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 @ 5:00 PM
Ignite Modification Date: 2025-12-25 @ 2:41 PM
NCT ID: NCT03445650
Description: None
Frequency Threshold: 0
Time Frame: The period of time when adverse events were collected was approximately 28 weeks.
Study: NCT03445650
Study Brief: RESET Trial - Part 1 - A Phase 3 Trial in Subjects With Sjögren-Larsson Syndrome (SLS)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ADX-102 1% Topical Dermal Cream ADX-102 1% Topical Dermal Cream: ADX-102 1% Topical Dermal Cream administered approximately every 24 hours for 6 months in Part 1 0 None 0 7 6 7 View
Vehicle Topical Dermal Cream Vehicle Topical Dermal Cream: Vehicle of ADX-102 Topical Dermal Cream administered approximately every 24 hours for 6 months in Part 1 0 None 0 4 2 4 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22.0 View
Dermatatitis diaper SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22.0 View
Dry Skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22.0 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22.0 View
Hordeolum SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Pharyngitis streptococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Pneumonia respiratory syncytial viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Feeling hot SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Eosinophilia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 22.0 View
Ichthyosis SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 22.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Skin laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22.0 View
Eosinophil count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View
Iron deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22.0 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 22.0 View