Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 2:59 PM
Ignite Modification Date: 2025-12-25 @ 1:23 PM
NCT ID: NCT03649659
Description: None
Frequency Threshold: 0
Time Frame: 8 months
Study: NCT03649659
Study Brief: Effectiveness of Silver Diamine Fluoride (SDF) in Arresting Cavitated Caries Lesions
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Silver Diamine Fluoride (SDF) SDF will be applied to the affected teeth twice during the study. Once at screening/baseline and again at the 6-month visit. Silver Diamine Fluoride: SDF will be applied twice during the study 0 None 3 414 103 414 View
Placebo The placebo will be applied to the affected teeth twice during the study. Once at screening/baseline and again at the 6-month visit. Placebo: This is being compared to the SDF and will also be applied twice 0 None 1 416 89 416 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalization due to Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hospitalization for Febrile Seizure SYSTEMATIC_ASSESSMENT General disorders None View
Hospitalization for Dental Abscess SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hospitalization for Appendix Removal SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dental Treatment SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Ear Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastrointestinal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abscess SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Allergic Reaction SYSTEMATIC_ASSESSMENT Immune system disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dental Trauma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Extraoral Staining SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Intraoral Staining SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Oral Erythema SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Surgical Procedure SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Skin and Tissue Disorders SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Sore Throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Oral Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Oral Ulceration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Respiratory Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other SYSTEMATIC_ASSESSMENT General disorders None View
Pulpal Exposure SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View