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 @ 6:51 PM
Ignite Modification Date: 2025-12-25 @ 4:24 PM
NCT ID: NCT02582957
Description: Events were considered serious if any of the following apply: 1. Fatal event 2. Life threatening event 3. Re-hospitalization 4. Event likely contributed to prolonging hospitalization 5. Disabling or incapacitating 6. Serious laboratory abnormality with clinical symptoms Events were detected through responses to routine questionnaires and medical chart review at study visits and also by spontaneous self-report. Other (Not Including Serious) Adverse Events were not monitored/assessed.
Frequency Threshold: 0
Time Frame: Participants were followed for 28 days
Study: NCT02582957
Study Brief: Sigh Ventilation to Increase Ventilator-Free Days in Victims of Trauma at Risk for Acute Respiratory Distress Syndrome
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Usual Care Usual care, meaning that the treating physician will be free to treat the patient in any way he or she sees fit, including utilizing invasive mechanical ventilation as they wish. 46 None 114 261 0 0 View
Sigh Breaths Sigh breaths consisting of a Tidal volume (VT) that produces a plateau pressure (Pplat) of 35 cmH2O (or 40 cmH2O in patients with BMIs \> 35 or in patients with moderate or severe abdominal distension from ascites, blood and/or ileum, or prone patients). The sigh breaths will be delivered once every 6 minutes, as part of usual invasive mechanical ventilation. Sigh breaths: Sigh breaths delivered once every 6 minutes, as part of usual invasive mechanical ventilation. 30 None 103 259 0 0 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary Embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cardiovascular SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Septic Shock SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hemorrhagic Shock SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other SYSTEMATIC_ASSESSMENT General disorders None View
Other Respiratory SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Stroke SYSTEMATIC_ASSESSMENT Vascular disorders None View
Gastrointestinal Bleed SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Brain Injury SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):