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 @ 5:49 PM
Ignite Modification Date: 2025-12-25 @ 3:15 PM
NCT ID: NCT03194568
Description: Surgery and Post-operative Phase (Day 0 - POD 90): All AEs \& SAEs will be noted. Extended Follow-up (POD 91-POD 730): All SAEs recorded. Only AEs which are deemed "device related" recorded. Long-term Follow-Up (POD 730 through two years after skeletal maturity): All SAEs identified from the medical records that are considered device related, up to two years after skeletal maturity, will be reported in accordance with FDA requirements. This will be performed under a separate research protocol.
Frequency Threshold: 0
Time Frame: Adverse event data was collected up to 2 years after the date of surgical implant for each subject. Additionally, the majority of the subjects enrolled in this study have also enrolled in an observational long-term follow up study.
Study: NCT03194568
Study Brief: Vertebral Body Tethering Outcomes for Pediatric Idiopathic Scoliosis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Anterior Vertebral Tethering Subjects receiving Anterior Vertebral Tethering intervention. Anterior Vertebral Tether: Vertebral body tethering through anterior thoracoscopic approach under general anesthesia and fluoroscopic guidance. 0 None 6 20 20 20 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Grade IIIB SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Clavien-Dindo View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Grade I SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Clavien-Dindo View
Grade II SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Clavien-Dindo View
Grade I SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Clavien-Dindo View
Grade I SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Clavien-Dindo View
Grade I SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Clavien-Dindo View
Grade I SYSTEMATIC_ASSESSMENT General disorders Clavien-Dindo View
Grade I SYSTEMATIC_ASSESSMENT Cardiac disorders Clavien-Dindo View
Grade I SYSTEMATIC_ASSESSMENT Psychiatric disorders Clavien-Dindo View
Grade I SYSTEMATIC_ASSESSMENT Product Issues Clavien-Dindo View