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: 2025-12-25 @ 3:21 AM
Ignite Modification Date: 2025-12-26 @ 2:00 AM
NCT ID: NCT00656305
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00656305
Study Brief: ExAblate (MRgFUS) Treatment of Metastatic Bone Tumors for the Palliation of Pain
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ExAblate Treatment Arm ExAblate 2000: MR guided focused ultrasound 8 None 8 87 49 87 View
ExAblate Sham Control Arm ExAblate 2000: MR guided focused ultrasound sham 0 None 0 28 1 28 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Death NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Hospitalization SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Hospitalization SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fever SYSTEMATIC_ASSESSMENT Infections and infestations None View
Deep Vein Thrombosis SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Skin burn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Numbness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neuropathy/leg pain SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pain/discomfort SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Apnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Fracture SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View