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 @ 7:42 PM
Ignite Modification Date: 2025-12-25 @ 5:21 PM
NCT ID: NCT03103503
Description: Serious adverse events were defined according to ISO14155.
Frequency Threshold: 0
Time Frame: Though study exit or study termination, an average of 1.1 years
Study: NCT03103503
Study Brief: Plexa ICD Lead Registry
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
BIOTRONIK Plexa ICD Lead Subjects consented and implanted with a BIOTRONIK ICD or CRT-D pulse generator and a Plexa lead. 64 None 44 901 12 901 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hematoma SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Loose set-screw SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Non-healing pocket dehiscence requiring intervention SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Cardiogenic shock during implantation SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Operation wound bleeding SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Venous occlusion associated with the implant procedure SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
LV lead related high pacing threshold SYSTEMATIC_ASSESSMENT Cardiac disorders None View
LV lead related lead dislodgement SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Twiddler's syndrome SYSTEMATIC_ASSESSMENT General disorders None View
RV lead related lead dislodgement SYSTEMATIC_ASSESSMENT Cardiac disorders None View
RV lead related other: high defibrillation threshold.no evidence for lead malfunction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
RA lead related lead dislodgement SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pulmonary Emboli SYSTEMATIC_ASSESSMENT General disorders None View
RV lead related high pacing threshold SYSTEMATIC_ASSESSMENT Cardiac disorders None View
RV lead related intermittent capture SYSTEMATIC_ASSESSMENT Cardiac disorders None View
RV lead related lead impedance out of range, high SYSTEMATIC_ASSESSMENT Cardiac disorders None View
RV lead related lead undersensing SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hematoma SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Non-healing pocket dehiscence requiring intervention SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Slow wound healing, no sign for infection SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Thrombosis SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
LV lead related extracardiac stimulation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
LV lead related lead impedance out of range, high SYSTEMATIC_ASSESSMENT Cardiac disorders None View
RV lead related lead dislodgement SYSTEMATIC_ASSESSMENT Cardiac disorders None View
RV lead related other: positional atrial undersensing SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Skin erosion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
RA lead related lead dislodgement SYSTEMATIC_ASSESSMENT Cardiac disorders None View
RA lead related no capture SYSTEMATIC_ASSESSMENT Cardiac disorders None View