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Table 2 FDA custom MACE end point

From: Cardiovascular safety of linagliptin in type 2 diabetes: a comprehensive patient-level pooled analysis of prospectively adjudicated cardiovascular events

The following MedDRA preferred terms (version 15.0) are included in the FDA custom MACE end point:

Myocardial infarction terms

Stroke terms

Myocardial Infarction terms

Basilar artery thrombosis

Acute myocardial infarction

Brain stem infarction

Coronary artery thrombosis

Brain stem stroke

Myocardial infarction

Brain stem thrombosis

Papillary muscle infarction

Carotid arterial embolus

Postprocedural myocardial infarction

Carotid artery thrombosis

Silent myocardial infarction

Cerebellar infarction

 

Cerebral artery embolism

 

Cerebral artery thrombosis

 

Embolic stroke

 

Haemorrhagic cerebral infarction

 

Haemorrhagic stroke

 

Haemorrhagic transformation stroke

 

Ischaemic cerebral infarction

 

Ischaemic stroke

 

Lacunar infarction

 

Lateral medullary syndrome

 

Moyamoya disease

 

Postprocedural stroke

 

Stroke in evolution

 

Thalamic infarction

 

Thrombotic cerebral infarction

 

Thrombotic stroke

 

Wallenberg syndrome

  1. FDA, Food and Drug Administration; MACE, major adverse cardiovascular event.