Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 5:48 PM
Ignite Modification Date: 2025-12-25 @ 3:15 PM
NCT ID: NCT02283268
Description: None
Frequency Threshold: 0
Time Frame: Throughout the study period (from the first exposure to investigational product until study completion or discontinuation date). Total study duration: 1 year and 3 months. Per participant: up to 58 days.
Study: NCT02283268
Study Brief: Recombinant Von Willebrand Factor in Subjects With Severe Von Willebrand Disease Undergoing Surgery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Recombinant Von Willebrand Factor (rVWF) Surgery participants treated with Recombinant von Willebrand Factor (rVWF) 0 None 2 15 6 15 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Diverticulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations 19.0 View
Deep vein thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders 19.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Acne NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 19.0 View
Dry skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 19.0 View
Iron deficiency anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 19.0 View
Peripheral swelling NON_SYSTEMATIC_ASSESSMENT General disorders 19.0 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations 19.0 View
Joint swelling NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 19.0 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders 19.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders 19.0 View
Pelvic pain NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders 19.0 View
Deep vein thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders 19.0 View