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 @ 12:04 AM
Ignite Modification Date: 2025-12-25 @ 10:02 PM
NCT ID: NCT01463358
Description: number of subjects with serious and non-serious adverse events of cardiac and non-cardiac origin, with identification of organ cause. Method for systematic assessment: regular investigator assessment at follow up.
Frequency Threshold: 0
Time Frame: 2 years
Study: NCT01463358
Study Brief: Prevention of Syncope by Cardiac Pacing in Patients With Bifascicular Block
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
DDI30 Control group based only on backup pacing with lower rate 30 ppm DDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific): pacing in DDDI30 is supposed to act as a safety backup upfront to episodes of syncope, presyncope or AV block, but not supposed to reduce symptoms. 2 None 33 49 22 49 View
DDD60 Treatment arm based on full pacing support (60 Lower Rate) DDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific): pacing in DDD60 is supposed to prevent events of syncope, presyncope of cardioinhibitory origin and symptom associated to av block 2 None 23 52 20 52 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Musculoskeletal trauma SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Renal disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Fever/virus SYSTEMATIC_ASSESSMENT General disorders None View
Tumor SYSTEMATIC_ASSESSMENT General disorders None View
transient ischemic attack SYSTEMATIC_ASSESSMENT Cardiac disorders None View
peripheral vascular disease SYSTEMATIC_ASSESSMENT Vascular disorders None View
symptomatic bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Miocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Syncope SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Vascular encephalopathy SYSTEMATIC_ASSESSMENT Vascular disorders None View
Pacing lead dislodgment SYSTEMATIC_ASSESSMENT Product Issues None View
Pacemaker system infection SYSTEMATIC_ASSESSMENT Product Issues None View
Gastrointestinal disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
atrio-ventricular block SYSTEMATIC_ASSESSMENT Cardiac disorders None View
symptomatic atrial arrhyhtmias SYSTEMATIC_ASSESSMENT Cardiac disorders None View
ventricular arrhyhtmias SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Heart Failure exhacerbation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
intervention for coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Stroke SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chronic obstructive pulmonary disease (COPD) SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Loss of pacemaker capture SYSTEMATIC_ASSESSMENT Product Issues None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dizziness SYSTEMATIC_ASSESSMENT Cardiac disorders None View
symptomatic Atrial Arrhythmias SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
pacemaker signal oversensing/undersensing SYSTEMATIC_ASSESSMENT Product Issues None View
pacemaker: rise in pacing threshold SYSTEMATIC_ASSESSMENT Product Issues None View
Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View