Table 4 Predefined event categories and system organ classes for adverse events
(a) Event categories | (b) System organ classes |
|---|---|
Angioedema and anaphylactic reaction Peripheral edema Hypotension Coronary heart disease Heart failure Stroke or transient ischemic attack Headache Dizziness or lightheadedness Flushing Cough after initiating antihypertensive Abdominal pain Muscle pain Falls and trauma Other | Systemic reactions Cardiovascular system Nervous systems Skin and appendages Respiratory system Gastrointestinal and hepatobiliary system Musculoskeletal system Electrolyte abnormalities Other |