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 @ 5:24 PM
Ignite Modification Date: 2025-12-25 @ 2:59 PM
NCT ID: NCT02820350
Description: None
Frequency Threshold: 5
Time Frame: During and 60 Days Post Treatment Initiation.
Study: NCT02820350
Study Brief: Safety and Efficacy of a Selective Cytopheretic Device (SCD) in Pediatric Patients With Acute Kidney Injury (AKI).
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
CRRT + SCD The Selective Cytopheretic Device (SCD) is comprised of tubing, connectors, and a synthetic membrane cartridge. The device is connected in series to a commercially available Continuous Renal Replacement Therapy (CRRT) device. Blood from the CRRT circuit is diverted after the CRRT hemoļ¬lter through to the extra capillary space (ECS) of the SCD. Blood circulates through this space and it is returned to the patient via the venous return line of the CRRT circuit. Regional citrate anticoagulation is used for the entire CRRT and SCD blood circuits. 4 None 8 16 14 16 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardio-respiratory arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pneumoperitoneum SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Stevens-Johnson syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Cerebral Hemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Adrenal Insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Vascular Graft Occlusion SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Post procedure pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cerebral hemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypothermia SYSTEMATIC_ASSESSMENT General disorders None View
Pneumoperitoneum SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Subcutaneous emphysema SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Intensive care unit delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View