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 @ 10:18 PM

Ignite Modification Date: 2025-12-25 @ 7:51 PM

NCT ID: NCT01709435

Description: Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.

Frequency Threshold: 0

Time Frame: Up to 5 years

Study: NCT01709435

Study Brief: Cabozantinib S-Malate in Treating Younger Patients With Recurrent or Refractory Solid Tumors

Event Groups(If Any):

Event Groups

Title	Description	Deaths # Affected	Deaths # At Risk	Serious # Affected	Serious # At Risk	Other # Affected	Other # At Risk	View

Part A Dose Level 2: 40 mg/m^2	Patients receive 40 mg/m\^2 cabozantinib S-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	1	None	5	9	9	9	View
Part A Dose Level 3: 55 mg/m^2	Patients receive 55 mg/m\^2 cabozantinib S-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	3	None	3	6	6	6	View
Part A Dose Level 1: 30 mg/m^2	Patients receive 30 mg/m\^2 cabozantinib S-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	3	None	3	6	6	6	View
Part B Dose Level 2: 40 mg/m^2	Patients receive 40 mg/m\^2 cabozantinib S-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	2	None	2	4	4	4	View
Part PK Dose Level 2: 40 mg/m^2	Patients receive 40 mg/m\^2 cabozantinib S-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	7	None	6	10	10	10	View
Part PK Dose Level 3: 55 mg/m^2	Patients receive 55 mg/m\^2 cabozantinib S-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	3	None	3	6	6	6	View

Serious Events(If Any):

Serious Events

Term	Type	Organ System	Vocab	View

Adult respiratory distress syndrome	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Agitation	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	None	View
Movements involuntary	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Multi-organ failure	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Somnolence	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Abdominal distension	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Abdominal pain	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Alanine aminotransferase increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Anorexia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Aspartate aminotransferase increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Ataxia	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Blood bilirubin increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Bone pain	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Constipation	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Dehydration	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Depressed level of consciousness	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Diarrhea	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Dysarthria	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Dyspnea	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Ejection fraction decreased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Enterocolitis infectious	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Fatigue	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Headache	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Hydrocephalus	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Hypernatremia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hypertension	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Hypoglycemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hypokalemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hyponatremia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hypoxia	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Ischemia cerebrovascular	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Left ventricular systolic dysfunction	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Lipase increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Lung infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Mitral valve disease	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Pain	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Palmar-plantar erythrodysesthesia syndrome	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Peripheral motor neuropathy	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Pleural effusion	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Proteinuria	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Reversible posterior leukoencephalopathy syndrome	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Seizure	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Skin infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Skin ulceration	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Syncope	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Thromboembolic event	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Tricuspid valve disease	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Tumor pain	SYSTEMATIC_ASSESSMENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	None	View
Urinary tract infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Urine output decreased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Vomiting	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View

Other Events(If Any):

Other Events

Term	Type	Organ System	Vocab	View

Edema limbs	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Electrocardiogram QT corrected interval prolonged	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Encephalopathy	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Enterocolitis infectious	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Epistaxis	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Extraocular muscle paresis	SYSTEMATIC_ASSESSMENT	Eye disorders	None	View
Eye infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Eye pain	SYSTEMATIC_ASSESSMENT	Eye disorders	None	View
Eyelid function disorder	SYSTEMATIC_ASSESSMENT	Eye disorders	None	View
Facial nerve disorder	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Facial pain	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Hearing impaired	SYSTEMATIC_ASSESSMENT	Ear and labyrinth disorders	None	View
Hematuria	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Hemoglobin increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Hemoglobinuria	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Hemolysis	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Hyponatremia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hypophosphatemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hypotension	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Hypothermia	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Hypothyroidism	SYSTEMATIC_ASSESSMENT	Endocrine disorders	None	View
Hypoxia	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
INR increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
IVth nerve disorder	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Ileal obstruction	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Insomnia	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	None	View
Intracranial hemorrhage	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Urinary incontinence	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Urinary retention	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Abdominal distension	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Abdominal pain	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Abducens nerve disorder	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Accessory nerve disorder	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Activated partial thromboplastin time prolonged	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Adrenal insufficiency	SYSTEMATIC_ASSESSMENT	Endocrine disorders	None	View
Agitation	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	None	View
Alanine aminotransferase increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Alkaline phosphatase increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Allergic reaction	SYSTEMATIC_ASSESSMENT	Immune system disorders	None	View
Allergic rhinitis	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Alopecia	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Anal hemorrhage	SYSTEMATIC_ASSESSMENT	Gastrointestinal 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
Aortic valve disease	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Arthralgia	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Aspartate aminotransferase increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Ataxia	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Atelectasis	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Avascular necrosis	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Back pain	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue 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
Bronchopulmonary hemorrhage	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Bruising	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
Burn	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
Buttock pain	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Cardiac troponin I increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Cheilitis	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Chills	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Cholesterol high	SYSTEMATIC_ASSESSMENT	Investigations	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	Respiratory, thoracic and mediastinal disorders	None	View
Fall	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
Fatigue	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Fecal incontinence	SYSTEMATIC_ASSESSMENT	Gastrointestinal 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
Fracture	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
GGT increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Gait disturbance	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Gastritis	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Gastroesophageal reflux disease	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Gastrointestinal pain	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Generalized muscle weakness	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Growth suppression	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Haptoglobin decreased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Head soft tissue necrosis	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Headache	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Hoarseness	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Hot flashes	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Hydrocephalus	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Hypercalcemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hyperglycemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hyperhidrosis	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue 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
Hypersomnia	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Hypertension	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Hyperthyroidism	SYSTEMATIC_ASSESSMENT	Endocrine disorders	None	View
Hypertriglyceridemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition 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
Hypoglycemia	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
Irregular menstruation	SYSTEMATIC_ASSESSMENT	Reproductive system and breast disorders	None	View
Irritability	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Joint effusion	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Joint range of motion decreased	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Laryngitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Lethargy	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Lipase increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Localized edema	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Lung infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Lymph gland infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Lymphedema	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Lymphocyte count decreased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Lymphocyte count increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Malaise	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Memory impairment	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Mitral valve disease	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Mucosal infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Mucositis oral	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Muscle weakness left-sided	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue 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 trunk	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
Neck pain	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Neutrophil count decreased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Non-cardiac chest pain	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Obesity	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Oculomotor nerve disorder	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Optic nerve disorder	SYSTEMATIC_ASSESSMENT	Eye disorders	None	View
Oral dysesthesia	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Oral hemorrhage	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Oral pain	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Osteoporosis	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Otitis media	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Pain	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Pain in extremity	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Pain of skin	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Palmar-plantar erythrodysesthesia syndrome	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Palpitations	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Pancreatic enzymes decreased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Papulopustular rash	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Paresthesia	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Paronychia	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Penile infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Penile pain	SYSTEMATIC_ASSESSMENT	Reproductive system and breast disorders	None	View
Pericardial effusion	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Perineal pain	SYSTEMATIC_ASSESSMENT	Reproductive system and breast disorders	None	View
Periorbital infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Peripheral motor neuropathy	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Peripheral sensory neuropathy	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Personality change	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	None	View
Photophobia	SYSTEMATIC_ASSESSMENT	Eye disorders	None	View
Platelet count decreased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Pleural effusion	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Pleuritic pain	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Pneumonitis	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Pneumothorax	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Productive cough	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Proteinuria	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Pruritus	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Pulmonary hypertension	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Purpura	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue 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 pain	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Right ventricular dysfunction	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Scalp pain	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Scoliosis	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Serum amylase increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Sinus bradycardia	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Sinus disorder	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Sinus pain	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Sinus tachycardia	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Sinusitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	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	Infections and infestations	None	View
Skin ulceration	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Sleep apnea	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Somnolence	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Sore throat	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Stomach pain	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Syncope	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Testicular pain	SYSTEMATIC_ASSESSMENT	Reproductive system and breast disorders	None	View
Tinnitus	SYSTEMATIC_ASSESSMENT	Ear and labyrinth disorders	None	View
Toothache	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Tremor	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Tricuspid valve disease	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Tumor pain	SYSTEMATIC_ASSESSMENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	None	View
Unequal limb length	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Upper respiratory infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Urinary frequency	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Urinary tract infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Urinary tract pain	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Urinary urgency	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Urine discoloration	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Vaginal hemorrhage	SYSTEMATIC_ASSESSMENT	Reproductive system and breast disorders	None	View
Vagus nerve disorder	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Vascular access complication	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
Vomiting	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Vulval infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Weight gain	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Weight loss	SYSTEMATIC_ASSESSMENT	Investigations	None	View
White blood cell decreased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Wound complication	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
Wound dehiscence	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
Creatinine increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Cushingoid	SYSTEMATIC_ASSESSMENT	Endocrine disorders	None	View
Dehydration	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Delayed puberty	SYSTEMATIC_ASSESSMENT	Endocrine disorders	None	View
Dental caries	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Depressed level of consciousness	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Depression	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	None	View
Diarrhea	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Dizziness	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Dry skin	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Dysarthria	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Dysgeusia	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Dysmenorrhea	SYSTEMATIC_ASSESSMENT	Reproductive system and breast disorders	None	View
Dyspepsia	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Dysphagia	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Dyspnea	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Ear pain	SYSTEMATIC_ASSESSMENT	Ear and labyrinth disorders	None	View
Edema face	SYSTEMATIC_ASSESSMENT	General disorders	None	View