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 @ 9:38 PM
Ignite Modification Date: 2025-12-25 @ 7:21 PM
NCT ID: NCT04899232
Description: None
Frequency Threshold: 0
Time Frame: 60 days
Study: NCT04899232
Study Brief: Antithrombin III in Infectious Disease Caused by COVID-19
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
AT3 Less Than 100% With SOC Plus AT3 Supplement Participants in this group, with endogenous Antithrombin lll less than 100%, will receive up to 5 doses of supplemental Antithrombin III on Days 1, 3, 5, 7 and 9, in addition to standard of care (SOC) treatment. Antithrombin III: A daily dose from 1,821 to 9,100 IUs Antithrombin III, depending on participant's weight and current antithrombin II level, will be administered intravenously every other infusion day (Days 1, 3, 5, 7 and 9). 2 None 0 15 5 15 View
AT3 Less Than 100% With SOC Only Participants in this group, with endogenous Antithrombin III less than 100%, will receive SOC treatment only. 3 None 0 20 5 20 View
AT3 of 100% or More, With SOC Only Participants in this group, with endogenous Antithrombin III 100% or more, will receive SOC treatment only. 3 None 0 12 8 12 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Insomnia SYSTEMATIC_ASSESSMENT General disorders None View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Acute Kidney Injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Shock SYSTEMATIC_ASSESSMENT General disorders None View
Heart Failure with reduced Ejection Fraction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Deep Vein Thrombosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Ureterovesical Junction (UVJ) Calculus SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Cardiac Arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Epistaxis SYSTEMATIC_ASSESSMENT General disorders None View
Gout SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Worsening Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulseless Electrical Activity SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Incidental Pulmonary Neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Necrotic Blister SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Critical Illness Polyneuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Leukocytosis SYSTEMATIC_ASSESSMENT Immune system disorders None View
Gastrointestinal Hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Asystole SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Bilateral Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Elevated D-Dimer SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Severe Acute Respiratory Distress Syndrome (ARDS) SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rhabdomyolysis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Alkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Right Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Subcutaneous Emphysema w/ Pneumomdiastinum SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypertriglyceridemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Dialysis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Thromocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Congestion SYSTEMATIC_ASSESSMENT General disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
MSSA Bacteremia SYSTEMATIC_ASSESSMENT Infections and infestations None View