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 @ 5:38 PM
Ignite Modification Date: 2025-12-25 @ 3:08 PM
NCT ID: NCT04009668
Description: None
Frequency Threshold: 0
Time Frame: 14 Weeks
Study: NCT04009668
Study Brief: Tumor Necrosis Factor Inhibition in Focal Segmental Glomerulosclerosis and Treatment Resistant Minimal Change 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
Adalimumab Adalimumab dose every other week (study weeks 0, 2, 4, 6, and 8), subcutaneously. Adalimumab will be dosed based on weight (20 mg for subjects weighing 15kg to \<30kg, or 40 mg for subjects \>30kg). 0 None 1 7 5 7 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Edema SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Anasarca and AKI SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
eGFR decline (greater than 25% since baseline) SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Volume depletion SYSTEMATIC_ASSESSMENT General disorders None View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations None View
Rhinovirus SYSTEMATIC_ASSESSMENT Infections and infestations None View
Increased edema SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View