Efficacy of Everolimus in Combination With Tacrolimus in... | NCT01551212

ID	Type	Description	Link
2011-003118-17	EudraCT Number

Label	Type	Description	Intervention Names
EVR/TAC	Experimental	Tacrolimus minimization arm. Everolimus (C0-h: 3-8 ng/mL) + tacrolimus (C0-h: < 5 ng/mL)	Drug: Everolimus Drug: Tacrolimus Drug: Corticosteroids
TAC	Active Comparator	Tacrolimus (C0-h: 6-10 ng/ml)	Drug: Tacrolimus Drug: Corticosteroids

Name	Type	Description	Arm Group Labels	Other Names
Everolimus	Drug	tablet containing 0.25mg, 0.5mg, 0.75mg or 1.0mg	EVR/TAC

Measure	Description	Time Frame
Estimated Glomerular Filtration Rate (GFR)	The estmated GFR was calculated using MDRD-4 formula (Modification of Diet in Renal Disease Study Group).	month 12

Measure	Description	Time Frame
Estimated GFR - PP Set	This was a sensitivity analysis for the primary outcome measure based on the per-protocol set of patients.	month 12
Percentage of Participants With Treated Biopsy Proven Acute Rejection (BPAR), Graft Loss or Death

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Aachen		52074	Germany
Novartis Investigative Site

PubMed Identifier	Type	Citation	Retractions
34525259	Derived	Nashan B, Schemmer P, Braun F, Schlitt HJ, Pascher A, Klein CG, Neumann UP, Kroeger I, Wimmer P; Hephaistos Study Group. Early Everolimus-Facilitated Reduced Tacrolimus in Liver Transplantation: Results From the Randomized HEPHAISTOS Trial. Liver Transpl. 2022 Jun;28(6):998-1010. doi: 10.1002/lt.26298. Epub 2021 Oct 12.
25873064

ID	Title	Description
FG000	Everolimus/Tacrolimus	Tacrolimus minimization arm. Everolimus (C0-h: 3-8 ng/mL) + tacrolimus (C0-h: < 5 ng/mL)
FG001	Tacrolimus	Tacrolimus (C0-h: 6-10 ng/ml)

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Aug 19, 2015	Aug 2, 2018

ID	Title	Description
BG000	Everolimus/Tacrolimus	Tacrolimus minimization arm. Everolimus (C0-h: 3-8 ng/mL) + tacrolimus (C0-h: < 5 ng/mL)
BG001	Tacrolimus	Tacrolimus (C0-h: 6-10 ng/ml)
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG000169 BG001164 BG002333

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA (19.1)	Systematic Assessment	EG0004 affected169 at risk EG0011 affected164 at risk
BONE MARROW TOXICITY	Blood and lymphatic system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
EVANS SYNDROME	Blood and lymphatic system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
HYPOCHROMIC ANAEMIA	Blood and lymphatic system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
IRON DEFICIENCY ANAEMIA	Blood and lymphatic system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
LYMPHOCYTOSIS	Blood and lymphatic system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
PANCYTOPENIA	Blood and lymphatic system disorders	MedDRA (19.1)	Systematic Assessment	EG0003 affected169 at risk EG0010 affected164 at risk
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
ACUTE MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0011 affected164 at risk
CARDIOGENIC SHOCK	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
CORONARY ARTERY DISEASE	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
MITRAL VALVE INCOMPETENCE	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
PERICARDIAL EFFUSION	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0011 affected164 at risk
SUPRAVENTRICULAR TACHYCARDIA	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0013 affected164 at risk
TACHYCARDIA	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
VENTRICULAR EXTRASYSTOLES	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
VENTRICULAR TACHYCARDIA	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected169 at risk EG0010 affected164 at risk
VERTIGO	Ear and labyrinth disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
GOITRE	Endocrine disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
TOXIC NODULAR GOITRE	Endocrine disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
MYDRIASIS	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
ABDOMINAL HERNIA	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0003 affected169 at risk EG0010 affected164 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected169 at risk EG0012 affected164 at risk
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected169 at risk EG0010 affected164 at risk
APHTHOUS ULCER	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected169 at risk EG0010 affected164 at risk
ASCITES	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0005 affected169 at risk EG0015 affected164 at risk
COLITIS	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0011 affected164 at risk
DENTAL CARIES	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected169 at risk EG0010 affected164 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0005 affected169 at risk EG0014 affected164 at risk
DUODENAL ULCER	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
ENTEROCOLITIS	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
FAECES DISCOLOURED	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
GASTRIC ULCER HAEMORRHAGE	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
GASTRITIS	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
GASTROINTESTINAL ANGIODYSPLASIA HAEMORRHAGIC	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
GASTROINTESTINAL INFLAMMATION	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
GASTROINTESTINAL NECROSIS	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0011 affected164 at risk
IMPAIRED GASTRIC EMPTYING	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
INCARCERATED INGUINAL HERNIA	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
INCARCERATED UMBILICAL HERNIA	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
INGUINAL HERNIA	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0011 affected164 at risk
INTESTINAL INFARCTION	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
INTESTINAL ISCHAEMIA	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
INTESTINAL PERFORATION	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
INTRA-ABDOMINAL FLUID COLLECTION	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0011 affected164 at risk
MESENTERIC VEIN THROMBOSIS	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
MESENTERIC VENOUS OCCLUSION	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
NAUSEA	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0003 affected169 at risk EG0011 affected164 at risk
PANCREATITIS	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected169 at risk EG0011 affected164 at risk
PANCREATITIS ACUTE	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
SUBILEUS	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
SWOLLEN TONGUE	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
UMBILICAL HERNIA	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0011 affected164 at risk
VOMITING	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0004 affected169 at risk EG0012 affected164 at risk
CHILLS	General disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
GENERAL PHYSICAL HEALTH DETERIORATION	General disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0011 affected164 at risk
IMPAIRED HEALING	General disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0013 affected164 at risk
INCARCERATED HERNIA	General disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
MALAISE	General disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
MUCOSAL INFLAMMATION	General disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
MULTIPLE ORGAN DYSFUNCTION SYNDROME	General disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
NON-CARDIAC CHEST PAIN	General disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
OEDEMA PERIPHERAL	General disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0012 affected164 at risk
PYREXIA	General disorders	MedDRA (19.1)	Systematic Assessment	EG0004 affected169 at risk EG0012 affected164 at risk
SURGICAL FAILURE	General disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
ACUTE HEPATIC FAILURE	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
BILE DUCT STENOSIS	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0005 affected169 at risk EG0016 affected164 at risk
BILE DUCT STONE	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
BILIARY ISCHAEMIA	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0005 affected169 at risk EG0014 affected164 at risk
BILIARY TRACT DISORDER	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
BILOMA	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected169 at risk EG0012 affected164 at risk
CHOLANGITIS	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG00013 affected169 at risk EG0017 affected164 at risk
CHOLANGITIS ACUTE	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
CHOLELITHIASIS	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
CHOLESTASIS	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0014 affected164 at risk
DRUG-INDUCED LIVER INJURY	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0011 affected164 at risk
HEPATIC ARTERY ANEURYSM	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0011 affected164 at risk
HEPATIC ARTERY STENOSIS	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
HEPATIC ARTERY THROMBOSIS	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
HEPATIC FAILURE	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
HEPATIC FUNCTION ABNORMAL	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
HEPATIC HAEMATOMA	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
HEPATIC HAEMORRHAGE	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
HEPATIC INFARCTION	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
HEPATIC ISCHAEMIA	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
HEPATIC LESION	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
HEPATIC NECROSIS	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
HEPATIC STEATOSIS	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
HEPATITIS TOXIC	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
HEPATOTOXICITY	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
LIVER DISORDER	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
NON-ALCOHOLIC STEATOHEPATITIS	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
PORTAL VEIN THROMBOSIS	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0012 affected164 at risk
VANISHING BILE DUCT SYNDROME	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
LIVER TRANSPLANT REJECTION	Immune system disorders	MedDRA (19.1)	Systematic Assessment	EG00012 affected169 at risk EG0019 affected164 at risk
ABDOMINAL ABSCESS	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0011 affected164 at risk
ABDOMINAL WALL ABSCESS	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
ABSCESS JAW	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
ANAL ABSCESS	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
APPENDICITIS	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
ATYPICAL PNEUMONIA	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0012 affected164 at risk
BACTERAEMIA	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
BACTERIAL INFECTION	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
BILIARY ABSCESS	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
BILIARY TRACT INFECTION	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
BRONCHOPULMONARY ASPERGILLOSIS	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
CELLULITIS	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
CHOLANGITIS INFECTIVE	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0006 affected169 at risk EG0011 affected164 at risk
CLOSTRIDIUM DIFFICILE INFECTION	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0002 affected169 at risk EG0010 affected164 at risk
CYTOMEGALOVIRUS COLITIS	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0012 affected164 at risk
CYTOMEGALOVIRUS HEPATITIS	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
CYTOMEGALOVIRUS INFECTION	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0006 affected169 at risk EG0013 affected164 at risk
CYTOMEGALOVIRUS SYNDROME	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
CYTOMEGALOVIRUS VIRAEMIA	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
DEVICE RELATED INFECTION	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
EMPYEMA	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
ENTERITIS INFECTIOUS	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
ENTEROCOCCAL INFECTION	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0011 affected164 at risk
EPIDIDYMITIS	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
EPSTEIN-BARR VIRUS INFECTION	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
ESCHERICHIA INFECTION	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
FEBRILE INFECTION	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
FOLLICULITIS	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0011 affected164 at risk
FUNGAL INFECTION	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
GASTROENTERITIS	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0003 affected169 at risk EG0011 affected164 at risk
GASTROENTERITIS CLOSTRIDIAL	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
GASTROENTERITIS CRYPTOSPORIDIAL	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
GASTROENTERITIS ROTAVIRUS	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
GASTROINTESTINAL INFECTION	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0011 affected164 at risk
GASTROINTESTINAL VIRAL INFECTION	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
HAEMATOMA INFECTION	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0002 affected169 at risk EG0013 affected164 at risk
HEPATITIS C	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0002 affected169 at risk EG0015 affected164 at risk
HERPES ZOSTER	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0012 affected164 at risk
HUMAN HERPESVIRUS 6 INFECTION	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
INFECTED SEROMA	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
INFECTION	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0004 affected169 at risk EG0013 affected164 at risk
LIVER ABSCESS	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0005 affected169 at risk EG0014 affected164 at risk
LOCALISED INFECTION	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
LUNG INFECTION	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
PARONYCHIA	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
PERITONITIS	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
PERITONITIS BACTERIAL	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0002 affected169 at risk EG0011 affected164 at risk
PHARYNGEAL ABSCESS	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
PILONIDAL CYST	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
PNEUMONIA	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG00010 affected169 at risk EG0017 affected164 at risk
PSEUDOMONAS INFECTION	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
SCARLET FEVER	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
SEPSIS	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0002 affected169 at risk EG0014 affected164 at risk
SEPTIC SHOCK	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0002 affected169 at risk EG0013 affected164 at risk
STAPHYLOCOCCAL INFECTION	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
TRANSPLANT ABSCESS	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0002 affected169 at risk EG0015 affected164 at risk
VARICELLA	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
VIRAL INFECTION	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
VIRAL UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0002 affected169 at risk EG0010 affected164 at risk
WOUND INFECTION	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0003 affected169 at risk EG0010 affected164 at risk
WOUND INFECTION STAPHYLOCOCCAL	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
ABDOMINAL WOUND DEHISCENCE	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0003 affected169 at risk EG0010 affected164 at risk
ACCIDENTAL OVERDOSE	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0011 affected164 at risk
ANASTOMOTIC STENOSIS	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0011 affected164 at risk
BILIARY ANASTOMOSIS COMPLICATION	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0008 affected169 at risk EG00113 affected164 at risk
BRAIN CONTUSION	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
COMPLICATIONS OF TRANSPLANTED LIVER	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0011 affected164 at risk
CONCUSSION	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
FALL	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
FEMUR FRACTURE	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0002 affected169 at risk EG0010 affected164 at risk
GRAFT LOSS	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
INCARCERATED INCISIONAL HERNIA	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
INCISIONAL HERNIA	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG00011 affected169 at risk EG0014 affected164 at risk
LUMBAR VERTEBRAL FRACTURE	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0002 affected169 at risk EG0010 affected164 at risk
OVERDOSE	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0002 affected169 at risk EG0010 affected164 at risk
PELVIC FRACTURE	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
POST PROCEDURAL BILE LEAK	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0013 affected164 at risk
SPINAL COMPRESSION FRACTURE	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
SPINAL FRACTURE	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
SUBARACHNOID HAEMORRHAGE	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
THORACIC VERTEBRAL FRACTURE	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
TRANSPLANT FAILURE	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
ULNA FRACTURE	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
VASCULAR PSEUDOANEURYSM	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
WEANING FAILURE	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
WOUND DEHISCENCE	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
ALANINE AMINOTRANSFERASE INCREASED	Investigations	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0012 affected164 at risk
ASPARTATE AMINOTRANSFERASE INCREASED	Investigations	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0012 affected164 at risk
BLOOD ALKALINE PHOSPHATASE INCREASED	Investigations	MedDRA (19.1)	Systematic Assessment	EG0002 affected169 at risk EG0010 affected164 at risk
BLOOD BILIRUBIN INCREASED	Investigations	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0011 affected164 at risk
BLOOD CREATINE PHOSPHOKINASE INCREASED	Investigations	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
BLOOD CREATININE INCREASED	Investigations	MedDRA (19.1)	Systematic Assessment	EG0003 affected169 at risk EG0013 affected164 at risk
BLOOD POTASSIUM INCREASED	Investigations	MedDRA (19.1)	Systematic Assessment	EG0002 affected169 at risk EG0010 affected164 at risk
C-REACTIVE PROTEIN INCREASED	Investigations	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0015 affected164 at risk
CHEST X-RAY ABNORMAL	Investigations	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
GAMMA-GLUTAMYLTRANSFERASE INCREASED	Investigations	MedDRA (19.1)	Systematic Assessment	EG0003 affected169 at risk EG0011 affected164 at risk
GLUTAMATE DEHYDROGENASE INCREASED	Investigations	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0011 affected164 at risk
HAEMOGLOBIN DECREASED	Investigations	MedDRA (19.1)	Systematic Assessment	EG0002 affected169 at risk EG0011 affected164 at risk
HEPATIC ARTERY FLOW DECREASED	Investigations	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
HEPATIC ENZYME INCREASED	Investigations	MedDRA (19.1)	Systematic Assessment	EG0006 affected169 at risk EG0017 affected164 at risk
LIVER FUNCTION TEST INCREASED	Investigations	MedDRA (19.1)	Systematic Assessment	EG0003 affected169 at risk EG0010 affected164 at risk
TRANSAMINASES INCREASED	Investigations	MedDRA (19.1)	Systematic Assessment	EG0002 affected169 at risk EG0016 affected164 at risk
TROPONIN INCREASED	Investigations	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
WHITE BLOOD CELL COUNT INCREASED	Investigations	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
ACIDOSIS HYPERCHLORAEMIC	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
DEHYDRATION	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
DIABETIC COMPLICATION	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
FLUID RETENTION	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0011 affected164 at risk
GOUT	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
HYPERGLYCAEMIA	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0003 affected169 at risk EG0011 affected164 at risk
HYPERINSULINAEMIC HYPOGLYCAEMIA	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
HYPERKALAEMIA	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0003 affected169 at risk EG0011 affected164 at risk
HYPONATRAEMIA	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0011 affected164 at risk
MUSCULOSKELETAL DISORDER	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
MYOPATHY	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
OSTEOCHONDROSIS	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
ACUTE MYELOID LEUKAEMIA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
CHRONIC MYELOID LEUKAEMIA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
HEPATOCELLULAR CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0013 affected164 at risk
LYMPHOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
PROSTATE CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
SQUAMOUS CELL CARCINOMA OF SKIN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
CEREBROVASCULAR ACCIDENT	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0011 affected164 at risk
EPILEPSY	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0011 affected164 at risk
HEMIPARESIS	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
LACUNAR STROKE	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
NERVOUS SYSTEM DISORDER	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
PARAPARESIS	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
POLYNEUROPATHY	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
PRESYNCOPE	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
SEIZURE	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected169 at risk EG0010 affected164 at risk
SYNCOPE	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
TRANSIENT ISCHAEMIC ATTACK	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0011 affected164 at risk
TREMOR	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
ABORTION SPONTANEOUS	Pregnancy, puerperium and perinatal conditions	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
DEVICE OCCLUSION	Product Issues	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0011 affected164 at risk
DISORIENTATION	Psychiatric disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
ACUTE KIDNEY INJURY	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG00010 affected169 at risk EG0018 affected164 at risk
ALBUMINURIA	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
CYSTITIS HAEMORRHAGIC	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
IGA NEPHROPATHY	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
OLIGURIA	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
PRERENAL FAILURE	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
PROTEINURIA	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected169 at risk EG0010 affected164 at risk
RENAL FAILURE	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0012 affected164 at risk
RENAL IMPAIRMENT	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0012 affected164 at risk
ACUTE RESPIRATORY DISTRESS SYNDROME	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
ASTHMA	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
HAEMOPTYSIS	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
PLEURAL EFFUSION	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0004 affected169 at risk EG0015 affected164 at risk
PLEURISY	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0011 affected164 at risk
PNEUMONIA ASPIRATION	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
PNEUMOTHORAX	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected169 at risk EG0010 affected164 at risk
RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0011 affected164 at risk
ANGIOEDEMA	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
DIABETIC FOOT	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
PRURITUS	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
ANGIODYSPLASIA	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
ARTERY DISSECTION	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
DIABETIC VASCULAR DISORDER	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
HAEMATOMA	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
HYPERTENSIVE CRISIS	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0011 affected164 at risk
INFERIOR VENA CAVA STENOSIS	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
INTERNAL HAEMORRHAGE	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected169 at risk EG0010 affected164 at risk
LYMPHATIC FISTULA	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected169 at risk EG0011 affected164 at risk
POOR PERIPHERAL CIRCULATION	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected169 at risk EG0011 affected164 at risk
THROMBOSIS	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected169 at risk EG0010 affected164 at risk
VENA CAVA THROMBOSIS	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected169 at risk EG0011 affected164 at risk

ID	Term
D020123	Sirolimus
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Everolimus/Tacrolimus	Tacrolimus minimization arm. Everolimus (C0-h: 3-8 ng/mL) + tacrolimus (C0-h: < 5 ng/mL)	3	169	111	169	164	169
EG001	Tacrolimus	Tacrolimus (C0-h: 6-10 ng/ml)	4	164	101	164	153	164

ID	Term
D000068338	Everolimus
D016559	Tacrolimus
D000305	Adrenal Cortex Hormones