Table 2.
Treatment-related side effects
| Side effects | Possible treatment related*, Patients (%) |
Probable treatment related** Patients (%) |
All treatment-related events Patients (%) |
| Fatigue | 2 (9.1) grade 1 | 1 (4.5) grade 1 | 3 (13.6) |
| Injection site reaction | 2 (9.1) grade 1 | 18 (81.8) grade 1 | 22 (100) |
| 4 (18.2) grade 2 | |||
| Viral upper respiratory tract infection | 1 (4.5) grade 1 | 1 (4.5) | |
| Headache | 1 (4.5) grade 1 | 1 (4.5) | |
| Paraesthesia | 1 (4.5) grade 1 | 1 (4.5) | |
| Hot flush | 1 (4.5) grade 1 | 1 (4.5) grade 1 | 2 (9.1) |
| Total no of patients† | 6 (27.3) | 22 (100) | 22 (100) |
Clinical events, including laboratory test abnormality, with a reasonable time sequence to administration of the vaccine, (*) which can also be explained by concurrent disease or other drugs or chemicals, or (**) which can unlikely be attributed to concurrent disease or other drugs or chemicals.
† Indicates the total number of patients reporting at least one event.