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 @ 4:42 AM
Ignite Modification Date: 2025-12-26 @ 3:43 AM
NCT ID: NCT03405818
Description: Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Adverse events were collected for safety population.
Frequency Threshold: 0
Time Frame: Baseline up to Week 52
Study: NCT03405818
Study Brief: An Evaluation of the Safety and Pharmacokinetics of Tavaborole Topical Solution for the Treatment of Fungal Disease of the Toenail in Children and Adolescents
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Kerydin Participants applied Kerydin (tavaborole) 5 percent solution, topically once daily for 48 weeks and followed up to 4 weeks after last dose of study drug. 0 None 1 54 30 54 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Appendicitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18 View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18 View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18 View
Acute sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18 View
Conjunctivitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18 View
Hand-foot-and-mouth disease NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18 View
Paronychia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18 View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18 View
Pilonidal cyst NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18 View
Respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18 View
Tinea pedis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18 View
Tooth infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18 View
Contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18 View
Concussion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18 View
Arthropod sting NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18 View
Eye injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18 View
Forearm fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18 View
Limb injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18 View
Thermal burn NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18 View
Wound NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18 View
Oropharyngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18 View
Sinus congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18 View
Upper respiratory tract congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18 View
Aphthous stomatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18 View
Acne NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18 View
Onychomadesis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18 View
Rash generalised NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18 View
Hypersensitivity NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 18 View
Seasonal allergy NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 18 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18 View
Iron deficiency anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18 View
Application site erythema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18 View
Blood iron decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18 View
Intervertebral disc protrusion NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18 View
Attention deficit/hyperactivity disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18 View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18 View
Nephrotic syndrome NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18 View