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 @ 9:33 PM
Ignite Modification Date: 2025-12-25 @ 7:17 PM
NCT ID: NCT00787332
Description: None
Frequency Threshold: 5
Time Frame: 30 days
Study: NCT00787332
Study Brief: A Comparative Sudy Comparing Argatroban® IV vs Desirudin SC for Suspected HIT With or Without Thrombosis Syndrome
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Desirudin Patients with suspected HIT randomized to SC Desirudin i None None 1 8 7 8 View
Argatroban® Patients with suspected HIT randomized to IV Argatroban® None None 2 8 7 8 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
esophageal hematoma SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
Sublingual Hematoma SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
femoral graft thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (10.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (10.0) View
hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (10.0) View
dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
non-sustained ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (10.0) View
right groin hematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (10.0) View
anxiety SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (10.0) View
sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (10.0) View
elevated LFT's SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
mild rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (10.0) View
shingles SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (10.0) View
fever SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View
clostridium difficile infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View
atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (10.0) View