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 @ 10:30 PM
Ignite Modification Date: 2025-12-25 @ 8:03 PM
NCT ID: NCT02633735
Description: The number analyzed are the sum of participants who completed the pre-implementation and implementation phase in both study arms. Negative appendicitis and appendiceal perforation were monitored for the subset of participants that had a surgical procedure following exposure to the clinical decision support intervention.
Frequency Threshold: 5
Time Frame: Within 7 days of index ED visit.
Study: NCT02633735
Study Brief: EHR-based Decision Support for Pediatric Acute Abdominal Pain in Emergency Care
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Appy CDS Intervention The Appy-cds intervention is a point of care clinical decision support system designed to identify pediatric patients at risk for appendicitis using EHR and supplemental data. The Appy-cds has multiple components, 1) presents risk prediction/stratification to provider, 2) provides recommendations consistent with standardized appendicitis care, 3) alerts for unnecessary exposure to ionizing radiation via a best practice alert. The intervention is administered to providers in this arm. Post Appy Clinical Decision Support: The Appy CDS is a point of care clinical decision support system that provides the provider with 1) risk for appendicitis based on EHR data, 2) recommendations on actions to take based on risk, 3) advises on imaging use. 0 None 96 3161 222 3161 View
Control People in the control arm receive usual care. 0 None 109 2779 224 2779 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Appendiceal perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Negative appendicitis SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Missed appendicitis SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Return to ED within 7 days of index SYSTEMATIC_ASSESSMENT General disorders None View