Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 12:43 AM
Ignite Modification Date: 2025-12-25 @ 10:54 PM
NCT ID: NCT02750267
Description: None
Frequency Threshold: 0
Time Frame: Adverse event data was collect over two 72 hour periods for each subject. Over the entire study, adverse events were collected over a 216 hour period (Group A's 72 hr home period, 72 hr hotel period, Group B's 72 hr home period).
Study: NCT02750267
Study Brief: Closed-Loop Control in Young Children 5-8 Years Old Using DiAs Platform
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Diabetes Assistant (DiAs) With Closed-Loop Control All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission. None None 0 12 1 12 View
Home Care (Pump+CGM) All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission. None None 0 12 0 12 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Sore Knee NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View