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 @ 11:52 AM
Ignite Modification Date: 2025-12-25 @ 11:53 AM
NCT ID: NCT00531661
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00531661
Study Brief: CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Control CONTROL group: standard of care HF management None None 155 280 174 280 View
Treatment TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System None None 121 270 175 270 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac Disorders None Cardiac disorders None View
Respiratory None Respiratory, thoracic and mediastinal disorders None View
infections None Infections and infestations None View
vascular None Vascular disorders None View
nervous system None Nervous system disorders None View
gastrointestinal None Gastrointestinal disorders None View
general disorders None General disorders None View
renal and urinary None Renal and urinary disorders None View
metabolism and nutrition None Metabolism and nutrition disorders None View
surgical None Surgical and medical procedures None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
respiratory None Respiratory, thoracic and mediastinal disorders None View
cardiac None Cardiac disorders None View
gastrointestinal None Gastrointestinal disorders None View
musculoskeletal None Musculoskeletal and connective tissue disorders None View
renal and urinary None Renal and urinary disorders None View
investigations None Investigations None View
injury None Injury, poisoning and procedural complications None View
infections None Infections and infestations None View
metabolism and nutrition None Metabolism and nutrition disorders None View
nervous system None Nervous system disorders None View
general disorders None General disorders None View
vascular None Vascular disorders None View
blood and lymphatic system None Blood and lymphatic system disorders None View
psychiatric None Psychiatric disorders None View
skin and subcutaneous tissue None Skin and subcutaneous tissue disorders None View