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Table 3 Predefined categories and system organ classes for adverse events

From: Statistical analysis plan for the control of blood pressure and risk attenuation-rural Bangladesh, Pakistan, Sri Lanka (COBRA-BPS) trial: a cluster randomized trial for a multicomponent intervention versus usual care in hypertensive patients

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