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 @ 1:24 AM
Ignite Modification Date: 2025-12-25 @ 11:34 PM
NCT ID: NCT01043393
Description: None
Frequency Threshold: 0
Time Frame: 4 months
Study: NCT01043393
Study Brief: Desoximetasone Spray 0.25%, Hypothalamic Pituitary Adrenal (HPA) Axis Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Psoriasis Involving 10-15% BSA Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of 10-15% of their body surface area (BSA). Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days None None 0 12 3 12 View
Psoriasis Involving >15% of BSA Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of \>15% of their body surface area (BSA). Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days None None 0 12 6 12 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Adrenal Suppression SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 10.0 View
Application Site Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Cyst SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.0 View
Sciatica SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View