Table 3. Adverse events (safety set).
| Adverse events | Rovasro® (n=63) | Crestor® (n=62) | p | |||
|---|---|---|---|---|---|---|
| No. of subjects (%) | No. of events | No. of subjects (%) | No. of events | |||
| Any adverse events | 15 (23.8) | 18 | 12 (19.3) | 12 | 0.70* | |
| Drug-related adverse events | 9 (14.3) | 9 | 6 (9.7) | 6 | 0.60* | |
| Serious adverse events | 1 (1.6) | 1 | 2 (3.2) | 2 | 0.62 | |
| Musculoskeletal | 5 (7.9) | 6 | 3 (4.8) | 3 | 0.72 | |
| Myalgia | 4 (6.4) | 4 | 2 (3.2) | 2 | ||
| Neck pain | 1 (1.6) | 1 | 0 (0) | 0 | ||
| Arthralgia | 0 (0) | 0 | 1 (1.6) | 1 | ||
| Nervous system | 3 (4.8) | 3 | 4 (6.4) | 4 | 0.72 | |
| Dizziness | 2 (3.2) | 2 | 2 (3.2) | 2 | ||
| Headache | 1 (1.6) | 1 | 2 (3.2) | 2 | ||
| Head and neck | 1 (1.6) | 1 | 3 (4.8) | 3 | 0.36 | |
| Facial edema | 0 (0) | 0 | 1 (1.61) | 1 | ||
| Erythema of eyelid | 1 (16) | 1 | 1 (1.6) | 1 | ||
| Blurred vision | 0 (0) | 0 | 1 (1.6) | 1 | ||
| Chest | 2 (3.2) | 2 | 1 (1.6) | 1 | >0.99 | |
| Chest pain | 1 (1.6) | 1 | 0 (0) | 0 | ||
| Cough | 0 (0) | 0 | 1 (1.6) | 1 | ||
| Dyspnea | 1 (1.6) | 1 | 0 (0) | 0 | ||
| Gastrointestinal | 1 (1.6) | 1 | 0 (0) | 0 | >0.99 | |
| Constipation | 1 (1.6) | 1 | 0 (0) | 0 | ||
| Infection | 1 (1.6) | 1 | 1 (1.6) | 1 | >0.99 | |
| Nasopharyngitis | 1 (1.6) | 1 | 0 (0) | 0 | ||
| Pyelonephritis | 0 (0) | 0 | 1 (1.6) | 1 | ||
| Laboratory abnormalities | 1 (1.6) | 3 | 0 (0) | 0 | >0.99 | |
| Liver enzyme elevation | 1 (1.6) | 1 | 0 (0) | 0 | ||
| Creatine kinase elevation | 1 (1.6) | 1 | 0 (0) | 0 | ||
| Gamma-glutamyltransferase elevation | 1 (1.6) | 1 | 0 (0) | 0 | ||
The p-values with asterisk are from χ2 test. Other p-values are from Fisher's exact test.