Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 11:57 PM
Ignite Modification Date: 2025-12-25 @ 9:54 PM
NCT ID: NCT01396551
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were recorded from the time of patient implantation until approximately 12 months following the completion of radiotherapy.
Study: NCT01396551
Study Brief: Evaluating an Anchored Transponder in Lung Cancer Patients Receiving Radiation Therapy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Transponder Implantation Implantation of anchored Beacon transponder in the lung: Anchored Beacon transponder has an anchoring feature to secure it in the small airways of the lung. Patients were implanted with 2-3 anchored transponders prior to radiotherapy. Transponders wereused for tumor localization during radiotherapy. 17 None 7 69 36 69 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
acute bronchopneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
consolidation on major fissure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
anethesia induced short cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Contiguous Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
lung infection with pulmonary abcess and bronchopleural fistula SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
imaging evidence of post obstructive pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
wheezing SYSTEMATIC_ASSESSMENT General disorders None View
excoriations in oropharynx SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
fatigue SYSTEMATIC_ASSESSMENT General disorders None View
weakness SYSTEMATIC_ASSESSMENT General disorders None View
neck pain SYSTEMATIC_ASSESSMENT General disorders None View
urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
dyspnea on exertion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
pulmonary edema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
nausea SYSTEMATIC_ASSESSMENT General disorders None View
throat/chest tightness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
headache SYSTEMATIC_ASSESSMENT General disorders None View
dry mouth SYSTEMATIC_ASSESSMENT General disorders None View
chills SYSTEMATIC_ASSESSMENT General disorders None View
sore throat SYSTEMATIC_ASSESSMENT General disorders None View
sputum production SYSTEMATIC_ASSESSMENT General disorders None View
post extubation bronchospasm SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
vomiting SYSTEMATIC_ASSESSMENT General disorders None View
hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
fever SYSTEMATIC_ASSESSMENT General disorders None View
hemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
anchored transponder migration outside the lung SYSTEMATIC_ASSESSMENT Product Issues None View
chest pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View