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 @ 4:37 PM
Ignite Modification Date: 2025-12-25 @ 2:27 PM
NCT ID: NCT02395666
Description: All subjects that received at least one dose of DFMO. Since both arms received the same exact treatment, they were combined into one reporting group.
Frequency Threshold: 4
Time Frame: Through study completion plus 30 days, an average of 2 years.
Study: NCT02395666
Study Brief: Preventative Trial of Difluoromethylornithine (DFMO) in High Risk Patients With Neuroblastoma That is in Remission
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
All Study Subjects All subjects that received at least one dose of DFMO. Since both arms received the same exact treatment, they were combined into one reporting group. 0 None 23 140 41 140 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Hyponatremia SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Benign vascular lesion SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (4.0) View
Swelling of Eye SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (4.0) View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Respiratory Disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
hearing loss SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE (4.0) View
Bacteremia SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Neutrophil count decrease SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Otitis Media SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
ALT elevation SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (4.0) View
AST elevation SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (4.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Hearing Loss SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE (4.0) View