A Study to Evaluate Efficacy in Subjects With Esophageal... | NCT03143153

ID	Type	Description	Link
2016-001514-20	EudraCT Number

Name	Class
Ono Pharmaceutical Co., Ltd.	INDUSTRY

Label	Type	Intervention Names
Nivolumab + Ipilimumab	Experimental	Biological: Nivolumab Biological: Ipilimumab
Nivolumab + Cisplatin + Fluorouacil	Experimental	Biological: Nivolumab Drug: Cisplatin Drug: Fluorouracil
Cisplatin + Fluorouracil	Active Comparator	Drug: Cisplatin Drug: Fluorouracil

Name	Type	Description	Arm Group Labels	Other Names
Nivolumab	Biological	Specified dose on specified days	Nivolumab + Cisplatin + Fluorouacil Nivolumab + Ipilimumab

Measure	Description	Time Frame
Overall Survival (OS) in Participants With Tumor Cell PD-L1	Overall Survival (OS) is defined as the time between the date of randomization and the date of death. For participants without documentation of death, OS will be censored on the last date the subject was known to be alive.	From the date of randomization to up to the date of death (up to approximately 20 months)
Progression-free Survival (PFS) as Assessed by BICR in Participants With Tumor Cell PD-L1	Progression-free survival (PFS) is defined as the time from randomization to the date of the first documented progressive disease (PD) per Blinded Independent Central Review (BICR) or death due to any cause. Participants who die without a reported prior PD per BICR (and die without start of subsequent therapy) will be considered to have progressed on the date of death. Participants who did not have documented PD per BICR per RECIST1.1 criteria and who did not die, will be censored at the date of the last evaluable tumor assessment on or prior to initiation of the subsequent anti-cancer therapy. Participants who did not have any on-study tumor assessments and did not die (or died after initiation of the subsequent anti-cancer therapy) will be censored at the randomization date. Participants who started any subsequent anti-cancer therapy without a prior reported PD per BICR will be censored at the last tumor assessment on or prior to initiation of the subsequent anti-cancer therapy.	From the date of randomization to up to the date of the first documented disease progression or death (up to approximately 9 months)

Measure	Description	Time Frame
Overall Survival (OS) in All Randomized Participants	Overall Survival (OS) is defined as the time between the date of randomization and the date of death. For participants without documentation of death, OS will be censored on the last date the subject was known to be alive.	From the date of randomization to up to the date of death (up to approximately 88 months)

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

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution - 0191		Mobile	Alabama	36608	United States
Arizona Cancer Center

PubMed Identifier	Type	Citation	Retractions
37139963	Derived	Zhang Y, Li C, Du K, Pengkhun N, Huang Z, Gong M, Li Y, Liu X, Li L, Wang D, Wang C, Chen F, Li J. Comparative analysis of immune checkpoint inhibitors in first-line treatment of esophageal squamous cell carcinoma: a network meta-analysis. Immunotherapy. 2023 Jul;15(10):737-750. doi: 10.2217/imt-2022-0236. Epub 2023 May 4.
36401133

Label	URL
BMS Clinical Trial Information	View source

ID	Title	Description
FG000	Arm A: Nivolumab + Ipilimumab	Participants will receive treatment with nivolumab 3 mg/kg as a 30-minute infusion every 2 weeks and ipilimumab as a 30-minute infusion 1 mg/kg every 6 weeks.
FG001	Arm B: Nivolumab + Chemotherapy

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 29, 2020	Jan 11, 2022

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0006 affected322 at risk EG0015 affected310 at risk EG0027 affected304 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0002 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Febrile bone marrow aplasia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0010 affected310 at risk EG0021 affected304 at risk
Febrile neutropenia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0006 affected322 at risk EG0017 affected310 at risk EG0025 affected304 at risk
Immune thrombocytopenia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Leukocytosis	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0021 affected304 at risk
Leukopenia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Lymphadenopathy	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0002 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Myelosuppression	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Neutropenia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0012 affected310 at risk EG0021 affected304 at risk
Pancytopenia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0021 affected304 at risk
Splenic haematoma	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Thrombocytopenia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Acute myocardial infarction	Cardiac disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0022 affected304 at risk
Angina pectoris	Cardiac disorders	27.1	Systematic Assessment	EG0002 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Arrhythmia	Cardiac disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Arteriospasm coronary	Cardiac disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0010 affected310 at risk EG0021 affected304 at risk
Atrial fibrillation	Cardiac disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0023 affected304 at risk
Cardiac arrest	Cardiac disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Cardiac failure congestive	Cardiac disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0010 affected310 at risk EG0021 affected304 at risk
Myocardial infarction	Cardiac disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0021 affected304 at risk
Palpitations	Cardiac disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0010 affected310 at risk EG0021 affected304 at risk
Pericardial effusion	Cardiac disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Supraventricular tachycardia	Cardiac disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Ventricular fibrillation	Cardiac disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Adrenal insufficiency	Endocrine disorders	27.1	Systematic Assessment	EG0008 affected322 at risk EG0013 affected310 at risk EG0020 affected304 at risk
Adrenocorticotropic hormone deficiency	Endocrine disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Endocrine disorder	Endocrine disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Hypercalcaemia of malignancy	Endocrine disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Hyperthyroidism	Endocrine disorders	27.1	Systematic Assessment	EG0002 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Hypophysitis	Endocrine disorders	27.1	Systematic Assessment	EG0006 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Hypopituitarism	Endocrine disorders	27.1	Systematic Assessment	EG0007 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Hypothyroidism	Endocrine disorders	27.1	Systematic Assessment	EG0003 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Inappropriate antidiuretic hormone secretion	Endocrine disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0021 affected304 at risk
Secondary adrenocortical insufficiency	Endocrine disorders	27.1	Systematic Assessment	EG0002 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Thyroiditis	Endocrine disorders	27.1	Systematic Assessment	EG0002 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Cataract	Eye disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Eye pain	Eye disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Retinal detachment	Eye disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0021 affected304 at risk
Uveitis	Eye disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Vogt-Koyanagi-Harada disease	Eye disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Abdominal distension	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Abdominal pain	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0013 affected310 at risk EG0022 affected304 at risk
Abdominal pain lower	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Abdominal pain upper	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0011 affected310 at risk EG0022 affected304 at risk
Aorto-oesophageal fistula	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Ascites	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Colitis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0004 affected322 at risk EG0015 affected310 at risk EG0020 affected304 at risk
Constipation	Gastrointestinal disorders	27.1	Systematic Assessment	EG0002 affected322 at risk EG0012 affected310 at risk EG0021 affected304 at risk
Diaphragmatic hernia	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Diarrhoea	Gastrointestinal disorders	27.1	Systematic Assessment	EG0005 affected322 at risk EG0017 affected310 at risk EG0023 affected304 at risk
Duodenal ulcer	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Dysphagia	Gastrointestinal disorders	27.1	Systematic Assessment	EG00012 affected322 at risk EG00121 affected310 at risk EG00216 affected304 at risk
Enteritis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Enterocolitis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0010 affected310 at risk EG0021 affected304 at risk
Gastric fistula	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0012 affected310 at risk EG0020 affected304 at risk
Gastric perforation	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0010 affected310 at risk EG0021 affected304 at risk
Gastritis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	27.1	Systematic Assessment	EG0005 affected322 at risk EG0011 affected310 at risk EG0022 affected304 at risk
Gastrointestinal obstruction	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Haematemesis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0002 affected322 at risk EG0010 affected310 at risk EG0022 affected304 at risk
Haematochezia	Gastrointestinal disorders	27.1	Systematic Assessment	EG0002 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Ileus	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0021 affected304 at risk
Ileus paralytic	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0010 affected310 at risk EG0021 affected304 at risk
Immune-mediated enterocolitis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Inguinal hernia	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Intestinal obstruction	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0022 affected304 at risk
Malignant ascites	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0010 affected310 at risk EG0021 affected304 at risk
Mechanical ileus	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0021 affected304 at risk
Melaena	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Nausea	Gastrointestinal disorders	27.1	Systematic Assessment	EG0002 affected322 at risk EG0014 affected310 at risk EG0025 affected304 at risk
Odynophagia	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Oesophageal fistula	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0010 affected310 at risk EG0023 affected304 at risk
Oesophageal haemorrhage	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Oesophageal mass	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Oesophageal motility disorder	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0021 affected304 at risk
Oesophageal obstruction	Gastrointestinal disorders	27.1	Systematic Assessment	EG0003 affected322 at risk EG0013 affected310 at risk EG0025 affected304 at risk
Oesophageal pain	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0010 affected310 at risk EG0021 affected304 at risk
Oesophageal perforation	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0013 affected310 at risk EG0021 affected304 at risk
Oesophageal stenosis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0003 affected322 at risk EG0019 affected310 at risk EG00213 affected304 at risk
Oesophageal-pulmonary fistula	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Oesophagomediastinal fistula	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Pancreatitis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0004 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Pancreatitis acute	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Pneumatosis intestinalis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Rectal perforation	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0010 affected310 at risk EG0021 affected304 at risk
Small intestinal haemorrhage	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0010 affected310 at risk EG0021 affected304 at risk
Small intestinal obstruction	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Stomatitis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0016 affected310 at risk EG0020 affected304 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	27.1	Systematic Assessment	EG0004 affected322 at risk EG0012 affected310 at risk EG0022 affected304 at risk
Vomiting	Gastrointestinal disorders	27.1	Systematic Assessment	EG0005 affected322 at risk EG0014 affected310 at risk EG00212 affected304 at risk
Asthenia	General disorders and administration site conditions	27.1	Systematic Assessment	EG0005 affected322 at risk EG0012 affected310 at risk EG0021 affected304 at risk
Catheter site discharge	General disorders and administration site conditions	27.1	Systematic Assessment	EG0000 affected322 at risk EG0010 affected310 at risk EG0021 affected304 at risk
Chest pain	General disorders and administration site conditions	27.1	Systematic Assessment	EG0001 affected322 at risk EG0012 affected310 at risk EG0020 affected304 at risk
Complication associated with device	General disorders and administration site conditions	27.1	Systematic Assessment	EG0000 affected322 at risk EG0010 affected310 at risk EG0021 affected304 at risk
Death	General disorders and administration site conditions	27.1	Systematic Assessment	EG0005 affected322 at risk EG0012 affected310 at risk EG0020 affected304 at risk
Disease progression	General disorders and administration site conditions	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Fatigue	General disorders and administration site conditions	27.1	Systematic Assessment	EG0003 affected322 at risk EG0013 affected310 at risk EG0021 affected304 at risk
Feeling cold	General disorders and administration site conditions	27.1	Systematic Assessment	EG0000 affected322 at risk EG0010 affected310 at risk EG0021 affected304 at risk
General physical health deterioration	General disorders and administration site conditions	27.1	Systematic Assessment	EG0002 affected322 at risk EG0011 affected310 at risk EG0021 affected304 at risk
Malaise	General disorders and administration site conditions	27.1	Systematic Assessment	EG0002 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Mucosal inflammation	General disorders and administration site conditions	27.1	Systematic Assessment	EG0000 affected322 at risk EG0012 affected310 at risk EG0022 affected304 at risk
Multiple organ dysfunction syndrome	General disorders and administration site conditions	27.1	Systematic Assessment	EG0001 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Nodule	General disorders and administration site conditions	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Non-cardiac chest pain	General disorders and administration site conditions	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Oedema peripheral	General disorders and administration site conditions	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Pain	General disorders and administration site conditions	27.1	Systematic Assessment	EG0002 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Performance status decreased	General disorders and administration site conditions	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Polyp	General disorders and administration site conditions	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Pyrexia	General disorders and administration site conditions	27.1	Systematic Assessment	EG00014 affected322 at risk EG0017 affected310 at risk EG0027 affected304 at risk
Sudden death	General disorders and administration site conditions	27.1	Systematic Assessment	EG0001 affected322 at risk EG0012 affected310 at risk EG0022 affected304 at risk
Autoimmune hepatitis	Hepatobiliary disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Bile duct stenosis	Hepatobiliary disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0010 affected310 at risk EG0021 affected304 at risk
Bile duct stone	Hepatobiliary disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Biliary obstruction	Hepatobiliary disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Cholangitis	Hepatobiliary disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Cholecystitis	Hepatobiliary disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0010 affected310 at risk EG0021 affected304 at risk
Cholecystitis acute	Hepatobiliary disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Hepatic failure	Hepatobiliary disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Hepatic function abnormal	Hepatobiliary disorders	27.1	Systematic Assessment	EG0009 affected322 at risk EG0010 affected310 at risk EG0021 affected304 at risk
Hepatitis	Hepatobiliary disorders	27.1	Systematic Assessment	EG0003 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Immune-mediated hepatitis	Hepatobiliary disorders	27.1	Systematic Assessment	EG0002 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Jaundice cholestatic	Hepatobiliary disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Anaphylactic shock	Immune system disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Drug hypersensitivity	Immune system disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Hypersensitivity	Immune system disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Appendicitis	Infections and infestations	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Bacteraemia	Infections and infestations	27.1	Systematic Assessment	EG0002 affected322 at risk EG0010 affected310 at risk EG0021 affected304 at risk
Bacterial infection	Infections and infestations	27.1	Systematic Assessment	EG0001 affected322 at risk EG0011 affected310 at risk EG0021 affected304 at risk
COVID-19 pneumonia	Infections and infestations	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Catheter site infection	Infections and infestations	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Cystitis	Infections and infestations	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Device related infection	Infections and infestations	27.1	Systematic Assessment	EG0000 affected322 at risk EG0012 affected310 at risk EG0023 affected304 at risk
Encephalitis	Infections and infestations	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Encephalitis bacterial	Infections and infestations	27.1	Systematic Assessment	EG0000 affected322 at risk EG0010 affected310 at risk EG0021 affected304 at risk
Enterocolitis infectious	Infections and infestations	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Gastroenteritis bacterial	Infections and infestations	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
H1N1 influenza	Infections and infestations	27.1	Systematic Assessment	EG0000 affected322 at risk EG0010 affected310 at risk EG0021 affected304 at risk
Infection	Infections and infestations	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0021 affected304 at risk
Large intestine infection	Infections and infestations	27.1	Systematic Assessment	EG0000 affected322 at risk EG0010 affected310 at risk EG0021 affected304 at risk
Lower respiratory tract infection	Infections and infestations	27.1	Systematic Assessment	EG0002 affected322 at risk EG0011 affected310 at risk EG0021 affected304 at risk
Lung abscess	Infections and infestations	27.1	Systematic Assessment	EG0001 affected322 at risk EG0011 affected310 at risk EG0021 affected304 at risk
Lymph gland infection	Infections and infestations	27.1	Systematic Assessment	EG0000 affected322 at risk EG0010 affected310 at risk EG0021 affected304 at risk
Mediastinitis	Infections and infestations	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Meningitis viral	Infections and infestations	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Neutropenic sepsis	Infections and infestations	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Oral infection	Infections and infestations	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Otitis media	Infections and infestations	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Otitis media acute	Infections and infestations	27.1	Systematic Assessment	EG0000 affected322 at risk EG0010 affected310 at risk EG0021 affected304 at risk
Parotitis	Infections and infestations	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Peritonitis	Infections and infestations	27.1	Systematic Assessment	EG0000 affected322 at risk EG0010 affected310 at risk EG0023 affected304 at risk
Pharyngitis	Infections and infestations	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Pneumonia	Infections and infestations	27.1	Systematic Assessment	EG00032 affected322 at risk EG00133 affected310 at risk EG00220 affected304 at risk
Pneumonia aspiration	Infections and infestations	27.1	Systematic Assessment	EG00012 affected322 at risk EG0016 affected310 at risk EG0028 affected304 at risk
Pneumonia bacterial	Infections and infestations	27.1	Systematic Assessment	EG0004 affected322 at risk EG0010 affected310 at risk EG0022 affected304 at risk
Pneumonia pseudomonal	Infections and infestations	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Postoperative wound infection	Infections and infestations	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Pulmonary sepsis	Infections and infestations	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Respiratory tract infection	Infections and infestations	27.1	Systematic Assessment	EG0000 affected322 at risk EG0013 affected310 at risk EG0020 affected304 at risk
Sepsis	Infections and infestations	27.1	Systematic Assessment	EG0004 affected322 at risk EG0013 affected310 at risk EG0023 affected304 at risk
Septic shock	Infections and infestations	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0021 affected304 at risk
Stoma site cellulitis	Infections and infestations	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Stoma site infection	Infections and infestations	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Upper respiratory tract infection	Infections and infestations	27.1	Systematic Assessment	EG0001 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Urethritis	Infections and infestations	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Urinary tract infection	Infections and infestations	27.1	Systematic Assessment	EG0000 affected322 at risk EG0013 affected310 at risk EG0020 affected304 at risk
Urosepsis	Infections and infestations	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Vascular device infection	Infections and infestations	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0022 affected304 at risk
Viral infection	Infections and infestations	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Wound infection	Infections and infestations	27.1	Systematic Assessment	EG0000 affected322 at risk EG0010 affected310 at risk EG0021 affected304 at risk
Anastomotic leak	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 affected322 at risk EG0010 affected310 at risk EG0021 affected304 at risk
Atrio-oesophageal fistula	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Brain contusion	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 affected322 at risk EG0010 affected310 at risk EG0021 affected304 at risk
Fall	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Fracture	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Gastrointestinal stoma complication	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0001 affected322 at risk EG0011 affected310 at risk EG0021 affected304 at risk
Heat illness	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Humerus fracture	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Infusion related reaction	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Lower limb fracture	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Overdose	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0005 affected322 at risk EG0010 affected310 at risk EG0021 affected304 at risk
Radiation oesophagitis	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Stoma site discharge	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Stoma site pain	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Subdural haematoma	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 affected322 at risk EG0010 affected310 at risk EG0021 affected304 at risk
Tracheal obstruction	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Adjusted calcium increased	Investigations	27.1	Systematic Assessment	EG0000 affected322 at risk EG0010 affected310 at risk EG0021 affected304 at risk
Alanine aminotransferase increased	Investigations	27.1	Systematic Assessment	EG0003 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Anticoagulation drug level above therapeutic	Investigations	27.1	Systematic Assessment	EG0000 affected322 at risk EG0010 affected310 at risk EG0021 affected304 at risk
Aspartate aminotransferase increased	Investigations	27.1	Systematic Assessment	EG0002 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Blood calcium increased	Investigations	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Blood creatine phosphokinase increased	Investigations	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Blood creatinine increased	Investigations	27.1	Systematic Assessment	EG0003 affected322 at risk EG0012 affected310 at risk EG0021 affected304 at risk
Blood sodium decreased	Investigations	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Blood thyroid stimulating hormone increased	Investigations	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
C-reactive protein increased	Investigations	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Cortisol decreased	Investigations	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Electrocardiogram Q wave abnormal	Investigations	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Haemoglobin decreased	Investigations	27.1	Systematic Assessment	EG0000 affected322 at risk EG0010 affected310 at risk EG0021 affected304 at risk
Lipase increased	Investigations	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Liver function test increased	Investigations	27.1	Systematic Assessment	EG0000 affected322 at risk EG0012 affected310 at risk EG0020 affected304 at risk
Neutrophil count decreased	Investigations	27.1	Systematic Assessment	EG0001 affected322 at risk EG0014 affected310 at risk EG0021 affected304 at risk
Platelet count decreased	Investigations	27.1	Systematic Assessment	EG0000 affected322 at risk EG0012 affected310 at risk EG0022 affected304 at risk
Transaminases increased	Investigations	27.1	Systematic Assessment	EG0000 affected322 at risk EG0010 affected310 at risk EG0021 affected304 at risk
Urine output decreased	Investigations	27.1	Systematic Assessment	EG0000 affected322 at risk EG0010 affected310 at risk EG0021 affected304 at risk
White blood cell count decreased	Investigations	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Cachexia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0010 affected310 at risk EG0021 affected304 at risk
Decreased appetite	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0009 affected322 at risk EG0014 affected310 at risk EG0027 affected304 at risk
Dehydration	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0009 affected322 at risk EG0014 affected310 at risk EG0026 affected304 at risk
Diabetes mellitus	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0010 affected310 at risk EG0021 affected304 at risk
Fulminant type 1 diabetes mellitus	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Gout	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0010 affected310 at risk EG0021 affected304 at risk
Hypercalcaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0005 affected322 at risk EG0014 affected310 at risk EG0024 affected304 at risk
Hyperglycaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0004 affected322 at risk EG0011 affected310 at risk EG0021 affected304 at risk
Hyperglycaemic hyperosmolar nonketotic syndrome	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Hyperkalaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Hypernatraemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Hypocalcaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Hypoglycaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Hypokalaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0014 affected310 at risk EG0022 affected304 at risk
Hyponatraemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0006 affected322 at risk EG0014 affected310 at risk EG0024 affected304 at risk
Hypophagia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0010 affected310 at risk EG0021 affected304 at risk
Malnutrition	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0011 affected310 at risk EG0021 affected304 at risk
Type 1 diabetes mellitus	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0002 affected322 at risk EG0012 affected310 at risk EG0020 affected304 at risk
Arthritis	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Back pain	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0002 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Gouty arthritis	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Immune-mediated arthritis	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Myositis	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Osteolysis	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Spinal stenosis	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Adult T-cell lymphoma/leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Benign neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0003 affected322 at risk EG0012 affected310 at risk EG0021 affected304 at risk
Colorectal adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Colorectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Hypopharyngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Laryngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG00059 affected322 at risk EG00161 affected310 at risk EG00265 affected304 at risk
Metastases to bone marrow	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0001 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Metastases to kidney	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0000 affected322 at risk EG0010 affected310 at risk EG0021 affected304 at risk
Metastases to meninges	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0021 affected304 at risk
Metastatic squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0002 affected322 at risk EG0012 affected310 at risk EG0020 affected304 at risk
Tumour associated fever	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Tumour compression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0000 affected322 at risk EG0010 affected310 at risk EG0021 affected304 at risk
Tumour fistulisation	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0023 affected304 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0024 affected304 at risk
Brain stem haemorrhage	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0010 affected310 at risk EG0021 affected304 at risk
Cerebral infarction	Nervous system disorders	27.1	Systematic Assessment	EG0002 affected322 at risk EG0010 affected310 at risk EG0021 affected304 at risk
Cerebral ischaemia	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0010 affected310 at risk EG0021 affected304 at risk
Cerebrovascular accident	Nervous system disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Facial paralysis	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Haemorrhage intracranial	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0021 affected304 at risk
Haemorrhagic stroke	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Hydrocephalus	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0010 affected310 at risk EG0021 affected304 at risk
Immune-mediated encephalitis	Nervous system disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Immune-mediated encephalopathy	Nervous system disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Peripheral sensory neuropathy	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Presyncope	Nervous system disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Seizure	Nervous system disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Spinal cord compression	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0010 affected310 at risk EG0021 affected304 at risk
Stupor	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Subdural hygroma	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0010 affected310 at risk EG0021 affected304 at risk
Syncope	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Pregnancy	Pregnancy, puerperium and perinatal conditions	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Device breakage	Product issues	27.1	Systematic Assessment	EG0000 affected322 at risk EG0010 affected310 at risk EG0021 affected304 at risk
Device dislocation	Product issues	27.1	Systematic Assessment	EG0000 affected322 at risk EG0010 affected310 at risk EG0021 affected304 at risk
Device occlusion	Product issues	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Patient-device incompatibility	Product issues	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Completed suicide	Psychiatric disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Delirium	Psychiatric disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Depression	Psychiatric disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Disorientation	Psychiatric disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Logorrhoea	Psychiatric disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Acute kidney injury	Renal and urinary disorders	27.1	Systematic Assessment	EG0002 affected322 at risk EG0019 affected310 at risk EG0024 affected304 at risk
Haematuria	Renal and urinary disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0021 affected304 at risk
Hydronephrosis	Renal and urinary disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0011 affected310 at risk EG0021 affected304 at risk
Renal failure	Renal and urinary disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0013 affected310 at risk EG0022 affected304 at risk
Urinary retention	Renal and urinary disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0010 affected310 at risk EG0021 affected304 at risk
Acquired tracheo-oesophageal fistula	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0012 affected310 at risk EG0020 affected304 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0002 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0011 affected310 at risk EG0021 affected304 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0010 affected310 at risk EG0021 affected304 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Bronchial obstruction	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0010 affected310 at risk EG0021 affected304 at risk
Bronchostenosis	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0021 affected304 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Cough	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0005 affected322 at risk EG0012 affected310 at risk EG0022 affected304 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0010 affected310 at risk EG0022 affected304 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Immune-mediated lung disease	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0005 affected322 at risk EG0012 affected310 at risk EG0022 affected304 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Mediastinal disorder	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Obstructive airways disorder	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Oesophagobronchial fistula	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0004 affected322 at risk EG0015 affected310 at risk EG0021 affected304 at risk
Pneumomediastinum	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0021 affected304 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG00013 affected322 at risk EG0016 affected310 at risk EG0021 affected304 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0002 affected322 at risk EG0012 affected310 at risk EG0023 affected304 at risk
Pulmonary thrombosis	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0010 affected310 at risk EG0021 affected304 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0014 affected310 at risk EG0021 affected304 at risk
Stridor	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0010 affected310 at risk EG0021 affected304 at risk
Tracheal fistula	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Tracheal stenosis	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0021 affected304 at risk
Drug eruption	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Erythema multiforme	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Rash	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG0003 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Subcutaneous emphysema	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Assisted suicide	Surgical and medical procedures	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Oesophageal operation	Surgical and medical procedures	27.1	Systematic Assessment	EG0000 affected322 at risk EG0010 affected310 at risk EG0021 affected304 at risk
Aortic dissection	Vascular disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Deep vein thrombosis	Vascular disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0021 affected304 at risk
Embolism	Vascular disorders	27.1	Systematic Assessment	EG0002 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Haematoma	Vascular disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Hypertension	Vascular disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0010 affected310 at risk EG0021 affected304 at risk
Hypertensive crisis	Vascular disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Hypotension	Vascular disorders	27.1	Systematic Assessment	EG0002 affected322 at risk EG0011 affected310 at risk EG0023 affected304 at risk
Hypovolaemic shock	Vascular disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0021 affected304 at risk
Internal haemorrhage	Vascular disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Orthostatic hypotension	Vascular disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0021 affected304 at risk
Poor venous access	Vascular disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0010 affected310 at risk EG0021 affected304 at risk
Shock	Vascular disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0010 affected310 at risk EG0022 affected304 at risk
Shock haemorrhagic	Vascular disorders	27.1	Systematic Assessment	EG0001 affected322 at risk EG0010 affected310 at risk EG0020 affected304 at risk
Subclavian vein thrombosis	Vascular disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Thrombophlebitis	Vascular disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0011 affected310 at risk EG0020 affected304 at risk
Venous thrombosis	Vascular disorders	27.1	Systematic Assessment	EG0000 affected322 at risk EG0010 affected310 at risk EG0021 affected304 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG00084 affected322 at risk EG001156 affected310 at risk EG002108 affected304 at risk
Neutropenia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0006 affected322 at risk EG00138 affected310 at risk EG00223 affected304 at risk
Hyperthyroidism	Endocrine disorders	27.1	Systematic Assessment	EG00020 affected322 at risk EG0017 affected310 at risk EG0021 affected304 at risk
Hypothyroidism	Endocrine disorders	27.1	Systematic Assessment	EG00044 affected322 at risk EG00123 affected310 at risk EG0021 affected304 at risk
Abdominal pain	Gastrointestinal disorders	27.1	Systematic Assessment	EG00022 affected322 at risk EG00123 affected310 at risk EG00218 affected304 at risk
Abdominal pain upper	Gastrointestinal disorders	27.1	Systematic Assessment	EG00016 affected322 at risk EG00122 affected310 at risk EG00213 affected304 at risk
Constipation	Gastrointestinal disorders	27.1	Systematic Assessment	EG00087 affected322 at risk EG001142 affected310 at risk EG002138 affected304 at risk
Diarrhoea	Gastrointestinal disorders	27.1	Systematic Assessment	EG00084 affected322 at risk EG00198 affected310 at risk EG00263 affected304 at risk
Dysphagia	Gastrointestinal disorders	27.1	Systematic Assessment	EG00039 affected322 at risk EG00142 affected310 at risk EG00231 affected304 at risk
Nausea	Gastrointestinal disorders	27.1	Systematic Assessment	EG00088 affected322 at risk EG001207 affected310 at risk EG002172 affected304 at risk
Stomatitis	Gastrointestinal disorders	27.1	Systematic Assessment	EG00034 affected322 at risk EG001100 affected310 at risk EG00275 affected304 at risk
Vomiting	Gastrointestinal disorders	27.1	Systematic Assessment	EG00053 affected322 at risk EG00177 affected310 at risk EG00260 affected304 at risk
Asthenia	General disorders and administration site conditions	27.1	Systematic Assessment	EG00025 affected322 at risk EG00124 affected310 at risk EG00226 affected304 at risk
Fatigue	General disorders and administration site conditions	27.1	Systematic Assessment	EG00056 affected322 at risk EG00183 affected310 at risk EG00263 affected304 at risk
Infusion site extravasation	General disorders and administration site conditions	27.1	Systematic Assessment	EG0006 affected322 at risk EG00115 affected310 at risk EG00220 affected304 at risk
Malaise	General disorders and administration site conditions	27.1	Systematic Assessment	EG00027 affected322 at risk EG00159 affected310 at risk EG00255 affected304 at risk
Mucosal inflammation	General disorders and administration site conditions	27.1	Systematic Assessment	EG0004 affected322 at risk EG00137 affected310 at risk EG00230 affected304 at risk
Oedema peripheral	General disorders and administration site conditions	27.1	Systematic Assessment	EG00032 affected322 at risk EG00145 affected310 at risk EG00225 affected304 at risk
Pyrexia	General disorders and administration site conditions	27.1	Systematic Assessment	EG00076 affected322 at risk EG00165 affected310 at risk EG00248 affected304 at risk
Hepatic function abnormal	Hepatobiliary disorders	27.1	Systematic Assessment	EG00017 affected322 at risk EG0013 affected310 at risk EG0021 affected304 at risk
Pneumonia	Infections and infestations	27.1	Systematic Assessment	EG00037 affected322 at risk EG00133 affected310 at risk EG00230 affected304 at risk
Alanine aminotransferase increased	Investigations	27.1	Systematic Assessment	EG00044 affected322 at risk EG00126 affected310 at risk EG00213 affected304 at risk
Aspartate aminotransferase increased	Investigations	27.1	Systematic Assessment	EG00048 affected322 at risk EG00128 affected310 at risk EG00212 affected304 at risk
Blood alkaline phosphatase increased	Investigations	27.1	Systematic Assessment	EG00019 affected322 at risk EG00122 affected310 at risk EG00210 affected304 at risk
Blood creatinine increased	Investigations	27.1	Systematic Assessment	EG00013 affected322 at risk EG00141 affected310 at risk EG00240 affected304 at risk
Creatinine renal clearance decreased	Investigations	27.1	Systematic Assessment	EG0000 affected322 at risk EG00120 affected310 at risk EG0029 affected304 at risk
Lymphocyte count decreased	Investigations	27.1	Systematic Assessment	EG0008 affected322 at risk EG00116 affected310 at risk EG0029 affected304 at risk
Neutrophil count decreased	Investigations	27.1	Systematic Assessment	EG00012 affected322 at risk EG00175 affected310 at risk EG00261 affected304 at risk
Platelet count decreased	Investigations	27.1	Systematic Assessment	EG00013 affected322 at risk EG00146 affected310 at risk EG00236 affected304 at risk
Weight decreased	Investigations	27.1	Systematic Assessment	EG00043 affected322 at risk EG00141 affected310 at risk EG00235 affected304 at risk
Weight increased	Investigations	27.1	Systematic Assessment	EG0006 affected322 at risk EG00125 affected310 at risk EG00214 affected304 at risk
White blood cell count decreased	Investigations	27.1	Systematic Assessment	EG00012 affected322 at risk EG00158 affected310 at risk EG00241 affected304 at risk
Decreased appetite	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG00070 affected322 at risk EG001161 affected310 at risk EG002156 affected304 at risk
Hypercalcaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG00011 affected322 at risk EG00120 affected310 at risk EG0029 affected304 at risk
Hyperkalaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG00012 affected322 at risk EG00120 affected310 at risk EG00222 affected304 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG00034 affected322 at risk EG00125 affected310 at risk EG00220 affected304 at risk
Hypocalcaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0009 affected322 at risk EG00118 affected310 at risk EG0025 affected304 at risk
Hypokalaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG00034 affected322 at risk EG00144 affected310 at risk EG00230 affected304 at risk
Hyponatraemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG00032 affected322 at risk EG00155 affected310 at risk EG00236 affected304 at risk
Hypophosphataemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG00014 affected322 at risk EG00117 affected310 at risk EG0024 affected304 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG00028 affected322 at risk EG00119 affected310 at risk EG00213 affected304 at risk
Back pain	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG00021 affected322 at risk EG00112 affected310 at risk EG00215 affected304 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG00018 affected322 at risk EG00115 affected310 at risk EG00219 affected304 at risk
Dizziness	Nervous system disorders	27.1	Systematic Assessment	EG00017 affected322 at risk EG00118 affected310 at risk EG00229 affected304 at risk
Dysgeusia	Nervous system disorders	27.1	Systematic Assessment	EG00010 affected322 at risk EG00123 affected310 at risk EG00219 affected304 at risk
Headache	Nervous system disorders	27.1	Systematic Assessment	EG00026 affected322 at risk EG00127 affected310 at risk EG00216 affected304 at risk
Neuropathy peripheral	Nervous system disorders	27.1	Systematic Assessment	EG0002 affected322 at risk EG00122 affected310 at risk EG00215 affected304 at risk
Peripheral sensory neuropathy	Nervous system disorders	27.1	Systematic Assessment	EG0005 affected322 at risk EG00131 affected310 at risk EG00228 affected304 at risk
Insomnia	Psychiatric disorders	27.1	Systematic Assessment	EG00033 affected322 at risk EG00154 affected310 at risk EG00240 affected304 at risk
Renal impairment	Renal and urinary disorders	27.1	Systematic Assessment	EG0002 affected322 at risk EG00112 affected310 at risk EG00217 affected304 at risk
Cough	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG00040 affected322 at risk EG00144 affected310 at risk EG00237 affected304 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG00024 affected322 at risk EG00114 affected310 at risk EG00211 affected304 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG00012 affected322 at risk EG00153 affected310 at risk EG00263 affected304 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG00017 affected322 at risk EG00120 affected310 at risk EG0026 affected304 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG00014 affected322 at risk EG00114 affected310 at risk EG00216 affected304 at risk
Alopecia	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG00010 affected322 at risk EG00142 affected310 at risk EG00242 affected304 at risk
Dry skin	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG00018 affected322 at risk EG00113 affected310 at risk EG00212 affected304 at risk
Pruritus	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG00059 affected322 at risk EG00138 affected310 at risk EG00220 affected304 at risk
Rash	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG00075 affected322 at risk EG00143 affected310 at risk EG00222 affected304 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG00018 affected322 at risk EG0018 affected310 at risk EG0023 affected304 at risk
Hypertension	Vascular disorders	27.1	Systematic Assessment	EG0009 affected322 at risk EG00124 affected310 at risk EG00222 affected304 at risk
Hypotension	Vascular disorders	27.1	Systematic Assessment	EG00011 affected322 at risk EG00113 affected310 at risk EG00216 affected304 at risk

ID	Title	Description
BG000	Arm A: Nivolumab + Ipilimumab	Participants will receive treatment with nivolumab 3 mg/kg as a 30-minute infusion every 2 weeks and ipilimumab as a 30-minute infusion 1 mg/kg every 6 weeks.
BG001	Arm B: Nivolumab + Chemotherapy	Participants will receive treatment with nivolumab 240 mg as a 30-minute infusion on Day 1 and Day 15, fluorouracil 800 mg/m²/day as an IV continuous infusion on Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² as a 30- to 120-minute infusion on Day 1 of 4-week cycle.
BG002	Arm C: Chemotherapy	Participants will receive treatment with fluorouracil 800 mg/m²/day as an IV continuous infusion from Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² as a 30- to 120-minute infusion on Day 1 of 4-week cycle.
BG003	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	Arm A: Nivolumab + Ipilimumab	Participants will receive treatment with nivolumab 3 mg/kg as a 30-minute infusion every 2 weeks and ipilimumab as a 30-minute infusion 1 mg/kg every 6 weeks.	270	325	243	322	301	322
EG001	Arm B: Nivolumab + Chemotherapy	Participants will receive treatment with nivolumab 240 mg as a 30-minute infusion on Day 1 and Day 15, fluorouracil 800 mg/m²/day as an IV continuous infusion on Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² as a 30- to 120-minute infusion on Day 1 of 4-week cycle.	273	321	226	310	307	310
EG002	Arm C: Chemotherapy	Participants will receive treatment with fluorouracil 800 mg/m²/day as an IV continuous infusion from Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² as a 30- to 120-minute infusion on Day 1 of 4-week cycle.	286	324	174	304	288	304

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
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds
D014498	Uracil
D011744	Pyrimidinones
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

ID	Term
D000077594	Nivolumab
D000074324	Ipilimumab
D002945	Cisplatin
D005472	Fluorouracil