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: 2025-12-26 @ 12:14 PM
Ignite Modification Date: 2025-12-26 @ 12:14 PM
NCT ID: NCT03914300
Description: None
Frequency Threshold: 0
Time Frame: Up to 2 years
Study: NCT03914300
Study Brief: Testing the Combination of Cabozantinib, Nivolumab, and Ipilimumab (CaboNivoIpi) for Advanced Differentiated Thyroid 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
Treatment (Cabozantinib S-malate, Nivolumab, Ipilimumab) Patients receive cabozantinib S-malate PO QD on days -14 to -1 prior to cycle 1, days 1-42 of cycles 1-4 and days 1-28 of subsequent cycles. Patients also receive nivolumab IV over 30 minutes on days 1, 15, and 29 of cycles 1-4 and day 1 of subsequent cycles and ipilimumab IV over 90 minutes on day 1 of cycles 1-4. Treatment repeats every 42 days for cycles 1-4 and every 28 days for subsequent cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI during screening, and blood sample collection throughout the study. Biospecimen Collection: Undergo blood sample collection Cabozantinib S-malate: Given PO Computed Tomography: Undergo CT Ipilimumab: Given IV Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV 7 None 6 11 11 11 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute Renal Failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE v.5.0 View
Adrenal insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE v.5.0 View
Alanine Aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Altered Mental Status SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v.5.0 View
Aspartate Aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Cardiac troponin increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE v.5.0 View
Diastolic Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v.5.0 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
Electrocardiogram QT corrected interval prolonged SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v.5.0 View
Generalized muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Gamma-Glutamyl Transferase (GGT) Increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Hepatitis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v.5.0 View
Hypercalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE v.5.0 View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE v.5.0 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v.5.0 View
Myocarditis SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v.5.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders CTCAE v.5.0 View
Non-small cell lung cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAE v.5.0 View
Palmar-plantar erythrodysesthesia syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v.5.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v.5.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Adrenal insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE v.5.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE v.5.0 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Axillary hydrandenitis suppurativa SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Bruising SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE v.5.0 View
Calcium decreased-intermittent SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders CTCAE v.5.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE v.5.0 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v.5.0 View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v.5.0 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Dygeusia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v.5.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE v.5.0 View
Electocardiogram QT Corrected interval prolonged SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE v.5.0 View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Gastroesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
General muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Generalized muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
GGT increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v.5.0 View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE v.5.0 View
Hemoptysis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE v.5.0 View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
Hidrandenitis suppurativa SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Hoarseness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Hypermagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Hyperphosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE v.5.0 View
Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE v.5.0 View
Hypertriglyceridemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Hpyophysitis SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE v.5.0 View
Hypopituitarism SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE v.5.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE v.5.0 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE v.5.0 View
Infusion related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE v.5.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE v.5.0 View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Mean cell volume decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Muscle cramp SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v.5.0 View
Myositis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Nail discoloration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Nasal pathway crustiness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v.5.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Orthopnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE v.5.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Palmar-plantar erythrodysesthesia syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v.5.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Platelet count increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE v.5.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Rash acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Rash pustular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Red blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Rhabdomyolysis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Serum amylase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Sinus pain SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v.5.0 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v.5.0 View
Skin rash, bilateral lower legs SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v.5.0 View
Sore throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
Spinal fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE v.5.0 View
Tail bone discomfort SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Throat discomfort SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE v.5.0 View
Total protein decreased- intermittent SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Upper Respiratory Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v.5.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v.5.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Weight loss SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View