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 @ 2:58 AM
Ignite Modification Date: 2025-12-26 @ 1:39 AM
NCT ID: NCT02601833
Description: Patients were assessed clinically at baseline, 3, 6 and 12 months, and contacted at 1, 2, 4.5 and 9.5 months. Some categories below have 0 patients at risk of the AE due to the AE only pertaining to one of the treatment arms. The SDF group did not have a restoration, so it could not have a missing restoration or secondary caries on that restoration. The Conventional group's lesion was no longer accessible as it was covered with a restoration, and so the the lesion texture could not be assessed.
Frequency Threshold: 0
Time Frame: 1 year
Study: NCT02601833
Study Brief: Effectiveness of Silver Diamine Fluoride as a Treatment for Caries in Comparison to Traditional Restorative Techniques
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Conventional Caries Management Restorative dental care according to American Academy of Pediatric Dentistry guidelines. This treatment typically includes administration of local anesthesia, placement of rubber dam, caries removal with rotary and hand instruments, and placement of a final restoration. Conventional Caries Management: These children will receive restorative dental care in alignment with the American Academy of Pediatric Dentistry guidelines, within the confines of the Mott Children's Health Center clinic and University of Michigan Pediatric Dental Clinic. 0 None 0 42 3 42 View
Silver Diamine Fluoride This arm will receive Silver Diamine Fluoride applied to their carious lesion, in lieu of restoration placement, with the goal of arresting caries. This is applied at baseline and at 6 Months. Silver Diamine Fluoride: No caries removal will take place. The tooth will be dried and Silver Diamine Fluoride will be placed on the carious dentin until saturated. Excess will be blotted dry with a cotton pellet. 0 None 0 56 36 56 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Radiographic signs of periapical infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Extraction SYSTEMATIC_ASSESSMENT Infections and infestations None View
Active (soft) Lesion SYSTEMATIC_ASSESSMENT Infections and infestations None View
Active (soft) Lesion with Progression SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hard (arrested) Lesion with Progression SYSTEMATIC_ASSESSMENT Infections and infestations None View
Missing Restoration SYSTEMATIC_ASSESSMENT Infections and infestations None View
Secondary caries and lesion progression SYSTEMATIC_ASSESSMENT Infections and infestations None View
Reversible Pulpitis SYSTEMATIC_ASSESSMENT Infections and infestations None View