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 @ 2:38 PM
Ignite Modification Date: 2025-12-25 @ 1:10 PM
NCT ID: NCT03585959
Description: An Adverse Event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. This definition includes events related to: 1. the superDimension™ Navigation System v7.2 with Fluoroscopic Navigation Technology and all superDimension™ tools and accessories. 2. the procedures involved, including bronchoscopy and sedation.
Frequency Threshold: 0
Time Frame: Adverse events will be collected after the ENB index procedure has been initiated (defined as introduction of the locatable guide or extended working channel into the subject). Adverse events will be collected immediately post procedure and at 7-day post procedure visit, with a window of 4-7 days post-procedure.
Study: NCT03585959
Study Brief: superDimension™ Navigation System Version 7.2 With Fluoroscopic Navigation Technology
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Fluoroscopic Navigation Arm An Electromagnetic navigation bronchoscopy (ENB) system which provides enhanced three-dimensional fluoroscopy to improve lesion visibility and to compensate for CT-to-body divergence, with an integrated real-time local registration feature allowing the operator to update the catheter position relative to the target during the procedure. superDimension™ Navigation System Version 7.2: superDimension™ Navigation System Version 7.2 with Fluoroscopic Navigation Technology in subjects undergoing lung lesion biopsy 0 None 1 50 7 50 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (21.0) View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (21.0) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (21.0) View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (21.0) View
Urinary Retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (21.0) View