Table 2.
Frequency of adverse events during the study
| Adverse event | Group A N = 12 |
Group B N = 13 |
Total N = 25 |
|---|---|---|---|
| Any adverse event | 8 (66.7%) | 12 (92.3%) | 20 (80.0%) |
| Site of administration (local events) | |||
| Nasopharyngeal itching | -- | 4 (30.8%) | 4 (16.0%) |
| Nasal mucous ardor | 1 (8.3%) | 2 (15.4%) | 3 (12.0%) |
| Sneezing | -- | 2 (15.4%) | 2 (8.0%) |
| Reddened nasal mucous | -- | 1 (7.7%) | 1 (4.0%) |
| Systemic events | |||
| Headache | 2 (16.7%) | 3 (23.1%) | 5 (20.0%) |
| Fever | 2 (16.7%) | -- | 2 (8.0%) |
| Arterial hypertension | 1 (8.3%) | -- | 1 (4.0%) |
| Diarrheas | -- | 1 (7.7%) | 1 (4.0%) |
| Pruritus | -- | 1 (7.7%) | 1 (4.0%) |
| Colics | -- | 1 (7.7%) | 1 (4.0%) |
| Epicondylitis | 1 (8.3%) | -- | 1 (4.0%) |
| Insomnia | -- | 1 (7.7%) | 1 (4.0%) |
| Cough | -- | 1 (7.7%) | 1 (4.0%) |
| Laboratory alterations | |||
| Hepatic enzymes increaseda | 2 (16.7%) | 3 (23.1%) | 5 (20.0%) |
| Anemiab | -- | 2 (15.4%) | 2 (8.0%) |
| Platelet count decreasedc | 1 (8.3%) | -- | 1 (4.0%) |
Data are presented as number of individuals with each adverse reaction (%)
aALT > 41 U/L (men) or >33 U/L (women); AST > 40 U/L (men) or >32 U/L (women); GGT > 60 U/L (men) or >40 U/L (women)
bHgb: < 130 g/L (men) or <120 g/L (women)
c < 150 × 109 cells/L