Table 6 Incidence of serious adverse drug reactions
Serious adverse drug reactions* | Safety analysis population | ||||||
|---|---|---|---|---|---|---|---|
Overall (%) n = 82 | Continuously treated patients (%) n = 17 | Newly treated patients (%) n = 65 | |||||
Number of patients who experienced serious adverse drug reactions (%) | 2 | (2.4) | 0 | (0.0) | 2 | (3.1) | |
Number of serious adverse drug reactions | 3 | 0 | 3 | ||||
Infections and infestations | 2 | (2.4) | 0 | (0.0) | 2 | (3.1) | |
Bronchitis | 1 | (1.2) | 0 | (0.0) | 1 | (1.5) | |
Pneumonia | 1 | (1.2) | 0 | (0.0) | 1 | (1.5) | |
Varicella | 1 | (1.2) | 0 | (0.0) | 1 | (1.5) | |