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 @ 5:07 AM
Ignite Modification Date: 2025-12-26 @ 4:11 AM
NCT ID: NCT02343627
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT02343627
Study Brief: Safety and Efficacy of NVXT Solution in Mild-to-Moderate Fungal Infection of the Toe Nail
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
NVXT Solution NVXT Solution once daily for 60 days NVXT Solution: NVXT Solution, applied to infected toe nails and 0.5 mm of adjacent skin once daily for 60 days. None None 0 35 7 35 View
Vehicle of Test Product Vehicle of test product, once daily for 60 days Vehicle of test product: Vehicle of test product applied to infected toe nails and 0.5 mm of adjacent skin once daily for 60 days. None None 0 12 3 12 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Common Cold SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pharangitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sinusitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Bronchitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Muscle Spasm SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Exacerbation of Tinea Pedis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View