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 @ 11:35 PM
Ignite Modification Date: 2025-12-25 @ 9:24 PM
NCT ID: NCT02280356
Description: None
Frequency Threshold: 5
Time Frame: 1 year
Study: NCT02280356
Study Brief: Radiation Therapy in Combination With Brachytherapy for Clinically Localized, Intermediate Risk Prostate Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Radiation Therapy in Combination With Brachytherapy Patients will undergo low dose rate (LDR) prostate brachytherapy using Pd-103 followed approximately 4 weeks later with hypofractionated image-guided external beam radiation therapy to the prostate \& seminal vesicles. 4 None 0 45 33 45 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Proctitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Erectile dysfunction SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary tract obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary tract pain SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Rectal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Renal and urinary disorders - Other, specify SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Urinary frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary urgency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View