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 @ 10:29 PM
Ignite Modification Date: 2025-12-25 @ 8:03 PM
NCT ID: NCT00529035
Description: None
Frequency Threshold: 3
Time Frame: 12 weeks. For patients who continued on extended-duration therapy, adverse events were reported as long as they received treatment.
Study: NCT00529035
Study Brief: Ultra-Low Dose Interleukin-2 for Refractory Chronic Graft Versus Host Disease
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ultra-low Dose Interleukin-2 Interleukin-2 (IL-2) will be given daily through an injection under the skin for a period of 8 weeks. To determine the highest safest dose of IL-2, the dose participants receive will increase as lower doses are determined to be safe. There will be three dose levels: Dose Level -A 0.3 x 106 (IU/m2/d) Dose Level -B 1 x 106 (IU/m2/d) Dose Level-C 3 x 106 (IU/m2/d) None None 9 29 4 29 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Thrombotic microangiopathy with renal failure SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
MRSA Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
MRSA furuncle SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hemophilius influenza type B bacteremia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Injection site induration SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Renal dysfunction (mild) SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Constitutional symptoms SYSTEMATIC_ASSESSMENT General disorders None View
Thrombocytopenia (mild) SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View