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 @ 9:40 PM
Ignite Modification Date: 2025-12-25 @ 7:22 PM
NCT ID: NCT00662532
Description: Adverse Events were a primary outcome measure, so we have used a 1% reporting threshold, rather than the standard 5%
Frequency Threshold: 1
Time Frame: 180 Days
Study: NCT00662532
Study Brief: Antibiotic Study for Dental Implants
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Minocycline HCl 1 mg microspheres of minocycline hydrochloride None None 1 22 6 22 View
No Intervention Control group receiving no drug intervention None None 3 22 4 22 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Volvulus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (12.0) View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA (12.0) View
Lung Neoplasm Malignant SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (12.0) View
Hysterectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (12.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Tooth Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (12.0) View
Onychomycosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (12.0) View
Bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (12.0) View
Tooth Extraction SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (12.0) View
Seasonal Allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA (12.0) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (12.0) View
Ear Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (12.0) View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (12.0) View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (12.0) View
Gastrooesophageal Reflux Disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (12.0) View
Tooth Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (12.0) View
Endodontic Procedure SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (12.0) View
Nodule SYSTEMATIC_ASSESSMENT General disorders MedDRA (12.0) View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA (12.0) View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (12.0) View
Joint Swelling SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (12.0) View
Lichen Planus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (12.0) View