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 @ 10:56 PM
Ignite Modification Date: 2025-12-25 @ 8:24 PM
NCT ID: NCT04452669
Description: None
Frequency Threshold: 0
Time Frame: Adverse event data were collected from randomization through 28 days post-randomization.
Study: NCT04452669
Study Brief: VentaProst in Subjects With COVID-19 Requiring Mechanical Ventilation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Study Treatment Up to 10 days of inhaled epoprostenol delivered by a breath actuated dedicated delivery system for patients with COVID-19 who are mechanically ventilated. VentaProst (inhaled epoprostenol delivered via a dedicated delivery system): VentaProst delivered for up to 10 days via mechanical ventilation at a dose range that may be up or down titrated to a patient's clinical condition. 1 None 1 6 0 6 View
Placebo Control Up to 10 days of inhaled 0.9% sodium chloride solution delivered by a breath actuated dedicated delivery system for patients with COVID-19 who are mechanically ventilated. VentaProst (inhaled epoprostenol delivered via a dedicated delivery system): VentaProst delivered for up to 10 days via mechanical ventilation at a dose range that may be up or down titrated to a patient's clinical condition. 4 None 4 5 1 5 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Worsening of ARDS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Worsening of Acute Hypoxic Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypercapnic Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders None View