A Study of Nivolumab Alone or Nivolumab Combination Thera... | NCT02060188

ID	Type	Description	Link
2013-003939-30	EudraCT Number

Label	Type	Intervention Names
Nivolumab Monotherapy	Experimental	Drug: Nivolumab
Nivolumab + Ipilimumab	Experimental	Drug: Ipilimumab Drug: Nivolumab
Nivolumab + Ipilimumab Cohort C3	Experimental	Drug: Ipilimumab Drug: Nivolumab
Nivolumab + Ipilimumab + Cobimetinib Cohort C4	Experimental	Drug: Ipilimumab Drug: Nivolumab Drug: Cobimetinib
Nivolumab + BMS-986016 Cohort C5	Experimental	Drug: Nivolumab Drug: BMS-986016
Nivolumab + Daratumumab Cohort C6	Experimental	Drug: Nivolumab Drug: Daratumumab

Name	Type	Description	Arm Group Labels	Other Names
Ipilimumab	Drug	Specified dose on specified days	Nivolumab + Ipilimumab Nivolumab + Ipilimumab + Cobimetinib Cohort C4 Nivolumab + Ipilimumab Cohort C3

Measure	Description	Time Frame
Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Per Investigator Assessment	Objective Response Rate (ORR) is defined as the number of randomized participants who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), based on investigator assessments \[using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\], divided by the number of all randomized participants. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.	From date of randomization to the date of objectively documented progression or the date of subsequent systemic cancer therapy, whichever occurs first (Up to approximately 127 months)

Measure	Description	Time Frame
Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Per Independent Review Committee (IRC)	Objective Response Rate (ORR) is defined as the number of randomized participants who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), based on IRC\[using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\], divided by the number of all randomized participants. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

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

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution - 0028		Gilbert	Arizona	85234	United States
Local Institution - 0004

PubMed Identifier	Type	Citation	Retractions
38821718	Derived	Overman MJ, Gelsomino F, Aglietta M, Wong M, Limon Miron ML, Leonard G, Garcia-Alfonso P, Hill AG, Cubillo Gracian A, Van Cutsem E, El-Rayes B, McCraith SM, He B, Lei M, Lonardi S. Nivolumab plus relatlimab in patients with previously treated microsatellite instability-high/mismatch repair-deficient metastatic colorectal cancer: the phase II CheckMate 142 study. J Immunother Cancer. 2024 May 31;12(5):e008689. doi: 10.1136/jitc-2023-008689.
34637336

Label	URL
BMS Clinical Trial Information	View source

ID	Title	Description
FG000	Cohort 1: Nivolumab Monotherapy	Nivolumab 3 mg/kg
FG001	Cohort 2: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg	Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Aug 27, 2021

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0012 affected119 at risk EG0020 affected45 at risk EG0030 affected10 at risk EG0040 affected3 at risk EG0050 affected10 at risk EG0063 affected30 at risk EG0070 affected50 at risk EG0080 affected44 at risk
Neutropenia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0001 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Aortic valve stenosis	Cardiac disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Atrial fibrillation	Cardiac disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Atrioventricular block first degree	Cardiac disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Cardiac failure congestive	Cardiac disorders	27.1	Systematic Assessment	EG0001 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Cardiogenic shock	Cardiac disorders	27.1	Systematic Assessment	EG0001 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Cardiomyopathy	Cardiac disorders	27.1	Systematic Assessment	EG0001 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Dilated cardiomyopathy	Cardiac disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0021 affected45 at risk EG003
Left ventricular dysfunction	Cardiac disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0021 affected45 at risk EG003
Myocardial infarction	Cardiac disorders	27.1	Systematic Assessment	EG0001 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Tympanic membrane perforation	Ear and labyrinth disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0021 affected45 at risk EG003
Adrenal insufficiency	Endocrine disorders	27.1	Systematic Assessment	EG0002 affected74 at risk EG0012 affected119 at risk EG0021 affected45 at risk EG003
Adrenocorticotropic hormone deficiency	Endocrine disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Autoimmune thyroiditis	Endocrine disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Hypophysitis	Endocrine disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0012 affected119 at risk EG0020 affected45 at risk EG003
Hypopituitarism	Endocrine disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Hypothyroidism	Endocrine disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Secondary adrenocortical insufficiency	Endocrine disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Thyroiditis	Endocrine disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Ocular myasthenia	Eye disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Vision blurred	Eye disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Abdominal distension	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Abdominal mass	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Abdominal pain	Gastrointestinal disorders	27.1	Systematic Assessment	EG0002 affected74 at risk EG0013 affected119 at risk EG0021 affected45 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Abdominal strangulated hernia	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Anal fistula	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Ascites	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Colitis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected74 at risk EG0013 affected119 at risk EG0023 affected45 at risk EG003
Constipation	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Diarrhoea	Gastrointestinal disorders	27.1	Systematic Assessment	EG0002 affected74 at risk EG0014 affected119 at risk EG0020 affected45 at risk EG003
Duodenal ulcer	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Enterocolitis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Enterovesical fistula	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Gastritis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Gastrointestinal disorder	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Haematemesis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	27.1	Systematic Assessment	EG0003 affected74 at risk EG0013 affected119 at risk EG0021 affected45 at risk EG003
Intestinal perforation	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0021 affected45 at risk EG003
Large intestinal obstruction	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0013 affected119 at risk EG0020 affected45 at risk EG003
Large intestinal stenosis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Melaena	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Nausea	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Oesophageal varices haemorrhage	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Oesophagitis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Pancreatitis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Pneumatosis intestinalis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Proctalgia	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	27.1	Systematic Assessment	EG0004 affected74 at risk EG0014 affected119 at risk EG0021 affected45 at risk EG003
Stomatitis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Vomiting	Gastrointestinal disorders	27.1	Systematic Assessment	EG0003 affected74 at risk EG0010 affected119 at risk EG0021 affected45 at risk EG003
Asthenia	General disorders and administration site conditions	27.1	Systematic Assessment	EG0001 affected74 at risk EG0010 affected119 at risk EG0021 affected45 at risk EG003
Fatigue	General disorders and administration site conditions	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Gait disturbance	General disorders and administration site conditions	27.1	Systematic Assessment	EG0001 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
General physical health deterioration	General disorders and administration site conditions	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0021 affected45 at risk EG003
Incarcerated hernia	General disorders and administration site conditions	27.1	Systematic Assessment	EG0001 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Influenza like illness	General disorders and administration site conditions	27.1	Systematic Assessment	EG0000 affected74 at risk EG0012 affected119 at risk EG0020 affected45 at risk EG003
Non-cardiac chest pain	General disorders and administration site conditions	27.1	Systematic Assessment	EG0001 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Oedema peripheral	General disorders and administration site conditions	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Pain	General disorders and administration site conditions	27.1	Systematic Assessment	EG0001 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Performance status decreased	General disorders and administration site conditions	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0021 affected45 at risk EG003
Peripheral swelling	General disorders and administration site conditions	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Pyrexia	General disorders and administration site conditions	27.1	Systematic Assessment	EG0002 affected74 at risk EG0014 affected119 at risk EG0024 affected45 at risk EG003
Stenosis	General disorders and administration site conditions	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Sudden death	General disorders and administration site conditions	27.1	Systematic Assessment	EG0001 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Suprapubic pain	General disorders and administration site conditions	27.1	Systematic Assessment	EG0001 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Swelling	General disorders and administration site conditions	27.1	Systematic Assessment	EG0001 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Acute hepatic failure	Hepatobiliary disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Autoimmune hepatitis	Hepatobiliary disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Biliary dilatation	Hepatobiliary disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Biliary obstruction	Hepatobiliary disorders	27.1	Systematic Assessment	EG0001 affected74 at risk EG0012 affected119 at risk EG0020 affected45 at risk EG003
Cholestasis	Hepatobiliary disorders	27.1	Systematic Assessment	EG0001 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Drug-induced liver injury	Hepatobiliary disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Hepatic cytolysis	Hepatobiliary disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Hepatic failure	Hepatobiliary disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Hepatitis	Hepatobiliary disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Hypertransaminasaemia	Hepatobiliary disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Drug hypersensitivity	Immune system disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0012 affected119 at risk EG0020 affected45 at risk EG003
Haemophagocytic lymphohistiocytosis	Immune system disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0021 affected45 at risk EG003
Abdominal abscess	Infections and infestations	27.1	Systematic Assessment	EG0001 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Abdominal wall abscess	Infections and infestations	27.1	Systematic Assessment	EG0001 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Abscess	Infections and infestations	27.1	Systematic Assessment	EG0001 affected74 at risk EG0010 affected119 at risk EG0021 affected45 at risk EG003
Appendicitis	Infections and infestations	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Bacterial infection	Infections and infestations	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0021 affected45 at risk EG003
Biliary sepsis	Infections and infestations	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Bronchitis	Infections and infestations	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Cellulitis	Infections and infestations	27.1	Systematic Assessment	EG0001 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Cholangitis infective	Infections and infestations	27.1	Systematic Assessment	EG0000 affected74 at risk EG0012 affected119 at risk EG0020 affected45 at risk EG003
Clostridium difficile infection	Infections and infestations	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Device related infection	Infections and infestations	27.1	Systematic Assessment	EG0001 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Encephalitis	Infections and infestations	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0021 affected45 at risk EG003
Encephalitis bacterial	Infections and infestations	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Enterobacter sepsis	Infections and infestations	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Escherichia infection	Infections and infestations	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Escherichia urinary tract infection	Infections and infestations	27.1	Systematic Assessment	EG0001 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Gastroenteritis	Infections and infestations	27.1	Systematic Assessment	EG0001 affected74 at risk EG0010 affected119 at risk EG0021 affected45 at risk EG003
Implant site infection	Infections and infestations	27.1	Systematic Assessment	EG0001 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Klebsiella infection	Infections and infestations	27.1	Systematic Assessment	EG0001 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Klebsiella sepsis	Infections and infestations	27.1	Systematic Assessment	EG0001 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Large intestine infection	Infections and infestations	27.1	Systematic Assessment	EG0000 affected74 at risk EG0012 affected119 at risk EG0020 affected45 at risk EG003
Lower respiratory tract infection	Infections and infestations	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0021 affected45 at risk EG003
Lung abscess	Infections and infestations	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Meningitis	Infections and infestations	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Metapneumovirus pneumonia	Infections and infestations	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Myelitis	Infections and infestations	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Pelvic infection	Infections and infestations	27.1	Systematic Assessment	EG0001 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Peritonitis	Infections and infestations	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0021 affected45 at risk EG003
Pharyngitis	Infections and infestations	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Pneumococcal infection	Infections and infestations	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0021 affected45 at risk EG003
Pneumonia	Infections and infestations	27.1	Systematic Assessment	EG0001 affected74 at risk EG0012 affected119 at risk EG0020 affected45 at risk EG003
Pseudomonas infection	Infections and infestations	27.1	Systematic Assessment	EG0001 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Pyelonephritis	Infections and infestations	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Respiratory tract infection	Infections and infestations	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Sepsis	Infections and infestations	27.1	Systematic Assessment	EG0001 affected74 at risk EG0011 affected119 at risk EG0022 affected45 at risk EG003
Septic shock	Infections and infestations	27.1	Systematic Assessment	EG0001 affected74 at risk EG0010 affected119 at risk EG0021 affected45 at risk EG003
Staphylococcal bacteraemia	Infections and infestations	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Staphylococcal infection	Infections and infestations	27.1	Systematic Assessment	EG0001 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Systemic infection	Infections and infestations	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Tooth infection	Infections and infestations	27.1	Systematic Assessment	EG0001 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Urinary tract infection	Infections and infestations	27.1	Systematic Assessment	EG0002 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Urinary tract infection bacterial	Infections and infestations	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Urosepsis	Infections and infestations	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Vascular device infection	Infections and infestations	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Viral infection	Infections and infestations	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Wound infection	Infections and infestations	27.1	Systematic Assessment	EG0001 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Accidental overdose	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0021 affected45 at risk EG003
Clavicle fracture	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Fall	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 affected74 at risk EG0012 affected119 at risk EG0020 affected45 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Limb injury	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Lumbar vertebral fracture	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Open fracture	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Post procedural haemorrhage	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Procedural intestinal perforation	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0021 affected45 at risk EG003
Shoulder fracture	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Spinal fracture	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Stomal hernia	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0021 affected45 at risk EG003
Tracheal deviation	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Ulna fracture	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Urinary tract stoma complication	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Wrist fracture	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Alanine aminotransferase increased	Investigations	27.1	Systematic Assessment	EG0001 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Aspartate aminotransferase increased	Investigations	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Blood bilirubin increased	Investigations	27.1	Systematic Assessment	EG0000 affected74 at risk EG0012 affected119 at risk EG0020 affected45 at risk EG003
Blood creatinine increased	Investigations	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0021 affected45 at risk EG003
C-reactive protein increased	Investigations	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Transaminases increased	Investigations	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Troponin I increased	Investigations	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Troponin increased	Investigations	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Dehydration	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0013 affected119 at risk EG0020 affected45 at risk EG003
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Diabetic ketoacidosis	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0001 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0021 affected45 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0021 affected45 at risk EG003
Malnutrition	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Metabolic acidosis	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0001 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Autoimmune arthritis	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0001 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0012 affected119 at risk EG0021 affected45 at risk EG003
Fistula	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0001 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Groin pain	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Myopathy	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Necrotising myositis	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Tendon disorder	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Colorectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Colorectal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Follicular lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG00013 affected74 at risk EG00112 affected119 at risk EG0023 affected45 at risk EG003
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0021 affected45 at risk EG003
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0021 affected45 at risk EG003
Metastases to meninges	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Metastasis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0001 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Second primary malignancy	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Tumour fistulisation	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0001 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Cauda equina syndrome	Nervous system disorders	27.1	Systematic Assessment	EG0001 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Cerebral haemorrhage	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0021 affected45 at risk EG003
Cerebral venous sinus thrombosis	Nervous system disorders	27.1	Systematic Assessment	EG0001 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Encephalopathy	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Epilepsy	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Haemorrhage intracranial	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Headache	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0021 affected45 at risk EG003
Malignant spinal cord compression	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Seizure	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Syncope	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0012 affected119 at risk EG0020 affected45 at risk EG003
Transient ischaemic attack	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0021 affected45 at risk EG003
Device dislocation	Product issues	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Thrombosis in device	Product issues	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Alcoholism	Psychiatric disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Depression	Psychiatric disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0021 affected45 at risk EG003
Mental status changes	Psychiatric disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Psychotic disorder	Psychiatric disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Acute kidney injury	Renal and urinary disorders	27.1	Systematic Assessment	EG0001 affected74 at risk EG0013 affected119 at risk EG0020 affected45 at risk EG003
Haematuria	Renal and urinary disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Nephrolithiasis	Renal and urinary disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Renal failure	Renal and urinary disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Renal impairment	Renal and urinary disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Renal tubular necrosis	Renal and urinary disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Urinary retention	Renal and urinary disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Benign prostatic hyperplasia	Reproductive system and breast disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Pelvic pain	Reproductive system and breast disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Vaginal haemorrhage	Reproductive system and breast disorders	27.1	Systematic Assessment	EG0001 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0001 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0002 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0001 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0002 affected74 at risk EG0011 affected119 at risk EG0021 affected45 at risk EG003
Psoriasis	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Rash	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Deep vein thrombosis	Vascular disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Hypotension	Vascular disorders	27.1	Systematic Assessment	EG0001 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Peripheral ischaemia	Vascular disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0021 affected45 at risk EG003
Venous thrombosis	Vascular disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG00033 affected74 at risk EG00141 affected119 at risk EG00210 affected45 at risk EG0031 affected10 at risk EG0040 affected3 at risk EG0054 affected10 at risk EG00614 affected30 at risk EG0079 affected50 at risk EG0086 affected44 at risk
Lymphopenia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Neutropenia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0007 affected74 at risk EG0019 affected119 at risk EG0023 affected45 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0004 affected74 at risk EG00116 affected119 at risk EG0020 affected45 at risk EG003
Palpitations	Cardiac disorders	27.1	Systematic Assessment	EG0001 affected74 at risk EG0015 affected119 at risk EG0025 affected45 at risk EG003
Sinus tachycardia	Cardiac disorders	27.1	Systematic Assessment	EG0002 affected74 at risk EG0012 affected119 at risk EG0020 affected45 at risk EG003
Hypoacusis	Ear and labyrinth disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0021 affected45 at risk EG003
Vertigo	Ear and labyrinth disorders	27.1	Systematic Assessment	EG0002 affected74 at risk EG0015 affected119 at risk EG0025 affected45 at risk EG003
Adrenal insufficiency	Endocrine disorders	27.1	Systematic Assessment	EG0001 affected74 at risk EG0018 affected119 at risk EG0021 affected45 at risk EG003
Hyperthyroidism	Endocrine disorders	27.1	Systematic Assessment	EG0004 affected74 at risk EG00118 affected119 at risk EG0026 affected45 at risk EG003
Hypothyroidism	Endocrine disorders	27.1	Systematic Assessment	EG0009 affected74 at risk EG00122 affected119 at risk EG00210 affected45 at risk EG003
Dry eye	Eye disorders	27.1	Systematic Assessment	EG0002 affected74 at risk EG0015 affected119 at risk EG0021 affected45 at risk EG003
Eyelid oedema	Eye disorders	27.1	Systematic Assessment	EG0001 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Serous retinopathy	Eye disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Vision blurred	Eye disorders	27.1	Systematic Assessment	EG0005 affected74 at risk EG0015 affected119 at risk EG0023 affected45 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	27.1	Systematic Assessment	EG0005 affected74 at risk EG0013 affected119 at risk EG0021 affected45 at risk EG003
Abdominal distension	Gastrointestinal disorders	27.1	Systematic Assessment	EG0003 affected74 at risk EG0016 affected119 at risk EG0021 affected45 at risk EG003
Abdominal pain	Gastrointestinal disorders	27.1	Systematic Assessment	EG00028 affected74 at risk EG00137 affected119 at risk EG00214 affected45 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	27.1	Systematic Assessment	EG0004 affected74 at risk EG0012 affected119 at risk EG0021 affected45 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	27.1	Systematic Assessment	EG00012 affected74 at risk EG00116 affected119 at risk EG0025 affected45 at risk EG003
Ascites	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Constipation	Gastrointestinal disorders	27.1	Systematic Assessment	EG00020 affected74 at risk EG00127 affected119 at risk EG0027 affected45 at risk EG003
Diarrhoea	Gastrointestinal disorders	27.1	Systematic Assessment	EG00043 affected74 at risk EG00173 affected119 at risk EG00220 affected45 at risk EG003
Dry mouth	Gastrointestinal disorders	27.1	Systematic Assessment	EG0004 affected74 at risk EG00111 affected119 at risk EG0025 affected45 at risk EG003
Dyspepsia	Gastrointestinal disorders	27.1	Systematic Assessment	EG00011 affected74 at risk EG0017 affected119 at risk EG0020 affected45 at risk EG003
Dysphagia	Gastrointestinal disorders	27.1	Systematic Assessment	EG0003 affected74 at risk EG0014 affected119 at risk EG0020 affected45 at risk EG003
Flatulence	Gastrointestinal disorders	27.1	Systematic Assessment	EG0002 affected74 at risk EG0013 affected119 at risk EG0022 affected45 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	27.1	Systematic Assessment	EG0007 affected74 at risk EG0015 affected119 at risk EG0021 affected45 at risk EG003
Haematochezia	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected74 at risk EG0011 affected119 at risk EG0022 affected45 at risk EG003
Nausea	Gastrointestinal disorders	27.1	Systematic Assessment	EG00036 affected74 at risk EG00139 affected119 at risk EG00217 affected45 at risk EG003
Stomatitis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0006 affected74 at risk EG0016 affected119 at risk EG0024 affected45 at risk EG003
Toothache	Gastrointestinal disorders	27.1	Systematic Assessment	EG0003 affected74 at risk EG00111 affected119 at risk EG0021 affected45 at risk EG003
Vomiting	Gastrointestinal disorders	27.1	Systematic Assessment	EG00030 affected74 at risk EG00131 affected119 at risk EG00214 affected45 at risk EG003
Asthenia	General disorders and administration site conditions	27.1	Systematic Assessment	EG00018 affected74 at risk EG00138 affected119 at risk EG00214 affected45 at risk EG003
Chills	General disorders and administration site conditions	27.1	Systematic Assessment	EG0005 affected74 at risk EG0019 affected119 at risk EG0022 affected45 at risk EG003
Fatigue	General disorders and administration site conditions	27.1	Systematic Assessment	EG00039 affected74 at risk EG00143 affected119 at risk EG00215 affected45 at risk EG003
Feeling of body temperature change	General disorders and administration site conditions	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
General physical health deterioration	General disorders and administration site conditions	27.1	Systematic Assessment	EG0001 affected74 at risk EG0010 affected119 at risk EG0022 affected45 at risk EG003
Influenza like illness	General disorders and administration site conditions	27.1	Systematic Assessment	EG0003 affected74 at risk EG00117 affected119 at risk EG0022 affected45 at risk EG003
Mucosal inflammation	General disorders and administration site conditions	27.1	Systematic Assessment	EG0002 affected74 at risk EG0016 affected119 at risk EG0023 affected45 at risk EG003
Non-cardiac chest pain	General disorders and administration site conditions	27.1	Systematic Assessment	EG0009 affected74 at risk EG0016 affected119 at risk EG0021 affected45 at risk EG003
Oedema	General disorders and administration site conditions	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0021 affected45 at risk EG003
Oedema peripheral	General disorders and administration site conditions	27.1	Systematic Assessment	EG00013 affected74 at risk EG00113 affected119 at risk EG0025 affected45 at risk EG003
Pain	General disorders and administration site conditions	27.1	Systematic Assessment	EG0004 affected74 at risk EG00114 affected119 at risk EG0026 affected45 at risk EG003
Pyrexia	General disorders and administration site conditions	27.1	Systematic Assessment	EG00025 affected74 at risk EG00152 affected119 at risk EG00215 affected45 at risk EG003
Drug-induced liver injury	Hepatobiliary disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Hepatic failure	Hepatobiliary disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Hypersensitivity	Immune system disorders	27.1	Systematic Assessment	EG0001 affected74 at risk EG0015 affected119 at risk EG0021 affected45 at risk EG003
Eye infection	Infections and infestations	27.1	Systematic Assessment	EG0000 affected74 at risk EG0012 affected119 at risk EG0020 affected45 at risk EG003
Gastroenteritis	Infections and infestations	27.1	Systematic Assessment	EG0001 affected74 at risk EG0017 affected119 at risk EG0022 affected45 at risk EG003
Influenza	Infections and infestations	27.1	Systematic Assessment	EG0002 affected74 at risk EG00110 affected119 at risk EG0022 affected45 at risk EG003
Nasopharyngitis	Infections and infestations	27.1	Systematic Assessment	EG00014 affected74 at risk EG00121 affected119 at risk EG0027 affected45 at risk EG003
Oral candidiasis	Infections and infestations	27.1	Systematic Assessment	EG0000 affected74 at risk EG00110 affected119 at risk EG0020 affected45 at risk EG003
Rash pustular	Infections and infestations	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0021 affected45 at risk EG003
Rhinitis	Infections and infestations	27.1	Systematic Assessment	EG0004 affected74 at risk EG0019 affected119 at risk EG0020 affected45 at risk EG003
Sepsis	Infections and infestations	27.1	Systematic Assessment	EG0000 affected74 at risk EG0012 affected119 at risk EG0020 affected45 at risk EG003
Sinusitis	Infections and infestations	27.1	Systematic Assessment	EG0004 affected74 at risk EG00112 affected119 at risk EG0023 affected45 at risk EG003
Upper respiratory tract infection	Infections and infestations	27.1	Systematic Assessment	EG00011 affected74 at risk EG00114 affected119 at risk EG0023 affected45 at risk EG003
Urinary tract infection	Infections and infestations	27.1	Systematic Assessment	EG00010 affected74 at risk EG00114 affected119 at risk EG0023 affected45 at risk EG003
Vascular device infection	Infections and infestations	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Fall	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0002 affected74 at risk EG00110 affected119 at risk EG0023 affected45 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0001 affected74 at risk EG0013 affected119 at risk EG0023 affected45 at risk EG003
Skin wound	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Alanine aminotransferase increased	Investigations	27.1	Systematic Assessment	EG00013 affected74 at risk EG00124 affected119 at risk EG0027 affected45 at risk EG003
Amylase increased	Investigations	27.1	Systematic Assessment	EG00010 affected74 at risk EG00119 affected119 at risk EG0027 affected45 at risk EG003
Aspartate aminotransferase increased	Investigations	27.1	Systematic Assessment	EG00013 affected74 at risk EG00128 affected119 at risk EG0024 affected45 at risk EG003
Blood albumin decreased	Investigations	27.1	Systematic Assessment	EG0001 affected74 at risk EG0010 affected119 at risk EG0021 affected45 at risk EG003
Blood alkaline phosphatase increased	Investigations	27.1	Systematic Assessment	EG00010 affected74 at risk EG00110 affected119 at risk EG0023 affected45 at risk EG003
Blood bilirubin increased	Investigations	27.1	Systematic Assessment	EG0007 affected74 at risk EG0017 affected119 at risk EG0022 affected45 at risk EG003
Blood calcium decreased	Investigations	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Blood creatine phosphokinase increased	Investigations	27.1	Systematic Assessment	EG0002 affected74 at risk EG0012 affected119 at risk EG0021 affected45 at risk EG003
Blood creatinine increased	Investigations	27.1	Systematic Assessment	EG0006 affected74 at risk EG00120 affected119 at risk EG0029 affected45 at risk EG003
Blood magnesium decreased	Investigations	27.1	Systematic Assessment	EG0001 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Blood potassium increased	Investigations	27.1	Systematic Assessment	EG0001 affected74 at risk EG0012 affected119 at risk EG0020 affected45 at risk EG003
Blood sodium decreased	Investigations	27.1	Systematic Assessment	EG0001 affected74 at risk EG0013 affected119 at risk EG0021 affected45 at risk EG003
Blood sodium increased	Investigations	27.1	Systematic Assessment	EG0001 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Gamma-glutamyltransferase increased	Investigations	27.1	Systematic Assessment	EG0003 affected74 at risk EG0012 affected119 at risk EG0022 affected45 at risk EG003
Lipase increased	Investigations	27.1	Systematic Assessment	EG00014 affected74 at risk EG00124 affected119 at risk EG0028 affected45 at risk EG003
Lymphocyte count decreased	Investigations	27.1	Systematic Assessment	EG0004 affected74 at risk EG0012 affected119 at risk EG0020 affected45 at risk EG003
Platelet count decreased	Investigations	27.1	Systematic Assessment	EG0006 affected74 at risk EG0016 affected119 at risk EG0022 affected45 at risk EG003
Transaminases increased	Investigations	27.1	Systematic Assessment	EG0000 affected74 at risk EG0015 affected119 at risk EG0022 affected45 at risk EG003
Troponin increased	Investigations	27.1	Systematic Assessment	EG0001 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Weight decreased	Investigations	27.1	Systematic Assessment	EG0008 affected74 at risk EG00114 affected119 at risk EG0027 affected45 at risk EG003
Weight increased	Investigations	27.1	Systematic Assessment	EG0009 affected74 at risk EG00110 affected119 at risk EG0023 affected45 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG00015 affected74 at risk EG00131 affected119 at risk EG00211 affected45 at risk EG003
Dehydration	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0007 affected74 at risk EG0019 affected119 at risk EG0023 affected45 at risk EG003
Diabetic ketoacidosis	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG00015 affected74 at risk EG0019 affected119 at risk EG0023 affected45 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0006 affected74 at risk EG0019 affected119 at risk EG0028 affected45 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0001 affected74 at risk EG0014 affected119 at risk EG0021 affected45 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0003 affected74 at risk EG0016 affected119 at risk EG0021 affected45 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0006 affected74 at risk EG00111 affected119 at risk EG0022 affected45 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0005 affected74 at risk EG00111 affected119 at risk EG0023 affected45 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0005 affected74 at risk EG0019 affected119 at risk EG0021 affected45 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG00024 affected74 at risk EG00131 affected119 at risk EG00216 affected45 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG00016 affected74 at risk EG00136 affected119 at risk EG0028 affected45 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0004 affected74 at risk EG0012 affected119 at risk EG0020 affected45 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0004 affected74 at risk EG0017 affected119 at risk EG0023 affected45 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0002 affected74 at risk EG0016 affected119 at risk EG0022 affected45 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG00010 affected74 at risk EG00113 affected119 at risk EG0025 affected45 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0006 affected74 at risk EG0019 affected119 at risk EG0023 affected45 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG00011 affected74 at risk EG00114 affected119 at risk EG00210 affected45 at risk EG003
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Dizziness	Nervous system disorders	27.1	Systematic Assessment	EG00011 affected74 at risk EG00113 affected119 at risk EG0025 affected45 at risk EG003
Dysgeusia	Nervous system disorders	27.1	Systematic Assessment	EG0002 affected74 at risk EG0014 affected119 at risk EG0022 affected45 at risk EG003
Headache	Nervous system disorders	27.1	Systematic Assessment	EG00017 affected74 at risk EG00125 affected119 at risk EG0025 affected45 at risk EG003
Neuropathy peripheral	Nervous system disorders	27.1	Systematic Assessment	EG0001 affected74 at risk EG0019 affected119 at risk EG0020 affected45 at risk EG003
Paraesthesia	Nervous system disorders	27.1	Systematic Assessment	EG0007 affected74 at risk EG00110 affected119 at risk EG0022 affected45 at risk EG003
Polyneuropathy	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0021 affected45 at risk EG003
Somnolence	Nervous system disorders	27.1	Systematic Assessment	EG0004 affected74 at risk EG0011 affected119 at risk EG0022 affected45 at risk EG003
Anxiety	Psychiatric disorders	27.1	Systematic Assessment	EG0009 affected74 at risk EG00114 affected119 at risk EG0025 affected45 at risk EG003
Depressed mood	Psychiatric disorders	27.1	Systematic Assessment	EG0001 affected74 at risk EG0013 affected119 at risk EG0022 affected45 at risk EG003
Depression	Psychiatric disorders	27.1	Systematic Assessment	EG0002 affected74 at risk EG0016 affected119 at risk EG0024 affected45 at risk EG003
Hallucination	Psychiatric disorders	27.1	Systematic Assessment	EG0001 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Insomnia	Psychiatric disorders	27.1	Systematic Assessment	EG00011 affected74 at risk EG00126 affected119 at risk EG0029 affected45 at risk EG003
Dysuria	Renal and urinary disorders	27.1	Systematic Assessment	EG0005 affected74 at risk EG0018 affected119 at risk EG0020 affected45 at risk EG003
Haematuria	Renal and urinary disorders	27.1	Systematic Assessment	EG0004 affected74 at risk EG0013 affected119 at risk EG0020 affected45 at risk EG003
Micturition urgency	Renal and urinary disorders	27.1	Systematic Assessment	EG0002 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Pollakiuria	Renal and urinary disorders	27.1	Systematic Assessment	EG0003 affected74 at risk EG0013 affected119 at risk EG0020 affected45 at risk EG003
Intermenstrual bleeding	Reproductive system and breast disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG00027 affected74 at risk EG00143 affected119 at risk EG00210 affected45 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0001 affected74 at risk EG0014 affected119 at risk EG0021 affected45 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG00012 affected74 at risk EG00120 affected119 at risk EG0027 affected45 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0002 affected74 at risk EG0011 affected119 at risk EG0023 affected45 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0002 affected74 at risk EG0014 affected119 at risk EG0020 affected45 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0004 affected74 at risk EG00111 affected119 at risk EG0024 affected45 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG00010 affected74 at risk EG00118 affected119 at risk EG0023 affected45 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0001 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0003 affected74 at risk EG0017 affected119 at risk EG0025 affected45 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG00010 affected74 at risk EG0016 affected119 at risk EG0021 affected45 at risk EG003
Dermatitis acneiform	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG0002 affected74 at risk EG0014 affected119 at risk EG0020 affected45 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG00010 affected74 at risk EG00121 affected119 at risk EG0024 affected45 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG0004 affected74 at risk EG00111 affected119 at risk EG0022 affected45 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG0001 affected74 at risk EG0012 affected119 at risk EG0021 affected45 at risk EG003
Night sweats	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG0001 affected74 at risk EG0017 affected119 at risk EG0022 affected45 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG00022 affected74 at risk EG00140 affected119 at risk EG00220 affected45 at risk EG003
Rash	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG00016 affected74 at risk EG00126 affected119 at risk EG00212 affected45 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG00011 affected74 at risk EG00110 affected119 at risk EG0023 affected45 at risk EG003
Rash pruritic	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0013 affected119 at risk EG0022 affected45 at risk EG003
Skin lesion	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG0004 affected74 at risk EG0015 affected119 at risk EG0023 affected45 at risk EG003
Deep vein thrombosis	Vascular disorders	27.1	Systematic Assessment	EG0001 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Flushing	Vascular disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Hot flush	Vascular disorders	27.1	Systematic Assessment	EG0006 affected74 at risk EG0013 affected119 at risk EG0020 affected45 at risk EG003
Hypertension	Vascular disorders	27.1	Systematic Assessment	EG00014 affected74 at risk EG00117 affected119 at risk EG0028 affected45 at risk EG003
Hypotension	Vascular disorders	27.1	Systematic Assessment	EG0001 affected74 at risk EG00110 affected119 at risk EG0021 affected45 at risk EG003
Colitis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0011 affected119 at risk EG0023 affected45 at risk EG003
Haemorrhoids	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected74 at risk EG0014 affected119 at risk EG0024 affected45 at risk EG003
Odynophagia	Gastrointestinal disorders	27.1	Systematic Assessment	EG0002 affected74 at risk EG0010 affected119 at risk EG0023 affected45 at risk EG003
Bronchitis	Infections and infestations	27.1	Systematic Assessment	EG0003 affected74 at risk EG0017 affected119 at risk EG0021 affected45 at risk EG003
Pneumonia	Infections and infestations	27.1	Systematic Assessment	EG0003 affected74 at risk EG0016 affected119 at risk EG0020 affected45 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0001 affected74 at risk EG0012 affected119 at risk EG0023 affected45 at risk EG003
Neuralgia	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0016 affected119 at risk EG0022 affected45 at risk EG003
Sciatica	Nervous system disorders	27.1	Systematic Assessment	EG0001 affected74 at risk EG0015 affected119 at risk EG0023 affected45 at risk EG003
Upper-airway cough syndrome	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0002 affected74 at risk EG0016 affected119 at risk EG0021 affected45 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG0002 affected74 at risk EG0016 affected119 at risk EG0020 affected45 at risk EG003
Rash papular	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG0001 affected74 at risk EG0011 affected119 at risk EG0023 affected45 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG0001 affected74 at risk EG0017 affected119 at risk EG0021 affected45 at risk EG003
Iron deficiency anaemia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Foreign body sensation in eyes	Eye disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Lacrimation increased	Eye disorders	27.1	Systematic Assessment	EG0002 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Photophobia	Eye disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Abdominal tenderness	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Aphthous ulcer	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Eructation	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Proctalgia	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected74 at risk EG0012 affected119 at risk EG0021 affected45 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Hyperbilirubinaemia	Hepatobiliary disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0021 affected45 at risk EG003
Genital herpes	Infections and infestations	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
International normalised ratio increased	Investigations	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0002 affected74 at risk EG0014 affected119 at risk EG0021 affected45 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0001 affected74 at risk EG0014 affected119 at risk EG0021 affected45 at risk EG003
Sacral pain	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0002 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Tumour thrombosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Restless legs syndrome	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Device occlusion	Product issues	27.1	Systematic Assessment	EG0001 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003
Acute kidney injury	Renal and urinary disorders	27.1	Systematic Assessment	EG0003 affected74 at risk EG0015 affected119 at risk EG0022 affected45 at risk EG003
Hydronephrosis	Renal and urinary disorders	27.1	Systematic Assessment	EG0001 affected74 at risk EG0011 affected119 at risk EG0020 affected45 at risk EG003
Renal pain	Renal and urinary disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0021 affected45 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0002 affected74 at risk EG0015 affected119 at risk EG0021 affected45 at risk EG003
Rash follicular	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG0000 affected74 at risk EG0010 affected119 at risk EG0020 affected45 at risk EG003

ID	Title	Description
BG000	Cohort 1: Nivolumab Monotherapy	Nivolumab 3 mg/kg
BG001	Cohort 2: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg	Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
BG002	Cohort 3: Nivolumab 3 mg/kg Q2W with Ipilimumab 1 mg/kg Q6W	Nivolumab 3 mg/kg Q2W with Ipilimumab 1 mg/kg twice in six weeks Q6W
BG003	MSS: Nivolumab 3 mg/kg Q2W with Ipilimumab 1 mg/kg Q6W	Nivolumab 3 mg/kg Q2W with Ipilimumab 1 mg/kg Q6W
BG004	Non-MSI-H: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg	Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
BG005	Non-MSI-H: Nivolumab 1 mg/kg + Ipilimumab 1 mg/kg	Nivolumab 1 mg/kg + Ipilimumab 1 mg/kg
BG006	Cohort 4: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg + Cobimetinib 60 mg	Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg + Cobimetinib 60 mg
BG007	Cohort 5: Nivolumab 240 mg + BMS-986016 80 mg	Nivolumab 240 mg + BMS-986016 80 mg
BG008	Cohort 6: Nivolumab FD + Daratumumab 16 mg/kg	Nivolumab FD + Daratumumab 16 mg/kg
BG009	Total	Total of all reporting groups

ID	Term
D000074324	Ipilimumab
D000077594	Nivolumab
C574276	cobimetinib
C556306	daratumumab
C000721227	relatlimab

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

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cohort 1: Nivolumab Monotherapy	Nivolumab 3 mg/kg	44	74	46	74	73	74
EG001	Cohort 2: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg	Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg	46	119	72	119	116	119
EG002	Cohort 3: Nivolumab 3 mg/kg Q2W with Ipilimumab 1 mg/kg Q6W	Nivolumab 3 mg/kg Q2W with Ipilimumab 1 mg/kg twice in six weeks Q6W	16	45	22	45	45	45
EG003	MSS Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg	MSS: Nivolumab 3 mg/kg Q2W with Ipilimumab 1 mg/kg Q6W	9	10	8	10	10	10
EG004	Non-MSI-H: Nivolumab 1 mg/kg + Ipilimumab 1 mg/kg	Non-MSI-H: Nivolumab 1 mg/kg + Ipilimumab 1 mg/kg	3	3	3	3	3	3
EG005	Non-MSI-H: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg	Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg	10	10	9	10	10	10
EG006	Cohort 4: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg + Cobimetinib 60 mg	Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg + Cobimetinib 60 mg	29	30	20	30	27	30
EG007	Cohort 5: Nivolumab 240 mg + BMS-986016 80 mg	Nivolumab 240 mg + BMS-986016 80 mg	27	50	28	50	48	50
EG008	Cohort 6: Nivolumab FD + Daratumumab 16 mg/kg	Nivolumab FD + Daratumumab 16 mg/kg	43	44	29	44	43	44