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 @ 12:17 AM
Ignite Modification Date: 2025-12-25 @ 10:20 PM
NCT ID: NCT03638258
Description: All enrolled participants are included in analysis of all-cause mortality. All participants who received ≥1 dose of study therapy are included in analysis of serious adverse events (SAEs) and nonserious adverse events (AEs).
Frequency Threshold: 5
Time Frame: Up to 16 weeks
Study: NCT03638258
Study Brief: The Safety, Efficacy and Pharmacokinetics of ARQ-151 Cream in Subjects 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
Roflumilast Cream 0.3% Roflumilast cream 0.3% was topically applied QD for 12 weeks. 0 None 1 109 8 109 View
Roflumilast Cream 0.15% Roflumilast cream 0.15% was topically applied QD for 12 weeks. 0 None 1 110 7 110 View
Vehicle Cream Vehicle cream matched to roflumilast cream (containing only excipients of active cream) was applied topically QD for 12 weeks. 0 None 2 107 0 107 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Chest pain SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (21.1) View
Malignant melanoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (21.1) View
Basal ganglia infarct SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (21.1) View
Abortion spontaneous SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA (21.1) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.1) View