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 @ 6:25 PM
Ignite Modification Date: 2025-12-25 @ 3:55 PM
NCT ID: NCT04398368
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were collected from baseline to end of study participation for a total of approximately 24 months on all participants.
Study: NCT04398368
Study Brief: Gemcitabine for the Prevention of Intravesical Recurrence of Urothelial Cancer in Patients With Upper Urinary Tract Urothelial Cancer Undergoing Radical Nephroureterectomy, GEMINI Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Prevention (Gemcitabine Hydrochloride) Patients receive gemcitabine hydrochloride intravesically for at least 1 hour at the time of RNU. Gemcitabine Hydrochloride: Given intravesically 3 None 4 25 19 25 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
atrioventricular block (complete) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cancer recurrence SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nectrotic segment of small intestine SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hearing Impared SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Sore Throat SYSTEMATIC_ASSESSMENT General disorders None View
Facial Flushing SYSTEMATIC_ASSESSMENT General disorders None View
Chest Pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nocturia SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hot Flashes SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Flank Pain SYSTEMATIC_ASSESSMENT General disorders None View
Acute Kidney Injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Penile Pain SYSTEMATIC_ASSESSMENT General disorders None View
Scrotal Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Perineal pain SYSTEMATIC_ASSESSMENT General disorders None View
Bladder Pain SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary Tract Obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Testicular Pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Phantom Pain SYSTEMATIC_ASSESSMENT General disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Chronic Kidney Disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Leg Edema SYSTEMATIC_ASSESSMENT Vascular disorders None View
Fever SYSTEMATIC_ASSESSMENT Immune system disorders None View
Loss of Appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Lightheadedness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Weakness/Fatigue SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Metallic taste SYSTEMATIC_ASSESSMENT General disorders None View
Bladder Leak SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hyperkalemia SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Scalp pain SYSTEMATIC_ASSESSMENT General disorders None View
Weight gain SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypertension SYSTEMATIC_ASSESSMENT General disorders None View
Groin pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Scrotal Bruising SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Knee pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Penile cancer SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Gross hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Abnormal liver function lab values SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Anxiety SYSTEMATIC_ASSESSMENT General disorders None View
Low platelet count SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Elevated creatinine SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Headaches SYSTEMATIC_ASSESSMENT General disorders None View
Urinary urgency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Increased urinary frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Rotation of right foot SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Shortness of breath SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Complete hearing loss SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Ear infection SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Elevated alkaline phosphatase SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Peritonitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Facial numbness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Gastrointestinal bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Increased red blood cell distribution width SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Elevated platelet count SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Spinal stenosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Elevated Blood urea nitrogen SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypocalcemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Low hematocrit SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Low erythrocytes SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
increased alanine aminotransferase (ALT) SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Degenerative arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Ptosis, unilateral SYSTEMATIC_ASSESSMENT Eye disorders None View
Cataract, unilateral SYSTEMATIC_ASSESSMENT Eye disorders None View
Atypical urothelial cells in urine SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hyponatremia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Low Chloride SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Decreased vision function, unilateral SYSTEMATIC_ASSESSMENT Eye disorders None View
Dry eye syndrome, bilateral SYSTEMATIC_ASSESSMENT Eye disorders None View
Bladder Spasm SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Pneumomediastinum SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Subcutaneous emphysema SYSTEMATIC_ASSESSMENT General disorders None View
Hyperlipidemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Fall (loss of balance) SYSTEMATIC_ASSESSMENT General disorders None View
Pneumoperitoneum SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Weight loss SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Osteopenia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Elevated white blood call count SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Unable to pass gas SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fissure, foot SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Polyp, colon SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vivasilar interstitial opacities SYSTEMATIC_ASSESSMENT General disorders None View
Clear cell cystic renal cell cancer SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Ehrlichiosis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Oral dysesthia SYSTEMATIC_ASSESSMENT General disorders None View
abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hemmorrhage SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hematuria SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Thoracic aorta calcification SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View