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 @ 2:23 PM
Ignite Modification Date: 2025-12-25 @ 12:59 PM
NCT ID: NCT02785159
Description: Adverse events were collected from participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-Baseline safety assessment (Safety Population).
Frequency Threshold: 5
Time Frame: 12 weeks
Study: NCT02785159
Study Brief: Safety and Efficacy of IDP-118 Lotion 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
IDP-118 Lotion Lotion IDP-118 Lotion: Lotion None None 1 60 10 60 View
Tazorac Cream Cream Tazorac Cream: Cream None None 1 57 8 57 View
IDP 118 Vehicle Lotion Lotion IDP-118 Vehicle Lotion: Lotion None None 0 15 4 15 View
IDP-118 Vehicle Cream Cream IDP-118 Vehicle Cream: Cream None None 0 16 0 16 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Skin atrophy NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (18.0) View
Application site pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
Application site pruritis NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
Dermatitis contact NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (18.0) View