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 @ 4:57 AM
Ignite Modification Date: 2025-12-26 @ 3:57 AM
NCT ID: NCT01175018
Description: None
Frequency Threshold: 0
Time Frame: 12 weeks
Study: NCT01175018
Study Brief: Anakinra to Prevent Adverse Post-infarction Remodeling (2)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Anakinra Anakinra 100 mg injectable subcutaneously daily None None 4 15 6 15 View
Placebo 0.67 ml of NaCl 0.9% solution None None 6 15 8 15 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Death SYSTEMATIC_ASSESSMENT Cardiac disorders None View
New onset heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Serious infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Recurrent myocardial infarction or repeat percutaneous coronary intervention SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Left ventricular thrombus SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac rupture SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bleeding (not serious) SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Injection site pain SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Presyncope SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Eosinophilia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hyperkalemia SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Infection (not serious) SYSTEMATIC_ASSESSMENT Infections and infestations None View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View