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: 2025-12-26 @ 2:42 PM
Ignite Modification Date: 2025-12-26 @ 2:42 PM
NCT ID: NCT05299606
Description: Participants were evaluated for AEs and SAEs at every study visit from the time of consent through the end-of-study (1 year following the initial ablation procedure).
Frequency Threshold: 2
Time Frame: 1 year following the initial ablation procedure.
Study: NCT05299606
Study Brief: POWER Study (Prospective Transbronchial Microwave + Robotic-Assisted Bronchoscopy)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Transbronchial Microwave Ablation Each participant underwent transbronchial microwave ablation to the target oligometastatic tumor(s) in the peripheral lung. The treating physician used the NEUWAVE FLEX Microwave Ablation System and Accessories, guided by the Auris MONARCH Platform for visualization and access while using cone beam CT (computed tomography) to confirm probe tip placement and final ablation zone. The treating physician determined the ablation time and power used on a case-by-case basis. 1 None 4 12 9 12 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Post-ablation syndrome NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA pref. term View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA pref. term View
Jaundice cholestatic NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA pref. term View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA pref. term View
Hemoptysis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA pref. term View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Post-ablation syndrome NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA pref. term View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA pref. term View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA pref. term View
Hemoptysis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA pref. term View
Pleural effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA pref. term View
Pleuritic pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA pref. term View
Pneumothorax NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA pref. term View
Productive cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA pref. term View
Chest pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA pref. term View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA pref. term View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA pref. term View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA pref. term View
Urinary Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA pref. term View