Table 3 Frequency and percentage of adverse events in the subset of patients with at least one adverse event and serious adverse event by body system, and COSTART term
Body System /COSTART | No. (%) of events | |
|---|---|---|
| Â | Ezetimibe (n = 18) | Statin (n = 16) |
Body as a Whole | Â | Â |
 Fever | 1 (5.6) | 0 |
 Headache | 1 (5.6) | 1 (6.3) |
 Pain back | 1 (5.6) | 0 |
 Pain chest | 1 (5.6) | 0 |
Cardiovascular System | Â | Â |
 Syncope | 0 | 1 (6.3) |
Digestive System | Â | Â |
 Esophagitis | 1 (5.6) | 0 |
 Nausea | 1 (5.6) | 1 (6.3) |
 Rectal discharge | 1 (5.6) | 0 |
Metabolic and Nutritional Disorders | Â | Â |
 Diabetes mellitus | 1 (5.6) | 0 |
 Gout | 1 (5.6) | 0 |
Nervous System | Â | Â |
 Anxiety | 1 (5.6) | 0 |
 Dizziness | 2 (11.1) | 1 (6.3) |
 Insomnia | 0 | 1 (6.3) |
 Vertigo | 0 | 3 (18.8) |
Respiratory System | Â | Â |
 Cough inc | 0 | 1 (6.3) |
 Pharyngitis | 3* (16.6) | 1 (6.3) |
 Rhinitis | 0 | 1 (6.3) |
 Sputum inc | 0 | 1 (6.3) |
 Voice altered | 0 | 1 (6.3) |
Skin and Appendages | Â | Â |
 Rash | 1 (5.6) | 0 |
Special Senses | Â | Â |
 Cataract | 1 (5.6) | 0 |
 Conjunctivitis | 1 (5.6) | 1 (6.3) |
 Deaf | 0 | 1 (6.3) |
 Tinnitus | 0 | 1 (6.3) |