Study of BTK Inhibitor, Ibrutinib in Combination With Car... | NCT01962792

ID	Type	Description	Link
Ibrutinib (PCI-32765)

Label	Type	Description	Intervention Names
Phase 1 - Dose Finding	Experimental	Ibrutinib PO 560mg + Carfilzomib IV 20/27mg/m2 + Dexamethasone PO 20mg	Drug: Ibrutinib Drug: Carfilzomib Drug: Dexamethasone
Phase 2b - Main Study	Experimental	Ibrutinib PO 560mg + Carfilzomib IV 20/36mg/m2 + Dexamethasone PO 20mg	Drug: Ibrutinib Drug: Carfilzomib Drug: Dexamethasone
Phase 2b - Sub-study	Experimental	Ibrutinib PO 840 mg + Carfilzomib IV 20/36 mg/m2 + Dexamethasone PO 20 mg	Drug: Ibrutinib Drug: Carfilzomib Drug: Dexamethasone

Name	Type	Description	Arm Group Labels	Other Names
Ibrutinib	Drug		Phase 1 - Dose Finding Phase 2b - Main Study Phase 2b - Sub-study
Carfilzomib

Measure	Description	Time Frame
Overall Response Rate (ORR)	-To evaluate the overall response (ORR) of ibrutinib in combination with carfilzomib and dexamethasone.	up to 4 years

Measure	Description	Time Frame
Duration of Response (DOR)	The time interval between the date of initial documentation of a response (PR or better) and the date of first documented evidence of progressive disease, death, or date of censoring for the subjects who had not progressed/died. The censoring date was the last adequate tumor assessment date.	Up to 4 years

Facility	Status	City	State	ZIP	Country	Contacts
City of Hope		Duarte	California	91010	United States
University of California Los Angeles

ID	Title	Description
FG000	Cohort 1 (560 mg)	Ibrutinib PO 560mg + Carfilzomib IV 20/27 mg/m2 Ibrutinib Carfilzomib
FG001	Cohort 2a (560 mg)	Ibrutinib PO 560 mg + Carfilzomib IV 20/36 mg/m2 Ibrutinib Carfilzomib

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	Sep 5, 2013

ID	Title	Description
BG000	Cohort 1 (560 mg)	Ibrutinib PO 560mg + Carfilzomib IV 20/27 mg/m2 Ibrutinib Carfilzomib
BG001	Cohort 2a (560 mg)	Ibrutinib PO 560 mg + Carfilzomib IV 20/36 mg/m2 Ibrutinib Carfilzomib
BG002	Cohort 2b (560 mg)	Ibrutinib PO 560 mg+ Carfilzomib IV 20/36 mg/m2 Dexamethasone PO 20 mg Ibrutinib Carfilzomib Dexamethasone
BG003	All RP2D (840 mg)	Ibrutinib PO 840 mg + Carfilzomib IV 20/36 mg/m2 + Dexamethasone PO 20 mg Ibrutinib Carfilzomib Dexamethasone
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG0003 BG0015 BG00217 BG00359 BG00484

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pneumonia	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0012 events2 affected5 at risk EG0021 affected17 at risk EG0036 events6 affected59 at risk
Atrial Flutter	Cardiac disorders	MedDRA Version 21.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected5 at risk EG0020 events0 affected17 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected5 at risk EG0020 events0 affected17 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected5 at risk EG0022 events2 affected17 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0020 events0 affected17 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0021 events1 affected17 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0021 events1 affected17 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0021 events1 affected17 at risk EG003
Left ventricular dysfunction	Cardiac disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0021 events1 affected17 at risk EG003
Mitral valve disease	Cardiac disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0021 events1 affected17 at risk EG003
Sinus bradycardia	Cardiac disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0021 events1 affected17 at risk EG003
Ventricular tachycardia	Cardiac disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0021 events1 affected17 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0021 events1 affected17 at risk EG003
Incarcerated umbilical hernia	Gastrointestinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0020 events0 affected17 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0021 events1 affected17 at risk EG003
Pyrexia	General disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0023 events3 affected17 at risk EG003
Asthenia	General disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected5 at risk EG0020 events0 affected17 at risk EG003
Fatigue	General disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0021 events1 affected17 at risk EG003
Multiple organ dysfunction syndrome	General disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0021 events1 affected17 at risk EG003
Sepsis	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0023 events3 affected17 at risk EG003
Bacteraemia	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0021 events1 affected17 at risk EG003
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0021 events1 affected17 at risk EG003
Clostridium difficile colitis	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected5 at risk EG0020 events0 affected17 at risk EG003
Escherichia bacteraemia	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0021 events1 affected17 at risk EG003
Escherichia sepsis	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0020 events0 affected17 at risk EG003
Gastrointestinal infection	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected5 at risk EG0020 events0 affected17 at risk EG003
Infection	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0021 events1 affected17 at risk EG003
Necrotising Fasciitis	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0021 events1 affected17 at risk EG003
Osteomyelitis	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0021 events1 affected17 at risk EG003
Pseudomonal sepsis	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0020 events0 affected17 at risk EG003
Blood creatinine increased	Investigations	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0022 events2 affected17 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0021 events1 affected17 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0021 events1 affected17 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0021 events1 affected17 at risk EG003
Tumor Lysis Syndrome	Metabolism and nutrition disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0020 events0 affected17 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0020 events0 affected17 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0021 events1 affected17 at risk EG003
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected5 at risk EG0020 events0 affected17 at risk EG003
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected5 at risk EG0020 events0 affected17 at risk EG003
Metastases to nervous sytem	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0020 events0 affected17 at risk EG003
Non - small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected5 at risk EG0020 events0 affected17 at risk EG003
Headche	Nervous system disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0021 events1 affected17 at risk EG003
Syncope	Nervous system disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0021 events1 affected17 at risk EG003
Mental status changes	Psychiatric disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected5 at risk EG0020 events0 affected17 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected5 at risk EG0022 events2 affected17 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0022 events2 affected17 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected5 at risk EG0020 events0 affected17 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0021 events1 affected17 at risk EG003
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0020 events0 affected17 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0021 events1 affected17 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0021 events1 affected17 at risk EG003
Pseudomonia	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0021 events1 affected17 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0020 events0 affected17 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0020 events0 affected17 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0020 events0 affected17 at risk EG003
Gastric haemmorrhage	Gastrointestinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0020 events0 affected17 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0020 events0 affected17 at risk EG003
Haematemesis	Gastrointestinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0020 events0 affected17 at risk EG003
Peripheral swelling	General disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0020 events0 affected17 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0020 events0 affected17 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0020 events0 affected17 at risk EG003
Acute haemorrhagic conjunctivitis	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0020 events0 affected17 at risk EG003
Acute sinusitis	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0020 events0 affected17 at risk EG003
Arthritis bacterial	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0020 events0 affected17 at risk EG003
Cellulitis	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0020 events0 affected17 at risk EG003
Clostridium difficile infection	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0020 events0 affected17 at risk EG003
Infection colitis	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0020 events0 affected17 at risk EG003
Pneumonia influenzal	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0020 events0 affected17 at risk EG003
Pneumonia viral	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0020 events0 affected17 at risk EG003
Pseudomonal bacteraemia	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0020 events0 affected17 at risk EG003
Septic shock	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0020 events0 affected17 at risk EG003
Sinusitis	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0020 events0 affected17 at risk EG003
Staphylococcal infection	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0020 events0 affected17 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0020 events0 affected17 at risk EG003
Viral Upper respiratory tract infection	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0020 events0 affected17 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0020 events0 affected17 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0020 events0 affected17 at risk EG003
Transfusion-related acute lung injury	Injury, poisoning and procedural complications	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0020 events0 affected17 at risk EG003
Hyperphosphataemia	Metabolism and nutrition disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0020 events0 affected17 at risk EG003
Chondrocalcinosis pyrophosphate	Musculoskeletal and connective tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0020 events0 affected17 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0020 events0 affected17 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0020 events0 affected17 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0020 events0 affected17 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0020 events0 affected17 at risk EG003
Dizziness	Nervous system disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0020 events0 affected17 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0020 events0 affected17 at risk EG003
Deep Vein Thrombosis	Vascular disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected5 at risk EG0020 events0 affected17 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA Version 21.1	Systematic Assessment	EG0001 affected3 at risk EG0013 affected5 at risk EG0026 affected17 at risk EG00324 affected59 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA Version 21.1	Systematic Assessment	EG0001 affected3 at risk EG0011 affected5 at risk EG0023 affected17 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA Version 21.1	Systematic Assessment	EG0001 affected3 at risk EG0011 affected5 at risk EG0022 affected17 at risk EG003
Atrial flutter	Cardiac disorders	MedDRA Version 21.1	Systematic Assessment	EG0001 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0001 affected3 at risk EG0012 affected5 at risk EG0025 affected17 at risk EG003
Pyrexia	General disorders	MedDRA Version 21.1	Systematic Assessment	EG0001 affected3 at risk EG0013 affected5 at risk EG0028 affected17 at risk EG003
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA Version 21.1	Systematic Assessment	EG0001 affected3 at risk EG0010 affected5 at risk EG0022 affected17 at risk EG003
Influenza	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0001 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0001 affected3 at risk EG0010 affected5 at risk EG0027 affected17 at risk EG003
Blood bilirubin increased	Investigations	MedDRA Version 21.1	Systematic Assessment	EG0001 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Headache	Nervous system disorders	MedDRA Version 21.1	Systematic Assessment	EG0001 affected3 at risk EG0012 affected5 at risk EG0028 affected17 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA Version 21.1	Systematic Assessment	EG0001 affected3 at risk EG0010 affected5 at risk EG0022 affected17 at risk EG003
cough	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0001 affected3 at risk EG0010 affected5 at risk EG0027 affected17 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0001 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Hypertension	Vascular disorders	MedDRA Version 21.1	Systematic Assessment	EG0001 affected3 at risk EG0012 affected5 at risk EG0026 affected17 at risk EG003
Hypotension	Vascular disorders	MedDRA Version 21.1	Systematic Assessment	EG0001 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected5 at risk EG0022 affected17 at risk EG003
Left ventricular dysfunction	Cardiac disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected5 at risk EG0021 affected17 at risk EG003
Sinus bradycardia	Cardiac disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected5 at risk EG0021 affected17 at risk EG003
Eye swelling	Eye disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected5 at risk EG0020 affected17 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0013 affected5 at risk EG00211 affected17 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected5 at risk EG0023 affected17 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected5 at risk EG0022 affected17 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected5 at risk EG0024 affected17 at risk EG003
Chills	General disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0013 affected5 at risk EG0021 affected17 at risk EG003
Fatigue	General disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0014 affected5 at risk EG00212 affected17 at risk EG003
Malaise	General disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0022 affected17 at risk EG003
Asthenia	General disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected5 at risk EG0021 affected17 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected5 at risk EG0020 affected17 at risk EG003
Oedema peripheral	General disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected5 at risk EG0020 affected17 at risk EG003
Pain	General disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected5 at risk EG0020 affected17 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected5 at risk EG0020 affected17 at risk EG003
Cellulitis	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected5 at risk EG0021 affected17 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected5 at risk EG0020 affected17 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected5 at risk EG0020 affected17 at risk EG003
Pneumonia	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected5 at risk EG0020 affected17 at risk EG003
Skin infection	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected5 at risk EG0020 affected17 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected5 at risk EG0025 affected17 at risk EG003
Skin laceration	Injury, poisoning and procedural complications	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected5 at risk EG0020 affected17 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected5 at risk EG0021 affected17 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected5 at risk EG0021 affected17 at risk EG003
Blood testosterone decreased	Investigations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected5 at risk EG0020 affected17 at risk EG003
Ejection fraction decreased	Investigations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected5 at risk EG0021 affected17 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0012 affected5 at risk EG0027 affected17 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected5 at risk EG0024 affected17 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0013 affected5 at risk EG0020 affected17 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected5 at risk EG0020 affected17 at risk EG003
Muscle twitching	Musculoskeletal and connective tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected5 at risk EG0020 affected17 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected5 at risk EG0021 affected17 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0013 affected5 at risk EG0023 affected17 at risk EG003
Balance disorder	Nervous system disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected5 at risk EG0022 affected17 at risk EG003
Dizziness	Nervous system disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected5 at risk EG0021 affected17 at risk EG003
Memory impairment	Nervous system disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected5 at risk EG0020 affected17 at risk EG003
Tremor	Nervous system disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected5 at risk EG0021 affected17 at risk EG003
Confusional state	Psychiatric disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected5 at risk EG0022 affected17 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected5 at risk EG0021 affected17 at risk EG003
Renal impairment	Renal and urinary disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected5 at risk EG0021 affected17 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0013 affected5 at risk EG0025 affected17 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0012 affected5 at risk EG0020 affected17 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0012 affected5 at risk EG0026 affected17 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected5 at risk EG0023 affected17 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected5 at risk EG0021 affected17 at risk EG003
Upper-airway cough syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected5 at risk EG0022 affected17 at risk EG003
Blister	Skin and subcutaneous tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected5 at risk EG0020 affected17 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected5 at risk EG0020 affected17 at risk EG003
Increased tendency to bruise	Blood and lymphatic system disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0022 affected17 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Sinus tachycardia	Cardiac disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0024 affected17 at risk EG003
Palpitations	Cardiac disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0023 affected17 at risk EG003
Mitral valve incompetence	Cardiac disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0022 affected17 at risk EG003
Tachycardia	Cardiac disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0022 affected17 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Aortic valve incompetence	Cardiac disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Atrial tachycardia	Cardiac disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Left atrial dilatation	Cardiac disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Right atrial dilatation	Cardiac disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Supraventricular extrasystoles	Cardiac disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Tricuspid valve incompetence	Cardiac disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Ear pain	Ear and labyrinth disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Middle ear effusion	Ear and labyrinth disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Vision blurred	Eye disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0022 affected17 at risk EG003
Dry eye	Eye disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Lacrimation increased	Eye disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Ocular hyperaemia	Eye disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Periorbital oedema	Eye disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0022 affected17 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0023 affected17 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0023 affected17 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0028 affected17 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Dental discomfort	Gastrointestinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Diverticulum	Gastrointestinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Eructation	Gastrointestinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Haematemesis	Gastrointestinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Melaena	Gastrointestinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Oral disorder	Gastrointestinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Oral dysaesthesia	Gastrointestinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Oral pain	Gastrointestinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Oral pruritus	Gastrointestinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Palatal ulcer	Gastrointestinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Pancreatic pseudocyst	Gastrointestinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Oedema peripheral	General disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0024 affected17 at risk EG003
Chest pain	General disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0022 affected17 at risk EG003
Gait disturbance	General disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0022 affected17 at risk EG003
Catheter site oedema	General disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Catheter site rash	General disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Oedema	General disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Feeling abnormal	General disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Localised oedema	General disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Systemic inflammatory response syndrome	General disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Peripheral swelling	General disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Candida infection	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Enterocolitis infectious	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Catheter site infection	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Fungal infection	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Laryngitis	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Onychomycosis	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Pneumonia Fungal	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Rash Pustular	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Skin infection	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Tinea pedis	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Urinary tract infection bacterial	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Vaginal infection	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Animal bite	Injury, poisoning and procedural complications	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Eyelid contusion	Injury, poisoning and procedural complications	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Post procedural contusion	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Skin abrasion	Injury, poisoning and procedural complications	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Blood creatinine increased	Investigations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0022 affected17 at risk EG003
Neutrophil count decreased	Investigations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0022 affected17 at risk EG003
Platelet count decreased	Investigations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0022 affected17 at risk EG003
White blood cell count decreased	Investigations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0022 affected17 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Blood creatine phosphokinase increased	Investigations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Brain natriuretic peptide increased	Investigations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Troponin increased	Investigations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Weight decreased	Investigations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Weight increased	Investigations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Hypocalcaemia	Investigations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0024 affected17 at risk EG003
Dehydration	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0023 affected17 at risk EG003
Hyperglycaemia	Investigations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0023 affected17 at risk EG003
Hypomagnesaemia	Investigations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0022 affected17 at risk EG003
Electrolyte imbalance	Investigations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Diabetes mellitus	Investigations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Fluid overload	Investigations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Hyperkalaemia	Investigations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Hypertriglyceridaemia	Investigations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Hyperuricaemia	Investigations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Hypoalbuminaemia	Investigations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Hyponatraemia	Investigations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Hypophosphataemia	Investigations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Lactic acidosis	Investigations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0025 affected17 at risk EG003
Arthralgia	Investigations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0024 affected17 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0023 affected17 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0024 affected17 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0023 affected17 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0022 affected17 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Joint stiffness	Musculoskeletal and connective tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Osteonecrosis of jaw	Musculoskeletal and connective tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Soft tissue mass	Musculoskeletal and connective tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0023 affected17 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0023 affected17 at risk EG003
Depressed level of consciousness	Nervous system disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Insomnia	Psychiatric disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0025 affected17 at risk EG003
Anxiety	Psychiatric disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0023 affected17 at risk EG003
Depression	Psychiatric disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0022 affected17 at risk EG003
Hallucination	Psychiatric disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0022 affected17 at risk EG003
Agitation	Psychiatric disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Disorientation	Psychiatric disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Irritability	Psychiatric disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Mania	Psychiatric disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Micturition urgency	Renal and urinary disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Chronic kidney disease	Renal and urinary disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 events0 affected5 at risk EG0022 affected17 at risk EG003
Incontinence	Renal and urinary disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Genital rash	Reproductive system and breast disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Vulvovaginal pruritus	Reproductive system and breast disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Rales	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0024 affected17 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0023 affected17 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0023 affected17 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0023 affected17 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0022 affected17 at risk EG003
Lower respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Sinus pain	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0024 affected17 at risk EG003
Rash maculo-papular	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0024 affected17 at risk EG003
Night sweats	Skin and subcutaneous tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0023 affected17 at risk EG003
Pain of skin	Skin and subcutaneous tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0023 affected17 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0022 affected17 at risk EG003
Skin fissures	Skin and subcutaneous tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0022 affected17 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Nail ridging	Skin and subcutaneous tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Flushing	Vascular disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0022 affected17 at risk EG003
Hot flush	Vascular disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0022 affected17 at risk EG003
Aortic dilatation	Vascular disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Venous thrombosis	Vascular disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0021 affected17 at risk EG003
Phlebitis	Vascular disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Jugular vein distension	Vascular disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Thrombophlebitis	Vascular disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Swelling face	Skin and subcutaneous tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Skin mass	Skin and subcutaneous tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Skin irritation	Skin and subcutaneous tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Skin discolouration	Skin and subcutaneous tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Scab	Skin and subcutaneous tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Onychoclasis	Skin and subcutaneous tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Nail disorder	Skin and subcutaneous tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Hair disorder	Skin and subcutaneous tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Dermatitis bullous	Skin and subcutaneous tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Rash macular	Skin and subcutaneous tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Pulmonary arterial hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Pharyngeal erythema	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0001 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Uterine prolapse	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Testicular cyst	Reproductive system and breast disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Scrotal oedema	Reproductive system and breast disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Pelvic pain	Reproductive system and breast disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Vulvovaginal discomfort	Reproductive system and breast disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Urinary hesitation	Renal and urinary disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Proteinuria	Renal and urinary disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Mood swings	Psychiatric disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Mood altered	Psychiatric disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Anxiety disorder	Psychiatric disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Psychotic disorder	Psychiatric disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Somnolence	Nervous system disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Peroneal nerve palsy	Nervous system disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Neuralgia	Nervous system disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Migraine	Nervous system disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Encephalopathy	Nervous system disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Ataxia	Nervous system disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Aphonia	Nervous system disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Amnesia	Nervous system disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Coordination abnormal	Nervous system disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Lethargy	Nervous system disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Temporomandibular joint syndrome	Musculoskeletal and connective tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Plantar fasciitis	Musculoskeletal and connective tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Muscle tightness	Musculoskeletal and connective tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Chondrocalcinosis pyrophosphate	Musculoskeletal and connective tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Joint lock	Musculoskeletal and connective tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Tumour lysis syndrome	Metabolism and nutrition disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Hypermagnesaemia	Metabolism and nutrition disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Hyperammonaemia	Metabolism and nutrition disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Fluid retention	Metabolism and nutrition disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Enzyme abnormality	Metabolism and nutrition disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Hypocalcaemia	Musculoskeletal and connective tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Hyperphosphataemia	Metabolism and nutrition disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
White blood cell count increased	Investigations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Transaminases increased	Investigations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Platelet count increased	Investigations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Lipase increased	Investigations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
International normalised ratio increased	Investigations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Electrocardiogram ST-T segment depression	Investigations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Blood uric acid decreased	Investigations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Blood phosphorus increased	Investigations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Bilirubin conjugated increased	Investigations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Urine output decreased	Investigations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Cardiac murmur	Investigations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Lymphocyte count decreased	Investigations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Blood lactate dehydrogenase increased	Investigations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Arthropod bite	Injury, poisoning and procedural complications	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Traumatic haematoma	Injury, poisoning and procedural complications	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Tooth infection	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Staphylococcal skin infection	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Pharyngitis	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Oral infection	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Oral bacterial infection	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Nail infection	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Mucosal infection	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Lymph gland infection	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Localised infection	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Infusion site cellulitis	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Herpes simplex	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Furuncle	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Folliculitis	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Endocarditis bacterial	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Ecthyma	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Diverticulitis	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Device related infection	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Cytomegalovirus infection	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Cystitis	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Clostridium difficile infection	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Catheter site pustule	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Bronchitis viral	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Acute sinusitis	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Acute haemorrhagic conjunctivitis	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Rhinovirus infection	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Respiratory syncytial virus infection	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Ear infection	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Corona virus infection	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Bronchitis	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Sinusitis	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Rash pustular	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Hypogammaglobulinaemia	Immune system disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Hepatomegaly	Hepatobiliary disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Hepatic function abnormal	Hepatobiliary disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Mucosal inflammation	General disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Infusion site reaction	General disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Feeling jittery	General disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Facial pain	General disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Catheter site pain	General disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Catheter site erythema	General disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Injection site bruising	General disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Face oedema	General disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Chest discomfort	General disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Influenza like illness	General disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Salivary hypersecretion	Gastrointestinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Oesophageal pain	Gastrointestinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Hypoaesthesia oral	Gastrointestinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Haematochezia	Gastrointestinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Anal incontinence	Gastrointestinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Presbyopia	Eye disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Eye pruritus	Eye disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Eye pain	Eye disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Eye irritation	Eye disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Eye haemorrhage	Eye disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Diplopia	Eye disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Blepharospasm	Eye disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Visual impairment	Eye disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Hypoparathyroidism	Endocrine disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Adrenal insufficiency	Endocrine disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Cushingoid	Endocrine disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Tympanic membrane perforation	Ear and labyrinth disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Tinnitus	Ear and labyrinth disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Middle ear inflammation	Ear and labyrinth disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Cerumen impaction	Ear and labyrinth disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Cardiac flutter	Cardiac disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Conjunctivitis Viral	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Eye Contusion	Injury, poisoning and procedural complications	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Urinary Incontinence	Gastrointestinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003
Gastroenteritis Viral	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected5 at risk EG0020 affected17 at risk EG003

ID	Term
D054219	Neoplasms, Plasma Cell
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D020141	Hemostatic Disorders
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D010265	Paraproteinemias
D001796	Blood Protein Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D006474	Hemorrhagic Disorders
D008232	Lymphoproliferative Disorders
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D013259	Steroids, Fluorinated

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 (560 mg)	Ibrutinib PO 560mg + Carfilzomib IV 20/27 mg/m2 Ibrutinib Carfilzomib	0	3	2	3	3	3
EG001	Cohort 2a (560 mg)	Ibrutinib PO 560 mg + Carfilzomib IV 20/36 mg/m2 Ibrutinib Carfilzomib	4	5	5	5	5	5
EG002	Cohort 2b (560 mg)	Ibrutinib PO 560 mg+ Carfilzomib IV 20/36 mg/m2 Dexamethasone PO 20 mg Ibrutinib Carfilzomib Dexamethasone	9	17	17	17	17	17
EG003	All RP2D (840 mg)	Ibrutinib PO 840 mg + Carfilzomib IV 20/36 mg/m2 + Dexamethasone PO 20 mg Ibrutinib Carfilzomib Dexamethasone	22	59	59	59	58	59