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 @ 6:27 PM
Ignite Modification Date: 2025-12-25 @ 3:57 PM
NCT ID: NCT03392168
Description: A treatment-emergent adverse event is an event that is temporally associated with administration of study product; events meeting this definition are those with a start date during or after administration of the first dose of study drug through the telephone follow-up in each cohort.
Frequency Threshold: 5
Time Frame: Up to approximately 5 months
Study: NCT03392168
Study Brief: Safety, Pharmacokinetics and Efficacy of ARQ-151 Cream in Adults With Mild to Moderate 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
Cohort 1 - ARQ-151 Cream 0.5% Single-dose application of ARQ-151 cream 0.5% to 25 cm\^2 of psoriatic plaque(s) 0 None 0 8 1 8 View
Cohort 2 - ARQ-151 Cream 0.5% ARQ-151 cream 0.5% applied daily for 28 days to all psoriatic plaques, not exceeding an application area of 5% BSA 0 None 0 30 9 30 View
Cohort 2 - ARQ-151 Cream 0.15% ARQ-151 cream 0.15% applied daily for 28 days to all psoriatic plaques, not exceeding an application area of 5% BSA 0 None 0 28 5 28 View
Cohort 2 - ARQ-151 Vehicle Cream Vehicle cream applied daily for 28 days to all psoriatic plaques, not exceeding an application area of 5% BSA 0 None 0 31 11 31 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.1 View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.1 View
Candiduria NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.1 View
Muscle strain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.1 View
Application site erythema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.1 View
Application site pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.1 View