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 @ 2:47 AM
Ignite Modification Date: 2025-12-26 @ 1:28 AM
NCT ID: NCT01275833
Description: An adverse event (AE) was defined as any undesirable clinical occurrence in a subject. This can be a subject complaint, change in health status, or product issue. An adverse event will not be reported if the underlying condition existed at enrollment and continued unchanged thereafter unless the event worsened considerably and required additional medical or pharmacological treatment.
Frequency Threshold: 0
Time Frame: Adverse events were reported as of ICF signature, and were supposed to be collected until the 12-month follow-up visit. However, the study was terminated early (1 subject had a 6-month follow-up visit, the second subject did not have a 6-month follw-up visit).
Study: NCT01275833
Study Brief: Restoration of Atrioventricular Synchrony Trial
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Device Programming That Modifies AV Timing Cardiac resynchronization therapy-defibrillator: Device programming that modifies AV timing 0 None 1 1 1 1 View
Device Programming That Allows Intrinsic AV Timing. Cardiac resynchronization therapy-defibrillator: Device programming that does not modifies AV timing 0 None 0 1 1 1 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Sarcoidosis induced cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cataract surgery SYSTEMATIC_ASSESSMENT Eye disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Prolonged hospitalization due to sarcoidosis induced cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Non-sustained ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View