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 @ 11:47 AM
Ignite Modification Date: 2025-12-26 @ 10:19 AM
NCT ID: NCT00166361
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00166361
Study Brief: Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Memokath 051 Ureteral Stent Subjects assigned to this arm received a Memokath 051 Ureteral Stent. None None 12 14 10 14 View
JJ Stent Subjects assigned to this arm received a JJ stent. None None 2 10 8 10 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalization for urinary tract infection (UTI) SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Surgery related to underlying disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Carcinoid heart disease SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Heart failure related to underlying disease SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ureteral Obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Bowel Obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hospitalization due to disease progression SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Edema of ureter SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Stent migrated into bladder SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypokalemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Dehydration SYSTEMATIC_ASSESSMENT General disorders None View
Acute renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Stent encrustation/obstruction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Acute Chronic Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hydroureteronephrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hospitalization for fractured ankle SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Trouble with stent placement due to faulty guide wire SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Atropy of the kidney SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Nephrectomy SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Partial ureterectomy SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hospitalization for sepsis SYSTEMATIC_ASSESSMENT General disorders None View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Essential hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Flank pain SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Groin pain SYSTEMATIC_ASSESSMENT General disorders None View
Hip pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Iliac pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Leg pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Left lower quadrant pain SYSTEMATIC_ASSESSMENT General disorders None View
Right lower quadrant pain SYSTEMATIC_ASSESSMENT General disorders None View
Thigh pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Acid reflux SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Difficulty eating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bladder spasms SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Decreased renal function SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hydronephrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Renal colic SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Ureterectasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary tract infections (UTI) SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urine leakage SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Burning when urinating SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary urgency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Chills SYSTEMATIC_ASSESSMENT General disorders None View
Deydration SYSTEMATIC_ASSESSMENT General disorders None View
Fall resulting in fractured ribs SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Flu like symptoms SYSTEMATIC_ASSESSMENT General disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Fragility SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Insomnia SYSTEMATIC_ASSESSMENT General disorders None View
Knee weakness SYSTEMATIC_ASSESSMENT General disorders None View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Night Sweats SYSTEMATIC_ASSESSMENT General disorders None View
Weight Loss SYSTEMATIC_ASSESSMENT General disorders None View
Tiredness/fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Weakness SYSTEMATIC_ASSESSMENT General disorders None View
Vasovagal episode SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View