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 @ 7:11 PM
Ignite Modification Date: 2025-12-25 @ 4:45 PM
NCT ID: NCT02327403
Description: None
Frequency Threshold: 0
Time Frame: 1 year
Study: NCT02327403
Study Brief: Belatacept Conversion in Proteinuric Kidney Transplant Recipients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Belatacept Conversion Kidney Transplant recipients with proteinuria who converted their immunosuppression from CNI to belatacept-based maintenance therapy 1 None 1 15 9 15 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac Arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypophosphatemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Shingles NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
MRSA Cellulitis with Abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pyelonephritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Acute Kidney Injury NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Basal Cell Carcinoma NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Recurrence of Bladder Tumor NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View