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: 2025-12-25 @ 1:24 AM
Ignite Modification Date: 2025-12-25 @ 11:34 PM
NCT ID: NCT04563793
Description: Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device hardware and/or procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device hardware and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
Frequency Threshold: 0
Time Frame: From the time a subject sign the PRESS 2 Study Informed Consent through 3-year visit or study withdrawal. Patients include previously implanted subjects and newly enrolled subjects up to 3 years post-procedure. Data for patients previously implanted includes retrospective data however adverse events were monitored/assess from the time a subject signed the PRESS 2 Study Informed Consent through study completion.
Study: NCT04563793
Study Brief: Postmarket Outcomes Study for Evaluation of the Superion™ Spacer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Superion™ IDS All patients to receive IDS for the treatment of their moderate Lumbar Spinal Stenosis Symptoms. Superion™ IDS: All patients to receive IDS for the treatment of moderate Lumbar Spinal Stenosis symptoms. 0 None 12 129 3 129 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Spinal Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Pneumocystis jirovecii pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Acute coronary syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
COVID-19 pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Osteonecrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Spinal operation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Deep Vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Colitis ulcerative SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Purulent discharge SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Incision site haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View