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 @ 11:58 PM
Ignite Modification Date: 2025-12-25 @ 9:56 PM
NCT ID: NCT04514458
Description: Adverse events are reported to the IRB via written report within 5 calendar days of the Principal Investigator becoming aware of the event. Adverse events reporting is only described for patient subjects as the exposure of interest would be expected to affect this study population. Adverse events were not monitored or assessed for provider subjects.
Frequency Threshold: 0
Time Frame: One year
Study: NCT04514458
Study Brief: Pragmatic Trial of Messaging to Providers About Treatment of 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
EHR-based Alert Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure. Best practice alert for the notification of patient HFrEF and recommended evidence-based therapies (NO drugs are being administered in this trial): Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure. 75 None 0 685 0 685 View
Usual Care Providers will not receive an alert and will proceed with usual care. 68 None 0 625 0 625 View
Serious Events(If Any):
Other Events(If Any):