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 @ 2:17 PM
Ignite Modification Date: 2025-12-25 @ 12:54 PM
NCT ID: NCT02370095
Description: None
Frequency Threshold: 0
Time Frame: From time of enrollment until end of follow-up, approximately 28 days.
Study: NCT02370095
Study Brief: Treprostinil Sodium Inhalation for Patients At High Risk for ARDS
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treprostinil Inhalation Solution Treprostinil will be randomized 2:1 to placebo. Treprostinil (6 mcg per breath) will be administered every 4 hours. The dose will increase from 6 to12 breaths (maximum 72 mcg) over the first 20 hours, maintained for 7 days, and tapered down over 3 days. Treprostinil Inhalation Solution: Treprostinil inhalation solution administered as blinded marketed product 4 None 4 10 6 10 View
Placebo Placebo administration will be administered as above for the active arm Placebo: Supplied by the manufacturer and similar to the active drug but containing no Treprostinil 0 None 0 4 1 4 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Death SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
septic shock SYSTEMATIC_ASSESSMENT Infections and infestations None View
Transfusion Reaction SYSTEMATIC_ASSESSMENT Immune system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea/Emesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cholelithiasis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Metapneumovirus SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumomediatinum/Bilateral pneumothoraces SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Retro-peritoneal hematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hematemesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Renal Failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Sleep Interference SYSTEMATIC_ASSESSMENT General disorders None View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Acute Kidney Injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hypernatremia SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Transfusion Reaction SYSTEMATIC_ASSESSMENT Immune system disorders None View
GI Bleed SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypoxemia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hyponatremia SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Elevated Transaminase SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Parapneuomonic Effusion with decortication SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Delirium SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hyperbilirubinemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View