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 @ 9:55 PM
Ignite Modification Date: 2025-12-25 @ 7:33 PM
NCT ID: NCT03640832
Description: The Safety Population included all participants who received at least 1 dose of the study product (test or reference product). Treatment-emergent adverse events (TEAEs) were defined as new adverse events (AEs) that occurred on or after the first product application. One participant might have experienced more than one AE during the study. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
Frequency Threshold: 0
Time Frame: up to 21 (+2) days
Study: NCT03640832
Study Brief: A Clinical Study to Investigate the Dermal and Ocular Tolerance of a Developmental Cosmetic Facial Serum Formulation in Healthy Females With Sensitive Skin
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Developmental Facial Serum (Test Product) Participants were randomized to topically (facial) apply Physiogel Developmental Facial Serum, twice daily (morning and evening) to the freshly cleansed skin before applying moisturizer up to 21 (+2) days 0 None 0 44 10 44 View
Physiogel Calming Relief Anti-redness Serum(Reference Product) Participants were randomized to topically (facial) apply Physiogel Calming Relief Anti-Redness Serum, twice daily (morning and evening) to the freshly cleansed skin before applying moisturizer up to 21 (+2) days 0 None 0 46 7 46 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Eye pruritus SYSTEMATIC_ASSESSMENT Eye disorders MedDRA vs 4.0 View
Skin irritation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA vs 4.0 View
Jaw cyst SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA vs 4.0 View
Arthropod bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA vs 4.0 View
Chalazion SYSTEMATIC_ASSESSMENT Eye disorders MedDRA vs 4.0 View
Eye paraesthesia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA vs 4.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA vs 4.0 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA vs 4.0 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA vs 4.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA vs 4.0 View
Dysmenorrhoea SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA vs 4.0 View
Nasal discomfort SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA vs 4.0 View
Acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA vs 4.0 View
Rash macular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA vs 4.0 View
Skin burning sensation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA vs 4.0 View