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 @ 1:16 AM
Ignite Modification Date: 2025-12-25 @ 11:25 PM
NCT ID: NCT03599193
Description: Adverse event data were collected from the time the Informed Consent Form was signed until study product treatment was discontinued, except for spontaneously reported SAEs, which were to be reported up to 30 days after discontinuing study product use.
Frequency Threshold: 5
Time Frame: From the time of study consent until end of treatment or treatment discontinuation (Approximately 21 days).
Study: NCT03599193
Study Brief: A Bioavailability Study of DFD-03 Compared to Tazorac® in Patients With Moderate Acne Vulgaris
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-03 Lotion DFD-03 Lotion was applied to the affected areas twice daily for 1 minute and rinsed off. Thirty four (34) subjects were enrolled into this arm, of whom 32 completed the study. Tazarotene Lotion, 0.1%: DFD-03 (Tazarotene Lotion, 0.1%) applied Twice Daily for 1 minute and rinsed off 0 None 0 34 34 34 View
Tazorac Cream Tazorac Cream was applied to the affected areas once daily and left on for \~12 hours. Twenty four (24) subjects were enrolled into this arm and 21 subjects completed the study. Tazarotene Cream, 0.1%: Tazorac® (tazarotene) Cream, 0.1% applied Once Daily and left for approximately 12 hours 0 None 0 24 23 24 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Application site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Application site exfoliation SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Application site dryness SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Application site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Application site pruritus SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Eczema Asteatotic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.0 View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View