Table 3.

AOE relevant MedDRA search terms used in the ENESTnd trial

MedDRA termPreferred term
Ischemic heart disease Any preferred term in the SMQ narrow terms for ischemic heart disease 
Ischemic cerebrovascular event Any AE reported under any PT in the SMQ narrow terms for ischemic cerebrovascular conditions 
Peripheral artery disease Arterial occlusive disease, arterial stenosis, femoral artery occlusion, intermittent claudication, ischemic limb pain, peripheral arterial occlusive disease, peripheral artery angioplasty, peripheral artery bypass, peripheral artery restenosis, peripheral artery stenosis, peripheral artery stent insertion, peripheral artery thrombosis, peripheral coldness, peripheral ischemia, peripheral revascularization, peripheral vascular disorder, poor peripheral circulation, and Raynaud phenomenon 
MedDRA termPreferred term
Ischemic heart disease Any preferred term in the SMQ narrow terms for ischemic heart disease 
Ischemic cerebrovascular event Any AE reported under any PT in the SMQ narrow terms for ischemic cerebrovascular conditions 
Peripheral artery disease Arterial occlusive disease, arterial stenosis, femoral artery occlusion, intermittent claudication, ischemic limb pain, peripheral arterial occlusive disease, peripheral artery angioplasty, peripheral artery bypass, peripheral artery restenosis, peripheral artery stenosis, peripheral artery stent insertion, peripheral artery thrombosis, peripheral coldness, peripheral ischemia, peripheral revascularization, peripheral vascular disorder, poor peripheral circulation, and Raynaud phenomenon 

CVEs were defined as ischemic heart disease, ischemic cerebrovascular event, and peripheral artery disease.21 

PT, preferred term; SMQ, standardized MedDRA queries.

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