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 @ 7:30 PM
Ignite Modification Date: 2025-12-25 @ 5:11 PM
NCT ID: NCT00420303
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00420303
Study Brief: Study Evaluating Etanercept for the Treatment of Refractory Heel Enthesitis in Spondylarthropathy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Etanercept 50mg subcutaneously once weekly None None 1 12 11 12 View
Placebo Subcutaneously once weekly None None 0 12 11 12 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pharyngolaryngeal pain NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Malaise NON_SYSTEMATIC_ASSESSMENT General disorders None View
Uveitis NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Injection site hypersensitivity NON_SYSTEMATIC_ASSESSMENT General disorders None View
Injection site pruritus NON_SYSTEMATIC_ASSESSMENT General disorders None View
Chest pain NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Injection site reaction NON_SYSTEMATIC_ASSESSMENT General disorders None View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Rhinitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tracheitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Arthropod bite NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Procedural headache NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Traumatic haematoma NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Restlessness NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Glycosuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Haematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Dysmenorrhoea NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Chronic obstructive pulmonary disease NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pharyngolaryngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dermatitis allergic NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Eczema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Transaminases increased NON_SYSTEMATIC_ASSESSMENT Investigations None View