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 @ 4:08 AM
Ignite Modification Date: 2025-12-26 @ 3:05 AM
NCT ID: NCT02324920
Description: None
Frequency Threshold: 0
Time Frame: median follow-up period of 14.1 months
Study: NCT02324920
Study Brief: Benefit of Dual-chamber Pacing With Closed Loop Stimulation (CLS) in Tilt-induced Cardioinhibitory Reflex Syncope
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Active Pacing (DDD+CLS) The pacemaker will be programmed in a dual-chamber DDD pacing mode with the Closed Loop Stimulation (CLS) function ON. DDD-CLS 0 None 4 64 20 64 View
Inactive Pacing (ODO) The pacemaker will be programmed in ODO mode. ODO 0 None 4 64 39 64 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Subtalar arthrodesis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
inguinal hernia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
NSTEMI SYSTEMATIC_ASSESSMENT Cardiac disorders None View
atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
pericarditis SYSTEMATIC_ASSESSMENT Cardiac disorders None View
lead dislodgement SYSTEMATIC_ASSESSMENT Cardiac disorders None View
lead was not properly connected to the pacemaker SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
inappropriate pacing due to undersensing SYSTEMATIC_ASSESSMENT Cardiac disorders None View
chest pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
fatigue (mild obstructive sleep apnea syndrome) SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
presyncope SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Keloid formation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
mild pocket bleeding SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
unspecified pain around the chest/ pocket. SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders None View