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 @ 1:06 AM
Ignite Modification Date: 2025-12-25 @ 11:18 PM
NCT ID: NCT01400893
Description: Trial results showed that a number of enrollees in the treated and control arms deviated from protocol requiring regional citrate anticoagulation due to a national shortage of injectable CaCl2. The Primary Outcome is reported for patients who were treated per protocol. Two subjects enrolled to CRRT alone arm were not treated, so not counted in SAEs. 60 Day Mortality does not include 6 subjects LTFU. Other Adverse Events were not collected.
Frequency Threshold: 0
Time Frame: Up to 7 days of SCD treatment or control. This time frame differs from the primary outcome measure of 60 day mortality since therapy was provided up to 7 days of SCD treatment. The adverse events were captured only during SCD treatment times since device related events would occur at that time frame. ITT patients are included in this table.
Study: NCT01400893
Study Brief: Efficacy Study of a Selective Cytopheretic Device (SCD) in Patients With Acute Kidney Injury
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 Patients with a diagnosis acute kidney injury with multiorgan failure requiring CRRT will be randomized. SCD: The selective cytopheretic device (SCD) is comprised of tubing, connectors and a hemofilter 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 hemofilter through to the extra capillary space (ECS) of the SCD. Blood circulates through this space and 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. 27 None 45 69 0 0 View
CRRT Alone Patients with a diagnosis acute kidney injury with multiorgan failure requiring CRRT will be randomized. 21 None 40 63 0 0 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Blood and lymphatic system disorders SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders ITT patients View
Cardiac disorders SYSTEMATIC_ASSESSMENT Cardiac disorders ITT patients View
General disorders and administration site conditions SYSTEMATIC_ASSESSMENT General disorders ITT patients View
Infections and infestations SYSTEMATIC_ASSESSMENT Infections and infestations ITT patients View
Injury, poisoning and procedural conplications SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications ITT patients View
Investigations SYSTEMATIC_ASSESSMENT Investigations ITT patients View
Metabolism and nutrition disorders SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders ITT patients View
Musculoskeletal and connective tissue disorders SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders ITT patients View
Psychiatric disorders SYSTEMATIC_ASSESSMENT Psychiatric disorders ITT patients View
Renal and urinary disorders SYSTEMATIC_ASSESSMENT Renal and urinary disorders ITT patients View
Respiratory, thoracic and mediastinal disorders SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders ITT patients View
Skin and subcutaneous tissue disorders SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders ITT patients View
Vascular disorders SYSTEMATIC_ASSESSMENT Vascular disorders ITT patients View
Gastrointestinal disorders SYSTEMATIC_ASSESSMENT Gastrointestinal disorders ITT patients View
Other Events(If Any):