Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 2:15 PM
Ignite Modification Date: 2025-12-25 @ 12:53 PM
NCT ID: NCT00686595
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00686595
Study Brief: A Study to Evaluate the Switch From Etanercept to Infliximab in Subjects With Moderate-to-Severe Psoriasis (Study P05133)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Infliximab 5 mg/kg Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22). None None 7 38 12 38 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Mitral Valve Prolapse None Cardiac disorders MedDRA 12.1 View
Electrocution None General disorders MedDRA 12.1 View
Overdose None Injury, poisoning and procedural complications MedDRA 12.1 View
Completed Suicide None Psychiatric disorders MedDRA 12.1 View
Cyst None General disorders MedDRA 12.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Gastritis None Gastrointestinal disorders MedDRA 12.1 View
Bronchitis None Infections and infestations MedDRA 12.1 View
Dizziness None Nervous system disorders MedDRA 12.1 View
Pruritus None Skin and subcutaneous tissue disorders MedDRA 12.1 View
Rhinitis None Infections and infestations MedDRA 12.1 View
Blood Triglycerides Increased None Investigations MedDRA 12.1 View
Transaminases Increased None Investigations MedDRA 12.1 View