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 @ 4:54 PM
Ignite Modification Date: 2025-12-25 @ 2:37 PM
NCT ID: NCT01578850
Description: The Open Label Safety Population is defined as all participants who had at least one dose of open label study drug during Period 1. The Double Blind Safety Population is defined as all randomized participants who had at least one dose of study drug during period 2.
Frequency Threshold: 5
Time Frame: Adverse events were reported from the signing of the informed consent to 28 days after the last dose of study medication through the last participant's visit.
Study: NCT01578850
Study Brief: Study Conducted in Subjects With Rheumatoid Arthritis Who Have Moderate to Severe Disease Activity Despite Methotrexate Therapy With or Without Other Non Biologic Disease Modifying Antirheumatic Drugs (DMARDs)for at Least 12 Weeks Prior to Screening
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 Treatment Participants in open-label treatment received ETN 50 mg with MTX (with or without other DMARDs). None None 13 489 26 489 View
Placebo Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs). None None 7 176 9 176 View
Etanercept Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs). None None 0 167 4 167 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Coronary artery disease NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Acute myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Sudden death NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Drug-induced liver injury NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 18.0 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Extradural abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Herpes zoster NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Intervertebral discitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Lower respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Pyelonephritis acute NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Salmonella sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Femoral neck fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Road traffic accident NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Ulna fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Osteoarthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Rheumatoid arthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Myopathy NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View