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 @ 9:30 PM
Ignite Modification Date: 2025-12-25 @ 7:16 PM
NCT ID: NCT02075632
Description: The safety population included all subjects who used the study medication at least once and completed the Visit 2 study procedures, regardless of the time elapsed from enrollment to that visit. Out of 148 participants, 144 participants qualified for safety population in the occasional itch arm.
Frequency Threshold: 1
Time Frame: Adverse events were collected up to 48 hours after visit 2(14 days)
Study: NCT02075632
Study Brief: Study to Evaluate Product Duration of Use Experience With Alclometasone Dipropionate Cream
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Chronic Condition Participants who suffered from eczema or psoriasis where an anti-itch medication would be used. None None 1 162 4 162 View
Occasional Itch Participants who suffered from occasional itchy skin experiences (such as poison ivy, oak, sumac, insect bites, or skin irritations due to jewelry, cosmetics, detergents, or soaps) where an anti-itch medication would be used. None None 0 144 3 144 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Malignant Neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View