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 @ 11:37 PM
Ignite Modification Date: 2025-12-25 @ 9:26 PM
NCT ID: NCT01682356
Description: Adverse event reporting used definitions from clinicaltrials.gov
Frequency Threshold: 0
Time Frame: One day per intervention with 7 days of washout in between
Study: NCT01682356
Study Brief: Dietary Nitrate for 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
Nitrate Beetroot juice with nitrate. 0 None 0 17 0 17 View
Placebo Beetroot juice without nitrate. 0 None 0 17 0 17 View
Serious Events(If Any):
Other Events(If Any):