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 @ 3:11 AM
Ignite Modification Date: 2025-12-26 @ 1:50 AM
NCT ID: NCT03179605
Description: Adverse events were collected at every visit (except Screening) by spontaneous reports from subjects and legal guardian, either verbal or recorded in the subject diary, by directed questioning of subjects and legal guardian, and by observation.
Frequency Threshold: 0
Time Frame: 1 month
Study: NCT03179605
Study Brief: Assess the Potential for Adrenal Suppression and Systemic Drug Absorption Following Multiple Dosing With DFD-06
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
DFD-06 Cream This is a single arm, open label study and there will be no reference or control product used in this study DFD06: Apply twice per day for 15 days 0 None 0 22 8 22 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
HPA Axis Suppression SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 21.0 View
Vein collapse SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View
Application Site Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Application Site Pain SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View