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: 2025-12-26 @ 11:46 AM
Ignite Modification Date: 2025-12-26 @ 11:46 AM
NCT ID: NCT05086016
Description: Serious Adverse Events are defined as procedure- or device-related SAEs resulting in an event of Death, Cardiac arrest and/or emergency ECMO cannulation, Stroke, Limb loss, Vessel dissection of target lesion, Device thrombosis/occlusion, Cardiac perforation requiring percutaneous or open surgical intervention, Persistent cardiac arrhythmia requiring a pacemaker. Adverse Events are defined as events related or possibly related to procedure or device
Frequency Threshold: 5
Time Frame: Adverse Events are collected through study completion. Structured visits include at time of procedure, post-procedure/discharge, 1 month, 3 months, 6 months 12 months, and annually thereafter through 5 years.
Study: NCT05086016
Study Brief: Growth Trial: Study of the Renata Minima Stent
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
All Treated The All Treated (AT) population is defined as all subjects who signed informed consent, meet eligibility criteria and for whom a procedure was begun (defined as the initiation of vascular access with the Renata Minima system). Catheterized Stenting: Catheterized stenting of vascular narrowings. 1 None 0 42 5 42 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Access Site Complications SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View