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 @ 11:56 PM
Ignite Modification Date: 2025-12-25 @ 9:52 PM
NCT ID: NCT02145351
Description: None
Frequency Threshold: 0
Time Frame: Adverse Events were assessed for all subjects during Pacemaker implantation (4 weeks), first treatment period (4 weeks), washout period (4 weeks), and second treatment period (4 weeks) for a total of approximately 16 weeks.
Study: NCT02145351
Study Brief: Efficacy Study of Pacemakers to Treat Slow Heart Rate in Patients With Heart Failure
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Pacing Off Subjects who received pacing off in either the first or last 4 weeks of the study Pacemaker system implanted but set to Pacing Off.: The identical pacing system will be implanted, but will be set to Pacing Off. 0 None 0 29 8 29 View
Washout Period After first intervention, both pacing off and pacing on groups will have a 4 week washout period when the pacemaker is turned off. 0 None 0 29 0 29 View
Pacing on Subjects who received pacing on either the first or last 4 weeks of the study Rate adaptive atrial pacing using a dual-chamber pacemaker: The Azure XT DR is a permanent, dual-chamber cardiac pacemaker with the ability to continuously monitor and record patient activity, and respond to activity by pacing faster and increasing the heart rate (rate adaptive atrial pacing). It will be programmed in AAIR mode to pace the right atrium. The leads will be placed in the right atrium and right ventricle using CapSureFix model 5086. 0 None 0 29 7 29 View
Pacemaker Implantation Subjects who experience adverse events during pacemaker implantation procedure only. This would be the timeframe after consent and prior to randomization to either pacing off or pacing on. 0 None 1 32 5 32 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Chest discomfort/palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pacing lead induced tricuspid regurgitation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Upper extremity deep venous thrombosis SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Incision site reaction SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Worsening fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Non pacemaker infection SYSTEMATIC_ASSESSMENT Infections and infestations None View