Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 1:14 AM
Ignite Modification Date: 2025-12-25 @ 11:24 PM
NCT ID: NCT01786993
Description: * Serious Adverse Events: Events that require invasive intervention (e.g. lead dislodgment requiring repositioning). * Other Adverse Events: Events that can be managed without invasive intervention (e.g., oversensing or loss of pacing capture, which is remedied by reprogramming of the pulse generator).
Frequency Threshold: 0
Time Frame: 3-month randomization to 9 months
Study: NCT01786993
Study Brief: MultiPoint Pacing IDE Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
MultiPoint Pacing Arm Subjects were programmed to MPP between 3 and 9 months. MPP programming was stipulated by the Echocardiographic measurements (e.g. EA VTI) during an acute hemodynamic assessment at the 3-month visit in the MPP IDE study. None None 4 201 40 201 View
Biventricular Arm Subjects were programmed to Quadripolar BiV pacing between 3 and 9 months using any of the 10 vectors available. None None 3 180 5 180 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
LV Lead Dislodgement or Migration SYSTEMATIC_ASSESSMENT Cardiac disorders None View
RA/RV Lead Dislodgement or Migration SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pulse Generator Erosion/Extrusion SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Generator Malfunction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Rise in Threshold And Exit Block Related to LV Lead SYSTEMATIC_ASSESSMENT Cardiac disorders None View
RA/RV Lead Elevated Pacing Thresholds SYSTEMATIC_ASSESSMENT Cardiac disorders None View
RA/RV Lead Loss of Capture SYSTEMATIC_ASSESSMENT Cardiac disorders None View
RA/RV Lead Oversensing SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Artifact Observed on Atrial Channel SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Discomfort Around Device SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Intolerance to MPP Pacing SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pulse Generator Oversensing SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pacemaker Mediated Tachycardia (PMT) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Intolerance to BiV Pacing SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Thrombo-Embolic Event SYSTEMATIC_ASSESSMENT Cardiac disorders None View
LV Lead Elevated Pacing Thresholds SYSTEMATIC_ASSESSMENT Cardiac disorders None View
LV Lead Loss of Capture SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Erythema to Lateral Aspect of Incision Site SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pericardial Effusion SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Phrenic Nerve/Diaphragmatic Stimulation Related to LV Lead SYSTEMATIC_ASSESSMENT Cardiac disorders None View