Table 3.
Incidence of AEs by system organ classes (SOCs).
| Test group | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| SOCs/PTs | Placebo group (n = 8) | 4 mg/kg group (n = 2) | 10 mg/kg group (n = 8) | 20 mg/kg group (n = 8) | 40 mg/kg group (n = 8) | 60 mg/kg group (n = 8) | Total (n = 34) | |||||||
| No. of AEs | No. of subjects (%) | No. of AEs | No. of subjects (%) | No. of AEs | No. of subjects (%) | No. of AEs | No. of subjects (%) | No. of AEs | No. of subjects (%) | No. of AEs | No. of subjects (%) | No. of AEs | No. of subjects (%) | |
| Total | 18 | 7 (87.5%) | 3 | 2 (100%) | 15 | 7 (87.5%) | 11 | 4 (50.0%) | 24 | 7 (87.5%) | 25 | 7 (87.5%) | 78 | 27 (79.4%) |
| Investigations | 12 | 7 (87.5%) | 3 | 2 (100%) | 9 | 6 (75.0%) | 8 | 3 (37.5%) | 21 | 7 (87.5%) | 20 | 6 (75.0%) | 61 | 24 (70.6%) |
| Positive bacterial test | 1 | 1 (12.5%) | 2 | 2 (100%) | 3 | 3 (37.5%) | 1 | 1 (12.5%) | 4 | 3 (37.5%) | 6 | 3 (37.5%) | 16 | 12 (35.3%) |
| Increased blood bilirubin | 3 | 2 (25.0%) | 0 | 0 (0%) | 0 | 0 (0%) | 1 | 1 (12.5%) | 1 | 1 (12.5%) | 4 | 2 (25.0%) | 6 | 4 (11.7%) |
| White blood cells in urine positive | 0 | 0 (0%) | 0 | 0 (0%) | 1 | 1 (12.5%) | 1 | 1 (12.5%) | 4 | 2 (25.0%) | 0 | 0 (0%) | 6 | 4 (11.7%) |
| Increased blood unconjugated bilirubin | 4 | 3 (37.5%) | 0 | 0 (0%) | 0 | 0 (0%) | 1 | 1 (12.5%) | 1 | 1 (12.5%) | 3 | 2 (25.0%) | 5 | 4 (11.7%) |
| Presence of ketone bodies in urine | 1 | 1 (12.5%) | 1 | 1 (50.0%) | 0 | 0 (0%) | 0 | 0 (0%) | 3 | 3(37.5%) | 1 | 1 (12.5%) | 5 | 5 (14.7%) |
| Decreased white blood cell count | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) | 1 | 1 (12.5%) | 3 | 2 (25.0%) | 0 | 0 (0%) | 4 | 3 (8.8%) |
| Electrocardiogram ST segment abnormal | 1 | 1 (12.5%) | 0 | 0 (0%) | 1 | 1 (12.5%) | 2 | 1 (12.5%) | 0 | 0 (0%) | 0 | 0 (0%) | 3 | 2 (5.9%) |
| Increased conjugated bilirubin | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) | 3 | 1 (12.5%) | 3 | 1 (2.9%) |
| Increased blood uric acid | 1 | 1 (12.5%) | 0 | 0 (0%) | 1 | 1 (12.5%) | 0 | 0 (0%) | 1 | 1 (12.5%) | 0 | 0 (0%) | 2 | 2 (5.9%) |
| Increased blood triglyceride | 0 | 0 (0%) | 0 | 0 (0%) | 1 | 1 (12.5%) | 0 | 0 (0%) | 1 | 1 (12.5%) | 0 | 0 (0%) | 2 | 2 (5.9%) |
| Decreased platelet count | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) | 1 | 1 (12.5%) | 1 | 1 (2.9%) |
| Increased blood urea | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) | 1 | 1 (12.5%) | 0 | 0 (0%) | 1 | 1 (2.9%) |
| Increased blood creatine phosphokinase | 1 | 1 (12.5%) | 0 | 0 (0%) | 0 | 0 (0%) | 1 | 1 (12.5%) | 0 | 0 (0%) | 0 | 0 (0%) | 1 | 1 (2.9%) |
| Electrocardiogram T wave abnormal | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) | 1 | 1 (12.5%) | 1 | 1 (2.9%) |
| Increased eosinophil percentage | 0 | 0 (0%) | 0 | 0 (0%) | 1 | 1 (12.5%) | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) | 1 | 1 (2.9%) |
| Increased urinary urobilinogen | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) | 1 | 1 (12.5%) | 1 | 1 (2.9%) |
| Blood in urine present | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) | 1 | 1 (12.5%) | 0 | 0 (0%) | 1 | 1 (2.9%) |
| Positive urinary occult blood | 0 | 0 (0%) | 0 | 0 (0%) | 1 | 1 (12.5%) | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) | 1 | 1 (2.9%) |
| Protein in urine present | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) | 1 | 1 (12.5%) | 0 | 0 (0%) | 1 | 1 (2.9%) |
| Vascular disorders | 1 | 1 (12.5%) | 0 | 0 (0%) | 2 | 1 (12.5%) | 1 | 1 (12.5%) | 0 | 0 (0%) | 1 | 1 (12.5%) | 4 | 3 (8.8%) |
| Hypertension | 1 | 1 (12.5%) | 0 | 0 (0%) | 2 | 1 (12.5%) | 1 | 1 (12.5%) | 0 | 0 (0%) | 1 | 1 (12.5%) | 4 | 3 (8.8%) |
| Infections and infestations | 1 | 1 (12.5%) | 0 | 0 (0%) | 0 | 0 (0%) | 2 | 2 (25.0%) | 1 | 1 (12.5%) | 0 | 0 (0%) | 3 | 3 (8.8%) |
| Upper respiratory tract infection | 1 | 1 (12.5%) | 0 | 0 (0%) | 0 | 0 (0%) | 1 | 1 (12.5%) | 1 | 1 (12.5%) | 0 | 0 (0%) | 2 | 2 (5.9%) |
| Conjunctivitis | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) | 1 | 1 (12.5%) | 0 | 0 (0%) | 0 | 0 (0%) | 1 | 1 (2.9%) |
| Cardiac disorders | 2 | 1 (12.5%) | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) | 1 | 1 (12.5%) | 1 | 1 (2.9%) |
| Sinus bradycardia | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) | 1 | 1 (12.5%) | 1 | 1 (2.9%) |
| Defective intraventricular conduction | 2 | 1 (12.5%) | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) |
| Respiratory, thoracic and mediastinal disorders | 1 | 1 (12.5%) | 0 | 0 (0%) | 1 | 1 (12.5%) | 0 | 0 (0%) | 0 | 0 (0%) | 1 | 1 (12.5%) | 2 | 2 (5.9%) |
| Oropharyngeal pain | 0 | 0 (0%) | 0 | 0 (0%) | 1 | 1 (12.5%) | 0 | 0 (0%) | 0 | 0 (0%) | 1 | 1 (12.5%) | 2 | 2 (5.9%) |
| Nasal obstruction | 1 | 1 (12.5%) | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) |
| Blood and lymphatic system disorders | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) | 2 | 1 (12.5%) | 0 | 0 (0%) | 2 | 1 (2.9%) |
| Anemia | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) | 2 | 1 (12.5%) | 0 | 0 (0%) | 2 | 1 (2.9%) |
| Gastrointestinal disorders | 1 | 1 (12.5%) | 0 | 0 (0%) | 1 | 1 (12.5%) | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) | 1 | 1 (2.9%) |
| Abdominal discomfort | 0 | 0 (0%) | 0 | 0 (0%) | 1 | 1 (12.5%) | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) | 1 | 1 (2.9%) |
| Nausea | 1 | 1 (12.5%) | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) |
| Skin and subcutaneous tissue disorders | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) | 2 | 1 (12.5%) | 2 | 1 (2.9%) |
| Pruritus | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) | 1 | 1 (12.5%) | 1 | 1 (2.9%) |
| Rash | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) | 1 | 1 (12.5%) | 1 | 1 (2.9%) |
| General disorders and administration site conditions | 0 | 0 (0%) | 0 | 0 (0%) | 1 | 1 (12.5%) | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) | 1 | 1 (2.9%) |
| Pyrexia | 0 | 0 (0%) | 0 | 0 (0%) | 1 | 1 (12.5%) | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) | 1 | 1 (2.9%) |
| Injury, poisoning and procedural complications | 0 | 0 (0%) | 0 | 0 (0%) | 1 | 1 (12.5%) | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) | 1 | 1 (2.9%) |
| Craniocerebral injury | 0 | 0 (0%) | 0 | 0 (0%) | 1 | 1 (12.5%) | 0 | 0 (0%) | 0 | 0 (0%) | 0 | 0 (0%) | 1 | 1 (2.9%) |