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 @ 3:37 AM
Ignite Modification Date: 2025-12-26 @ 2:21 AM
NCT ID: NCT01578902
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01578902
Study Brief: Hypofractionated Accelerated Radiotherapy for Low Risk Localized 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
Hypofractionated Radiation 35 Gy in 5 fractions of image-guided intensity modulated radiotherapy (IGRT) delivered over 29 days. The co-primary outcome variable (Grade 3+ acute gastrointestinal toxicity) was observed in 0% of patients. None None 2 84 34 84 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
acute urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
rectalcutaneous fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
acute grade 2 genitourinary SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
acute grade 2 gastrointestinal toxicity None Gastrointestinal disorders None View
late grade 2 gastrointestinal toxicity SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
late grade 2 genitourinary toxicity SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
late grade 3+ GI toxicity SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
late grade 3+ GU toxicity SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
acute grade 3+ GU toxicity SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View