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 @ 11:50 AM
Ignite Modification Date: 2025-12-24 @ 11:50 AM
NCT ID: NCT03617861
Description: None
Frequency Threshold: 0
Time Frame: Adverse events will be collected on each patient for each of the two individual study days, over a total duration of approximately one year.
Study: NCT03617861
Study Brief: Effect of Secretin in Functional Dyspepsia and Healthy Subjects
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Healthy Controls: Secretin Healthy controls who received human Secretin 0.2 mcg/kg via IV over 1 min. 0 None 0 10 0 10 View
Healthy Controls: Placebo Healthy controls who received placebo treatment (normal saline matching Secretin dose) via IV over 1 min. 0 None 0 10 1 10 View
Functional Dyspepsia: Secretin Functional Dyspepsia subjects who received human Secretin 0.2 mcg/kg via IV over 1 min. 0 None 0 10 10 10 View
Functional Dyspepsia: Placebo Functional Dyspepsia subjects who received placebo treatment (normal saline matching Secretin dose) via IV over 1 min. 0 None 0 10 10 10 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT General disorders None View
Postprandial fullness SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Dizziness SYSTEMATIC_ASSESSMENT General disorders None View