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 @ 2:02 AM
Ignite Modification Date: 2025-12-26 @ 12:26 AM
NCT ID: NCT03200860
Description: None
Frequency Threshold: 5
Time Frame: 60 days
Study: NCT03200860
Study Brief: Effects of Empagliflozin on Clinical Outcomes in Patients With Acute Decompensated Heart Failure
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Empagliflozin Empagliflozin 10 mg daily, oral, 30 days Empagliflozin 10 MG: 10 mg daily, oral, 30 days 1 None 8 40 29 40 View
Placebo Matching Placebo 10 mg daily, oral, 30 days Placebo Oral Tablet: Matching Placebo, 10 mg daily, oral, 30 days 3 None 10 39 31 39 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Worsening Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Worsening Renal Function SYSTEMATIC_ASSESSMENT General disorders None View
Acute Kidney Injury SYSTEMATIC_ASSESSMENT General disorders None View
Angioedema NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hypovolemic shock NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Delirium NON_SYSTEMATIC_ASSESSMENT General disorders None View
Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
S. Aureus Bacteremia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Syncope NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Respiratory Failure NON_SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Renal/Urinary SYSTEMATIC_ASSESSMENT General disorders None View
Cardiovascular NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Respiratory NON_SYSTEMATIC_ASSESSMENT General disorders None View
Gastrointestinal NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Metabolic SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Musculoskeletal SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Other SYSTEMATIC_ASSESSMENT General disorders None View