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: 2025-12-24 @ 10:22 PM
Ignite Modification Date: 2025-12-25 @ 7:55 PM
NCT ID: NCT03343535
Description: Non-serious adverse events were not captured as part of this study. Only lung graft related SAEs and deaths were captured through investigator assessment.
Frequency Threshold: 0
Time Frame: Lung graft related SAEs (LGRSAEs) data was collected for transplanted recipients through 30-days post-transplant or through the initial hospital stay, if longer than 30 days (a mean of 41.5 days post-transplant). All cause mortality is reported through 36-months post-transplant for all transplanted recipients.
Study: NCT03343535
Study Brief: OCS Lung System EXPAND II Trial
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
OCS Preservation OCS Lung Preservation: OCS Lung Preservation 12 None 16 46 0 0 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Respiratory failure/protracted ventilation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Major pulmonary-related infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bronchial anastomotic complication SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Biopsy-proven moderate or severe acute rejection SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):