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 @ 12:02 AM
Ignite Modification Date: 2025-12-25 @ 10:00 PM
NCT ID: NCT01839058
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01839058
Study Brief: Is Non-Cardiac Chest Pain Caused by Sustained Longitudinal Smooth Muscle Contraction?
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Non Cardiac Chest Pain Patients Patients with Chest Pain where Coronary Artery Disease has been formally ruled out are to undergo esophageal manometry testing. Esophageal Manometry: Both cohorts will undergo standard high resolution esophageal manometry testing. This entails a catheter passed through the nose into the esophagus and measures pressure changes with a series of wet swallows. As part of the study, we will also be instilling both weak acid and saline into the esophagus. 0 None 0 21 0 21 View
Healthy Controls Healthy volunteers without esophageal symptoms are to undergo esophageal manometry testing. Esophageal Manometry: Both cohorts will undergo standard high resolution esophageal manometry testing. This entails a catheter passed through the nose into the esophagus and measures pressure changes with a series of wet swallows. As part of the study, we will also be instilling both weak acid and saline into the esophagus. 0 None 0 19 0 19 View
Serious Events(If Any):
Other Events(If Any):