Pembrolizumab (MK-3475) Plus Gemcitabine/Cisplatin Versus... | NCT04003636

ID	Type	Description
MK-3475-966	Other Identifier	MSD
KEYNOTE-966	Other Identifier	MSD
195007	Registry Identifier	JAPIC-CTI
2023-506657-38-00	Registry Identifier	EU CT
U1111-1294-1943	Registry Identifier	UTN
2019-000944-82	EudraCT Number

Label	Type	Description	Intervention Names
Arm A (Pembrolizumab+Chemotherapy)	Experimental	Participants receive pembrolizumab, 200 mg intravenous (IV) infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS gemcitabine, 1000 mg/m^2, IV infusion Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS cisplatin, 25 mg/m^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles. Eligible participants who stop the initial course of pembrolizumab with stable disease (SD) or better but progress after discontinuation will initiate a second course of pembrolizumab 200 mg IV Q3W, Day 1 of each 3-week cycle for up to 17 cycles. Treatment with gemcitabine can be stopped at anytime in first or second course due to toxicity or disease progression.	Biological: Pembrolizumab Drug: Gemcitabine Drug: Cisplatin
Arm B (Placebo+Chemotherapy)	Placebo Comparator	Participants receive placebo to pembrolizumab, 200 mg IV infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS gemcitabine, 1000 mg/m^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS cisplatin, 25 mg/m^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles.	Drug: Gemcitabine Drug: Cisplatin Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Pembrolizumab	Biological	Pembrolizumab by intravenous (IV) infusion	Arm A (Pembrolizumab+Chemotherapy)

Measure	Description	Time Frame
Overall Survival (OS)	Overall survival was defined as the time from randomization to death due to any cause.	Up to approximately 38 months

Measure	Description	Time Frame
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (BICR)	PFS was defined as the time from randomization to the first documented disease progression (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. PFS as assessed by BICR per RECIST 1.1 was presented.

Name	Affiliation	Role
Medical Director	Merck Sharp & Dohme LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham Comprehensive Cancer Ctr ( Site 0016)		Birmingham	Alabama	35294	United States

PubMed Identifier	Type	Citation	Retractions
37075781	Result	Kelley RK, Ueno M, Yoo C, Finn RS, Furuse J, Ren Z, Yau T, Klumpen HJ, Chan SL, Ozaka M, Verslype C, Bouattour M, Park JO, Barajas O, Pelzer U, Valle JW, Yu L, Malhotra U, Siegel AB, Edeline J, Vogel A; KEYNOTE-966 Investigators. Pembrolizumab in combination with gemcitabine and cisplatin compared with gemcitabine and cisplatin alone for patients with advanced biliary tract cancer (KEYNOTE-966): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2023 Jun 3;401(10391):1853-1865. doi: 10.1016/S0140-6736(23)00727-4. Epub 2023 Apr 16.
42176183

Label	URL
Merck Clinical Trials Information	View source

ID	Title	Description
FG000	Arm A: Pembrolizumab + Chemotherapy	Participants received pembrolizumab, 200 mg intravenous (IV) infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m^2, IV infusion Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation initiated a second course of pembrolizumab 200mg IV Q3W, Day 1 of each 3-week cycle for up to 17 cycles. Treatment with Gemcitabine could have been stopped at any time in first or second course due to toxicity or disease progression.

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	Jun 16, 2022

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG00013 events13 affected529 at risk EG00110 events10 affected534 at risk EG0020 events0 affected10 at risk
Coombs negative haemolytic anaemia	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Febrile bone marrow aplasia	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0008 events7 affected529 at risk EG0018 events8 affected534 at risk EG0020 events0 affected10 at risk
Immune thrombocytopenia	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Microangiopathic haemolytic anaemia	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Myelosuppression	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Thrombotic microangiopathy	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Angina pectoris	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Cardiac arrest	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Cardiac failure	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0006 events6 affected529 at risk EG0013 events3 affected534 at risk EG0020 events0 affected10 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Cardiomyopathy	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Myocardial infarction	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected529 at risk EG0014 events4 affected534 at risk EG0020 events0 affected10 at risk
Myocarditis	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Pericardial effusion	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Pericarditis	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Deafness neurosensory	Ear and labyrinth disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Sudden hearing loss	Ear and labyrinth disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0012 events2 affected534 at risk EG0020 events0 affected10 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Hypophysitis	Endocrine disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Hypopituitarism	Endocrine disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Hypothyroidism	Endocrine disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Inappropriate antidiuretic hormone secretion	Endocrine disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Retinal detachment	Eye disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0007 events6 affected529 at risk EG0017 events7 affected534 at risk EG0020 events0 affected10 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Ascites	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0007 events6 affected529 at risk EG00114 events13 affected534 at risk EG0020 events0 affected10 at risk
Autoimmune colitis	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Colitis	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected529 at risk EG0012 events2 affected534 at risk EG0020 events0 affected10 at risk
Colonic fistula	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Constipation	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected529 at risk EG0012 events2 affected534 at risk EG0020 events0 affected10 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected529 at risk EG0016 events6 affected534 at risk EG0020 events0 affected10 at risk
Diverticular perforation	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Duodenal obstruction	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Fistula of small intestine	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Gastric stenosis	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Gastritis	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0005 events5 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Gastrointestinal toxicity	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0002 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Haemoperitoneum	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Ileus	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0004 events4 affected529 at risk EG0016 events4 affected534 at risk EG0020 events0 affected10 at risk
Ileus paralytic	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Immune-mediated enterocolitis	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected529 at risk EG0013 events3 affected534 at risk EG0020 events0 affected10 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Intestinal varices haemorrhage	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Jejunal perforation	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Malignant gastrointestinal obstruction	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0012 events2 affected534 at risk EG0020 events0 affected10 at risk
Mechanical ileus	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Melaena	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0014 events2 affected534 at risk EG0020 events0 affected10 at risk
Nausea	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected529 at risk EG0012 events2 affected534 at risk EG0020 events0 affected10 at risk
Obstruction gastric	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Oesophageal stenosis	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Oesophageal varices haemorrhage	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0012 events2 affected534 at risk EG0020 events0 affected10 at risk
Pancreatolithiasis	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Pneumatosis intestinalis	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Prepyloric stenosis	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Small intestinal haemorrhage	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0005 events4 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Subileus	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected529 at risk EG0013 events3 affected534 at risk EG0020 events0 affected10 at risk
Vomiting	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0008 events8 affected529 at risk EG0014 events4 affected534 at risk EG0020 events0 affected10 at risk
Asthenia	General disorders	MedDRA 28.0	Systematic Assessment	EG0003 events2 affected529 at risk EG0013 events3 affected534 at risk EG0020 events0 affected10 at risk
Death	General disorders	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected529 at risk EG0015 events5 affected534 at risk EG0020 events0 affected10 at risk
Fatigue	General disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected529 at risk EG0012 events2 affected534 at risk EG0020 events0 affected10 at risk
General physical health deterioration	General disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Hyperpyrexia	General disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Influenza like illness	General disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Malaise	General disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Oedema peripheral	General disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0012 events2 affected534 at risk EG0020 events0 affected10 at risk
Pain	General disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Peripheral swelling	General disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Puncture site haemorrhage	General disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Pyrexia	General disorders	MedDRA 28.0	Systematic Assessment	EG00034 events30 affected529 at risk EG00114 events12 affected534 at risk EG0020 events0 affected10 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Bile duct stenosis	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Biliary dilatation	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Biliary obstruction	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG00014 events12 affected529 at risk EG00118 events16 affected534 at risk EG0020 events0 affected10 at risk
Biloma	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG00039 events31 affected529 at risk EG00138 events24 affected534 at risk EG0020 events0 affected10 at risk
Cholangitis acute	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0008 events7 affected529 at risk EG0013 events3 affected534 at risk EG0020 events0 affected10 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected529 at risk EG0013 events3 affected534 at risk EG0020 events0 affected10 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Cholestasis	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Drug-induced liver injury	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Gallbladder rupture	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Hepatic displacement	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Hepatic haemorrhage	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Hepatic ischaemia	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Hepatorenal syndrome	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Immune-mediated hepatitis	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0004 events4 affected529 at risk EG0014 events4 affected534 at risk EG0020 events0 affected10 at risk
Jaundice cholestatic	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected529 at risk EG0016 events5 affected534 at risk EG0020 events0 affected10 at risk
Liver injury	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Portal hypertension	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Portal vein thrombosis	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Steatohepatitis	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Contrast media allergy	Immune system disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Infusion related hypersensitivity reaction	Immune system disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Abdominal abscess	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Abdominal infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Abdominal wall abscess	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Arthritis bacterial	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Bacteraemia	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0008 events8 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Biliary sepsis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0013 events3 affected534 at risk EG0020 events0 affected10 at risk
Biliary tract infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG00021 events17 affected529 at risk EG00126 events18 affected534 at risk EG0020 events0 affected10 at risk
Bronchiolitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Burkholderia cepacia complex infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
COVID-19	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0007 events7 affected529 at risk EG0018 events8 affected534 at risk EG0020 events0 affected10 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0006 events6 affected529 at risk EG0013 events3 affected534 at risk EG0020 events0 affected10 at risk
Cellulitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0013 events3 affected534 at risk EG0020 events0 affected10 at risk
Chlamydial infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Cholangitis infective	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0014 events3 affected534 at risk EG0020 events0 affected10 at risk
Device related infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Diarrhoea infectious	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Diverticulitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Encephalitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Enterobacter sepsis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Enterocolitis infectious	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Escherichia bacteraemia	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0012 events1 affected534 at risk EG0020 events0 affected10 at risk
Febrile infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0012 events2 affected534 at risk EG0020 events0 affected10 at risk
Fungal sepsis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Gastroenteritis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Helicobacter infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Hepatic infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Herpes zoster	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0004 events4 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Intervertebral discitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Klebsiella bacteraemia	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Klebsiella infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Liver abscess	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0004 events4 affected529 at risk EG00113 events11 affected534 at risk EG0020 events0 affected10 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Lung abscess	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Mucosal infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Neutropenic infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Neutropenic sepsis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Peritonitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0004 events4 affected529 at risk EG0013 events3 affected534 at risk EG0020 events0 affected10 at risk
Peritonitis bacterial	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Pleural infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Pneumococcal bacteraemia	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Pneumococcal sepsis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Pneumonia	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0009 events8 affected529 at risk EG00110 events8 affected534 at risk EG0020 events0 affected10 at risk
Pneumonia acinetobacter	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Pneumonia aspiration	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0013 events3 affected534 at risk EG0020 events0 affected10 at risk
Pneumonia viral	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Postoperative abscess	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Pseudomembranous colitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Pyelonephritis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Sepsis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG00015 events13 affected529 at risk EG00117 events16 affected534 at risk EG0020 events0 affected10 at risk
Septic embolus	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Septic shock	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0014 events4 affected534 at risk EG0020 events0 affected10 at risk
Skin infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Spontaneous bacterial peritonitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Systemic candida	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Tuberculosis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Urinary tract infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG00010 events10 affected529 at risk EG0016 events6 affected534 at risk EG0020 events0 affected10 at risk
Urosepsis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0002 events1 affected529 at risk EG0012 events2 affected534 at risk EG0020 events0 affected10 at risk
Brain contusion	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Compression fracture	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Foreign body in gastrointestinal tract	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Post procedural bile leak	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Post procedural complication	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Post procedural fever	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Postoperative adhesion	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Stoma site ulcer	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Ureteric injury	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Alanine aminotransferase increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected529 at risk EG0014 events4 affected534 at risk EG0020 events0 affected10 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Blood bilirubin increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0005 events5 affected529 at risk EG0014 events4 affected534 at risk EG0020 events0 affected10 at risk
Blood creatinine increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Neutrophil count decreased	Investigations	MedDRA 28.0	Systematic Assessment	EG00013 events11 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Neutrophil count increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Platelet count decreased	Investigations	MedDRA 28.0	Systematic Assessment	EG00019 events19 affected529 at risk EG00112 events10 affected534 at risk EG0020 events0 affected10 at risk
Transaminases increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Troponin increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
White blood cell count decreased	Investigations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0012 events2 affected534 at risk EG0020 events0 affected10 at risk
Alkalosis	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0004 events4 affected529 at risk EG0015 events5 affected534 at risk EG0020 events0 affected10 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Food refusal	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected529 at risk EG0012 events1 affected534 at risk EG0020 events0 affected10 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0014 events4 affected534 at risk EG0020 events0 affected10 at risk
Hypophagia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Chest wall haematoma	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Osteoporotic fracture	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0012 events2 affected534 at risk EG0020 events0 affected10 at risk
Benign neoplasm of testis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0013 events3 affected534 at risk EG0020 events0 affected10 at risk
Colorectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Lymphangiosis carcinomatosa	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Tumour associated fever	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0012 events2 affected534 at risk EG0020 events0 affected10 at risk
Altered state of consciousness	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Aphasia	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Cerebellar infarction	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Cerebral infarction	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected529 at risk EG0013 events3 affected534 at risk EG0020 events0 affected10 at risk
Cerebral venous sinus thrombosis	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0005 events5 affected529 at risk EG0014 events4 affected534 at risk EG0020 events0 affected10 at risk
Epilepsy	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Headache	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Hepatic encephalopathy	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0013 events2 affected534 at risk EG0020 events0 affected10 at risk
Lethargy	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Loss of consciousness	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Myasthenia gravis	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Radicular pain	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Syncope	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Device dislocation	Product Issues	MedDRA 28.0	Systematic Assessment	EG0003 events2 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Device malfunction	Product Issues	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Device occlusion	Product Issues	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Confusional state	Psychiatric disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0012 events2 affected534 at risk EG0020 events0 affected10 at risk
Delirium	Psychiatric disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Depressed mood	Psychiatric disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 28.0	Systematic Assessment	EG0005 events4 affected529 at risk EG00112 events10 affected534 at risk EG0020 events0 affected10 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Haematuria	Renal and urinary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Renal failure	Renal and urinary disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0013 events2 affected534 at risk EG0020 events0 affected10 at risk
Renal impairment	Renal and urinary disorders	MedDRA 28.0	Systematic Assessment	EG0002 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Renal vein thrombosis	Renal and urinary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Ureterolithiasis	Renal and urinary disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Urinary retention	Renal and urinary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0012 events2 affected534 at risk EG0020 events0 affected10 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected529 at risk EG0014 events4 affected534 at risk EG0020 events0 affected10 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0002 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0014 events4 affected534 at risk EG0020 events0 affected10 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0007 events7 affected529 at risk EG0013 events3 affected534 at risk EG0020 events0 affected10 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG00011 events11 affected529 at risk EG0018 events8 affected534 at risk EG0020 events0 affected10 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0012 events2 affected534 at risk EG0020 events0 affected10 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Tachypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Upper respiratory tract inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Cutaneous vasculitis	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Dermatitis exfoliative	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Stevens-Johnson syndrome	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Euthanasia	Surgical and medical procedures	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Aortic aneurysm	Vascular disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Embolism	Vascular disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0012 events2 affected534 at risk EG0020 events0 affected10 at risk
Haematoma	Vascular disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Hypertension	Vascular disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Hypovolaemic shock	Vascular disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Inferior vena caval occlusion	Vascular disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Peripheral artery thrombosis	Vascular disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Shock	Vascular disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Shock haemorrhagic	Vascular disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0020 events0 affected10 at risk
Thrombosis	Vascular disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk
Vena cava embolism	Vascular disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0011 events1 affected534 at risk EG0020 events0 affected10 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG000530 events315 affected529 at risk EG001488 events307 affected534 at risk EG0020 events0 affected10 at risk
Hypothyroidism	Endocrine disorders	MedDRA 28.0	Systematic Assessment	EG00047 events46 affected529 at risk EG00114 events14 affected534 at risk EG0020 events0 affected10 at risk
Blepharitis	Eye disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0010 events0 affected534 at risk EG0021 events1 affected10 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG00041 events37 affected529 at risk EG00143 events34 affected534 at risk EG0021 events1 affected10 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG000124 events89 affected529 at risk EG001155 events117 affected534 at risk EG0022 events2 affected10 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG00053 events40 affected529 at risk EG00174 events58 affected534 at risk EG0020 events0 affected10 at risk
Ascites	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG00032 events30 affected529 at risk EG00134 events33 affected534 at risk EG0020 events0 affected10 at risk
Constipation	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG000227 events185 affected529 at risk EG001234 events189 affected534 at risk EG0023 events3 affected10 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG000150 events102 affected529 at risk EG001155 events97 affected534 at risk EG0021 events1 affected10 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG00038 events33 affected529 at risk EG00165 events56 affected534 at risk EG0022 events2 affected10 at risk
Nausea	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG000419 events233 affected529 at risk EG001425 events248 affected534 at risk EG0024 events3 affected10 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0012 events2 affected534 at risk EG0022 events2 affected10 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG00031 events26 affected529 at risk EG00137 events34 affected534 at risk EG0021 events1 affected10 at risk
Vomiting	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG000234 events120 affected529 at risk EG001276 events128 affected534 at risk EG0020 events0 affected10 at risk
Asthenia	General disorders	MedDRA 28.0	Systematic Assessment	EG000134 events75 affected529 at risk EG001166 events93 affected534 at risk EG0021 events1 affected10 at risk
Fatigue	General disorders	MedDRA 28.0	Systematic Assessment	EG000284 events187 affected529 at risk EG001234 events172 affected534 at risk EG0021 events1 affected10 at risk
Influenza like illness	General disorders	MedDRA 28.0	Systematic Assessment	EG00013 events13 affected529 at risk EG0017 events7 affected534 at risk EG0022 events1 affected10 at risk
Malaise	General disorders	MedDRA 28.0	Systematic Assessment	EG00073 events36 affected529 at risk EG00160 events32 affected534 at risk EG0020 events0 affected10 at risk
Mucosal inflammation	General disorders	MedDRA 28.0	Systematic Assessment	EG00034 events28 affected529 at risk EG00132 events23 affected534 at risk EG0020 events0 affected10 at risk
Oedema peripheral	General disorders	MedDRA 28.0	Systematic Assessment	EG00088 events74 affected529 at risk EG001125 events86 affected534 at risk EG0020 events0 affected10 at risk
Pyrexia	General disorders	MedDRA 28.0	Systematic Assessment	EG000239 events119 affected529 at risk EG001174 events96 affected534 at risk EG0020 events0 affected10 at risk
COVID-19	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG00020 events19 affected529 at risk EG00115 events15 affected534 at risk EG0021 events1 affected10 at risk
Urinary tract infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG00037 events29 affected529 at risk EG00126 events23 affected534 at risk EG0020 events0 affected10 at risk
Alanine aminotransferase increased	Investigations	MedDRA 28.0	Systematic Assessment	EG000152 events86 affected529 at risk EG001170 events111 affected534 at risk EG0020 events0 affected10 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 28.0	Systematic Assessment	EG000175 events88 affected529 at risk EG001185 events99 affected534 at risk EG0021 events1 affected10 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 28.0	Systematic Assessment	EG00060 events43 affected529 at risk EG00173 events52 affected534 at risk EG0020 events0 affected10 at risk
Blood bilirubin increased	Investigations	MedDRA 28.0	Systematic Assessment	EG00074 events48 affected529 at risk EG00181 events61 affected534 at risk EG0020 events0 affected10 at risk
Blood creatinine increased	Investigations	MedDRA 28.0	Systematic Assessment	EG000105 events56 affected529 at risk EG001105 events59 affected534 at risk EG0021 events1 affected10 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 28.0	Systematic Assessment	EG00030 events23 affected529 at risk EG00139 events29 affected534 at risk EG0020 events0 affected10 at risk
Lymphocyte count decreased	Investigations	MedDRA 28.0	Systematic Assessment	EG00049 events23 affected529 at risk EG00148 events29 affected534 at risk EG0020 events0 affected10 at risk
Neutrophil count decreased	Investigations	MedDRA 28.0	Systematic Assessment	EG0001,405 events328 affected529 at risk EG0011,298 events327 affected534 at risk EG0024 events2 affected10 at risk
Platelet count decreased	Investigations	MedDRA 28.0	Systematic Assessment	EG000576 events208 affected529 at risk EG001604 events212 affected534 at risk EG0021 events1 affected10 at risk
Weight decreased	Investigations	MedDRA 28.0	Systematic Assessment	EG00052 events51 affected529 at risk EG00177 events65 affected534 at risk EG0020 events0 affected10 at risk
White blood cell count decreased	Investigations	MedDRA 28.0	Systematic Assessment	EG000742 events141 affected529 at risk EG001653 events127 affected534 at risk EG0020 events0 affected10 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG000186 events142 affected529 at risk EG001207 events152 affected534 at risk EG0022 events1 affected10 at risk
Fluid retention	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0011 events1 affected534 at risk EG0021 events1 affected10 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG00062 events36 affected529 at risk EG00151 events40 affected534 at risk EG0020 events0 affected10 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG00078 events35 affected529 at risk EG00135 events29 affected534 at risk EG0020 events0 affected10 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG00052 events38 affected529 at risk EG00168 events50 affected534 at risk EG0020 events0 affected10 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG00068 events49 affected529 at risk EG00196 events68 affected534 at risk EG0020 events0 affected10 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG000148 events79 affected529 at risk EG001139 events79 affected534 at risk EG0020 events0 affected10 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG00086 events51 affected529 at risk EG00159 events49 affected534 at risk EG0020 events0 affected10 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG00031 events18 affected529 at risk EG00149 events28 affected534 at risk EG0020 events0 affected10 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG00045 events39 affected529 at risk EG00152 events41 affected534 at risk EG0021 events1 affected10 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG00070 events56 affected529 at risk EG00177 events72 affected534 at risk EG0020 events0 affected10 at risk
Exostosis	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0010 events0 affected534 at risk EG0021 events1 affected10 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG00037 events28 affected529 at risk EG00135 events31 affected534 at risk EG0020 events0 affected10 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG00035 events28 affected529 at risk EG00125 events23 affected534 at risk EG0020 events0 affected10 at risk
Dizziness	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG00044 events32 affected529 at risk EG00155 events50 affected534 at risk EG0021 events1 affected10 at risk
Dysgeusia	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG00034 events31 affected529 at risk EG00134 events32 affected534 at risk EG0020 events0 affected10 at risk
Headache	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG00080 events53 affected529 at risk EG00154 events46 affected534 at risk EG0020 events0 affected10 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG00023 events21 affected529 at risk EG00132 events30 affected534 at risk EG0020 events0 affected10 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG00033 events31 affected529 at risk EG00129 events28 affected534 at risk EG0020 events0 affected10 at risk
Insomnia	Psychiatric disorders	MedDRA 28.0	Systematic Assessment	EG00048 events43 affected529 at risk EG00145 events41 affected534 at risk EG0020 events0 affected10 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected529 at risk EG0015 events5 affected534 at risk EG0021 events1 affected10 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG00044 events38 affected529 at risk EG00145 events39 affected534 at risk EG0020 events0 affected10 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG00059 events51 affected529 at risk EG00156 events51 affected534 at risk EG0020 events0 affected10 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG00018 events16 affected529 at risk EG0015 events5 affected534 at risk EG0021 events1 affected10 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG00011 events11 affected529 at risk EG0016 events5 affected534 at risk EG0021 events1 affected10 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0006 events6 affected529 at risk EG0017 events7 affected534 at risk EG0021 events1 affected10 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG00058 events55 affected529 at risk EG00171 events68 affected534 at risk EG0020 events0 affected10 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG00029 events25 affected529 at risk EG00122 events18 affected534 at risk EG0021 events1 affected10 at risk
Onychoclasis	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0010 events0 affected534 at risk EG0021 events1 affected10 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected529 at risk EG0014 events4 affected534 at risk EG0021 events1 affected10 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG000107 events78 affected529 at risk EG00160 events51 affected534 at risk EG0021 events1 affected10 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG000114 events89 affected529 at risk EG00164 events49 affected534 at risk EG0022 events2 affected10 at risk
Skin hypopigmentation	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected529 at risk EG0010 events0 affected534 at risk EG0021 events1 affected10 at risk
Hypertension	Vascular disorders	MedDRA 28.0	Systematic Assessment	EG00040 events34 affected529 at risk EG00161 events37 affected534 at risk EG0020 events0 affected10 at risk
Vasculitis	Vascular disorders	MedDRA 28.0	Systematic Assessment	EG0003 events2 affected529 at risk EG0011 events1 affected534 at risk EG0021 events1 affected10 at risk

ID	Title	Description
BG000	Arm A: Pembrolizumab + Chemotherapy	Participants received pembrolizumab, 200 mg intravenous (IV) infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m^2, IV infusion Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation initiated a second course of pembrolizumab 200mg IV Q3W, Day 1 of each 3-week cycle for up to 17 cycles. Treatment with Gemcitabine could have been stopped at any time in first or second course due to toxicity or disease progression.
BG001	Arm B: Placebo + Chemotherapy	Participants received Placebo to Pembrolizumab, 200 mg IV infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	First Course: Arm A: Pembrolizumab + Chemotherapy	Participants received pembrolizumab, 200 mg intravenous (IV) infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m^2, IV infusion Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation initiated a second course of pembrolizumab 200mg IV Q3W, Day 1 of each 3-week cycle for up to 17 cycles. Treatment with Gemcitabine could have been stopped at any time in first or second course due to toxicity or disease progression.	483	533	280	529	513	529
EG001	First Course: Arm B: Placebo + Chemotherapy	Participants received Placebo to Pembrolizumab, 200 mg IV infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles.	505	536	264	534	522	534
EG002	Second Course: Arm A: Pembrolizumab + Chemotherapy	Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation initiated a second course of pembrolizumab 200 mg IV Q3W, Day 1 of each 3-week cycle for up to 17 cycles. Treatment with Gemcitabine could have been stopped at any time in first or second course due to toxicity or disease progression.	4	10	0	10	10	10

ID	Term
C565324	Parkinson Disease 4, Autosomal Dominant Lewy Body
D018281	Cholangiocarcinoma
D005706	Gallbladder Neoplasms
D001650	Bile Duct Neoplasms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D001661	Biliary Tract Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D001660	Biliary Tract Diseases
D004066	Digestive System Diseases
D005705	Gallbladder Diseases
D001649	Bile Duct Diseases

ID	Term
D006571	Heterocyclic Compounds
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds