatigue | 4 (16.0) | 5 (20.8) | 5 (20.0) | 3 (11.5) | 4 (16.0) |
| Nausea | 1 (4.0) | 5 (20.8) | 1 (4.0) | 6 (23.1) | 6 (24.0) |
| Pain in extremity | 1 (4.0) | 5 (20.8) | 4 (16.0) | 3 (11.5) | 2 (8.0) |
| SAEs, n (%) | |||||
| Metastatic colon cancer | 0 | 0 | 0 | 0 | 1 (4.0) |
| Metastatic bladder cancer | 0 | 1 (4.2) | 0 | 0 | 0 |
| Prostate cancer | 0 | 1 (4.2) | 0 | 0 | 0 |
| Viral upper respiratory tract infection | 0 | 0 | 0 | 1 (3.8) | 0 |
| Patients Reporting an AE by Severity, n (%) | |||||
| Mild | 14 (56.0) | 12 (50.0) | 13 (52.0) | 12 (46.2) | 9 (36.0) |
| Moderate | 7 (28.0) | 9 (37.5) | 7 (28.0) | 8 (30.8) | 9 (36.0) |
| Severe | 0 | 1 (4.2) | 0 | 1 (3.8) | 1 (4.0) |
| Life Threatening | 0 | 0 | 0 | 0 | 0 |
| Death | 0 | 1 (4.2) Unrelated | 0 | 0 | 0 |
| Patients Reporting an AE and Relationship to Treatment, n (%) | |||||
| Not related | 6 (24.0) | 5 (20.8) | 2 (8.0) | 4 (15.4) | 4 (16.0) |
| Unlikely related | 0 | 1 (4.2) | 0 | 2 (7.7) | 1 (4.0) |
| Possibly related | 8 (32.0) | 9 (37.5) | 5 (20.0) | 9 (34.6) | 10 (40.0) |
| Related | 7 (28.0) | 7 (29.2) | 13 (52.0) | 9 (34.6) | 3 (12.0) |
AE: adverse event; SAE: serious adverse event; TTX: Tetrodotoxin; BID: twice daily; QD: once daily; n: number of subjects. All AEs were coded using the Medical Dictionary for Regulatory Activities, version 14.0. a AEs with >10% occurrence in safety population.