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 @ 5:25 PM
Ignite Modification Date: 2025-12-25 @ 2:59 PM
NCT ID: NCT01084668
Description: None
Frequency Threshold: 0
Time Frame: Up to 1 year (from the time of participant consent through the final Week 52 visit) plus 70 days following administration of the last dose of physician-prescribed study treatment.
Study: NCT01084668
Study Brief: Quality of Life in Adalimumab Treated Psoriasis Patients Failing Other Biologic Disease Modifying Anti-rheumatic Drugs
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Adalimumab Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatic drug (BDMARD) failure None None 1 42 8 42 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Arthroscopic surgery NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 14.0 View
Ligament rupture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Acute tonsillitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Injection site pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Injection site reaction NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Injection site urticaria NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 14.0 View
Psoriasis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 14.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 14.0 View
Tooth fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View