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: 2025-12-25 @ 2:41 AM

Ignite Modification Date: 2025-12-26 @ 1:19 AM

NCT ID: NCT02302833

Description: None

Frequency Threshold: 0

Time Frame: 9 years

Study: NCT02302833

Study Brief: Cabozantinib S-malate in Treating Patients With Metastatic Pheochromocytomas or Paragangliomas That Cannot Be Removed by Surgery

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	Patients with advanced and progressive pheochromocytomas and paragangliomas meeting inclusion and exclusion criteria Patients receive cabozantinib s-malate PO QD on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO	0	None	20	20	20	20	View

Serious Events(If Any):

Serious Events

Term	Type	Organ System	Vocab	View

Abdominal pain	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Anemia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Atelectasis	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Bronchial infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Chest Pain	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Constipation	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Dyspnea	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Gastrointestinal fistula	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Heart Failure	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Heart Failure, Death	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Hypersomnia	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Hypertension	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Left Ventricular systolic dysfunction	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Musculoskeletal and connective tissue disorder-other, Specify	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Myelodysplastic Syndrome, Death	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Nausea	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Oral Hemorrhage	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Pleural effusion	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Small Intestine obstruction	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Stroke	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Surgical and medical Procedures Other, Laminectomy, Tumor resection	SYSTEMATIC_ASSESSMENT	Surgical and medical procedures	None	View
Surgical and medical Procedures Other: Hip Replacement	SYSTEMATIC_ASSESSMENT	Surgical and medical procedures	None	View
Surgical and medical Procedures Other: Laminectomy Sacrum	SYSTEMATIC_ASSESSMENT	Surgical and medical procedures	None	View
Thromboembolic Event	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Urinary Tract Infection	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Vomiting	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View

Other Events(If Any):

Other Events

Term	Type	Organ System	Vocab	View

Abdominal distension	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Abdominal pain	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Activated partial thromboplastin time prolonged	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Agitation	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Alanine aminotransferase increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Alkaline phosphatase increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Allergic rhinitis	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Alopecia	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
ALT increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Anal fistula	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Anal pain	SYSTEMATIC_ASSESSMENT	General disorders	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
Arthralgia	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Ascites	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Aspartate aminotransferase increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Atelectasis	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Back pain	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Bloating	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Blood and lymphatic system disorders	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Blood bilirubin increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Blurred vision	SYSTEMATIC_ASSESSMENT	Eye disorders	None	View
Bone pain	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Bruising	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Burn	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Buttock pain	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Cerebrospinal fluid leakage	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Chills	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Concentration impairment	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	None	View
Confusion	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	None	View
Conjunctivitis	SYSTEMATIC_ASSESSMENT	Eye disorders	None	View
Constipation	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Cough	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Creatinine increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Dehydration	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Depression	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	None	View
Diarrhea	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Dizziness	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Dry mouth	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Dry skin	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Dysgeusia	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Dyspepsia	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Dysphagia	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Dyspnea	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Ear and labyrinth disorders	SYSTEMATIC_ASSESSMENT	Ear and labyrinth disorders	None	View
Edema limbs	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Electrocardiogram QT corrected interval prolonged	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Endocrine disorders	SYSTEMATIC_ASSESSMENT	Endocrine disorders	None	View
Epistaxis	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Erectile dysfunction	SYSTEMATIC_ASSESSMENT	Reproductive system and breast disorders	None	View
Erythema multiforme	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Extraocular muscle paresis	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Eye disorders	SYSTEMATIC_ASSESSMENT	Eye disorders	None	View
Eye pain	SYSTEMATIC_ASSESSMENT	Eye disorders	None	View
Fall	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Fatigue	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Fecal incontinence	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Fever	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Flank pain	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Flatulence	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Flu like symptoms	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Flushing	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Gastroesophageal reflux disease	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Gastrointestinal disorders	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
General disorders and administration site conditions	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Generalized muscle weakness	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
GERD	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Hand and foot syndrome	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Headache	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Heart Failure	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Hematuria	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Hoarseness	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Hot flashes	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Hypercalcemia	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Hyperglycemia	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Hyperhidrosis	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Hyperkalemia	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Hypertension	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Hyperthyroidism	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Hyperuricemia	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Hypoalbuminemia	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Hypocalcemia	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Hypoglycemia	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Hypokalemia	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Hypomagnesemia	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Hyponatremia	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Hypophosphatemia	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Hypotension	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Hypothyroidism	SYSTEMATIC_ASSESSMENT	Endocrine disorders	None	View
Immune system disorders	SYSTEMATIC_ASSESSMENT	Immune system disorders	None	View
INR increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Insomnia	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	None	View
Investigations	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Irregular menstruation	SYSTEMATIC_ASSESSMENT	Reproductive system and breast disorders	None	View
Irritability	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Laryngeal inflammation	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
LDH	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Libido decreased	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Lipase increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Lymphocyte count decreased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Memory impairment	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Metabolism and nutrition disorders	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Mucosal infection	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Mucositis oral	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Muscle weakness lower limb	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Muscle weakness right-sided	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Muscle weakness upper limb	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Musculoskeletal and connective tissue disorder	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Myalgia	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Myelodysplastic syndrome	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Nail ridging	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Nasal congestion	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Nausea	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Neck pain	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Nervous system disorders	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Neutrophil Abs Increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Neutrophil count decreased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Non-cardiac chest pain	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Oral dysesthesia	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Pain	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Pain in extremity	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Palmar-plantar erythrodysesthesia syndrome	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Palpitations	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Paresthesia	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Paronychia	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Periorbital edema	SYSTEMATIC_ASSESSMENT	Eye disorders	None	View
Pharyngeal mucositis	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Photophobia	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Photosensitivity	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Platelet count decreased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Platelet Count increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Pleural effusion	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Pneumonitis	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Proteinuria	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Psychiatric disorders	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	None	View
Rash acneiform	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Rash maculo-papular	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Rectal fistula	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Renal and urinary disorders	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Respiratory, thoracic and mediastinal disorders	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Right hip cramp	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Scalp pain	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Serum amylase increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Sinus Bradycardia	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Sinus tachycardia	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Skin and subcutaneous tissue disorders	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Skin hyperpigmentation	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Skin hypopigmentation	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Skin induration	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Skin infection	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Skin ulceration	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Somnolence	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Sore throat	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Stroke	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Surgical and medical procedures	SYSTEMATIC_ASSESSMENT	Surgical and medical procedures	None	View
Thromboembolic event	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Toothache	SYSTEMATIC_ASSESSMENT	General disorders	None	View
U prot/Creat increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Upper respiratory infection	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Urinary frequency	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Urinary incontinence	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Urinary tract infection	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Urine color change	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Vasculitis	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Vitamin D Deficiency	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Vomiting	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Watering eyes	SYSTEMATIC_ASSESSMENT	Eye disorders	None	View
WBC count increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Weight loss	SYSTEMATIC_ASSESSMENT	General disorders	None	View
White blood cell decreased	SYSTEMATIC_ASSESSMENT	Investigations	None	View