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 @ 7:51 PM
Ignite Modification Date: 2025-12-25 @ 5:27 PM
NCT ID: NCT02151604
Description: Standard definitions apply. All AEs observed by the investigator or reported by the patient during and for 24 hours following xenon MRI are reported. Only adverse events where there is a reasonable possibility of a relationship to xenon, and any adverse event considered to be of medical interest/ importance are reported. Description, date of onset and end date, severity, assessment of relatedness to trial medication, other suspect drug or device and action taken will be recorded.
Frequency Threshold: 0
Time Frame: Adverse events were collected from the participants from the time of the first bag of xenon inhaled until 2 weeks after the date of the last scan, up to 6 months
Study: NCT02151604
Study Brief: Hyperpolarized Xenon Gas MR Imaging in NSCLC Radiotherapy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
129 Xenon MR Imaging Group Xenon gas is inhaled immediately before acquisition of an MR image to enable the lung structure to be seen. Inhalation of hyperpolarized xenon gas: The xenon gas is inhaled immediately before acquisition of an MR image to enable the lung structure to be seen. Patients with cancer with planned radiotherapy to their thorax which may affect their lungs. Up to 6 xenon scans per visit at baseline (pre-treatment), mid-point, and end fo radiotherapy. Patients would already receive CT chest at the baseline and end-of-treatment visits. 0 None 0 22 14 22 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dysgeusia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Voice alteration NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Euphoria NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sore throat NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Palpitations NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypersalivation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Chest tightness NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Paresthesia (Lips) NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View