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 @ 5:06 AM
Ignite Modification Date: 2025-12-26 @ 4:10 AM
NCT ID: NCT00422227
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00422227
Study Brief: Study Comparing Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis in the Asia Pacific Region
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/MTX Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection. None None 6 197 66 197 View
DMARD/MTX Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy. None None 3 103 71 103 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pneumocystis jiroveci pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia bacterial NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Muscle strain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pelvic fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Road traffic accident NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Transaminases increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Herpes zoster NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Gastrointestinal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Non-cardiac chest pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Leukopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View