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 @ 4:58 PM
Ignite Modification Date: 2025-12-25 @ 2:39 PM
NCT ID: NCT02570750
Description: Same event may appear as both an adverse event and serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Adverse events data was planned to be reported for overall population.
Frequency Threshold: 0
Time Frame: Baseline up to 1 year
Study: NCT02570750
Study Brief: The Effect Of Smoking Status Of The Patient On The Success Of Etanercept Therapy In 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
Etanercept: Smokers Smoker participants (defined as those who smoke more than 10 cigarettes per day), diagnosed with moderate to severe plaque psoriasis, and who were eligible for initiating the etanercept treatment based on physician's discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection. 1 None 3 68 4 68 View
Etanercept: Non Smokers Non-smoker participants (defined as those who never smoked or quitted smoking at least 1 year prior to the enrollment in study) diagnosed with moderate to severe plaque psoriasis and who were eligible for initiating the etanercept treatment based on physician's discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection. 0 None 2 96 4 96 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Inflammation at site injection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v20.0 View
Diabetic gangrene NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA v20.0 View
Cerebellar haematoma NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v20.0 View
Acute respiratory distress syndrome NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v20.0 View
Erytrodermic psoriasis NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA v20.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Erytrodermic psoriasis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v20.0 View
Injection site erythema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v20.0 View
Leukopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v20.0 View
Proteinuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v20.0 View
Pustular psoriasis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v20.0 View
Increase of serum transaminases NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.0 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v20.0 View