Table 2.
Treatment emergent adverse events.
Adverse Event | 15 µg TTX a (%) (Severity/Relationship) |
30 µg TTX (%) (Severity/Relationship) |
45 µg TTX (%) (Severity/Relationship) |
Overall TTX (%) | 400 mg b Moxifloxacin (%) |
Placebo c (%) |
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---|---|---|---|---|---|---|---|---|---|
Total TEAEs d | 9 (100%) | 24 (100%) | 46 (100%) | 79 (100%) | 14 (100%) | 8 (100%) | |||
Arthralgia | 0 | 0 | 1 (2%) | 1 (1%) | 0 | 0 | |||
Mild | Possibly | ||||||||
Back Pain | 0 | 1 (4%) | 1 (2%) | 2 (3%) | 0 | 0 | |||
Mild | Unlikely | Moderate | Unlikely | ||||||
Chest Discomfort | 0 | 0 | 1 (2%) | 1 (1%) | 0 | 0 | |||
Mild | Possibly | ||||||||
Chills | 0 | 0 | 1 (2%) | 1 (1%) | 1 (7%) | 0 | |||
Mild | Possibly | ||||||||
Cough | 0 | 1 (4%) | 0 | 1 (1%) | 0 | 0 | |||
Mild | Unlikely | ||||||||
Dizziness | 1 (11%) | 3 (13%) | 4 (9%) | 8 (10%) | 2 (14%) | 1 (13%) | |||
Mild | Probably | 3x Mild | 3x Probably | 4x Mild | 4x Probably | ||||
Dry Throat | 0 | 0 | 1 (2%) | 1 (1%) | 0 | 0 | |||
Mild | Probably | ||||||||
Ear Pruritus | 0 | 1 (4%) | 0 | 1 (1%) | 0 | 0 | |||
Mild | Possibly | ||||||||
Fatigue | 0 | 1 (4%) | 0 | 1 (1%) | 0 | 0 | |||
Mild | Unlikely | ||||||||
Feeling Hot | 0 | 0 | 1 (2%) | 1 (1%) | 0 | 1 (13%) | |||
Mild | Possibly | ||||||||
Headache | 3 (33%) | 2 (8%) | 4 (9%) | 9 (11%) | 1 (7%) | 2 (25%) | |||
2x Mild 1x Moderate |
2x Probably1x Possibly | 1x Mild 1x Moderate |
1x Probably 1x Possibly |
2x Mild 2x Moderate |
4x Probably | ||||
Hyperhidrosis | 1 (11%) | 0 | 0 | 1 (1%) | 0 | 0 | |||
Mild | Possibly | ||||||||
Myalgia | 1 (11%) | 0 | 3 (7%) | 4 (5%) | 2 (14%) | 1 (13%) | |||
Mild | Possibly | 3x Mild | 1x Probably 2x Unlikely |
||||||
Nausea | 0 | 2 (8%) | 2 (4%) | 4 (5%) | 1 (7%) | 0 | |||
2x Mild | 2x Probably | 2x Mild | 2x Probably | ||||||
Papule | 0 | 2 (8%) | 0 | 2 (3%) | 0 | 0 | |||
2x Mild | 2x Possibly | ||||||||
Paresthesia | 2 (22%) | 6 (25%) | 10 (22%) | 18 (23%) | 0 | 0 | |||
2x Mild | 2x Probably | 6x Mild | 6x Probably | 10x Mild | 9x Probably 1x Possibly |
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Paresthesia Oral | 0 | 3 (13%) | 8 (17%) | 11 (14%) | 0 | 0 | |||
3x Mild | 3x Probably | 8x Mild | 8x Probably | ||||||
Pharyngeal Paresthesia | 0 | 0 | 3 (7%) | 3 (4%) | 0 | 0 | |||
3x Mild | 3x Probably | ||||||||
Productive Cough | 0 | 0 | 1 (2%) | 1 (1%) | 0 | 0 | |||
Mild | Possibly | ||||||||
Pruritus | 0 | 1 (4%) | 2 (4%) | 3 (4%) | 0 | 0 | |||
Mild | Possibly | 2x Mild | 2x Possibly | ||||||
Rash Erythematous | 0 | 0 | 1 (2%) | 1 (1%) | 0 | 0 | |||
Mild | Possibly | ||||||||
Tachycardia | 1 (11%) | 0 | 0 | 1 (1%) | 0 | 0 | |||
Mild | Possibly | ||||||||
Throat Tightness | 0 | 0 | 1 (2%) | 1 (1%) | 0 | 0 | |||
Mild | Probably | ||||||||
Vessel Puncture Site Pain | 0 | 1 (4%) | 0 | 1 (1%) | 1 (7%) | 0 | |||
Mild | Unrelated | ||||||||
Wheezing | 0 | 0 | 1 (2%) | 1 (1%) | 0 | 0 | |||
Mild | Possibly |
a TTX is abbreviation for tetrodotoxin; b, c For each TTX-related AE, the corresponding results for moxifloxacin and placebo groups were included for comparison; d TEAE is abbreviation for treatment emergent adverse events.