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 @ 3:25 PM
Ignite Modification Date: 2025-12-25 @ 1:42 PM
NCT ID: NCT02802592
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT02802592
Study Brief: EPOgen and Restrictive Transfusions in Patients Undergoing Cardiac Surgery (EPORT)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
All Participants 1000 IU/kg Epogen in 250 ml of normal saline infused over 1 hr Epogen: 1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm OR 250 ml normal saline infused over 1 hr Normal Saline: 1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm 0 None 0 4 4 4 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cerebrovascular Accident None Blood and lymphatic system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Mediastinal bleeding SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Complete Heart Block None Cardiac disorders None View
Pleural Effusion None Blood and lymphatic system disorders None View
Acute Congestive Heart Failure None Cardiac disorders None View
Ankle Edema (Bilateral) None Blood and lymphatic system disorders None View
Atrial Flutter None Cardiac disorders None View