Nivolumab Combined With Ipilimumab Versus Sunitinib in Pr... | NCT02231749

ID	Type	Description	Link
2014-001750-42	EudraCT Number

Name	Class
Ono Pharmaceutical Co., Ltd.	INDUSTRY

Label	Type	Description	Intervention Names
Arm A: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg	Experimental	Nivolumab 3 mg/kg combined with Ipilimumab 1 mg/kg solutions intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solutions intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends	Biological: Nivolumab Biological: Ipilimumab
Arm B: Sunitinib 50 mg	Active Comparator	Sunitinib 50 mg capsules by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends After completion of final analysis eligible participants may switch from receiving Sunitinib to receiving Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240mg flat dose IV every 2 weeks	Biological: Nivolumab Biological: Ipilimumab Drug: Sunitinib

Name	Type	Description	Arm Group Labels	Other Names
Nivolumab	Biological		Arm A: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Arm B: Sunitinib 50 mg	BMS-936558

Measure	Description	Time Frame
Objective Response Rate (ORR) in Intermediate/Poor Risk Participants Per Independent Radiology Review Committee (IRRC) Using RECIST v1.1	ORR was defined as the proportion of randomized subjects who achieved a best response of complete response (CR) or partial response (PR) using the RECIST v1.1 criteria based on Independent Radiology Review Committee (IRRC) assessment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), greater than or equal to 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR	From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (assessed up to June 2017, approximately 31 months)
Overall Survival (OS) in Intermediate/Poor-Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC)	OS was defined as the time from randomization to the date of death from any cause. Survival time was censored at the date of last contact ("last known alive date") for subjects who were alive.	From the date of randomization to the date of death (assessed up to June 2017, approximately 31 months)
Progression-Free Survival (PFS) in Intermediate/Poor-Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC)	PFS was defined as the time between the date of randomization and the first date of documented progression, as determined by the IRRC (as per RECIST 1.1 criteria), or death due to any cause, whichever occurred first. Subsequent therapy included anticancer therapy, tumor directed radiotherapy, or tumor directed surgery. Subjects who died without a reported progression were considered to have progressed on the date of their death.	From date of first dose to date of documented disease progression or death due to any cause, whichever occurs first (assessed up to June 2017, approximately 31 months)

Measure	Description	Time Frame
Investigator-assessed Objective Response Rate(ORR) in Any Risk Participants Per IRRC Using RECIST v1.1	ORR was defined as the proportion of randomized subjects who achieved a best response of complete response (CR) or partial response (PR) using the RECIST v1.1 criteria based on IRRC assessment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), greater than or equal to 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution - 0006		Duarte	California	91010	United States
Local Institution - 0057

PubMed Identifier	Type	Citation	Retractions
39060019	Derived	Mantia CM, Jegede OA, Plimack ER, Powles T, Motzer RJ, Tannir NM, Lee CH, Tomita Y, Voss MH, Choueiri TK, Rini BI, Hammers HJ, Escudier B, Albiges L, Rosenblatt L, Atkins MB, Regan MM, McDermott DF. Treatment-free survival and partitioned survival analysis of patients with advanced renal cell carcinoma treated with nivolumab plus ipilimumab versus sunitinib: 5-year update of CheckMate 214. J Immunother Cancer. 2024 Jul 25;12(7):e009495. doi: 10.1136/jitc-2024-009495.
38280218

Label	URL
BMS Clinical Trial Information	View source

ID	Title	Description
FG000	Nivolumab + Ipilimumab	Nivolumab 3 mg/kg combined with Ipilimumab 1 mg/kg solutions intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solutions intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
FG001

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol: Revised Protocol 03	Nov 13, 2017

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0007 affected547 at risk EG0019 affected535 at risk EG0020 affected25 at risk
Aplastic anaemia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Autoimmune neutropenia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Febrile neutropenia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0002 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Immune thrombocytopenia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Neutropenia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Pancytopenia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Splenic lesion	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Thrombocytopenia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Acute coronary syndrome	Cardiac disorders	27.1	Systematic Assessment	EG0002 affected547 at risk EG0013 affected535 at risk EG0020 affected25 at risk
Acute myocardial infarction	Cardiac disorders	27.1	Systematic Assessment	EG0003 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Angina pectoris	Cardiac disorders	27.1	Systematic Assessment	EG0002 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Arrhythmia	Cardiac disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Atrial fibrillation	Cardiac disorders	27.1	Systematic Assessment	EG0003 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Cardiac arrest	Cardiac disorders	27.1	Systematic Assessment	EG0003 affected547 at risk EG0012 affected535 at risk EG0020 affected25 at risk
Cardiac failure	Cardiac disorders	27.1	Systematic Assessment	EG0004 affected547 at risk EG0013 affected535 at risk EG0020 affected25 at risk
Cardiac failure chronic	Cardiac disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Cardiac failure congestive	Cardiac disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0013 affected535 at risk EG0020 affected25 at risk
Cardio-respiratory arrest	Cardiac disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0012 affected535 at risk EG0020 affected25 at risk
Cardiopulmonary failure	Cardiac disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Cardiovascular disorder	Cardiac disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Coronary artery stenosis	Cardiac disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Myocardial infarction	Cardiac disorders	27.1	Systematic Assessment	EG0008 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Myocarditis	Cardiac disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Pericardial effusion	Cardiac disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Right ventricular failure	Cardiac disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Sinus bradycardia	Cardiac disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Sinus node dysfunction	Cardiac disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Tachycardia	Cardiac disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Ventricular fibrillation	Cardiac disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Thyroglossal cyst	Congenital, familial and genetic disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Vertigo	Ear and labyrinth disorders	27.1	Systematic Assessment	EG0003 affected547 at risk EG0012 affected535 at risk EG0021 affected25 at risk
Addison's disease	Endocrine disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Adrenal insufficiency	Endocrine disorders	27.1	Systematic Assessment	EG00013 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Adrenocortical insufficiency acute	Endocrine disorders	27.1	Systematic Assessment	EG0002 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Adrenocorticotropic hormone deficiency	Endocrine disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Autoimmune hypothyroidism	Endocrine disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Goitre	Endocrine disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Graves' disease	Endocrine disorders	27.1	Systematic Assessment	EG0002 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Hyperthyroidism	Endocrine disorders	27.1	Systematic Assessment	EG0003 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Hypophysitis	Endocrine disorders	27.1	Systematic Assessment	EG00014 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Hypopituitarism	Endocrine disorders	27.1	Systematic Assessment	EG0002 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Hypothalamo-pituitary disorder	Endocrine disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Hypothyroidism	Endocrine disorders	27.1	Systematic Assessment	EG0003 affected547 at risk EG0012 affected535 at risk EG0020 affected25 at risk
Secondary adrenocortical insufficiency	Endocrine disorders	27.1	Systematic Assessment	EG0002 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Steroid withdrawal syndrome	Endocrine disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Thyroiditis	Endocrine disorders	27.1	Systematic Assessment	EG0003 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Cataract	Eye disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Diplopia	Eye disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Eye pain	Eye disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Glaucoma	Eye disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Inflammation of lacrimal passage	Eye disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Macular hole	Eye disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Visual field defect	Eye disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Abdominal pain	Gastrointestinal disorders	27.1	Systematic Assessment	EG0008 affected547 at risk EG0016 affected535 at risk EG0021 affected25 at risk
Abdominal pain upper	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Anal fistula	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Ascites	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Autoimmune colitis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Colitis	Gastrointestinal disorders	27.1	Systematic Assessment	EG00011 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Constipation	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Dental caries	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Diarrhoea	Gastrointestinal disorders	27.1	Systematic Assessment	EG00029 affected547 at risk EG0015 affected535 at risk EG0020 affected25 at risk
Diarrhoea haemorrhagic	Gastrointestinal disorders	27.1	Systematic Assessment	EG0002 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Diverticular perforation	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Duodenal obstruction	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Duodenal ulcer	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Duodenitis haemorrhagic	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Dysphagia	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Enterocolitis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0011 affected535 at risk EG0021 affected25 at risk
Enterovesical fistula	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Gastric haemorrhage	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Gastric ulcer	Gastrointestinal disorders	27.1	Systematic Assessment	EG0002 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Gastritis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	27.1	Systematic Assessment	EG0002 affected547 at risk EG0016 affected535 at risk EG0020 affected25 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Ileus	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Immune-mediated enterocolitis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Inguinal hernia	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Intestinal obstruction	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Intestinal perforation	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Intussusception	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Large intestine perforation	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0012 affected535 at risk EG0020 affected25 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Malabsorption	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Nausea	Gastrointestinal disorders	27.1	Systematic Assessment	EG00010 affected547 at risk EG0013 affected535 at risk EG0020 affected25 at risk
Oesophagitis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Oesophagitis ulcerative	Gastrointestinal disorders	27.1	Systematic Assessment	EG0002 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Pancreatitis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0007 affected547 at risk EG0016 affected535 at risk EG0020 affected25 at risk
Pancreatitis acute	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0013 affected535 at risk EG0021 affected25 at risk
Rectal haemorrhage	Gastrointestinal disorders	27.1	Systematic Assessment	EG0002 affected547 at risk EG0012 affected535 at risk EG0020 affected25 at risk
Retroperitoneal haemorrhage	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Small intestinal obstruction	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Stomatitis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0012 affected535 at risk EG0020 affected25 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0012 affected535 at risk EG0020 affected25 at risk
Vomiting	Gastrointestinal disorders	27.1	Systematic Assessment	EG0007 affected547 at risk EG0014 affected535 at risk EG0020 affected25 at risk
Adhesion	General disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Asthenia	General disorders	27.1	Systematic Assessment	EG0002 affected547 at risk EG0016 affected535 at risk EG0020 affected25 at risk
Chest discomfort	General disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Chest pain	General disorders	27.1	Systematic Assessment	EG0004 affected547 at risk EG0012 affected535 at risk EG0020 affected25 at risk
Death	General disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Fatigue	General disorders	27.1	Systematic Assessment	EG0004 affected547 at risk EG0016 affected535 at risk EG0020 affected25 at risk
Gait disturbance	General disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
General physical health deterioration	General disorders	27.1	Systematic Assessment	EG0008 affected547 at risk EG0018 affected535 at risk EG0020 affected25 at risk
Influenza like illness	General disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Malaise	General disorders	27.1	Systematic Assessment	EG0003 affected547 at risk EG0012 affected535 at risk EG0020 affected25 at risk
Mucosal inflammation	General disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Non-cardiac chest pain	General disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Oedema peripheral	General disorders	27.1	Systematic Assessment	EG0002 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Pain	General disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0014 affected535 at risk EG0020 affected25 at risk
Pyrexia	General disorders	27.1	Systematic Assessment	EG00027 affected547 at risk EG0019 affected535 at risk EG0020 affected25 at risk
Sudden death	General disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0013 affected535 at risk EG0020 affected25 at risk
Autoimmune hepatitis	Hepatobiliary disorders	27.1	Systematic Assessment	EG0002 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Biliary colic	Hepatobiliary disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0012 affected535 at risk EG0020 affected25 at risk
Biliary obstruction	Hepatobiliary disorders	27.1	Systematic Assessment	EG0002 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Cholangitis	Hepatobiliary disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Cholangitis acute	Hepatobiliary disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Cholecystitis	Hepatobiliary disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0014 affected535 at risk EG0020 affected25 at risk
Cholecystitis acute	Hepatobiliary disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Cholelithiasis	Hepatobiliary disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0012 affected535 at risk EG0021 affected25 at risk
Drug-induced liver injury	Hepatobiliary disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Gallbladder disorder	Hepatobiliary disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Gallbladder obstruction	Hepatobiliary disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Hepatic failure	Hepatobiliary disorders	27.1	Systematic Assessment	EG0002 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Hepatic function abnormal	Hepatobiliary disorders	27.1	Systematic Assessment	EG0002 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Hepatic pain	Hepatobiliary disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Hepatitis	Hepatobiliary disorders	27.1	Systematic Assessment	EG0004 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Hepatitis acute	Hepatobiliary disorders	27.1	Systematic Assessment	EG0002 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Hepatitis toxic	Hepatobiliary disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Hepatobiliary disease	Hepatobiliary disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Hepatotoxicity	Hepatobiliary disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Hypertransaminasaemia	Hepatobiliary disorders	27.1	Systematic Assessment	EG0002 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Jaundice	Hepatobiliary disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Jaundice cholestatic	Hepatobiliary disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0012 affected535 at risk EG0020 affected25 at risk
Portal vein thrombosis	Hepatobiliary disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Anaphylactic reaction	Immune system disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Autoimmune disorder	Immune system disorders	27.1	Systematic Assessment	EG0002 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Contrast media allergy	Immune system disorders	27.1	Systematic Assessment	EG0003 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Hypersensitivity	Immune system disorders	27.1	Systematic Assessment	EG0002 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Abdominal abscess	Infections and infestations	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0021 affected25 at risk
Abdominal infection	Infections and infestations	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Anal abscess	Infections and infestations	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0021 affected25 at risk
Appendicitis	Infections and infestations	27.1	Systematic Assessment	EG0002 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Appendicitis perforated	Infections and infestations	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Bronchitis	Infections and infestations	27.1	Systematic Assessment	EG0002 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Bronchopulmonary aspergillosis	Infections and infestations	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
COVID-19	Infections and infestations	27.1	Systematic Assessment	EG0002 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Cellulitis	Infections and infestations	27.1	Systematic Assessment	EG0004 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Cholecystitis infective	Infections and infestations	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0021 affected25 at risk
Conjunctivitis	Infections and infestations	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Diverticulitis	Infections and infestations	27.1	Systematic Assessment	EG0001 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Encephalitis	Infections and infestations	27.1	Systematic Assessment	EG0002 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Enterococcal sepsis	Infections and infestations	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Epididymitis	Infections and infestations	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Escherichia infection	Infections and infestations	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Gastroenteritis	Infections and infestations	27.1	Systematic Assessment	EG0003 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Gastrointestinal fungal infection	Infections and infestations	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Herpes zoster disseminated	Infections and infestations	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Infected skin ulcer	Infections and infestations	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Infection	Infections and infestations	27.1	Systematic Assessment	EG0002 affected547 at risk EG0012 affected535 at risk EG0021 affected25 at risk
Infectious mononucleosis	Infections and infestations	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Influenza	Infections and infestations	27.1	Systematic Assessment	EG0001 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Intestinal sepsis	Infections and infestations	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Laryngitis	Infections and infestations	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Lower respiratory tract infection	Infections and infestations	27.1	Systematic Assessment	EG0003 affected547 at risk EG0013 affected535 at risk EG0020 affected25 at risk
Lung abscess	Infections and infestations	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Meningitis aseptic	Infections and infestations	27.1	Systematic Assessment	EG0002 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Oesophageal candidiasis	Infections and infestations	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Paronychia	Infections and infestations	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Peritonsillar abscess	Infections and infestations	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Pneumocystis jirovecii pneumonia	Infections and infestations	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Pneumonia	Infections and infestations	27.1	Systematic Assessment	EG00029 affected547 at risk EG00112 affected535 at risk EG0020 affected25 at risk
Pneumonia aspiration	Infections and infestations	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Pneumonia bacterial	Infections and infestations	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Pulmonary sepsis	Infections and infestations	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Rectal abscess	Infections and infestations	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Respiratory tract infection	Infections and infestations	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Sepsis	Infections and infestations	27.1	Systematic Assessment	EG00012 affected547 at risk EG0017 affected535 at risk EG0021 affected25 at risk
Septic shock	Infections and infestations	27.1	Systematic Assessment	EG0003 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Soft tissue infection	Infections and infestations	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Upper respiratory tract infection	Infections and infestations	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Urinary tract infection	Infections and infestations	27.1	Systematic Assessment	EG0009 affected547 at risk EG0012 affected535 at risk EG0020 affected25 at risk
Urosepsis	Infections and infestations	27.1	Systematic Assessment	EG0001 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Viral infection	Infections and infestations	27.1	Systematic Assessment	EG0001 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Contusion	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Fall	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0001 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Femur fracture	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0001 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Fracture	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Hip fracture	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0002 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Humerus fracture	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0001 affected547 at risk EG0012 affected535 at risk EG0020 affected25 at risk
Incisional hernia	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0002 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Injury	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0001 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Joint dislocation	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0001 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Pneumonitis chemical	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Product administration error	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Seroma	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Traumatic fracture	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Upper limb fracture	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Wound	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Wrist fracture	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0001 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Activated partial thromboplastin time prolonged	Investigations	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Alanine aminotransferase increased	Investigations	27.1	Systematic Assessment	EG00010 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Aspartate aminotransferase increased	Investigations	27.1	Systematic Assessment	EG0005 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Blood bilirubin increased	Investigations	27.1	Systematic Assessment	EG0002 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Blood creatinine increased	Investigations	27.1	Systematic Assessment	EG0006 affected547 at risk EG0012 affected535 at risk EG0020 affected25 at risk
Blood potassium increased	Investigations	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Influenza A virus test positive	Investigations	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Lipase increased	Investigations	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Liver function test increased	Investigations	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Pancreatic enzymes increased	Investigations	27.1	Systematic Assessment	EG0002 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Platelet count decreased	Investigations	27.1	Systematic Assessment	EG0001 affected547 at risk EG0014 affected535 at risk EG0020 affected25 at risk
Respiratory syncytial virus test positive	Investigations	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Transaminases increased	Investigations	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Troponin increased	Investigations	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Acidosis	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Decreased appetite	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0002 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Dehydration	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0008 affected547 at risk EG00111 affected535 at risk EG0020 affected25 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Diabetic complication	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0002 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Failure to thrive	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Fulminant type 1 diabetes mellitus	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0002 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Hypercalcaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0006 affected547 at risk EG0015 affected535 at risk EG0020 affected25 at risk
Hyperglycaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0007 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Hyperkalaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0002 affected547 at risk EG0012 affected535 at risk EG0020 affected25 at risk
Hypervolaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Hypoglycaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0004 affected547 at risk EG0013 affected535 at risk EG0020 affected25 at risk
Hypokalaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0002 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0012 affected535 at risk EG0020 affected25 at risk
Hyponatraemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG00011 affected547 at risk EG0015 affected535 at risk EG0020 affected25 at risk
Hypophosphataemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Type 1 diabetes mellitus	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0002 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0007 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Arthritis	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0003 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Back pain	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0007 affected547 at risk EG0014 affected535 at risk EG0020 affected25 at risk
Bone pain	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0002 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Fistula	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Flank pain	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Groin pain	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0003 affected547 at risk EG0012 affected535 at risk EG0020 affected25 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Myalgia	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Myositis	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Neck mass	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Neck pain	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0013 affected535 at risk EG0020 affected25 at risk
Osteolysis	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Osteonecrosis of jaw	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0012 affected535 at risk EG0021 affected25 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0002 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0004 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Sjogren's syndrome	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Synovial cyst	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Synovitis	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0002 affected547 at risk EG0014 affected535 at risk EG0020 affected25 at risk
Brain neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0001 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Cholangiocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Diffuse large B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Gastric adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG00046 affected547 at risk EG00174 affected535 at risk EG0020 affected25 at risk
Metastases to adrenals	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0003 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0004 affected547 at risk EG0014 affected535 at risk EG0020 affected25 at risk
Metastases to kidney	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Metastatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Metastatic renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0002 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0000 affected547 at risk EG0012 affected535 at risk EG0021 affected25 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0002 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Small intestine adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0001 affected547 at risk EG0012 affected535 at risk EG0020 affected25 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Tumour thrombosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Aphasia	Nervous system disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Bell's palsy	Nervous system disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Brain oedema	Nervous system disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Central nervous system lesion	Nervous system disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Cerebral haemorrhage	Nervous system disorders	27.1	Systematic Assessment	EG0003 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Cerebral infarction	Nervous system disorders	27.1	Systematic Assessment	EG0003 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Cerebrovascular accident	Nervous system disorders	27.1	Systematic Assessment	EG0004 affected547 at risk EG0012 affected535 at risk EG0020 affected25 at risk
Cervical cord compression	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Dysarthria	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Embolic cerebral infarction	Nervous system disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Encephalopathy	Nervous system disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Facial nerve disorder	Nervous system disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Facial paresis	Nervous system disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Haemorrhage intracranial	Nervous system disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0012 affected535 at risk EG0020 affected25 at risk
Headache	Nervous system disorders	27.1	Systematic Assessment	EG0003 affected547 at risk EG0012 affected535 at risk EG0020 affected25 at risk
Hemiplegia	Nervous system disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
IIIrd nerve paralysis	Nervous system disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Intracranial aneurysm	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Intracranial pressure increased	Nervous system disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Ischaemic stroke	Nervous system disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Myasthenia gravis	Nervous system disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Neuropathy peripheral	Nervous system disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Paraesthesia	Nervous system disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Paraparesis	Nervous system disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Peripheral motor neuropathy	Nervous system disorders	27.1	Systematic Assessment	EG0002 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Polyneuropathy	Nervous system disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Seizure	Nervous system disorders	27.1	Systematic Assessment	EG0006 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Somnolence	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Speech disorder	Nervous system disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Spinal cord compression	Nervous system disorders	27.1	Systematic Assessment	EG0004 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Subarachnoid haemorrhage	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0012 affected535 at risk EG0020 affected25 at risk
Syncope	Nervous system disorders	27.1	Systematic Assessment	EG0003 affected547 at risk EG0012 affected535 at risk EG0020 affected25 at risk
Thecal sac compression	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Transient ischaemic attack	Nervous system disorders	27.1	Systematic Assessment	EG0002 affected547 at risk EG0012 affected535 at risk EG0021 affected25 at risk
Trigeminal neuralgia	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Pregnancy	Pregnancy, puerperium and perinatal conditions	27.1	Systematic Assessment	EG0001 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Device breakage	Product Issues	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Anxiety	Psychiatric disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Confusional state	Psychiatric disorders	27.1	Systematic Assessment	EG0008 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Delirium	Psychiatric disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Depression	Psychiatric disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0012 affected535 at risk EG0020 affected25 at risk
Mental status changes	Psychiatric disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Suicide attempt	Psychiatric disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Acute kidney injury	Renal and urinary disorders	27.1	Systematic Assessment	EG00014 affected547 at risk EG0019 affected535 at risk EG0020 affected25 at risk
Autoimmune nephritis	Renal and urinary disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Haematuria	Renal and urinary disorders	27.1	Systematic Assessment	EG0002 affected547 at risk EG0019 affected535 at risk EG0021 affected25 at risk
Hydronephrosis	Renal and urinary disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0012 affected535 at risk EG0020 affected25 at risk
Micturition urgency	Renal and urinary disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Nephritis	Renal and urinary disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Nephrolithiasis	Renal and urinary disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Polyuria	Renal and urinary disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Renal failure	Renal and urinary disorders	27.1	Systematic Assessment	EG0003 affected547 at risk EG0013 affected535 at risk EG0020 affected25 at risk
Renal impairment	Renal and urinary disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0012 affected535 at risk EG0020 affected25 at risk
Renal injury	Renal and urinary disorders	27.1	Systematic Assessment	EG0002 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Renal mass	Renal and urinary disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Tubulointerstitial nephritis	Renal and urinary disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Urinary retention	Renal and urinary disorders	27.1	Systematic Assessment	EG0002 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Urinary tract obstruction	Renal and urinary disorders	27.1	Systematic Assessment	EG0002 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Ovarian cyst	Reproductive system and breast disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Prostatitis	Reproductive system and breast disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Uterine haemorrhage	Reproductive system and breast disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Acquired diaphragmatic eventration	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Bronchial obstruction	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0002 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Chylothorax	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Cough	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0002 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG00013 affected547 at risk EG00113 affected535 at risk EG0020 affected25 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0013 affected535 at risk EG0020 affected25 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0013 affected535 at risk EG0020 affected25 at risk
Hydrothorax	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0012 affected535 at risk EG0020 affected25 at risk
Immune-mediated lung disease	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0002 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Laryngeal dyspnoea	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Laryngeal oedema	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Lung consolidation	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Malignant pleural effusion	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Orthopnoea	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0009 affected547 at risk EG00112 affected535 at risk EG0020 affected25 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG00018 affected547 at risk EG0013 affected535 at risk EG0020 affected25 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0003 affected547 at risk EG0013 affected535 at risk EG0020 affected25 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0006 affected547 at risk EG0015 affected535 at risk EG0020 affected25 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0002 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Reflux laryngitis	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0002 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Drug eruption	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Erythema multiforme	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0021 affected25 at risk
Haemorrhage subcutaneous	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Pruritus	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Rash	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG0002 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG0002 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Stevens-Johnson syndrome	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Immobile	Social circumstances	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Pregnancy of partner	Social circumstances	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Angiopathy	Vascular disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Aortic dissection	Vascular disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Deep vein thrombosis	Vascular disorders	27.1	Systematic Assessment	EG0002 affected547 at risk EG0013 affected535 at risk EG0020 affected25 at risk
Embolism	Vascular disorders	27.1	Systematic Assessment	EG0002 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Haematoma	Vascular disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Hypertension	Vascular disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0013 affected535 at risk EG0020 affected25 at risk
Hypotension	Vascular disorders	27.1	Systematic Assessment	EG0004 affected547 at risk EG0012 affected535 at risk EG0020 affected25 at risk
Orthostatic hypotension	Vascular disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Peripheral arterial occlusive disease	Vascular disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Peripheral ischaemia	Vascular disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG0011 affected535 at risk EG0020 affected25 at risk
Shock	Vascular disorders	27.1	Systematic Assessment	EG0002 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Thrombosis	Vascular disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Vein rupture	Vascular disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Vena cava thrombosis	Vascular disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Venous occlusion	Vascular disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Venous thrombosis	Vascular disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG00091 affected547 at risk EG001116 affected535 at risk EG0029 affected25 at risk
Leukopenia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0004 affected547 at risk EG00133 affected535 at risk EG0024 affected25 at risk
Neutropenia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0008 affected547 at risk EG00175 affected535 at risk EG0025 affected25 at risk
Thrombocytopenia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG00016 affected547 at risk EG001101 affected535 at risk EG0022 affected25 at risk
Adrenal insufficiency	Endocrine disorders	27.1	Systematic Assessment	EG00034 affected547 at risk EG0010 affected535 at risk EG0020 affected25 at risk
Hyperthyroidism	Endocrine disorders	27.1	Systematic Assessment	EG00064 affected547 at risk EG00119 affected535 at risk EG0022 affected25 at risk
Hypothyroidism	Endocrine disorders	27.1	Systematic Assessment	EG000107 affected547 at risk EG001155 affected535 at risk EG0029 affected25 at risk
Vision blurred	Eye disorders	27.1	Systematic Assessment	EG00034 affected547 at risk EG00111 affected535 at risk EG0020 affected25 at risk
Abdominal distension	Gastrointestinal disorders	27.1	Systematic Assessment	EG00015 affected547 at risk EG00127 affected535 at risk EG0022 affected25 at risk
Abdominal pain	Gastrointestinal disorders	27.1	Systematic Assessment	EG00079 affected547 at risk EG00192 affected535 at risk EG0026 affected25 at risk
Abdominal pain upper	Gastrointestinal disorders	27.1	Systematic Assessment	EG00032 affected547 at risk EG00147 affected535 at risk EG0024 affected25 at risk
Constipation	Gastrointestinal disorders	27.1	Systematic Assessment	EG000112 affected547 at risk EG001106 affected535 at risk EG0023 affected25 at risk
Diarrhoea	Gastrointestinal disorders	27.1	Systematic Assessment	EG000230 affected547 at risk EG001318 affected535 at risk EG00215 affected25 at risk
Dry mouth	Gastrointestinal disorders	27.1	Systematic Assessment	EG00040 affected547 at risk EG00138 affected535 at risk EG0022 affected25 at risk
Dyspepsia	Gastrointestinal disorders	27.1	Systematic Assessment	EG00034 affected547 at risk EG001114 affected535 at risk EG0024 affected25 at risk
Flatulence	Gastrointestinal disorders	27.1	Systematic Assessment	EG00010 affected547 at risk EG00132 affected535 at risk EG0022 affected25 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	27.1	Systematic Assessment	EG00017 affected547 at risk EG00170 affected535 at risk EG0023 affected25 at risk
Haemorrhoids	Gastrointestinal disorders	27.1	Systematic Assessment	EG00015 affected547 at risk EG00127 affected535 at risk EG0021 affected25 at risk
Nausea	Gastrointestinal disorders	27.1	Systematic Assessment	EG000176 affected547 at risk EG001240 affected535 at risk EG00210 affected25 at risk
Oral pain	Gastrointestinal disorders	27.1	Systematic Assessment	EG0003 affected547 at risk EG00131 affected535 at risk EG0020 affected25 at risk
Stomatitis	Gastrointestinal disorders	27.1	Systematic Assessment	EG00042 affected547 at risk EG001157 affected535 at risk EG0029 affected25 at risk
Toothache	Gastrointestinal disorders	27.1	Systematic Assessment	EG00014 affected547 at risk EG00129 affected535 at risk EG0023 affected25 at risk
Vomiting	Gastrointestinal disorders	27.1	Systematic Assessment	EG000120 affected547 at risk EG001163 affected535 at risk EG00210 affected25 at risk
Asthenia	General disorders	27.1	Systematic Assessment	EG000100 affected547 at risk EG001104 affected535 at risk EG0026 affected25 at risk
Chest pain	General disorders	27.1	Systematic Assessment	EG00029 affected547 at risk EG00132 affected535 at risk EG0023 affected25 at risk
Chills	General disorders	27.1	Systematic Assessment	EG00034 affected547 at risk EG00148 affected535 at risk EG0022 affected25 at risk
Fatigue	General disorders	27.1	Systematic Assessment	EG000259 affected547 at risk EG001296 affected535 at risk EG0029 affected25 at risk
Influenza like illness	General disorders	27.1	Systematic Assessment	EG00052 affected547 at risk EG00131 affected535 at risk EG0024 affected25 at risk
Malaise	General disorders	27.1	Systematic Assessment	EG00014 affected547 at risk EG00127 affected535 at risk EG0023 affected25 at risk
Mucosal inflammation	General disorders	27.1	Systematic Assessment	EG00024 affected547 at risk EG001157 affected535 at risk EG0028 affected25 at risk
Oedema peripheral	General disorders	27.1	Systematic Assessment	EG00087 affected547 at risk EG00175 affected535 at risk EG0024 affected25 at risk
Pain	General disorders	27.1	Systematic Assessment	EG00040 affected547 at risk EG00149 affected535 at risk EG0023 affected25 at risk
Pyrexia	General disorders	27.1	Systematic Assessment	EG000146 affected547 at risk EG00193 affected535 at risk EG0026 affected25 at risk
Bronchitis	Infections and infestations	27.1	Systematic Assessment	EG00029 affected547 at risk EG00121 affected535 at risk EG0023 affected25 at risk
Nasopharyngitis	Infections and infestations	27.1	Systematic Assessment	EG00061 affected547 at risk EG00126 affected535 at risk EG0022 affected25 at risk
Pneumonia	Infections and infestations	27.1	Systematic Assessment	EG00033 affected547 at risk EG00113 affected535 at risk EG0022 affected25 at risk
Upper respiratory tract infection	Infections and infestations	27.1	Systematic Assessment	EG00050 affected547 at risk EG00142 affected535 at risk EG0022 affected25 at risk
Urinary tract infection	Infections and infestations	27.1	Systematic Assessment	EG00037 affected547 at risk EG00128 affected535 at risk EG0023 affected25 at risk
Alanine aminotransferase increased	Investigations	27.1	Systematic Assessment	EG00077 affected547 at risk EG00165 affected535 at risk EG0025 affected25 at risk
Amylase increased	Investigations	27.1	Systematic Assessment	EG00085 affected547 at risk EG00145 affected535 at risk EG0025 affected25 at risk
Aspartate aminotransferase increased	Investigations	27.1	Systematic Assessment	EG00080 affected547 at risk EG00163 affected535 at risk EG0026 affected25 at risk
Blood alkaline phosphatase increased	Investigations	27.1	Systematic Assessment	EG00040 affected547 at risk EG00127 affected535 at risk EG0023 affected25 at risk
Blood creatinine increased	Investigations	27.1	Systematic Assessment	EG00080 affected547 at risk EG00156 affected535 at risk EG0025 affected25 at risk
Blood thyroid stimulating hormone increased	Investigations	27.1	Systematic Assessment	EG00014 affected547 at risk EG00134 affected535 at risk EG0025 affected25 at risk
Lipase increased	Investigations	27.1	Systematic Assessment	EG000108 affected547 at risk EG00172 affected535 at risk EG0027 affected25 at risk
Neutrophil count decreased	Investigations	27.1	Systematic Assessment	EG00013 affected547 at risk EG00141 affected535 at risk EG0028 affected25 at risk
Platelet count decreased	Investigations	27.1	Systematic Assessment	EG00018 affected547 at risk EG00180 affected535 at risk EG00210 affected25 at risk
Weight decreased	Investigations	27.1	Systematic Assessment	EG00059 affected547 at risk EG00148 affected535 at risk EG0022 affected25 at risk
White blood cell count decreased	Investigations	27.1	Systematic Assessment	EG00011 affected547 at risk EG00147 affected535 at risk EG0027 affected25 at risk
Decreased appetite	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG000136 affected547 at risk EG001168 affected535 at risk EG0027 affected25 at risk
Dehydration	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG00032 affected547 at risk EG00124 affected535 at risk EG0022 affected25 at risk
Hyperglycaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG00062 affected547 at risk EG00130 affected535 at risk EG0023 affected25 at risk
Hyperkalaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG00045 affected547 at risk EG00126 affected535 at risk EG0022 affected25 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG00024 affected547 at risk EG00134 affected535 at risk EG0024 affected25 at risk
Hyponatraemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG00042 affected547 at risk EG00133 affected535 at risk EG0024 affected25 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG000164 affected547 at risk EG001115 affected535 at risk EG0029 affected25 at risk
Back pain	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG000113 affected547 at risk EG001107 affected535 at risk EG0027 affected25 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG00044 affected547 at risk EG00135 affected535 at risk EG0024 affected25 at risk
Myalgia	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG00071 affected547 at risk EG00139 affected535 at risk EG0024 affected25 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG00073 affected547 at risk EG00185 affected535 at risk EG0027 affected25 at risk
Dizziness	Nervous system disorders	27.1	Systematic Assessment	EG00072 affected547 at risk EG00163 affected535 at risk EG0026 affected25 at risk
Dysgeusia	Nervous system disorders	27.1	Systematic Assessment	EG00039 affected547 at risk EG001123 affected535 at risk EG0026 affected25 at risk
Headache	Nervous system disorders	27.1	Systematic Assessment	EG000113 affected547 at risk EG001132 affected535 at risk EG0028 affected25 at risk
Paraesthesia	Nervous system disorders	27.1	Systematic Assessment	EG00037 affected547 at risk EG00133 affected535 at risk EG0021 affected25 at risk
Taste disorder	Nervous system disorders	27.1	Systematic Assessment	EG0008 affected547 at risk EG00168 affected535 at risk EG0025 affected25 at risk
Anxiety	Psychiatric disorders	27.1	Systematic Assessment	EG00038 affected547 at risk EG00123 affected535 at risk EG0021 affected25 at risk
Depression	Psychiatric disorders	27.1	Systematic Assessment	EG00034 affected547 at risk EG00119 affected535 at risk EG0021 affected25 at risk
Insomnia	Psychiatric disorders	27.1	Systematic Assessment	EG00075 affected547 at risk EG00141 affected535 at risk EG0022 affected25 at risk
Cough	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG000165 affected547 at risk EG001148 affected535 at risk EG0028 affected25 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG00026 affected547 at risk EG00135 affected535 at risk EG0021 affected25 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG000112 affected547 at risk EG001100 affected535 at risk EG0022 affected25 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG00012 affected547 at risk EG00179 affected535 at risk EG0029 affected25 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG00030 affected547 at risk EG00142 affected535 at risk EG0021 affected25 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG00030 affected547 at risk EG0015 affected535 at risk EG0020 affected25 at risk
Alopecia	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG0008 affected547 at risk EG00129 affected535 at risk EG0020 affected25 at risk
Dry skin	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG00062 affected547 at risk EG00158 affected535 at risk EG0022 affected25 at risk
Hair colour changes	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG0001 affected547 at risk EG00132 affected535 at risk EG0022 affected25 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG00019 affected547 at risk EG001246 affected535 at risk EG00220 affected25 at risk
Pruritus	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG000199 affected547 at risk EG00169 affected535 at risk EG0026 affected25 at risk
Rash	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG000155 affected547 at risk EG00197 affected535 at risk EG00210 affected25 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG00058 affected547 at risk EG00130 affected535 at risk EG0020 affected25 at risk
Skin discolouration	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG0005 affected547 at risk EG00129 affected535 at risk EG0021 affected25 at risk
Yellow skin	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG0000 affected547 at risk EG00147 affected535 at risk EG0023 affected25 at risk
Hypertension	Vascular disorders	27.1	Systematic Assessment	EG00072 affected547 at risk EG001241 affected535 at risk EG00215 affected25 at risk
Vertigo	Ear and labyrinth disorders	27.1	Systematic Assessment	EG00016 affected547 at risk EG00115 affected535 at risk EG0022 affected25 at risk
Periorbital oedema	Eye disorders	27.1	Systematic Assessment	EG0002 affected547 at risk EG00122 affected535 at risk EG0022 affected25 at risk
Abdominal discomfort	Gastrointestinal disorders	27.1	Systematic Assessment	EG00011 affected547 at risk EG00121 affected535 at risk EG0022 affected25 at risk
Dental caries	Gastrointestinal disorders	27.1	Systematic Assessment	EG0006 affected547 at risk EG0015 affected535 at risk EG0022 affected25 at risk
Face oedema	General disorders	27.1	Systematic Assessment	EG0003 affected547 at risk EG00118 affected535 at risk EG0022 affected25 at risk
Hepatic function abnormal	Hepatobiliary disorders	27.1	Systematic Assessment	EG0003 affected547 at risk EG0019 affected535 at risk EG0022 affected25 at risk
Cystitis	Infections and infestations	27.1	Systematic Assessment	EG0007 affected547 at risk EG0018 affected535 at risk EG0022 affected25 at risk
Folliculitis	Infections and infestations	27.1	Systematic Assessment	EG0003 affected547 at risk EG0018 affected535 at risk EG0022 affected25 at risk
Herpes zoster	Infections and infestations	27.1	Systematic Assessment	EG0008 affected547 at risk EG0017 affected535 at risk EG0022 affected25 at risk
Rhinitis	Infections and infestations	27.1	Systematic Assessment	EG00027 affected547 at risk EG00112 affected535 at risk EG0022 affected25 at risk
Sinusitis	Infections and infestations	27.1	Systematic Assessment	EG00027 affected547 at risk EG00114 affected535 at risk EG0022 affected25 at risk
Tooth infection	Infections and infestations	27.1	Systematic Assessment	EG0009 affected547 at risk EG00112 affected535 at risk EG0022 affected25 at risk
Arthropod bite	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0001 affected547 at risk EG0012 affected535 at risk EG0022 affected25 at risk
Contusion	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG00016 affected547 at risk EG00113 affected535 at risk EG0023 affected25 at risk
Limb injury	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0005 affected547 at risk EG0015 affected535 at risk EG0022 affected25 at risk
Blood bilirubin increased	Investigations	27.1	Systematic Assessment	EG00020 affected547 at risk EG00124 affected535 at risk EG0022 affected25 at risk
Blood uric acid increased	Investigations	27.1	Systematic Assessment	EG0009 affected547 at risk EG0015 affected535 at risk EG0022 affected25 at risk
Lymphocyte count decreased	Investigations	27.1	Systematic Assessment	EG00016 affected547 at risk EG00124 affected535 at risk EG0023 affected25 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG00017 affected547 at risk EG00123 affected535 at risk EG0022 affected25 at risk
Hypokalaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG00024 affected547 at risk EG00117 affected535 at risk EG0022 affected25 at risk
Hypophosphataemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG00020 affected547 at risk EG00124 affected535 at risk EG0022 affected25 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0004 affected547 at risk EG0012 affected535 at risk EG0022 affected25 at risk
Arthritis	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG00020 affected547 at risk EG0016 affected535 at risk EG0022 affected25 at risk
Flank pain	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG00014 affected547 at risk EG00124 affected535 at risk EG0022 affected25 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG00017 affected547 at risk EG00122 affected535 at risk EG0022 affected25 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0008 affected547 at risk EG0019 affected535 at risk EG0022 affected25 at risk
Neuropathy peripheral	Nervous system disorders	27.1	Systematic Assessment	EG00012 affected547 at risk EG00112 affected535 at risk EG0022 affected25 at risk
Peripheral sensory neuropathy	Nervous system disorders	27.1	Systematic Assessment	EG00014 affected547 at risk EG0019 affected535 at risk EG0022 affected25 at risk
Haematuria	Renal and urinary disorders	27.1	Systematic Assessment	EG00018 affected547 at risk EG00124 affected535 at risk EG0023 affected25 at risk
Dermatitis acneiform	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG00014 affected547 at risk EG00114 affected535 at risk EG0022 affected25 at risk
Eczema	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG00010 affected547 at risk EG00111 affected535 at risk EG0024 affected25 at risk
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG0004 affected547 at risk EG0018 affected535 at risk EG0023 affected25 at risk

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D007680	Kidney Neoplasms
D014571	Urologic Neoplasms
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D007674	Kidney Diseases
D014570	Urologic Diseases
D052801	Male Urogenital Diseases

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins
D011758	Pyrroles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

ID	Title	Description
BG000	Nivolumab + Ipilimumab	Nivolumab 3 mg/kg combined with Ipilimumab 1 mg/kg solutions intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solutions intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
BG001	Sunitinib	Sunitinib 50 mg capsules by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends After completion of final analysis eligible participants may switch from receiving Sunitinib to receiving Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240mg flat dose IV every 2 weeks
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Nivolumab + Ipilimumab	Nivolumab 3 mg/kg combined with Ipilimumab 1 mg/kg solutions intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solutions intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends	367	550	367	547	534	547
EG001	Sunitinib	Sunitinib 50 mg capsules by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends After completion of final analysis eligible participants may switch from receiving Sunitinib to receiving Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240mg flat dose IV every 2 weeks	417	546	277	535	523	535
EG002	Sunitinib Crossover	Participants received Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240 mg flat dose IV every 2 weeks	11	25	6	25	25	25