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 @ 10:18 PM
NCT ID: NCT01686958
Description: Adverse events were assessed and documented at each follow-up visit. The severity was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).
Frequency Threshold: 0
Time Frame: 12 months
Study: NCT01686958
Study Brief: Safety Study of MRI-guided Transurethral Ultrasound Ablation of Prostate Tissue to Treat 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
MR-Guided Transurethral US Ablation MR-Guided Transurethral US Ablation of Prostate Tissue MR-Guided Transurethral US Ablation of Prostate Tissue: The technology is developed to treat patients with organ confined prostate cancer. The therapeutic endpoint of this technology is thermal coagulation of prescribed prostate tissue. None None 2 30 30 30 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Epididymitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary retention NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Epididymitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary retention NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary incontinence NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary stricture NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Rectal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fecal straining NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bloating NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bladder inflammation NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Bladder irritability NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Bladder spasm NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Edema: penile and/or scrotal NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Edema: testicular NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hemorrhagic cystitis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Increased post void urinary residual in bladder NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Nocturia NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Obstructive micturition NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Penile discharge or bleeding NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Prostate anatomical change or discoloration NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Prostate inflammation NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Prostate tissue sloughing NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Scarred urethra NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urethral skin tags NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary frequency NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary hesitancy NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary sensation to void NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary urgency NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urine abnormality NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Erectile dysfunction or worsening erectile function NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Ejaculation disorder NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Hematospermia NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Distended abdomen NON_SYSTEMATIC_ASSESSMENT General disorders None View
Ear drainage NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fever NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hematoma or Ecchymosis: Buttock NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hemtoma or Ecchymosis: Femur NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hematoma or Ecchymosis: Sacral bone NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hyperkalemia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Patient movement at onset of treatment NON_SYSTEMATIC_ASSESSMENT General disorders None View
Raised lump: Back NON_SYSTEMATIC_ASSESSMENT General disorders None View
Sore throat NON_SYSTEMATIC_ASSESSMENT General disorders None View
Dysuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Pain: Back, hips, shoulder, upon catheter removal NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pain: Bladder, penile, perineal, prostate, urethral NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Suprapubic Catheter: bleeding around SPC, urine leaking around SPC, blocked SPC, catheter fell out NON_SYSTEMATIC_ASSESSMENT General disorders None View