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 @ 11:37 PM
Ignite Modification Date: 2025-12-25 @ 9:27 PM
NCT ID: NCT02780856
Description: All adverse events and device deficiencies were collected throughout the study on Adverse Event Forms
Frequency Threshold: 0
Time Frame: 7 to 14 days
Study: NCT02780856
Study Brief: Safety and Performance Evaluation of the Calcivis System
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Sound and Unsound Teeth Sound (ICDAS 0) canines or incisors and unsound (ICDAS 2 or 3) molars or pre-molars - imaging with the Calcivis System Imaging with the Calcivis System: Following identification of both sound and unsound tooth surfaces, the teeth will be air-dried and images of each tooth taken immediately before and after application of a small amount of disclosing solution. The images of each tooth will be overlaid and a resulting demineralization map of the tooth produced, indicating areas of elevated bioluminescence corresponding to free calcium ions on the surface of the tooth (active caries) 0 None 0 110 3 110 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Device Deficiency SYSTEMATIC_ASSESSMENT Product Issues ISO 14155:2011(E) View