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 @ 10:50 PM
Ignite Modification Date: 2025-12-25 @ 8:20 PM
NCT ID: NCT00927069
Description: None
Frequency Threshold: 5
Time Frame: The period in which adverse events were recorded was between the signing of the informed consent at screening and Week 28 (approximately 32 weeks).
Study: NCT00927069
Study Brief: Safety and Efficacy of Adalimumab in Patients Who Showed an Unsatisfactory Response to Etanercept
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Group B Patients who showed a satisfactory response to 3 months or more of etanercept 50 mg twice a week followed by a loss of response after dose reduction to 50 mg etanercept once a week prior to screening. None None 0 35 8 35 View
Group A Patients who have shown an unsatisfactory response to 3 months of etanercept 50 mg twice a week without dose reduction prior to screening. None None 0 50 20 50 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Common Cold NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Upper Respiratory Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Back Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View