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 @ 3:53 AM
Ignite Modification Date: 2025-12-26 @ 2:42 AM
NCT ID: NCT02886702
Description: None
Frequency Threshold: 1
Time Frame: Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 85 days
Study: NCT02886702
Study Brief: A Study Comparing Tazarotene Cream 0.05% to TAZORAC® (Tazarotene) Cream 0.05% and Both to a Placebo Control in the Treatment of 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
Reference TAZORAC® (tazarotene) Cream 0.05% (Allergan, Inc.) 0 None 0 286 24 286 View
Test Tazarotene Cream 0.05% (Fougera Pharmaceuticals Inc.) 0 None 0 284 31 284 View
Placebo Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.) 0 None 3 285 21 285 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 19.1 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 19.1 View
Prostate cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA Version 19.1 View
Ischaemic nephropathy SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA Version 19.1 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 19.1 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 19.1 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 19.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Application site rash SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 19.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 19.1 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 19.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 19.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 19.1 View
Application site dryness SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 19.1 View
Application site erosion SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 19.1 View
Application site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 19.1 View
Application site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 19.1 View
Application site pruritus SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 19.1 View