Table 10.
Adverse events and adverse drug reactions with an incidence of 5 % or more
| Adverse Events | |||||
|---|---|---|---|---|---|
| 120 μg | 240 μg | Placebo | |||
| Headache | 5 (13.9 %) | Nasopharyngitis | 11 (26.8 %) | Nasopharyngitis | 8 (22.9 %) |
| Nasopharyngitis | 4 (11.1 %) | Headache | 7 (17.1 %) | Pruritus | 3 (8.6 %) |
| Back pain | 3 (8.3 %) | Diarrhea | 5 (12.2 %) | Fever | 3 (8.6 %) |
| Hyperkalemia | 2 (5.6 %) | Malaise | 3 (7.3 %) | Hyperkalemia | 3 (8.6 %) |
| Dizziness | 2 (5.6 %) | Influenza | 2 (5.7 %) | ||
| Hypertension | 2 (5.6 %) | Hyperkalemia | 2 (5.7 %) | ||
| Upper respiratory tract inflammation | 2 (5.6 %) | Muscle Spasm | 2 (5.7 %) | ||
| Diarrhea | 2 (5.6 %) | Genital Bleeding | 2 (5.7 %) | ||
| Vomiting | 2 (5.6 %) | ||||
| Arthralgia | 2 (5.6 %) | ||||
| Adverse drug reactions | |||||
| 120 μg | 240 μg | Placebo | |||
| Hypertension | 2 (5.6 %) | Headache | 6 (14.6 %) | Genital Bleeding | 2 (5.7 %) |
| Malaise | 3 (7.3 %) | ||||
(): Incidence rate