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: 2025-12-25 @ 2:07 AM
Ignite Modification Date: 2025-12-26 @ 12:33 AM
NCT ID: NCT03943160
Description: Adverse events were limited to: SAEs, TRA Related Events, Significant Angiographic Events and OAS and ViperCath device related serious injuries. The reporting of AEs began immediately after the subject was enrolled through study exit.
Frequency Threshold: 0
Time Frame: The reporting of adverse events (AEs) began immediately after the subject was enrolled through the first standard of care follow-up visit (7 - 45 days post-procedure). For the purposes of this study, pre-planned interventions noted at baseline were not considered reportable AEs.
Study: NCT03943160
Study Brief: Radial accEss for nAvigation to Your CHosen Lesion for Peripheral Vascular Intervention: REACH PVI
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
OAS Use Via Transradial Access (TRA) All patients undergoing peripheral vascular intervention (PVI) via transradial access (TRA) and for whom TRA has been successfully achieved and peripheral lesion deemed appropriate for treatment via TRA per physician discretion. 0 None 2 50 0 50 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Lower Extremity Disorders SYSTEMATIC_ASSESSMENT Vascular disorders None View
Procedural Complications, Lower Extremities SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other Events(If Any):