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 @ 10:15 PM
Ignite Modification Date: 2025-12-25 @ 7:49 PM
NCT ID: NCT00577135
Description: Only Serious Adverse Events were collected for this study
Frequency Threshold: 0
Time Frame: None
Study: NCT00577135
Study Brief: Determining Optimal Dose and Duration of Diuretic Treatment in People With Acute Heart Failure (The DOSE-AHF 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
Q 12 Hour Bolus None None None 69 156 0 0 View
Continuous Infusion None None None 67 152 0 0 View
Low Intensification None None None 76 151 0 0 View
High Intensification None None None 60 157 0 0 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac Failure None Cardiac disorders None View
Cardiac Failure Acute None Cardiac disorders None View
Ventricular Tachycardia None Cardiac disorders None View
Renal Failure None Renal and urinary disorders None View
Hypotension None Vascular disorders None View
Anemia None Blood and lymphatic system disorders None View
Acute Myocardial Infarction None Cardiac disorders None View
Cardiac Arrest None Cardiac disorders None View
Sepsis None Infections and infestations None View
Renal Failure Acute None Renal and urinary disorders None View
Angina Pectoris None Cardiac disorders None View
Atrial Fibrillation None Cardiac disorders None View
Atrial Tachycardia None Cardiac disorders None View
Cardiac Failure Chronic None Cardiac disorders None View
Cardiogenic Shock None Cardiac disorders None View
Myocardial Infarction None Cardiac disorders None View
Ventricular Arrhythmia None Cardiac disorders None View
Arterial Thrombosis Limb None Vascular disorders None View
Deep Vein Thrombosis None Vascular disorders None View
Shock Haemorrhagic None Vascular disorders None View
Renal Failure Chronic None Renal and urinary disorders None View
Cerebrovascular Accident None Nervous system disorders None View
Hyperkalaemia None Metabolism and nutrition disorders None View
Other Events(If Any):