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 @ 6:38 PM
Ignite Modification Date: 2025-12-25 @ 4:08 PM
NCT ID: NCT03737357
Description: None
Frequency Threshold: 0
Time Frame: 12 months
Study: NCT03737357
Study Brief: Dental Implants With a SLActive® vs. SLA® Surface
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
SLActive® Implant SLActive® implant: One study test (SLActive® surface) (and simultaneously, in a split-mouth design one study control (SLA® surface) implant (Bone Level Tapered, Roxolid®)) will be placed in two different quadrants of partially edentulous patients. The implants will be placed at premolars, molars and canine positions in the mandible and maxilla (healed extraction sites). Implants will be restored with a single crown or splinted restorations 8 weeks after implant placement. 0 None 2 68 26 68 View
SLA® Implant SLA® implant: One study test (SLActive® surface) (and simultaneously, in a split-mouth design one study control (SLA® surface) implant (Bone Level Tapered, Roxolid®)) will be placed in two different quadrants of partially edentulous patients. The implants will be placed at premolars, molars and canine positions in the mandible and maxilla (healed extraction sites). Implants will be restored with a single crown or splinted restorations 8 weeks after implant placement. 0 None 2 68 26 68 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hernia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Anal fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Biological Complications SYSTEMATIC_ASSESSMENT General disorders None View
Other complications SYSTEMATIC_ASSESSMENT General disorders None View
Mechanical complications SYSTEMATIC_ASSESSMENT Product Issues None View
Biological Complications - hard tissue related SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View