TABLE 3.
Incidence of all adverse eventsa
| Adverse event | No. (%) of subjects with adverse events by treatment group |
|||
|---|---|---|---|---|
| Test drug (n = 36) |
Reference drug (n = 36) |
|||
| Treatment related | Non-treatment related | Treatment related | Non-treatment related | |
| Body as a whole | ||||
| Fatigue | 3 (1.7) | 2 (1.2) | ||
| Cardiovascular | ||||
| Atrioventricular block, first degree | 1 (0.6) | 1 (0.6) | ||
| Palpitation | 2 (1.2) | |||
| Postural hypotension | 2 (1.2) | 1 (0.6) | ||
| Gastrointestinal | ||||
| Abdominal pain | 5 (2.9) | 9 (5.2) | ||
| Bloating | 5 (2.9) | 3 (1.7) | ||
| Burning stomach | 1 (0.6) | 1 (0.6) | ||
| Nausea | 6 (3.5) | 11 (6.4) | ||
| Vomiting | 1 (0.6) | 1 (0.6) | ||
| Diarrhea | 6 (3.5) | 6 (3.5) | ||
| Respiratory | ||||
| Cough | 2 (1.2) | 1 (0.6) | 1 (0.6) | |
| Flu symptoms | 1 (0.6) | 1 (0.6) | 1 (0.6) | |
| Nasal congestion | 3 (1.7) | 3 (1.7) | ||
| Upper respiratory infection | 1 (0.6) | 1 (0.6) | ||
| Psychiatric and nervous system | ||||
| Loss of appetite | 2 (1.2) | 3 (1.7) | ||
| Dizziness | 19 (11.0) | 15 (8.7) | ||
| Drowsiness | 2 (1.2) | 1 (0.6) | ||
| Skin | ||||
| Flushed | 12 (7.0) | 14 (8.1) | ||
| Laboratory test | ||||
| Decrease in neutrophiles | 1 (0.6) | 2 (1.2) | ||
| Decrease in WBC | 1 (0.6) | 2 (1.2) | 1 (0.6) | |
| Increase in ALT | 2 (1.2) | |||
| Increase in AST | 1 (0.6) | |||
| Increase in bilirubin | 1 (0.6) | |||
| Miscellaneous | ||||
| Amaurosis | 1 (0.6) | 2 (1.2) | ||
| Dental ulcer | 1 (0.6) | 1 (0.6) | ||
| Dyspepsia | 1 (0.6) | |||
| Headache | 1 (0.6) | |||
| External ear inflammation | 1 (0.6) | 1 (0.6) | 1 (0.6) | |
| Night sweat | 1 (0.6) | |||
| Pharyngalgia | 1 (0.6) | |||
| Total (R or NR) | 78 (45) | 8 (4.7) | 76 (44) | 10 (5.8) |
| Total (R + NR) | 86 (50) | 86 (50) | ||
a
Data represent adverse events of mild to moderate severity. WBC, white blood cells; ALT, alanine transaminase; AST, aspartate transaminase; R, treatment related; NR, non-treatment related.