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 @ 4:23 PM
Ignite Modification Date: 2025-12-25 @ 2:18 PM
NCT ID: NCT01654666
Description: None
Frequency Threshold: 5
Time Frame: Through 6 months post carotid artery stenting.
Study: NCT01654666
Study Brief: Protective Effects of Long-term Remote Limb Ischemic Preconditioning For Carotid Artery Stenting
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
RIPC Group Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting. Remote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min. Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis. None None 1 52 10 52 View
Control Group Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting. Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis. None None 3 56 26 56 View
Sham RIPC Group Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting. Sham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min. Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis. None None 3 54 23 54 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hyperperfusion Syndrome NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Symptomatic Ischemic Stroke NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Transient Ischemic Attack NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
At least one new lesion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View