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 @ 2:43 AM
Ignite Modification Date: 2025-12-26 @ 1:22 AM
NCT ID: NCT03696433
Description: Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion.
Frequency Threshold: 0
Time Frame: Baseline up to 8 weeks
Study: NCT03696433
Study Brief: Visualizing Vascular Mechanisms of Salt Sensitivity
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Low Salt Diet Low-salt diet: The low-salt diet (7 days) will consist of meals, snacks and water provided by Vanderbilt's metabolic kitchen. 0 None 0 19 1 19 View
High Salt Diet High-salt diet: The high-salt diet (7 days) consists of each subject's typical diet, supplemented each day with 2 bullion broth packets, which will be provided to the subject by the study staff. 0 None 0 19 0 19 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
episode of syncope NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View