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 @ 11:29 PM
Ignite Modification Date: 2025-12-25 @ 9:16 PM
NCT ID: NCT04069156
Description: An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Frequency Threshold: 1
Time Frame: All adverse events occurring through study completion (median follow up of 14 months) were collected.
Study: NCT04069156
Study Brief: The ARIES HeartMate 3 Pump IDE 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 Arm (Modified Intent-to-treat Population) Patients randomized to the placebo arm were given placebo medication. 21 None 208 296 200 296 View
Aspirin Arm (Modified Intent-to-treat Population) Patients randomized to the aspirin arm were given aspirin medication (100mg/day). 22 None 223 293 181 293 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bleeding SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders Study Protocol View
Hemolysis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders Study Protocol View
Cardiac Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders Study Protocol View
Right Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders Study Protocol View
Hepatic Dysfunction SYSTEMATIC_ASSESSMENT Hepatobiliary disorders Study Protocol View
Major Infection SYSTEMATIC_ASSESSMENT Infections and infestations Study Protocol View
Neurologic Dysfunction SYSTEMATIC_ASSESSMENT Nervous system disorders Study Protocol View
Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Study Protocol View
Renal Dysfunction SYSTEMATIC_ASSESSMENT Renal and urinary disorders Study Protocol View
Venous Thromboembolism SYSTEMATIC_ASSESSMENT Vascular disorders Study Protocol View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders Study Protocol View
Blood And Lymphatic System Disorders SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA system View
Cardiac Disorders SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA system View
Ear And Labyrinth Disorders SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA system View
Endocrine Disorders SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA system View
Eye Disorders SYSTEMATIC_ASSESSMENT Eye disorders MedDRA system View
Gastrointestinal Disorders SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA system View
General Disorders And Administration Site Conditions SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA system View
Hepatobiliary Disorders SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA system View
Immune System Disorders SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA system View
Infections And Infestations SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA system View
Injury, Poisoning And Procedural Complications SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA system View
Investigations SYSTEMATIC_ASSESSMENT Investigations MedDRA system View
Metabolism And Nutrition Disorders SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA system View
Musculoskeletal And Connective Tissue Disorders SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA system View
Neoplasms Benign, Malignant And Unspecified (Incl Cysts And Polyps) SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA system View
Nervous System Disorders SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA system View
Pregnancy, Puerperium And Perinatal Conditions SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA system View
Psychiatric Disorders SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA system View
Renal And Urinary Disorders SYSTEMATIC_ASSESSMENT Renal and urinary disorders Study Protocol View
Respiratory, Thoracic And Mediastinal Disorders SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA system View
Skin And Subcutaneous Tissue Disorders SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA system View
Social Circumstances SYSTEMATIC_ASSESSMENT Social circumstances MedDRA system View
Surgical And Medical Procedures SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA system View
Vascular Disorders SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA system View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Major Infection SYSTEMATIC_ASSESSMENT Infections and infestations Study Protocol View
Cardiac Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders Study Protocol View
Hepatic Dysfunction SYSTEMATIC_ASSESSMENT Hepatobiliary disorders Study Protocol View
Venous Thromboembolism SYSTEMATIC_ASSESSMENT Vascular disorders Study Protocol View
Bleeding SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders Study Protocol View
Renal Dysfunction SYSTEMATIC_ASSESSMENT Renal and urinary disorders Study Protocol View
Blood And Lymphatic System Disorders SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA system View
Cardiac Disorders SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA system View
Eye Disorders SYSTEMATIC_ASSESSMENT Eye disorders MedDRA system View
Gastrointestinal Disorders SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Study Protocol View
General Disorders And Administration Site Conditions SYSTEMATIC_ASSESSMENT General disorders MedDRA system View
Hepatobiliary Disorders SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA system View
Infections And Infestations SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA system View
Injury, Poisoning And Procedural Complications SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA system View
Investigations SYSTEMATIC_ASSESSMENT Investigations MedDRA system View
Metabolism And Nutrition Disorders SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA system View
Musculoskeletal And Connective Tissue Disorders SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA system View
Nervous System Disorders SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA system View
Psychiatric Disorders SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA system View
Renal And Urinary Disorders SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA system View
Reproductive System And Breast Disorders SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA system View
Respiratory, Thoracic And Mediastinal Disorders SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA system View
Skin And Subcutaneous Tissue Disorders SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA system View
Vascular Disorders SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA system View