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 @ 9:18 PM
Ignite Modification Date: 2025-12-25 @ 7:06 PM
NCT ID: NCT00468104
Description: adverse events that occurred in patients after they received both Alteplase and Placebo were placed in a separate group as we were unable to determine which intervention ( Alteplase or Placebo) caused the problem
Frequency Threshold: 1
Time Frame: soon after drug instillation and for the first 24 hours in the hospital and then followed up for six months
Study: NCT00468104
Study Brief: Efficacy and Safety of Activase (Ateplase) vs Placebo in Complicated Pleural Effusions (CPE)/Empyemas
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Received Alteplase Only These patients received only Alteplase and were not crossed over None None 1 42 10 42 View
Received Placebo Only These patients received Placebo only and were not crossed over None None 0 8 5 8 View
Received Both Alteplase and Placebo These patients were crossed over and received both Alteplase and Placebo None None 0 40 8 40 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
serious bleeding at the chest tube site SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Shortness of breath, worsening sepsis SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
severe chest pain post drug instillation SYSTEMATIC_ASSESSMENT General disorders None View
mild to moderate chest pain SYSTEMATIC_ASSESSMENT General disorders None View
hypotension and worsening renal function SYSTEMATIC_ASSESSMENT General disorders hypotension View
blood loss--pleural fluid SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders other View
increasing shortness of breath SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders other View
worsening sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View