Table 2.
Summary of adverse events and grade in OrienX010 vaccination dose escalation study.
| Single dose: 4 × 108 Pfu |
Multiple dose: 1 × 108 Pfu |
Multiple dose: 4 × 108 Pfu |
||||
|---|---|---|---|---|---|---|
| Body system/adverse events | Grade 1/2 | Grade 3/4 | Grade 1/2 | Grade 3/4 | Grade 1/2 | Grade 3/4 |
| Blood and lymphatic system disorders | ||||||
| Leukopenia | 0 | 0 | 1 | 0 | 0 | 0 |
| Cardiovascular disorders | ||||||
| Tachycardia | 2 | 0 | 1 | 0 | 0 | 0 |
| Atrioventricular block | 1 | 0 | 0 | 0 | 0 | 0 |
| Endocrine disorders | ||||||
| Hyperglycemia | 0 | 0 | 1 | 0 | 0 | 0 |
| Gastrointestinal disorders | ||||||
| GGT increase | 1 | 0 | 0 | 0 | 0 | 0 |
| Constipation | 0 | 0 | 0 | 0 | 1 | 0 |
| Genitourinary disorders | ||||||
| Hematuria | 0 | 0 | 2 | 0 | 0 | 0 |
| General disorders and administration site conditions | ||||||
| Fever | 2 | 0 | 3 | 0 | 3 | 0 |
| Pain (at injection site) | 1 | 0 | 0 | 0 | 3 | 0 |
| Psychiatric disorders | ||||||
| Insomnia | 0 | 0 | 1 | 0 | 0 | 0 |
| Skin and subcutaneous tissue disorders | ||||||
| Purpura | 0 | 0 | 0 | 0 | 1 | 0 |