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 @ 7:16 PM
Ignite Modification Date: 2025-12-25 @ 4:53 PM
NCT ID: NCT00793403
Description: The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Frequency Threshold: 0
Time Frame: None
Study: NCT00793403
Study Brief: Current Adoption of Composite Indices in Evaluating Rheumatoid Arthritis Patients: An Observational Study
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 Participants Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months. None None 4 293 7 293 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Suspect of feocromocitoma NON_SYSTEMATIC_ASSESSMENT General disorders No Coding Applied View
Hospitalization for dermatitis NON_SYSTEMATIC_ASSESSMENT General disorders No Coding Applied View
Local aedematous reaction, hard and pain NON_SYSTEMATIC_ASSESSMENT General disorders No Coding Applied View
None NON_SYSTEMATIC_ASSESSMENT General disorders No Coding Applied View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Skin rash on abdomen and chest NON_SYSTEMATIC_ASSESSMENT General disorders No Coding Applied View
Foot finger infection NON_SYSTEMATIC_ASSESSMENT General disorders No Coding Applied View
Visus disorder NON_SYSTEMATIC_ASSESSMENT General disorders No Coding Applied View
Erythematous reaction in the injection site NON_SYSTEMATIC_ASSESSMENT General disorders No Coding Applied View
Vasculite episode NON_SYSTEMATIC_ASSESSMENT General disorders No Coding Applied View
Defluvium Capillorum NON_SYSTEMATIC_ASSESSMENT General disorders No Coding Applied View
Cystitis with fever NON_SYSTEMATIC_ASSESSMENT General disorders No Coding Applied View