Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 10:55 PM
Ignite Modification Date: 2025-12-25 @ 8:23 PM
NCT ID: NCT00761969
Description: At the time of yearly follow-up, non-fatal major ischemic events and revascularization procedures in the previous year were recorded according to medical records. In case of a "no show" on a scheduled visit, subjects or their relatives and their family physician were actively contacted.
Frequency Threshold: 1
Time Frame: Death of all causes, non-fatal major ischemic events (myocardial infarction, ischemic stroke, critical limb ischemia) and revascularization procedures were recorded yearly for 5 years.
Study: NCT00761969
Study Brief: Prevention of Ischemic Events in Patients With Peripheral Arterial Disease
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Peripheral Arterial Disease Subjects with stable peripheral arterial disease; ankle-brachial pressure index on at least one leg =\< 0.90. Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice (Eur Heart J 2003; 24: 1601-10, Eur J Cardiovasc Prev Rehabil. 2007;14 Suppl 2:S1-113). None None 195 742 284 742 View
Control Subjects without peripheral arterial disease (palpable pedal pulses and a normal ankle-brachial pressure index of 0.91-1.30), age- and sex-matched to the stuy group with PAD Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice (Eur Heart J 2003; 24: 1601-10, Eur J Cardiovasc Prev Rehabil. 2007;14 Suppl 2:S1-113). None None 82 713 30 713 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Death of all causes SYSTEMATIC_ASSESSMENT General disorders None View
Non-fatal myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Non-fatal ischemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Critical limb ischemia SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Peripheral arterial revascularization procedure SYSTEMATIC_ASSESSMENT Vascular disorders None View
Coronary revascularization procedure SYSTEMATIC_ASSESSMENT Vascular disorders None View
Carotid revascularization SYSTEMATIC_ASSESSMENT Vascular disorders None View
Abdominal aortic revascularization SYSTEMATIC_ASSESSMENT Vascular disorders None View