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 @ 11:39 PM
Ignite Modification Date: 2025-12-25 @ 9:30 PM
NCT ID: NCT02621151
Description: investigator assessment at each treatment and follow-up visit
Frequency Threshold: 0
Time Frame: AEs and SAEs assessed for 16 weeks (consent through 30 days post treatment); All cause mortality assessed throughout the 5 year study period
Study: NCT02621151
Study Brief: Pembrolizumab (MK3475), Gemcitabine, and Concurrent Hypofractionated Radiation Therapy for Muscle-Invasive Urothelial Cancer of the Bladder
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Pembrolizumab, Gemcitabine, and RT * Lead-in single dose Pembrolizumab 200 mg, intravenously (IV) * Transurethral Resection of Bladder Tumor (TURBT) at pre-RT (maximal) and completion of therapy (diagnostic) * External Beam Radiation Therapy (EBRT) - 52 Gy in 20 fractions over 4 weeks (1 fraction = 2.6 Gy) * Gemcitabine 27 mg/m\^2 IV twice weekly for 4 weeks concurrent with EBRT * Pembrolizumab 200 mg IV every 3 weeks for total 3 doses starting day 1 of EBRT Pembrolizumab Transurethral Resection of Bladder Tumor Gemcitabine External Beam Radiation Therapy 16 None 15 54 54 54 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Aspartate Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations None View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Colonic Perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Immune System Disorders - Other SYSTEMATIC_ASSESSMENT Immune system disorders None View
Leukemia secondary to oncology chemotherapy SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Neoplasms Benign, Malignant And Unspecified (Incl Cysts And Polyps) - Other SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Small Intestinal Obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Upper Respiratory Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary Tract Obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Chest Pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Death SYSTEMATIC_ASSESSMENT General disorders None View
Protein Losing Enteropathy SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal Distention SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Acute Kidney Injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Alanine Aminotransferace Increased SYSTEMATIC_ASSESSMENT Investigations None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders None View
Bladder Spasm SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Blood And Lymphatic System Disorders - Other SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Blood Bilirubin Increased SYSTEMATIC_ASSESSMENT Investigations None View
Bronchial Infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Bruising SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Cardiac Disorders - Other SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chills SYSTEMATIC_ASSESSMENT General disorders None View
Chronic Kidney Disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Cold SYSTEMATIC_ASSESSMENT General disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Creatinine Increase SYSTEMATIC_ASSESSMENT Investigations None View
Cystitis Noninfective SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dry Mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry Skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Otitis Media SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Ear And Labyrinth Disorders - Other SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Elevated Lft SYSTEMATIC_ASSESSMENT Investigations None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Febrile Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Fecal Incontinence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Flu Like Symptoms SYSTEMATIC_ASSESSMENT General disorders None View
Gait Disturbance SYSTEMATIC_ASSESSMENT General disorders None View
Gas SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal Disorders - Other SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
General Disorders And Administration Site Conditions - Other SYSTEMATIC_ASSESSMENT General disorders None View
Generalized Muscle Weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Fecal Urgency SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diverticulosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Loose Stool SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypercalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypermagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypernatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperphosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hyperuricemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Kidney Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infection - Other SYSTEMATIC_ASSESSMENT Infections and infestations None View
Irritability SYSTEMATIC_ASSESSMENT General disorders None View
Flank Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Lower Abdominal Discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pelvic Pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Lymphocyte Count Decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Malaise SYSTEMATIC_ASSESSMENT General disorders None View
Metabolism And Nutrition Disorders, Other SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Musocal Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Muscle Weakness Upper Limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nasal Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Peripheral Sensory Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Proctitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rectal Mucus Discharge SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Rectal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Rectal Spasms SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Rectal Ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Sinus Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sinusitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Skin And Other Subcutaneous Tissue Disorders - Other SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin Infection SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin Lesion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Sneezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sore Throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Stomach Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Supraventricular Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Thromboembolitic Event SYSTEMATIC_ASSESSMENT Vascular disorders None View
Tooth Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary Frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary Incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary Retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary Tract Pain SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary Urgency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Vascular Disorder, Other SYSTEMATIC_ASSESSMENT Vascular disorders None View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Weight Gain SYSTEMATIC_ASSESSMENT Investigations None View
White Blood Cell Decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Gastroesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Rectal Urgency SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Renal And Urinary Disorders - Other SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Retinopathy SYSTEMATIC_ASSESSMENT Eye disorders None View
Sinus Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Arthalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Intraoperative Urinary Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Iron Deficiency Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Platelet Count Decreased SYSTEMATIC_ASSESSMENT Investigations None View