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 @ 7:11 PM
Ignite Modification Date: 2025-12-25 @ 4:45 PM
NCT ID: NCT00329303
Description: Averse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
Frequency Threshold: 5
Time Frame: Over the 12 week duration of the study.
Study: NCT00329303
Study Brief: Efficacy of Re-treatment With Cimzia® in Subject With Chronic Plaque Psoriasis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Certolizumab Pegol (CZP) 200 mg Subcutaneous injections of 400 mg initial dose at Week 0 with 200 mg every 2 weeks thereafter 0 None 0 34 9 34 View
Certolizumab Pegol (CZP) 400 mg Subcutaneous injections of 400 mg every 2 weeks 0 None 0 37 11 37 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Tonsillitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Tendonitis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pharyngolaryngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Psoriasis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View