Table 2.
Treatment-emergent adverse events.
| Low (0.2 mg) | High (0.4 mg) | Total | |
|---|---|---|---|
| N = 10 | N = 10 | N = 20 | |
| n [95% CI] | n [95% CI] | n [95% CI] | |
| Treatment-emergent adverse event | 7 [34.8, 93.3] | 10 [69.2, 100.9] | 17 [62.1, 96.8] |
| Blood cell disorders (anemia) | 1 [0.3, 44.5] | 0 [0.0, 30.8] | 1 [0.1, 24.9] |
| Cardiac disorders (bradycardia) | 0 [0.0, 30.8] | 1 [0.3, 44.5] | 1 [0.1, 24.9] |
| Gastrointestinal disorders | 3 [6.7, 65.2] | 2 [2.5, 55.6] | 5 [8.7, 49.1] |
| Abdominal pain | 1 [0.3, 44.5] | 0 [0.0, 30.8] | 1 [0.1, 24.9] |
| Diarrhea | 3 [6.7, 65.2] | 2 [2.5, 55.6] | 5 [8.7, 49.1] |
| Nausea | 1 [0.3, 44.5] | 0 [0.0, 30.8] | 1 [0.1, 24.9] |
| General disorders and administration site conditions | 4 [12.2, 73.8] | 8 [44.4, 97.5] | 12 [36.1, 80.9] |
| Fatigue | 0 [0.0, 30.8] | 1 [0.3, 44.5] | 1 [0.1, 24.9] |
| Malaise | 0 [0.0, 30.8] | 2 [2.5, 55.6] | 2 [1.2, 31.7] |
| Vaccination site erythema | 1 [0.3, 44.5] | 3 [6.7, 65.2] | 4 [5.7, 43.7] |
| Vaccination site rash | 1 [0.3, 44.5] | 0 [0.0, 30.8] | 1 [0.1, 24.9] |
| Vaccination site induration | 1 [0.3, 44.5] | 1 [0.3, 44.5] | 2 [1.2, 31.7] |
| Vaccination site pain | 2 [2.5, 55.6] | 2 [2.5, 55.6] | 4 [5.7, 43.7] |
| Vaccination site itching | 0 [0.0, 30.8] | 1 [0.3, 44.5] | 1 [0.1, 24.9] |
| Vaccination site internal hemorrhage | 0 [0.0, 30.8] | 1 [0.3, 44.5] | 1 [0.1, 24.9] |
| Vaccination site swelling | 1 [0.3, 44.5] | 0 [0.0, 30.8] | 1 [0.1, 24.9] |
| Hepatobiliary disorders (abnormal hepatic function) | 0 [0.0, 30.8] | 1 [0.3, 44.5] | 1 [0.1, 24.9] |
| Infections and infestations | 2 [2.5, 55.6] | 4 [12.2, 73.8] | 6 [11.9, 54.3] |
| Cystitis | 0 [0.0, 30.8] | 2 [2.5, 55.6] | 2 [1.2, 31.7] |
| Periodontitis | 1 [0.3, 44.5] | 0 [0.0, 30.8] | 1 [0.1, 24.9] |
| Nasopharyngitis | 1 [0.3, 44.5] | 1 [0.3, 44.5] | 2 [1.2, 31.7] |
| Pyuria | 0 [0.0, 30.8] | 1 [0.3, 44.5] | 1 [0.1, 24.9] |
| Investigations | 1 [0.3, 44.5] | 2 [2.5, 55.6] | 3 [3.2, 37.9] |
| High blood pressure | 0 [0.0, 30.8] | 2 [2.5, 55.6] | 2 [1.2, 31.7] |
| Blood uric acid increased | 1 [0.3, 44.5] | 0 [0.0, 30.8] | 1 [0.1, 24.9] |
| Metabolism and nutrition disorders (hypoglycemia) | 0 [0.0, 30.8] | 1 [0.3, 44.5] | 1 [0.1, 24.9] |
| Musculoskeletal and connective disorders | 1 [0.3, 44.5] | 2 [2.5, 55.6] | 3 [3.2, 37.9] |
| Joint pain | 1 [0.3, 44.5] | 0 [0.0, 30.8] | 1 [0.1, 24.9] |
| Back pain | 0 [0.0, 30.8] | 1 [0.3, 44.5] | 1 [0.1, 24.9] |
| Disc protrusion | 0 [0.0, 30.8] | 1 [0.3, 44.5] | 1 [0.1, 24.9] |
| Nervous system disorders | 2 [2.5, 55.6] | 4 [12.2, 73.8] | 6 [11.9, 54.3] |
| Headache | 2 [2.5, 55.6] | 4 [12.2, 73.8] | 6 [11.9, 54.3] |
| Somnolence | 1 [0.3, 44.5] | 0 [0.0, 30.8] | 1 [0.1, 24.9] |
| Respiratory, thoracic, and mediastinal disorders (cough) | 1 [0.3, 44.5] | 0 [0.0, 30.8] | 1 [0.1, 24.9] |
| Skin and subcutaneous tissue disorders (itching) | 0 [0.0, 30.8] | 1 [0.3, 44.5] | 1 [0.1, 24.9] |