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: 2025-12-25 @ 4:14 AM
Ignite Modification Date: 2025-12-26 @ 3:13 AM
NCT ID: NCT01251120
Description: None
Frequency Threshold: 0
Time Frame: The study was terminated prematurely due to lack of enrollment. Adverse events were recorded from the date of screening until study termination.
Study: NCT01251120
Study Brief: A Study of RoActemra/Actemra (Tocilizumab) in Combination With DMARDs Versus Current Best Practice DMARD Therapy 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
Tocilizumab Participants received tocilizumab 8 mg/kg intravenously every 4 weeks along with background DMARDs including methotrexate. All participants who received methotrexate also received at least 5 mg oral folic acid weekly. None None 0 1 1 1 View
Non-biologic DMARDs Participants received non-biologic DMARDs (including methotrexate) according to current best practice. All participants who received methotrexate also received at least 5 mg oral folic acid weekly. None None 0 1 0 1 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Gastointestinal Disorder NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View