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 @ 3:11 AM
Ignite Modification Date: 2025-12-26 @ 1:49 AM
NCT ID: NCT00824005
Description: None
Frequency Threshold: 5
Time Frame: Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)
Study: NCT00824005
Study Brief: Effectiveness of Stem Cell Treatment for Adults With Ischemic Cardiomyopathy (The FOCUS Study)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Injections Participants received placebo injections. None None 6 31 11 31 View
Active Stem Cell Injections Participants received active stem cell injections. None None 9 61 19 61 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Chest pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Change in BNP levels SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Shortness of breath SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View