Adverse Events Module

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 @ 9:14 PM
Ignite Modification Date: 2025-12-25 @ 7:03 PM
NCT ID: NCT03534804
Description: Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Frequency Threshold: 0
Time Frame: Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment.
Study: NCT03534804
Study Brief: Cabozantinib Plus Pembrolizumab as First-Line Therapy for Cisplatin-Ineligible Advanced Urothelial Carcinoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cabozantinib and Pembrolizumab, All Patients Cabozantinib: Cabozantinib was administered at 40 mg oral daily. Pembrolizumab: Pembrolizumab was administered at a fixed dose of 200mg intravenously every 3 weeks. 12 None 22 37 37 37 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (5.0) View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (5.0) View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (5.0) View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (5.0) View
Bladder perforation SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (5.0) View
Cardiac disorders - Other, specify SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (5.0) View
Chest pain - cardiac SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (5.0) View
Colonic perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Disease progression SYSTEMATIC_ASSESSMENT General disorders CTCAE (5.0) View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Guillain-Barre syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (5.0) View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (5.0) View
Hepatitis viral SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (5.0) View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (5.0) View
Immune system disorders - Other, specify SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE (5.0) View
Infections and infestations - Other, specify SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (5.0) View
Musculoskeletal and connective tissue disorder - Other, specify SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (5.0) View
Paroxysmal atrial tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (5.0) View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (5.0) View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (5.0) View
Rectal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Renal and urinary disorders - Other, specify SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (5.0) View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (5.0) View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (5.0) View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (5.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Activated partial thromboplastin time prolonged SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (5.0) View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Allergic rhinitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (5.0) View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (5.0) View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (5.0) View
Anosmia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (5.0) View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (5.0) View
Immune system disorders - Other, specify SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE (5.0) View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Sore throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (5.0) View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (5.0) View
Bladder spasm SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (5.0) View
Bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Blurred vision SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (5.0) View
Bullous dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (5.0) View
Cardiac disorders - Other, specify SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (5.0) View
Cardiac troponin I increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Chest wall pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (5.0) View
Chills SYSTEMATIC_ASSESSMENT General disorders CTCAE (5.0) View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (5.0) View
Cognitive disturbance SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Concentration impairment SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (5.0) View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (5.0) View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (5.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (5.0) View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (5.0) View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (5.0) View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (5.0) View
Ear and labyrinth disorders - Other, specify SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE (5.0) View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE (5.0) View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders CTCAE (5.0) View
Electrocardiogram QT corrected interval prolonged SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Endocrine disorders - Other, specify SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE (5.0) View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (5.0) View
Eye disorders - Other, specify SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (5.0) View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (5.0) View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (5.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (5.0) View
Fecal incontinence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE (5.0) View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (5.0) View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Flu like symptoms SYSTEMATIC_ASSESSMENT General disorders CTCAE (5.0) View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders CTCAE (5.0) View
Gastroesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Gastrointestinal disorders - Other, specify SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
General disorders and administration site conditions - Other, specify SYSTEMATIC_ASSESSMENT General disorders CTCAE (5.0) View
Generalized edema SYSTEMATIC_ASSESSMENT General disorders CTCAE (5.0) View
Generalized muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (5.0) View
Hair color changes SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (5.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (5.0) View
Hemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Hoarseness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (5.0) View
Hypercalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (5.0) View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (5.0) View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (5.0) View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (5.0) View
Hypermagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (5.0) View
Hypernatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (5.0) View
Hyperparathyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE (5.0) View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (5.0) View
Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE (5.0) View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (5.0) View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (5.0) View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (5.0) View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (5.0) View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (5.0) View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (5.0) View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (5.0) View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE (5.0) View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (5.0) View
Investigations - Other, specify SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (5.0) View
Malaise SYSTEMATIC_ASSESSMENT General disorders CTCAE (5.0) View
Metabolism and nutrition disorders - Other, specify SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (5.0) View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Muscle cramp SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (5.0) View
Musculoskeletal and connective tissue disorder - Other, specify SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (5.0) View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (5.0) View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (5.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAE (5.0) View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders CTCAE (5.0) View
Oral dysesthesia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE (5.0) View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (5.0) View
Palmar-plantar erythrodysesthesia syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (5.0) View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Pelvic pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (5.0) View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (5.0) View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (5.0) View
Postnasal drip SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (5.0) View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (5.0) View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (5.0) View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (5.0) View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (5.0) View
Renal and urinary disorders - Other, specify SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (5.0) View
Reproductive system and breast disorders - Other, specify SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (5.0) View
Respiratory, thoracic and mediastinal disorders - Other, specify SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (5.0) View
Rhinorrhea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (5.0) View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (5.0) View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (5.0) View
Skin and subcutaneous tissue disorders - Other, specify SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (5.0) View
Skin atrophy SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (5.0) View
Skin ulceration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (5.0) View
Spinal fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (5.0) View
Stomach pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Surgical and medical procedures - Other, specify SYSTEMATIC_ASSESSMENT Surgical and medical procedures CTCAE (5.0) View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (5.0) View
Thrush SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (5.0) View
Tumor pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAE (5.0) View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (5.0) View
Urinary frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (5.0) View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (5.0) View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (5.0) View
Urinary tract obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (5.0) View
Urine output decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Vascular disorders - Other, specify SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (5.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Weight loss SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (5.0) View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (5.0) View