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 @ 9:57 PM
Ignite Modification Date: 2025-12-25 @ 7:35 PM
NCT ID: NCT02353832
Description: None
Frequency Threshold: 5
Time Frame: All-Cause Mortality assessed for up to 5 years. Serious and Other Adverse Events assessed for up to 540 days.
Study: NCT02353832
Study Brief: Stereotactic Ablative Radiotherapy (SABR) for Low Risk Prostate Cancer With Injectable Rectal Spacer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Single Arm: Injectable Rectal Spacer Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product) 2 None 0 44 20 44 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Anal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Anorexia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Fecal Incontinence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Bowel Frequency NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Bowel Urgency NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Tenesmus NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Gastrointestinal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Hemorrhoidal Hemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Hemorrhoids NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Pelvic Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Perineal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Proctitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Rectal Hemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Rectal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Rectal Ulcer NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Telangiectasia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Bladder Spasm NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Cystitis Noninfective NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Genital Edema NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Hematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Infection, Site of Spacer NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Prostatic Infection NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Prostatic Obstruction NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Dysuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Urinary Tract Infection NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Weak Urine Stream NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Scrotal Pain NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Urinary Frequency NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Urinary Incontinence NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Urinary Obstruction NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Urinary Retention NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Urinary Tract Pain NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Urinary Urgency NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Decreased Libido NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Ejaculation Disorder NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (4.0) View
Erectile Dysfunction NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (4.0) View
Blood in Semen NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (4.0) View
Anxiety NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Paresthesia NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Rash Acneiform NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Weight Gain NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View