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 @ 1:47 AM
Ignite Modification Date: 2025-12-26 @ 12:05 AM
NCT ID: NCT00992394
Description: The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Frequency Threshold: 5
Time Frame: Post baseline period
Study: NCT00992394
Study Brief: Study Comparing 2 Different Strategies For Management of Subjects With Plaque Psoriasis Who Have Responded 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
Stop Arm Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator None None 6 87 25 87 View
Maintenance Arm Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator None None 4 84 32 84 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Angina Pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders t_br2, MedDRA 15.1 View
Inguinal Hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders t_br2, MedDRA 15.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders t_br2, MedDRA 15.1 View
Bacterial Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations t_br2, MedDRA 15.1 View
Escherichia Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations t_br2, MedDRA 15.1 View
Furuncle SYSTEMATIC_ASSESSMENT Infections and infestations t_br2, MedDRA 15.1 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations t_br2, MedDRA 15.1 View
Animal Bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications t_br2, MedDRA 15.1 View
Facial Bones Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications t_br2, MedDRA 15.1 View
Viith Nerve Paralysis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders t_br2, MedDRA 15.1 View
Abortion Spontaneous SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions t_br2, MedDRA 15.1 View
Pregnancy SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions t_br2, MedDRA 15.1 View
Nasal Polyps SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders t_br2, MedDRA 15.1 View
Arterial Stenosis SYSTEMATIC_ASSESSMENT Vascular disorders t_br2, MedDRA 15.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations t_br1, MedDRA 15.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations t_br1, MedDRA 15.1 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations t_br2, MedDRA 15.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders t_br2, MedDRA 15.1 View