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 @ 7:19 PM
Ignite Modification Date: 2025-12-25 @ 4:57 PM
NCT ID: NCT02080403
Description: All randomized patients who were treated with at least 1 study treatment or who underwent subgingival debridement.
Frequency Threshold: 2
Time Frame: Screening through Week 24
Study: NCT02080403
Study Brief: The Efficacy and Safety of Chlorhexidine Gluconate Chip (PerioChip®) in Therapy of Peri-implantitis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment Treatment, 2.5 mg Chlorhexidine Gluconate chip (PerioChip®) inserted every two weeks starting at Baseline for the first 3 months, plus mechanical Subgingival Debridement at Baseline and 3 months. 2.5 mg Chlorhexidine gluconate chip: Subgingival debridement will be carried out for each one of the target implant. Upon completion of the debridement a PerioChip® will be inserted in each one of the target implant. 0 None 4 146 43 146 View
Control Mechanical Subgingival Debridement at Baseline and 3 months. 2 None 3 144 19 144 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Ventricular tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Death NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Diverticulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Forearm fracture NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Colon cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.0 View
Facial paralysis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Implant site pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Post procedural discomfort NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Tooth repair NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 21.0 View
Gingivitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Artificial crown procedure NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 21.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Implant site swelling NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Aphthous ulcer NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Toothache NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Gingival pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View