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: 2025-12-25 @ 12:16 AM
Ignite Modification Date: 2025-12-25 @ 10:19 PM
NCT ID: NCT02967458
Description: None
Frequency Threshold: 0
Time Frame: Assessed for 30 minutes post-injection
Study: NCT02967458
Study Brief: Detection of High Grade Prostate Cancer With Subharmonic Ultrasound Imaging, A Pilot Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Prostate Biopsy Patients Patients who are scheduled for a clinically indicated prostate biopsy, and who are able to undergo contrast enhanced transrectal ultrasound will be included in this single arm study. Each of the study subjects will receive in intravenous infusion of a microbubble contrast agent known as Definity™, (Perflutren Lipid Microsphere, Lantheus Medical Imaging, Inc; N. Billerica, MA). Based upon our previous experience, two vials of Perflutren Lipid Microsphere will be mixed and diluted in 50 ml of normal saline, yielding a concentration of 49.4 μl/ml. For the purpose of contrast-enhanced imaging, Perflutren Lipid Microsphere will be infused over approximately 10-12 minutes, during which time ultrasound imaging and biopsy will be performed. Perflutren Lipid Microsphere Intravenous Suspension: The intravenous administration of Perflutren Lipid Microsphere will provide enhancement of vascular tissue when performing subharmonic prostate ultrasound imaging. This enhancement will be used 0 None 0 55 2 55 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hives NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Throat Tightness NON_SYSTEMATIC_ASSESSMENT General disorders None View