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 @ 10:00 PM
Ignite Modification Date: 2025-12-25 @ 7:37 PM
NCT ID: NCT00071032
Description: Medical events were captured during hospitalization (up to 30 days); mortality was determined at 60 days. There were a total of 2016 Number of Participants at Risk (1007 in the "Liberal Strategy" and 1009 in the "Restrictive Strategy" Arms/Groups), however, the number at risk was not the same for all events due to some missing data.
Frequency Threshold: 5
Time Frame: Up to 60 days following randomization
Study: NCT00071032
Study Brief: Safety and Effectiveness of Two Blood Transfusion Strategies in Surgical Patients With Cardiovascular Disease
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Restrictive Strategy Symptomatic transfusion strategy, in which blood transfusion is withheld until the patient develops symptoms of anemia or at physician discretion of the hemoglobin level falls below 8 g/dL None None 66 1009 0 1009 View
Liberal (10 g/dL) Transfusion Strategy Transfusion strategy that maintains post randomization Hgb levels \>= 10 g/dL None None 76 1007 0 1007 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Unstable Angina SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Death at 60 days SYSTEMATIC_ASSESSMENT General disorders None View
Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Congestive Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Stroke SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):