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 @ 3:20 PM
Ignite Modification Date: 2025-12-25 @ 1:40 PM
NCT ID: NCT01843192
Description: None
Frequency Threshold: 3
Time Frame: Duration of follow-up was scheduled through approximately 4 weeks post surgery
Study: NCT01843192
Study Brief: Powered Echelon Device in VATS Surgery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Lobectomy Subjects undergoing VATS lobectomy None None 4 34 6 34 View
Wedge Resection With Lobectomy Subjects undergoing VATS wedge resection that also required lobectomy None None 2 11 3 11 View
Wedge Resection Subjects undergoing VATS wedge resection None None 2 26 8 26 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Chylothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (12.0) View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Pulmonary air leakage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Haemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (12.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Subcutaneous emphysema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (12.0) View
Vascular injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (12.0) View
Corneal abrasion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (12.0) View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (12.0) View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (12.0) View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (12.0) View
Supraventricular extrasystoles SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (12.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (12.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (12.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (12.0) View
Renal cyst SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (12.0) View
Dyspnoea exertional SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (12.0) View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (12.0) View