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 @ 5:04 PM
Ignite Modification Date: 2025-12-25 @ 2:44 PM
NCT ID: NCT03400150
Description: CTCAE 4.0
Frequency Threshold: 5
Time Frame: Events within 6 months from implantation
Study: NCT03400150
Study Brief: BioProtect Balloon Implant™ Balloon System Pivotal Study BP-007
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Balloon Group Marking + Balloon implantation + IMRT Balloon implantation 1 None 12 143 108 143 View
Control Group Marking + IMRT Control: Control - Marking \& IMRT are standard of care for prostate cancer - there is no study-specific intervention 0 None 10 79 60 79 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rectal bleeding NON_SYSTEMATIC_ASSESSMENT Product Issues None View
Acute urinary retention NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Cerebral vascular retention NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Rectal wall puncture NON_SYSTEMATIC_ASSESSMENT Product Issues None View
Other NON_SYSTEMATIC_ASSESSMENT Investigations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hot flashes NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Nocturia NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urgent, frequent urination NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Erectile dysfunction NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Burning with urination NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View