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 @ 3:55 AM
Ignite Modification Date: 2025-12-26 @ 2:46 AM
NCT ID: NCT01871402
Description: The Safety population included all subjects enrolled in the study who were dispensed the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all enrolled subjects (N=221) were included in the safety population. Most AEs were mild in severity.
Frequency Threshold: 0
Time Frame: Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
Study: NCT01871402
Study Brief: A Comparison of 000-0551 Lotion Versus Vehicle Lotion in Subjects With Plaque Psoriasis (Study -304)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Active Arm Topical lotion, applied twice daily 000-0551 Lotion None None 0 110 2 110 View
Vehicle Arm Topical lotion, applied twice daily Vehicle Lotion None None 0 111 7 111 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (16.0) View
Toothache NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (16.0) View
Application site erythema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (16.0) View
Application site pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (16.0) View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (16.0) View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (16.0) View