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 @ 1:22 AM
Ignite Modification Date: 2025-12-25 @ 11:32 PM
NCT ID: NCT03839693
Description: None
Frequency Threshold: 0
Time Frame: 26 weeks
Study: NCT03839693
Study Brief: ET-01 in Subjects With Lateral Canthal Lines, LCL-208
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ET-01 1100U botulinum toxin, Type A, Higher Dose 2, 1100U botulinum toxin, Type A: topical liniment 0 None 0 20 5 20 View
ET-01 345U botulinum toxin, Type A, Lower Dose 1, 345U botulinum toxin, Type A: topical liniment 0 None 0 30 4 30 View
Vehicle Vehicle Vehicle: Vehicle Formulation 0 None 0 25 13 25 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Application site pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (21.0) View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (21.0) View
Blepharitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (21.0) View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Cough SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Cystitis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (21.0) View
Dermatitis contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (21.0) View
Dry throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (21.0) View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Ear infection SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA (21.0) View
Endodontic procedure SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (21.0) View
Endometrial ablation SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (21.0) View
Headache SYSTEMATIC_ASSESSMENT General disorders MedDRA (21.0) View
Hordeolum SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (21.0) View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Mammoplasty SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (21.0) View
Nail dystrophy SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (21.0) View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (21.0) View
Nausea SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (21.0) View
Rhinitis allergic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (21.0) View
Sinusitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (21.0) View
Skin discolouration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (21.0) View
Thyroiditis subacute SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA (21.0) View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (21.0) View