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%) |