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 @ 7:59 PM
Ignite Modification Date: 2025-12-25 @ 5:33 PM
NCT ID: NCT04856904
Description: The safety (SAF) population included the ITT population participants who applied the study drug at least once.
Frequency Threshold: 0
Time Frame: From screening up to Week 28
Study: NCT04856904
Study Brief: Study of Trifarotene Cream to Assess Risk of a Trophic Acne Scar Formation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Trifarotene 50mcg/g Cream Participants applied a thin layer of trifarotene cream to half of their face topically once daily for up to 24 weeks. 0 None 0 121 7 121 View
Trifarotene Vehicle Cream Participants applied a thin layer of trifarotene vehicle cream to another half of their face topically once daily for up to 24 weeks. 0 None 0 121 3 121 View
All Acne Vulgaris Participants All participants applied a thin layer of trifarotene 50 mcg/g cream to half of their face and trifarotene vehicle cream to another half of their face topically once daily for up to 24 weeks. 0 None 0 121 33 121 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
COVID-19 NON_SYSTEMATIC_ASSESSMENT Infections and infestations 24.0 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations 24.0 View
Gastroenteritis viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations 24.0 View
Tooth abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations 24.0 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations 24.0 View
Viral infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations 24.0 View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 24.0 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 24.0 View
Dermatitis contact NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 24.0 View
Erythema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 24.0 View
Skin irritation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 24.0 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 24.0 View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 24.0 View
Food poisoning NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 24.0 View
Hyperaesthesia teeth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 24.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 24.0 View
Skin laceration NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 24.0 View
Arthropod bite NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 24.0 View
Hand fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 24.0 View
Face oedema NON_SYSTEMATIC_ASSESSMENT General disorders 24.0 View
Influenza like illness NON_SYSTEMATIC_ASSESSMENT General disorders 24.0 View
Burning sensation NON_SYSTEMATIC_ASSESSMENT Nervous system disorders 24.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders 24.0 View
Presyncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders 24.0 View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders 24.0 View
SARS-CoV-2 test positive NON_SYSTEMATIC_ASSESSMENT Investigations 24.0 View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders 24.0 View
Sinus congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 24.0 View
Food allergy NON_SYSTEMATIC_ASSESSMENT Immune system disorders 24.0 View
Kidney infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations 24.0 View
Skin tightness NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 24.0 View
Haemorrhoids NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 24.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 24.0 View
Accidental exposure to product NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 24.0 View
Adverse reaction NON_SYSTEMATIC_ASSESSMENT General disorders 24.0 View
Vaccination site pain NON_SYSTEMATIC_ASSESSMENT General disorders 24.0 View
Agitation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders 24.0 View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 24.0 View
Neck pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 24.0 View