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: 2025-12-25 @ 2:49 AM
Ignite Modification Date: 2025-12-26 @ 1:31 AM
NCT ID: NCT03468933
Description: Definition of adverse event and/or serious adverse event, used to collect adverse event information does not differ from the clinicaltrials.gov.
Frequency Threshold: 0
Time Frame: The perioperative period until hospital discharge, an average of 4 weeks per participant
Study: NCT03468933
Study Brief: Fibrinolysis Compared to Thoracoscopy for Pleural Infection
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Medical Thoracoscopy Group Patients randomized to the Thoracoscopy group will undergo medical thoracoscopy. Medical Thoracoscopy: Medical thoracoscopy will be performed as per standard protocols. 1 None 0 16 1 16 View
Fibrinolytic Therapy Group Patients randomized to the Fibrinolytic group will receive intrapleural therapy of combined tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase) via chest tube. tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase): Patients will receive intrapleural combination of TPA (10 mg) and DNAse (5 mg). Therapy will be given twice daily for a maximum of 6 dose 0 None 0 16 1 16 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Respiratory NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View