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 @ 3:01 PM
Ignite Modification Date: 2025-12-25 @ 1:25 PM
NCT ID: NCT03764059
Description: None
Frequency Threshold: 0
Time Frame: Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.
Study: NCT03764059
Study Brief: Clinical Study of Filtek™ Bulk Fill Posterior Restorative in Class I and II Restorations
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Investigational Device/Experimental Group: Filtek™ Bulk Fill Posterior Restorative The investigational device, Filtek™ Bulk Fill Posterior Restorative, was used for class 1 or 2 restorative in experimental group. The clinical assessments were performed immediately after restoration and included restoration retention/fracture, marginal fracture, anatomic form/marginal integrity, proximal contact, color match, surface texture/roughness, staining, marginal discoloration/secondary caries and pulp vitality. Subjects returned to the site for follow up visits at 1 week and 1 year postoperative for the same clinical assessments. 0 None 0 120 45 120 View
Control Device/Control Group: Filtek™ Z350XT Universal Restorative The control device, Filtek™ Z350XT Universal Restorative, which was approved by CFDA in 2010 and has been in the market for 5 years with some validated clinical data, was used for class 1 or 2 restorative in control group. The clinical assessments were performed immediately after restoration and included restoration retention/fracture, marginal fracture, anatomic form/marginal integrity, proximal contact, color match, surface texture/roughness, staining, marginal discoloration/secondary caries and pulp vitality. Subjects returned to the site for follow up visits at 1 week and 1 year postoperative for the same clinical assessments. 0 None 0 120 36 120 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Right ankle fracture NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hordeolum NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Pregnancy NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Chronic periodontitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Chronic periapical periodontitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Plaque-induced gingivitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gum bleeding on the target side NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gum pain on the target side NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mild redness and swelling of gingival margin on the target side NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pain of buccal mucosa of target teeth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mucosal ulceration of target teeth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Radiolucent area of root tip of target teeth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Malaise of occlusion of target teeth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Spontaneous discomfort of target teeth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Edge caries of non-target teeth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Non-target residual root NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Falling of filling material of non-target teeth NON_SYSTEMATIC_ASSESSMENT Product Issues None View
Pericoronitis of non-target teeth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Secondary Caries of non-target teeth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Secondary Caries of non-target teeth (after endodontic treatment) NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Reversible pulpitis of non-target teeth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Chronic pulpitis of non-target teeth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Acute attack of chronic pulpitis of non-target teeth NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Non-target caries, gingivitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Sensitivity of non-target teeth after operation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Microdontia of non-target teeth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Wedge-shaped defect of non-target teeth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pulpitis of non-target teeth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dental defect of non-target teeth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gingival ulcer of non-target teeth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Treatment of non-target teeth NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Mild redness and swelling of gingival margin of non-target teeth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Recurrent oral ulcer NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Upper respiratory infection NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Non-target caries NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Post-operative tooth sensitivity NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Impacted wisdom teeth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Wisdom tooth extraction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Acne NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Periodontitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Irregular dentition NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Tooth sensitivity during operation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Kidney stone NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Generalized chronic periodontitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Acute laryngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pain in the injection point of buccal anesthetics NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Redness and swelling of gingiva near middle palatal side NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Coughing NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Chestnut eruption NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Other Treatments NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Gingival margin of palatine side injured by rubber dam NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Gingival edema NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View