Table 3.

Predefined categories and system organ classes for adverse events

Categories	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 Other