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 @ 5:00 PM
Ignite Modification Date: 2025-12-25 @ 2:41 PM
NCT ID: NCT02659150
Description: None
Frequency Threshold: 1
Time Frame: 13-18 weeks
Study: NCT02659150
Study Brief: Effect of Subcutaneous ACTEMRA on Inflamed Atherosclerotic Plaques in Patients With Rheumatoid Arthritis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Open-Label Tocilizumab tocilizumab will be given to rheumatoid arthritis patients at a dose of 162 mg subcutaneously a week tocilizumab: subjects will be treated with 162mg of weekly subcutaneous tocilizumab in an open-label manner, this will be done addition to MTX or monotherapy. On subsequent weeks after the first dose of tocilizumab, subjects will be instructed to inject the full amount of syringe according to the directions provided in the Instructions For Use (IFU). 0 None 1 16 4 16 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
elevated hepatic enzymes SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Leukopenia and Throbocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
traumatic fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
squamous cell carcinoma SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Adenomiomatosys of the fundus of the gallbladder SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
sinusitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
cyst in the right kidney SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
pericardial cyst SYSTEMATIC_ASSESSMENT Cardiac disorders None View
vertebral hemangioma SYSTEMATIC_ASSESSMENT Vascular disorders None View