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 @ 7:49 PM
Ignite Modification Date: 2025-12-25 @ 5:26 PM
NCT ID: NCT00688103
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00688103
Study Brief: Efficacy and Safety of Etanercept in Active RA Despite Methotrexate Therapy in Japan
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ETN Alone Etanercept alone treatment group (25mg, twice/week, s.c.) None None 2 71 34 71 View
ETN+MTX Etanercept combined with MTX group (25mg, twice/week, s.c.+MTX 6-8mg/week) None None 9 76 39 76 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
bone fracture NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Herpes Zoster NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
congestive heart failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
brain hemorrhage NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
mammary carcinoma NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
upper airway viral infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
gastroentelitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
injection site reaction NON_SYSTEMATIC_ASSESSMENT General disorders None View
rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
mild injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View