A Study of Intravenous or Subcutaneous Methoxy Polyethyle... | NCT00090753

NCT00090753

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Methoxy Polyethylene Glycol-Epoetin Beta	Experimental	Patients received the same weekly dose of methoxy polyethylene glycol-epoetin beta via the same route of administration (iv or sc) as they received in the Phase II or Phase III study that qualified the patient for participation in this study. Methoxy polyethylene glycol-epoetin beta was administered every 2 or every 4 weeks in the initial 104-week treatment period. Patients on a 4-week dosing interval were switched to once-monthly administration in the 24-month extension phase. The dose of methoxy polyethylene glycol-epoetin beta was adjusted to maintain the patient's hemoglobin (Hb) within a target range of 11 to 13 g/dL.	Drug: Methoxy Polyethylene Glycol-Epoetin Beta
Comparator ESA	Active Comparator	Patients received the same comparator ESA [epoetin alfa, epoetin beta, or darbepoetin alfa] at the same weekly dose and dosing interval via the same route of administration (iv or sc) as they received in the Phase III study that qualified the patient for participation in this study. The dose of the comparator drug was adjusted to maintain the patient's Hb within a target range of 11 to 13 g/dL. Of the 480 patients in the comparator drug group, 170 received darbepoetin alfa, 134 received epoetin alfa, and 176 received epoetin beta.	Drug: Epoetin alfa Drug: Epoetin beta Drug: Darbepoetin alfa

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Methoxy Polyethylene Glycol-Epoetin Beta	Drug	Methoxy polyethylene glycol-epoetin beta was provided as a sterile single-use injectable solution in 2-mL glass vials containing 1 mL solution or in single-use sterile pre-filled syringes (PFSs) containing 0.3 mL or 0.6 mL injectable solution. The injectable solution was available in vials with the following strengths: 50, 100, 200, 400, and 1000 μg/mL. The injectable solution was available in PFSs with the following strengths: 30, 40, 50, 60, 75, 100, 120, 150, 200, and 250 μg/0.3 mL; and 360 and 400 μg/0.6 mL.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Hemoglobin Concentration to the Last Month of Study Participation	Blood samples were collected at each study visit, that is, every 4 weeks for the first 12 weeks, every 12 weeks until week 105 of the first study period, every 3 months thereafter, and at the end of study or the last visit if the patient discontinued the study prematurely.	Baseline to the end of the study (Up to 49 Months)

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Patients Who Had at Least 1 Adverse Event	See the adverse events section of the results for more information.	From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months)

Eligibility Module

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Birmingham	Alabama	35211	United States

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Methoxy Polyethylene Glycol-Epoetin Beta	Patients received the same weekly dose of methoxy polyethylene glycol-epoetin beta (Mircera) via the same route of administration (iv or sc) as they received in the Phase II or Phase III study that qualified the patient for participation in this study. Methoxy polyethylene glycol-epoetin beta was administered every 2 or every 4 weeks in the initial 104-week treatment period. Patients on a 4-week dosing interval were switched to once-monthly administration in the 24-month extension phase. The dose of methoxy polyethylene glycol-epoetin beta was adjusted to maintain the patient's hemoglobin (Hb) within a target range of 11 to 13 g/dL.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Methoxy Polyethylene Glycol-Epoetin Beta	Patients received the same weekly dose of methoxy polyethylene glycol-epoetin beta via the same route of administration (iv or sc) as they received in the Phase II or Phase III study that qualified the patient for participation in this study. Methoxy polyethylene glycol-epoetin beta was administered every 2 or every 4 weeks in the initial 104-week treatment period. Patients on a 4-week dosing interval were switched to once-monthly administration in the 24-month extension phase. The dose of methoxy polyethylene glycol-epoetin beta was adjusted to maintain the patient's hemoglobin (Hb) within a target range of 11 to 13 g/dL.
BG001	Comparator ESA	Patients received the same comparator ESA [epoetin alfa, epoetin beta, or darbepoetin alfa] at the same weekly dose and dosing interval via the same route of administration (iv or sc) as they received in the Phase III study that qualified the patient for participation in this study. The dose of the comparator drug was adjusted to maintain the patient's Hb within a target range of 11 to 13 g/dL. Of the 480 patients in the comparator drug group, 170 received darbepoetin alfa, 134 received epoetin alfa, and 176 received epoetin beta.
BG002	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline in Hemoglobin Concentration to the Last Month of Study Participation

Blood samples were collected at each study visit, that is, every 4 weeks for the first 12 weeks, every 12 weeks until week 105 of the first study period, every 3 months thereafter, and at the end of study or the last visit if the patient discontinued the study prematurely.

Analysis includes participants from the Intent-to-treat population (all patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA) who had hemoglobin values available for analysis.

Posted

Mean

Standard Deviation

g/dL

Baseline to the end of the study (Up to 49 Months)

ID	Title	Description
OG000	Methoxy Polyethylene Glycol-Epoetin Beta	Patients received the same weekly dose of methoxy polyethylene glycol-epoetin beta via the same route of administration (iv or sc) as they received in the Phase II or Phase III study that qualified the patient for participation in this study. Methoxy polyethylene glycol-epoetin beta was administered every 2 or every 4 weeks in the initial 104-week treatment period. Patients on a 4-week dosing interval were switched to once-monthly administration in the 24-month extension phase. The dose of methoxy polyethylene glycol-epoetin beta was adjusted to maintain the patient's hemoglobin (Hb) within a target range of 11 to 13 g/dL.
OG001	Comparator ESA	Patients received the same comparator ESA [epoetin alfa, epoetin beta, or darbepoetin alfa] at the same weekly dose and dosing interval via the same route of administration (iv or sc) as they received in the Phase III study that qualified the patient for participation in this study. The dose of the comparator drug was adjusted to maintain the patient's Hb within a target range of 11 to 13 g/dL. Of the 480 patients in the comparator drug group, 170 received darbepoetin alfa, 134 received epoetin alfa, and 176 received epoetin beta.

Units	Counts
Participants	OG000735 OG001476

Title

Denominators

Categories

Title	Measurements
	OG000-0.55± 1.832 OG001-0.38± 1.614

Secondary

Percentage of Patients Who Had at Least 1 Adverse Event

See the adverse events section of the results for more information.

Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.

Posted

Number

Percentage of participants

From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months)

ID	Title	Description
OG000	Methoxy Polyethylene Glycol-Epoetin Beta	Patients received the same weekly dose of methoxy polyethylene glycol-epoetin beta via the same route of administration (iv or sc) as they received in the Phase II or Phase III study that qualified the patient for participation in this study. Methoxy polyethylene glycol-epoetin beta was administered every 2 or every 4 weeks in the initial 104-week treatment period. Patients on a 4-week dosing interval were switched to once-monthly administration in the 24-month extension phase. The dose of methoxy polyethylene glycol-epoetin beta was adjusted to maintain the patient's hemoglobin (Hb) within a target range of 11 to 13 g/dL.
OG001	Comparator ESA	Patients received the same comparator ESA [epoetin alfa, epoetin beta, or darbepoetin alfa] at the same weekly dose and dosing interval via the same route of administration (iv or sc) as they received in the Phase III study that qualified the patient for participation in this study. The dose of the comparator drug was adjusted to maintain the patient's Hb within a target range of 11 to 13 g/dL. Of the 480 patients in the comparator drug group, 170 received darbepoetin alfa, 134 received epoetin alfa, and 176 received epoetin beta.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Methoxy Polyethylene Glycol-Epoetin Beta	Patients received the same weekly dose of methoxy polyethylene glycol-epoetin beta via the same route of administration (iv or sc) as they received in the Phase II or Phase III study that qualified the patient for participation in this study. Methoxy polyethylene glycol-epoetin beta was administered every 2 or every 4 weeks in the initial 104-week treatment period. Patients on a 4-week dosing interval were switched to once-monthly administration in the 24-month extension phase. The dose of methoxy polyethylene glycol-epoetin beta was adjusted to maintain the patient's hemoglobin (Hb) within a target range of 11 to 13 g/dL.			499	748	624	748
EG001	Comparator ESA	Patients received the same comparator ESA [epoetin alfa, epoetin beta, or darbepoetin alfa] at the same weekly dose and dosing interval via the same route of administration (iv or sc) as they received in the Phase III study that qualified the patient for participation in this study. The dose of the comparator drug was adjusted to maintain the patient's Hb within a target range of 11 to 13 g/dL. Of the 480 patients in the comparator drug group, 170 received darbepoetin alfa, 134 received epoetin alfa, and 176 received epoetin beta.			316	480	390	480

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
PNEUMONIA	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG00053 affected748 at risk EG00135 affected480 at risk
SEPSIS	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG00024 affected748 at risk EG00112 affected480 at risk
CELLULITIS	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG00015 affected748 at risk EG0017 affected480 at risk
BRONCHITIS	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG00010 affected748 at risk EG0018 affected480 at risk
GASTROENTERITIS	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG00011 affected748 at risk EG0014 affected480 at risk
CATHETER SEPSIS	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0007 affected748 at risk EG0016 affected480 at risk
ARTERIOVENOUS GRAFT SITE INFECTION	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0007 affected748 at risk EG0015 affected480 at risk
GANGRENE	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0007 affected748 at risk EG0015 affected480 at risk
SEPTIC SHOCK	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0008 affected748 at risk EG0014 affected480 at risk
BRONCHOPNEUMONIA	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0006 affected748 at risk EG0015 affected480 at risk
CATHETER RELATED INFECTION	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0008 affected748 at risk EG0013 affected480 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0007 affected748 at risk EG0014 affected480 at risk
STAPHYLOCOCCAL SEPSIS	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0006 affected748 at risk EG0014 affected480 at risk
CLOSTRIDIUM DIFFICILE COLITIS	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0005 affected748 at risk EG0014 affected480 at risk
STAPHYLOCOCCAL BACTERAEMIA	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0006 affected748 at risk EG0013 affected480 at risk
GASTROENTERITIS VIRAL	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0005 affected748 at risk EG0013 affected480 at risk
OSTEOMYELITIS	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0005 affected748 at risk EG0013 affected480 at risk
DIABETIC GANGRENE	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0005 affected748 at risk EG0012 affected480 at risk
DIVERTICULITIS	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0006 affected748 at risk EG0011 affected480 at risk
CENTRAL LINE INFECTION	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0004 affected748 at risk EG0012 affected480 at risk
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0004 affected748 at risk EG0012 affected480 at risk
APPENDICITIS	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0004 affected748 at risk EG0011 affected480 at risk
ARTERIOVENOUS FISTULA SITE INFECTION	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0014 affected480 at risk
ENDOCARDITIS	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0003 affected748 at risk EG0012 affected480 at risk
LOWER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0004 affected748 at risk EG0011 affected480 at risk
POSTOPERATIVE WOUND INFECTION	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0003 affected748 at risk EG0012 affected480 at risk
UROSEPSIS	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0004 affected748 at risk EG0011 affected480 at risk
INFECTED SKIN ULCER	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0004 affected748 at risk EG0010 affected480 at risk
PERITONITIS BACTERIAL	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0013 affected480 at risk
WOUND INFECTION	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0003 affected748 at risk EG0011 affected480 at risk
BACTERAEMIA	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0011 affected480 at risk
CATHETER BACTERAEMIA	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0003 affected748 at risk EG0010 affected480 at risk
CHOLECYSTITIS INFECTIVE	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0011 affected480 at risk
DIABETIC FOOT INFECTION	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0012 affected480 at risk
INTERVERTEBRAL DISCITIS	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0011 affected480 at risk
LUNG INFECTION	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0011 affected480 at risk
ABDOMINAL WALL ABSCESS	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0011 affected480 at risk
ABSCESS LIMB	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0011 affected480 at risk
BACTERIAL INFECTION	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0010 affected480 at risk
BACTERIAL SEPSIS	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0011 affected480 at risk
CATHETER SITE INFECTION	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0010 affected480 at risk
CELLULITIS GANGRENOUS	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0010 affected480 at risk
ERYSIPELAS	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0012 affected480 at risk
FUNGAEMIA	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0010 affected480 at risk
GRAFT INFECTION	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0011 affected480 at risk
GROIN ABSCESS	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0011 affected480 at risk
PNEUMONIA STAPHYLOCOCCAL	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0010 affected480 at risk
PNEUMONIA STREPTOCOCCAL	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0010 affected480 at risk
PYELONEPHRITIS	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0010 affected480 at risk
STAPHYLOCOCCAL INFECTION	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0011 affected480 at risk
STREPTOCOCCAL SEPSIS	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0011 affected480 at risk
VIRAL INFECTION	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0011 affected480 at risk
ABDOMINAL SEPSIS	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
ANOGENITAL WARTS	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
ARTERIOSCLEROTIC GANGRENE	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
ARTERITIS INFECTIVE	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
ARTHRITIS BACTERIAL	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
ARTHRITIS INFECTIVE	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
BACTERIAL DIARRHOEA	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
BALANOPOSTHITIS INFECTIVE	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
CELLULITIS OF MALE EXTERNAL	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
GENITAL ORGAN CELLULITIS STREPTOCOCCAL	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
CHRONIC TONSILLITIS	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
CYSTITIS	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
DISSEMINATED TUBERCULOSIS	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
EMPHYSEMATOUS CHOLECYSTITIS	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
EMPYEMA	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
ENDOCARDITIS STAPHYLOCOCCAL	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
ENTEROCOCCAL SEPSIS	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
ESCHERICHIA SEPSIS	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
ESCHERICHIA URINARY TRACT INFECTION	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
EYE INFECTION STAPHYLOCOCCAL	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
FUNGAL PERITONITIS	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
GASTRIC ULCER HELICOBACTER	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
HAEMATOMA INFECTION	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
HEPATITIS C	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
INFECTED BITES	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
INFECTED CYST	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
INFECTION	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
INFLUENZA	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
KLEBSIELLA SEPSIS	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
LIVER ABSCESS	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
LOBAR PNEUMONIA	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
LOCALISED INFECTION	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
NOSOCOMIAL INFECTION	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
ORAL INFECTION	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
OSTEOMYELITIS CHRONIC	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
PANCREAS INFECTION	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
PAROTID ABSCESS	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
PHARYNGEAL ABSCESS	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
PHARYNGITIS	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
PNEUMOCOCCAL SEPSIS	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
PNEUMONIA BACTERIAL	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
PNEUMONIA KLEBSIELLA	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
PNEUMONIA PRIMARY ATYPICAL	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
POST PROCEDURAL INFECTION	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
POST PROCEDURAL SEPSIS	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
PSEUDOMEMBRANOUS COLITIS	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
PULMONARY SEPSIS	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
PULMONARY TUBERCULOSIS	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
RECTAL ABSCESS	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
RESPIRATORY TRACT INFECTION VIRAL	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
SEPTIC ARTHRITIS STAPHYLOCOCCAL	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
SERRATIA BACTERAEMIA	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
SERRATIA INFECTION	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
STAPHYLOCOCCAL ABSCESS	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
STAPHYLOCOCCAL OSTEOMYELITIS	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
SUBCUTANEOUS ABSCESS	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
TUBERCULOSIS	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
TUBERCULOUS PLEURISY	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
WEST NILE VIRAL INFECTION	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG00027 affected748 at risk EG00115 affected480 at risk
CARDIAC FAILURE CONGESTIVE	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG00019 affected748 at risk EG00121 affected480 at risk
ACUTE MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG00026 affected748 at risk EG00110 affected480 at risk
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG00016 affected748 at risk EG00119 affected480 at risk
CARDIAC ARREST	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG00016 affected748 at risk EG00111 affected480 at risk
ANGINA PECTORIS	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG00016 affected748 at risk EG0019 affected480 at risk
CORONARY ARTERY DISEASE	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0009 affected748 at risk EG0019 affected480 at risk
ACUTE CORONARY SYNDROME	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG00010 affected748 at risk EG0013 affected480 at risk
CARDIO-RESPIRATORY ARREST	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0005 affected748 at risk EG0016 affected480 at risk
MYOCARDIAL ISCHAEMIA	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0007 affected748 at risk EG0014 affected480 at risk
ATRIAL FLUTTER	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0007 affected748 at risk EG0013 affected480 at risk
VENTRICULAR FIBRILLATION	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0006 affected748 at risk EG0014 affected480 at risk
BRADYCARDIA	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0008 affected748 at risk EG0011 affected480 at risk
CARDIAC FAILURE	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0005 affected748 at risk EG0013 affected480 at risk
ARRHYTHMIA	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0004 affected748 at risk EG0012 affected480 at risk
CARDIOGENIC SHOCK	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0004 affected748 at risk EG0011 affected480 at risk
CARDIOPULMONARY FAILURE	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0004 affected748 at risk EG0011 affected480 at risk
ANGINA UNSTABLE	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0004 affected748 at risk EG0010 affected480 at risk
ATRIOVENTRICULAR BLOCK COMPLETE	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0013 affected480 at risk
CORONARY ARTERY STENOSIS	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0013 affected480 at risk
PERICARDITIS	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0003 affected748 at risk EG0011 affected480 at risk
VENTRICULAR TACHYCARDIA	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0003 affected748 at risk EG0011 affected480 at risk
ARTERIOSCLEROSIS CORONARY ARTERY	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0003 affected748 at risk EG0010 affected480 at risk
LEFT VENTRICULAR FAILURE	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0011 affected480 at risk
MITRAL VALVE INCOMPETENCE	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0012 affected480 at risk
SUPRAVENTRICULAR TACHYCARDIA	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0011 affected480 at risk
TACHYCARDIA	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0011 affected480 at risk
ATRIOVENTRICULAR BLOCK	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0011 affected480 at risk
CARDIAC FAILURE CHRONIC	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0011 affected480 at risk
COR PULMONALE	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0010 affected480 at risk
CORONARY ARTERY OCCLUSION	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0011 affected480 at risk
ISCHAEMIC CARDIOMYOPATHY	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0010 affected480 at risk
PALPITATIONS	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0011 affected480 at risk
SICK SINUS SYNDROME	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0011 affected480 at risk
AORTIC VALVE STENOSIS	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
ATRIOVENTRICULAR BLOCK FIRST DEGREE	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
ATRIOVENTRICULAR DISSOCIATION	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
BUNDLE BRANCH BLOCK RIGHT	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
CARDIAC FAILURE ACUTE	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
CARDIOMYOPATHY	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
CARDIOVASCULAR DISORDER	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
CONGESTIVE CARDIOMYOPATHY	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
CORONARY ARTERY DISSECTION	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
ELECTROMECHANICAL DISSOCIATION	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
HYPERTENSIVE CARDIOMYOPATHY	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
HYPERTENSIVE HEART DISEASE	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
HYPERTROPHIC CARDIOMYOPATHY	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
LEFT VENTRICULAR HYPERTROPHY	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
NODAL ARRHYTHMIA	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
PERICARDIAL DISEASE	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
PERICARDIAL EFFUSION	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
SINUS ARRHYTHMIA	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
TACHYARRHYTHMIA	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
VENTRICULAR ARRHYTHMIA	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
VENTRICULAR EXTRASYSTOLES	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
VENTRICULAR HYPERTROPHY	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
ARTERIOVENOUS FISTULA THROMBOSIS	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG00026 affected748 at risk EG00120 affected480 at risk
ARTERIOVENOUS GRAFT THROMBOSIS	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG00016 affected748 at risk EG0018 affected480 at risk
ARTERIOVENOUS FISTULA SITE COMPLICATION	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0006 affected748 at risk EG0019 affected480 at risk
FEMORAL NECK FRACTURE	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG00011 affected748 at risk EG0013 affected480 at risk
ARTERIOVENOUS FISTULA SITE HAEMORRHAGE	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0007 affected748 at risk EG0014 affected480 at risk
PROCEDURAL HYPOTENSION	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0009 affected748 at risk EG0012 affected480 at risk
VASCULAR GRAFT COMPLICATION	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0006 affected748 at risk EG0014 affected480 at risk
FEMUR FRACTURE	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0005 affected748 at risk EG0014 affected480 at risk
POST PROCEDURAL HAEMORRHAGE	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0007 affected748 at risk EG0012 affected480 at risk
SUBDURAL HAEMATOMA	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0003 affected748 at risk EG0016 affected480 at risk
HIP FRACTURE	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0005 affected748 at risk EG0013 affected480 at risk
ARTERIOVENOUS FISTULA ANEURYSM	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0004 affected748 at risk EG0013 affected480 at risk
POST PROCEDURAL HAEMATOMA	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0005 affected748 at risk EG0012 affected480 at risk
PELVIC FRACTURE	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0013 affected480 at risk
ARTERIOVENOUS GRAFT SITE HAEMORRHAGE	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0003 affected748 at risk EG0011 affected480 at risk
TENDON RUPTURE	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0012 affected480 at risk
GRAFT THROMBOSIS	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0012 affected480 at risk
HEAD INJURY	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0011 affected480 at risk
INCISIONAL HERNIA	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0011 affected480 at risk
OVERDOSE	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0011 affected480 at risk
RADIUS FRACTURE	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0011 affected480 at risk
VASCULAR PSEUDOANEURYSM	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0011 affected480 at risk
WRIST FRACTURE	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0011 affected480 at risk
ANAEMIA POSTOPERATIVE	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0010 affected480 at risk
ANKLE FRACTURE	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0012 affected480 at risk
CONCUSSION	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0010 affected480 at risk
FACIAL BONES FRACTURE	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0011 affected480 at risk
FIBULA FRACTURE	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0011 affected480 at risk
HUMERUS FRACTURE	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0010 affected480 at risk
IN-STENT CORONARY ARTERY RESTENOSIS	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0012 affected480 at risk
JOINT INJURY	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0010 affected480 at risk
LOWER LIMB FRACTURE	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0010 affected480 at risk
MULTIPLE FRACTURES	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0010 affected480 at risk
PNEUMOTHORAX TRAUMATIC	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0011 affected480 at risk
POST PROCEDURAL COMPLICATION	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0012 affected480 at risk
PUBIC RAMI FRACTURE	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0010 affected480 at risk
RIB FRACTURE	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0012 affected480 at risk
THERAPEUTIC AGENT TOXICITY	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0012 affected480 at risk
TIBIA FRACTURE	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0011 affected480 at risk
ACETABULUM FRACTURE	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
ALCOHOL POISONING	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
ARTERIOVENOUS FISTULA OCCLUSION	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
ARTERIOVENOUS FISTULA SITE HAEMATOMA	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
ARTERIOVENOUS GRAFT ANEURYSM	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
CHEST INJURY	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
CLAVICLE FRACTURE	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
CONTUSION	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
DELAYED RECOVERY FROM ANAESTHESIA	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
DEVICE MALFUNCTION	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
DIALYSIS DEVICE COMPLICATION	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
DISLOCATION OF JOINT PROSTHESIS	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
FALL	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
FOOT FRACTURE	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
FOREARM FRACTURE	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
FRACTURED COCCYX	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
HEPATIC HAEMATOMA	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
JOINT DISLOCATION	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
LUMBAR VERTEBRAL FRACTURE	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
MUSCLE RUPTURE	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
PERIORBITAL HAEMATOMA	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
PERIRENAL HAEMATOMA	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
POST PROCEDURAL MYOCARDIAL INFARCTION	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
POST PROCEDURAL PULMONARY EMBOLISM	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
POSTOPERATIVE FEVER	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
POSTOPERATIVE WOUND COMPLICATION	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
POSTPERICARDIOTOMY SYNDROME	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
PROCEDURAL COMPLICATION	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
PROCEDURAL PAIN	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
PROCEDURAL VOMITING	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
SKULL FRACTURE	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
SOFT TISSUE INJURY	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
SPLENIC RUPTURE	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
SUBDURAL HAEMORRHAGE	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
SYNOVIAL RUPTURE	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
ULNA FRACTURE	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
UPPER LIMB FRACTURE	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
UROSTOMY COMPLICATION	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
VASCULAR GRAFT OCCLUSION	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
WOUND	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0008 affected748 at risk EG0018 affected480 at risk
PERITONITIS	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0008 affected748 at risk EG0016 affected480 at risk
GASTRITIS	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0009 affected748 at risk EG0013 affected480 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0007 affected748 at risk EG0014 affected480 at risk
PANCREATITIS	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0008 affected748 at risk EG0012 affected480 at risk
UPPER GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0005 affected748 at risk EG0012 affected480 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0004 affected748 at risk EG0012 affected480 at risk
CONSTIPATION	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0014 affected480 at risk
DIVERTICULUM INTESTINAL HAEMORRHAGIC	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0004 affected748 at risk EG0012 affected480 at risk
GASTRIC ULCER HAEMORRHAGE	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0004 affected748 at risk EG0012 affected480 at risk
VOMITING	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0004 affected748 at risk EG0012 affected480 at risk
COLITIS ISCHAEMIC	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0005 affected748 at risk EG0010 affected480 at risk
SMALL INTESTINAL OBSTRUCTION	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0003 affected748 at risk EG0012 affected480 at risk
COLITIS	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0003 affected748 at risk EG0011 affected480 at risk
COLONIC POLYP	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0003 affected748 at risk EG0011 affected480 at risk
INTESTINAL INFARCTION	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0012 affected480 at risk
MELAENA	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0012 affected480 at risk
ABDOMINAL HERNIA	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0011 affected480 at risk
DIVERTICULAR PERFORATION	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0012 affected480 at risk
DUODENAL ULCER HAEMORRHAGE	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0011 affected480 at risk
DUODENITIS	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0003 affected748 at risk EG0010 affected480 at risk
GASTROOESOPHAGEAL REFLUX DISEASE	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0003 affected748 at risk EG0010 affected480 at risk
HAEMORRHOIDS	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0013 affected480 at risk
ILEUS	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0011 affected480 at risk
INGUINAL HERNIA	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0012 affected480 at risk
INTESTINAL ISCHAEMIA	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0011 affected480 at risk
PANCREATITIS ACUTE	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0012 affected480 at risk
RECTAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0011 affected480 at risk
ABDOMINAL STRANGULATED HERNIA	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0010 affected480 at risk
CAECITIS	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0012 affected480 at risk
DIVERTICULUM	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0012 affected480 at risk
DIVERTICULUM INTESTINAL	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0010 affected480 at risk
DUODENAL ULCER	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0011 affected480 at risk
GASTRITIS HAEMORRHAGIC	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0010 affected480 at risk
INTESTINAL OBSTRUCTION	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0011 affected480 at risk
LARGE INTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0011 affected480 at risk
PANCREATITIS CHRONIC	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0011 affected480 at risk
REFLUX OESOPHAGITIS	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0010 affected480 at risk
SUBILEUS	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0011 affected480 at risk
ABDOMINAL HERNIA OBSTRUCTIVE	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
ACUTE ABDOMEN	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
ASCITES	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
DIVERTICULITIS INTESTINAL HAEMORRHAGIC	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
DUODENAL OBSTRUCTION	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
DUODENAL ULCER PERFORATION	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
DUODENITIS HAEMORRHAGIC	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
DYSPHAGIA	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
EROSIVE DUODENITIS	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
EROSIVE OESOPHAGITIS	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
FLATULENCE	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
GASTRIC DISORDER	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
GASTRITIS EROSIVE	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
GASTRODUODENITIS	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
GASTROINTESTINAL DISORDER	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
GASTROINTESTINAL OBSTRUCTION	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
GASTROINTESTINAL TELANGIECTASIA	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
GASTROINTESTINAL ULCER HAEMORRHAGE	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
HAEMATEMESIS	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
ILEUS PARALYTIC	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
INTESTINAL PERFORATION	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
IRRITABLE BOWEL SYNDROME	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
LOWER GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
MEGACOLON	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
PEPTIC ULCER	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
RETROPERITONEAL FIBROSIS	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
RETROPERITONEAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
SMALL INTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
CEREBROVASCULAR ACCIDENT	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0007 affected748 at risk EG0018 affected480 at risk
TRANSIENT ISCHAEMIC ATTACK	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0006 affected748 at risk EG0016 affected480 at risk
CEREBRAL HAEMORRHAGE	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0008 affected748 at risk EG0010 affected480 at risk
ISCHAEMIC STROKE	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0005 affected748 at risk EG0013 affected480 at risk
CEREBRAL INFARCTION	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0004 affected748 at risk EG0013 affected480 at risk
SYNCOPE	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0005 affected748 at risk EG0012 affected480 at risk
CAROTID ARTERY STENOSIS	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0005 affected748 at risk EG0011 affected480 at risk
CARPAL TUNNEL SYNDROME	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0005 affected748 at risk EG0011 affected480 at risk
HAEMORRHAGIC STROKE	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0004 affected748 at risk EG0011 affected480 at risk
CEREBROVASCULAR DISORDER	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0003 affected748 at risk EG0011 affected480 at risk
CONVULSION	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0003 affected748 at risk EG0011 affected480 at risk
CEREBRAL ISCHAEMIA	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0003 affected748 at risk EG0010 affected480 at risk
ISCHAEMIC CEREBRAL INFARCTION	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0011 affected480 at risk
PRESYNCOPE	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0011 affected480 at risk
DIZZINESS	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0010 affected480 at risk
EMBOLIC CEREBRAL INFARCTION	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0011 affected480 at risk
EMBOLIC STROKE	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0011 affected480 at risk
EPILEPSY	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0012 affected480 at risk
HAEMORRHAGE INTRACRANIAL	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0012 affected480 at risk
HEADACHE	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0011 affected480 at risk
HYPOGLYCAEMIC COMA	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0010 affected480 at risk
HYPOXIC ENCEPHALOPATHY	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0011 affected480 at risk
LACUNAR INFARCTION	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0011 affected480 at risk
REVERSIBLE ISCHAEMIC NEUROLOGICAL DEFICIT	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0011 affected480 at risk
URAEMIC NEUROPATHY	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0010 affected480 at risk
ALTERED STATE OF CONSCIOUSNESS	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
ANOXIC ENCEPHALOPATHY	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
BALANCE DISORDER	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
BENIGN INTRACRANIAL HYPERTENSION	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
CEREBRAL ARTERIOSCLEROSIS	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
CEREBRAL ATROPHY	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
CERVICAL MYELOPATHY	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
COGNITIVE DISORDER	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
COMA HEPATIC	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
COMPLEX PARTIAL SEIZURES	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
DEMENTIA ALZHEIMER'S TYPE	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
DEMENTIA WITH LEWY BODIES	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
ENCEPHALOPATHY	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
HAEMORRHAGIC CEREBRAL INFARCTION	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
HEPATIC ENCEPHALOPATHY	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
HYDROCEPHALUS	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
HYPERTENSIVE ENCEPHALOPATHY	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
INTRACRANIAL HAEMATOMA	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
LOSS OF CONSCIOUSNESS	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
METABOLIC ENCEPHALOPATHY	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
MUSCLE SPASTICITY	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
NEURALGIA	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
NEUROTOXICITY	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
PARKINSON'S DISEASE	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
PERIPHERAL SENSORIMOTOR NEUROPATHY	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
POLYNEUROPATHY	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
SENILE DEMENTIA	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
SPONDYLITIC MYELOPATHY	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
STUPOR	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
SUBARACHNOID HAEMORRHAGE	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
HYPOTENSION	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG00012 affected748 at risk EG0016 affected480 at risk
HYPERTENSION	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0009 affected748 at risk EG0016 affected480 at risk
PERIPHERAL ISCHAEMIA	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0007 affected748 at risk EG0016 affected480 at risk
DEEP VEIN THROMBOSIS	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0005 affected748 at risk EG0012 affected480 at risk
PERIPHERAL VASCULAR DISORDER	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0004 affected748 at risk EG0013 affected480 at risk
DIABETIC VASCULAR DISORDER	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0004 affected748 at risk EG0012 affected480 at risk
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0004 affected748 at risk EG0012 affected480 at risk
HYPERTENSIVE CRISIS	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0013 affected480 at risk
ARTERIAL THROMBOSIS LIMB	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0004 affected748 at risk EG0010 affected480 at risk
FEMORAL ARTERIAL STENOSIS	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0003 affected748 at risk EG0011 affected480 at risk
AORTIC ANEURYSM RUPTURE	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0003 affected748 at risk EG0010 affected480 at risk
ARTERIAL STENOSIS LIMB	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0012 affected480 at risk
HYPERTENSIVE EMERGENCY	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0011 affected480 at risk
ORTHOSTATIC HYPOTENSION	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0011 affected480 at risk
VENOUS STENOSIS	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0012 affected480 at risk
ACCELERATED HYPERTENSION	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0010 affected480 at risk
AORTIC STENOSIS	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0011 affected480 at risk
ARTERIAL STENOSIS	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0012 affected480 at risk
ARTERIOSCLEROSIS	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0011 affected480 at risk
ARTERIOSCLEROSIS OBLITERANS	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0010 affected480 at risk
CIRCULATORY COLLAPSE	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0010 affected480 at risk
EXTREMITY NECROSIS	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0010 affected480 at risk
FEMORAL ARTERY OCCLUSION	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0010 affected480 at risk
ILIAC ARTERY STENOSIS	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0011 affected480 at risk
INTERMITTENT CLAUDICATION	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0012 affected480 at risk
STEAL SYNDROME	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0011 affected480 at risk
ANEURYSM	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
ANEURYSM RUPTURED	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
ANGIOPATHY	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
AORTIC ANEURYSM	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
AORTIC DISSECTION	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
ARTERIAL DISORDER	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
BRACHIOCEPHALIC VEIN STENOSIS	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
FEMORAL ARTERY EMBOLISM	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
HAEMATOMA	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
HYPOVOLAEMIC SHOCK	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
ISCHAEMIA	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
JUGULAR VEIN THROMBOSIS	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
MICROANGIOPATHY	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
PERIPHERAL ARTERY ANEURYSM	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
PHLEBITIS	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
SUBCLAVIAN VEIN THROMBOSIS	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
VASCULAR CALCIFICATION	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
VASCULAR RUPTURE	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
VASCULAR STENOSIS	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
VASCULITIS	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
VENA CAVA THROMBOSIS	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
VENOUS INSUFFICIENCY	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
VENOUS THROMBOSIS	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0009 affected748 at risk EG00112 affected480 at risk
PLEURAL EFFUSION	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG00010 affected748 at risk EG0017 affected480 at risk
CHRONIC OBSTRUCTIVE PULMONARY DISEASE	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0006 affected748 at risk EG0015 affected480 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0005 affected748 at risk EG0013 affected480 at risk
RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0006 affected748 at risk EG0012 affected480 at risk
PNEUMONIA ASPIRATION	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0005 affected748 at risk EG0012 affected480 at risk
ACUTE PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0003 affected748 at risk EG0013 affected480 at risk
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0005 affected748 at risk EG0011 affected480 at risk
ACUTE RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0004 affected748 at risk EG0010 affected480 at risk
NON-CARDIOGENIC PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0012 affected480 at risk
PULMONARY HYPERTENSION	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0003 affected748 at risk EG0011 affected480 at risk
ASTHMA	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0012 affected480 at risk
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0011 affected480 at risk
HAEMOTHORAX	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0011 affected480 at risk
BRONCHITIS CHRONIC	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0010 affected480 at risk
HYPOXIA	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0011 affected480 at risk
LUNG INFILTRATION	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0010 affected480 at risk
ATELECTASIS	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
BRONCHOSPASM	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
CHOKING	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
EMPHYSEMA	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
HYDROTHORAX	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
MEDIASTINAL HAEMORRHAGE	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
PLEURITIC PAIN	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
PNEUMONITIS	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
PULMONARY FIBROSIS	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
PULMONARY GRANULOMA	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
PULMONARY HAEMORRHAGE	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
PULMONARY VASCULITIS	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
RESPIRATORY DISTRESS	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
TRACHEAL ULCER	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
UPPER RESPIRATORY TRACT INFLAMMATION	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
WEGENER'S GRANULOMATOSIS	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
FLUID OVERLOAD	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG00016 affected748 at risk EG00111 affected480 at risk
HYPERKALAEMIA	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG00015 affected748 at risk EG00112 affected480 at risk
HYPOGLYCAEMIA	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0007 affected748 at risk EG00110 affected480 at risk
DIABETIC FOOT	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0003 affected748 at risk EG0017 affected480 at risk
CACHEXIA	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0004 affected748 at risk EG0015 affected480 at risk
DIABETES MELLITUS INADEQUATE CONTROL	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0004 affected748 at risk EG0013 affected480 at risk
HYPOCALCAEMIA	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0013 affected480 at risk
DEHYDRATION	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0003 affected748 at risk EG0011 affected480 at risk
HYPERGLYCAEMIA	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0012 affected480 at risk
GOUT	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0003 affected748 at risk EG0010 affected480 at risk
HYPERCALCAEMIA	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0011 affected480 at risk
CALCIPHYLAXIS	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0011 affected480 at risk
DIABETES MELLITUS	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
ELECTROLYTE IMBALANCE	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
FAILURE TO THRIVE	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
FLUID RETENTION	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
HYPERVOLAEMIA	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
HYPONATRAEMIA	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
HYPOVOLAEMIA	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
DEATH	General disorders	MedDRA (12.1)	Systematic Assessment	EG0007 affected748 at risk EG0018 affected480 at risk
PYREXIA	General disorders	MedDRA (12.1)	Systematic Assessment	EG00010 affected748 at risk EG0015 affected480 at risk
NON-CARDIAC CHEST PAIN	General disorders	MedDRA (12.1)	Systematic Assessment	EG0009 affected748 at risk EG0014 affected480 at risk
CATHETER THROMBOSIS	General disorders	MedDRA (12.1)	Systematic Assessment	EG0003 affected748 at risk EG0014 affected480 at risk
SUDDEN DEATH	General disorders	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0014 affected480 at risk
CATHETER RELATED COMPLICATION	General disorders	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0013 affected480 at risk
CHEST PAIN	General disorders	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0012 affected480 at risk
MULTI-ORGAN FAILURE	General disorders	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0012 affected480 at risk
ASTHENIA	General disorders	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0011 affected480 at risk
GENERAL PHYSICAL HEALTH DETERIORATION	General disorders	MedDRA (12.1)	Systematic Assessment	EG0003 affected748 at risk EG0010 affected480 at risk
HYPERPYREXIA	General disorders	MedDRA (12.1)	Systematic Assessment	EG0003 affected748 at risk EG0010 affected480 at risk
HERNIA OBSTRUCTIVE	General disorders	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0010 affected480 at risk
HYPERTHERMIA	General disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0011 affected480 at risk
SUDDEN CARDIAC DEATH	General disorders	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0010 affected480 at risk
VESSEL PUNCTURE SITE HAEMATOMA	General disorders	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0010 affected480 at risk
CALCINOSIS	General disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
CATHETER SITE HAEMORRHAGE	General disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
CHEST DISCOMFORT	General disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
CHILLS	General disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
IMPAIRED HEALING	General disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
IMPLANT SITE NECROSIS	General disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
INFLAMMATION	General disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
MULTI-ORGAN DISORDER	General disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
OEDEMA DUE TO RENAL DISEASE	General disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
PAIN	General disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
PSEUDOCYST	General disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
RENAL FAILURE CHRONIC	Renal and urinary disorders	MedDRA (12.1)	Systematic Assessment	EG00022 affected748 at risk EG00115 affected480 at risk
RENAL FAILURE ACUTE	Renal and urinary disorders	MedDRA (12.1)	Systematic Assessment	EG0004 affected748 at risk EG0011 affected480 at risk
HAEMATURIA	Renal and urinary disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0013 affected480 at risk
AZOTAEMIA	Renal and urinary disorders	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0011 affected480 at risk
CALCULUS URETERIC	Renal and urinary disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0012 affected480 at risk
CYSTITIS HAEMORRHAGIC	Renal and urinary disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0011 affected480 at risk
NEPHROLITHIASIS	Renal and urinary disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0011 affected480 at risk
RENAL FAILURE	Renal and urinary disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0011 affected480 at risk
RENAL IMPAIRMENT	Renal and urinary disorders	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0010 affected480 at risk
NEPHROPATHY TOXIC	Renal and urinary disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
OBSTRUCTIVE UROPATHY	Renal and urinary disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
PYELOCALIECTASIS	Renal and urinary disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
RENAL CYST RUPTURED	Renal and urinary disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
RENAL DISORDER	Renal and urinary disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
RENAL HAEMORRHAGE	Renal and urinary disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
RENAL HYPERTENSION	Renal and urinary disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
RENAL TUBULAR NECROSIS	Renal and urinary disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
URINARY BLADDER POLYP	Renal and urinary disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
COLON CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0005 affected748 at risk EG0012 affected480 at risk
PROSTATE CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0004 affected748 at risk EG0011 affected480 at risk
LUNG NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0012 affected480 at risk
BREAST CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0011 affected480 at risk
LUNG CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0013 affected480 at risk
LUNG NEOPLASM MALIGNANT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0003 affected748 at risk EG0010 affected480 at risk
RENAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0011 affected480 at risk
BLADDER TRANSITIONAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0010 affected480 at risk
COLON CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0010 affected480 at risk
LUNG SQUAMOUS CELL CARCINOMA STAGE UNSPECIFIED	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0010 affected480 at risk
METASTATIC NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0011 affected480 at risk
PANCREATIC CARCINOMA METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0011 affected480 at risk
RENAL NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0010 affected480 at risk
ADENOID CYSTIC CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
BASAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
BLADDER NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
BREAST CANCER IN SITU	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
BREAST CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
CHRONIC LYMPHOCYTIC LEUKAEMIA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
COLON ADENOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
LUNG ADENOCARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
MALIGNANT PLEURAL EFFUSION	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
METASTASES TO CENTRAL NERVOUS SYSTEM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
METASTASES TO LIVER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
METASTATIC GASTRIC CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
MULTIPLE MYELOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
PANCREATIC NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
PARATHYROID TUMOUR	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
PROSTATE CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
RENAL CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
RENAL ONCOCYTOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
SKIN CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
SMALL CELL LUNG CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
SMALL CELL LUNG CANCER STAGE UNSPECIFIED	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
SQUAMOUS CELL CARCINOMA OF SKIN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
THYROID CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
THYROID NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
URINARY TRACT NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
UTERINE LEIOMYOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
OSTEOARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0004 affected748 at risk EG0014 affected480 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0004 affected748 at risk EG0010 affected480 at risk
SPINAL OSTEOARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0012 affected480 at risk
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0012 affected480 at risk
ARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0010 affected480 at risk
INTERVERTEBRAL DISC DISORDER	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0011 affected480 at risk
MUSCULAR WEAKNESS	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0011 affected480 at risk
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0011 affected480 at risk
CERVICAL SPINAL STENOSIS	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
COSTOCHONDRITIS	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
DACTYLITIS	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
FASCIITIS	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
FLANK PAIN	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
HAEMARTHROSIS	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
INTERVERTEBRAL DISC PROTRUSION	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
MUSCLE HAEMORRHAGE	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
MUSCULOSKELETAL CHEST PAIN	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
MYOPATHY	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
OSTEITIS	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
OSTEODYSTROPHY	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
OSTEOLYSIS	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
OSTEONECROSIS	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
OSTEOPOROSIS	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
POLYMYALGIA RHEUMATICA	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
ROTATOR CUFF SYNDROME	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
SOFT TISSUE NECROSIS	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
SPINAL COLUMN STENOSIS	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
SYNOVITIS	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
MUSCULOSKELETAL PAIN	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0011 affected480 at risk
HYPERPARATHYROIDISM SECONDARY	Endocrine disorders	MedDRA (12.1)	Systematic Assessment	EG00015 affected748 at risk EG0016 affected480 at risk
HYPERPARATHYROIDISM TERTIARY	Endocrine disorders	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0012 affected480 at risk
HYPERPARATHYROIDISM	Endocrine disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0012 affected480 at risk
HYPERTHYROIDISM	Endocrine disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0011 affected480 at risk
GOITRE	Endocrine disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
CHOLELITHIASIS	Hepatobiliary disorders	MedDRA (12.1)	Systematic Assessment	EG0007 affected748 at risk EG0012 affected480 at risk
CHOLECYSTITIS	Hepatobiliary disorders	MedDRA (12.1)	Systematic Assessment	EG0004 affected748 at risk EG0011 affected480 at risk
CHOLECYSTITIS ACUTE	Hepatobiliary disorders	MedDRA (12.1)	Systematic Assessment	EG0003 affected748 at risk EG0011 affected480 at risk
BILE DUCT OBSTRUCTION	Hepatobiliary disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
BILE DUCT STENOSIS	Hepatobiliary disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
BILE DUCT STONE	Hepatobiliary disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
GALLBLADDER POLYP	Hepatobiliary disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
HEPATIC CIRRHOSIS	Hepatobiliary disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
HEPATIC CONGESTION	Hepatobiliary disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
HEPATIC FIBROSIS	Hepatobiliary disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
HEPATITIS	Hepatobiliary disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
HEPATOSPLENOMEGALY	Hepatobiliary disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
JAUNDICE CHOLESTATIC	Hepatobiliary disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
MENTAL STATUS CHANGES	Psychiatric disorders	MedDRA (12.1)	Systematic Assessment	EG0004 affected748 at risk EG0015 affected480 at risk
CONFUSIONAL STATE	Psychiatric disorders	MedDRA (12.1)	Systematic Assessment	EG0003 affected748 at risk EG0011 affected480 at risk
ANXIETY	Psychiatric disorders	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0011 affected480 at risk
DEPRESSION	Psychiatric disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0011 affected480 at risk
ACUTE PSYCHOSIS	Psychiatric disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
ANXIETY DISORDER	Psychiatric disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
BIPOLAR I DISORDER	Psychiatric disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
COMPLETED SUICIDE	Psychiatric disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
DELIRIUM	Psychiatric disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
DEPRESSION SUICIDAL	Psychiatric disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
DISORIENTATION	Psychiatric disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
MAJOR DEPRESSION	Psychiatric disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
MENTAL DISORDER DUE TO A GENERAL MEDICAL CONDITION	Psychiatric disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
PSYCHOTIC DISORDER	Psychiatric disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
SUICIDE ATTEMPT	Psychiatric disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
SKIN ULCER	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0009 affected748 at risk EG0013 affected480 at risk
ANGIOEDEMA	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0003 affected748 at risk EG0010 affected480 at risk
DECUBITUS ULCER	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0010 affected480 at risk
DRY GANGRENE	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0010 affected480 at risk
DERMATITIS	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
DIABETIC NEUROPATHIC ULCER	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
DRUG ERUPTION	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
LIPODYSTROPHY ACQUIRED	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
PENILE ULCERATION	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
SKIN DISORDER	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
SKIN FISSURES	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
ANAEMIA	Blood and lymphatic system disorders	MedDRA (12.1)	Systematic Assessment	EG00010 affected748 at risk EG0016 affected480 at risk
COAGULOPATHY	Blood and lymphatic system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
DISSEMINATED INTRAVASCULAR COAGULATION	Blood and lymphatic system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
HEPARIN-INDUCED THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
HYPOPROTHROMBINAEMIA	Blood and lymphatic system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
LEUKOPENIA	Blood and lymphatic system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
CATARACT	Eye disorders	MedDRA (12.1)	Systematic Assessment	EG0003 affected748 at risk EG0014 affected480 at risk
CONJUNCTIVAL HAEMORRHAGE	Eye disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
GLAUCOMA	Eye disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
RETINAL DETACHMENT	Eye disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
BENIGN PROSTATIC HYPERPLASIA	Reproductive system and breast disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
CERVIX INFLAMMATION	Reproductive system and breast disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
CYSTOCELE	Reproductive system and breast disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
GENITAL PROLAPSE	Reproductive system and breast disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
OVARIAN CYST	Reproductive system and breast disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
PROSTATISM	Reproductive system and breast disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
PROSTATITIS	Reproductive system and breast disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
TESTICULAR INFARCTION	Reproductive system and breast disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
UTERINE CERVICAL SQUAMOUS METAPLASIA	Reproductive system and breast disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
KIDNEY TRANSPLANT REJECTION	Immune system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0013 affected480 at risk
ANAPHYLACTIC REACTION	Immune system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
ANAPHYLACTOID REACTION	Immune system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
CONTRAST MEDIA ALLERGY	Immune system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
DRUG HYPERSENSITIVITY	Immune system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
GASTROINTESTINAL ANGIODYSPLASIA HAEMORRHAGIC	Congenital, familial and genetic disorders	MedDRA (12.1)	Systematic Assessment	EG0002 affected748 at risk EG0010 affected480 at risk
CONGENITAL CYSTIC KIDNEY DISEASE	Congenital, familial and genetic disorders	MedDRA (12.1)	Systematic Assessment	EG0001 affected748 at risk EG0010 affected480 at risk
VERTIGO	Ear and labyrinth disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0012 affected480 at risk
VERTIGO POSITIONAL	Ear and labyrinth disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk
BACTERIAL CULTURE POSITIVE	Investigations	MedDRA (12.1)	Systematic Assessment	EG0000 affected748 at risk EG0011 affected480 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
NASOPHARYNGITIS	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG000107 affected748 at risk EG00164 affected480 at risk
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG00081 affected748 at risk EG00163 affected480 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG00077 affected748 at risk EG00157 affected480 at risk
BRONCHITIS	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG00075 affected748 at risk EG00149 affected480 at risk
INFLUENZA	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG00048 affected748 at risk EG00123 affected480 at risk
GASTROENTERITIS	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG00033 affected748 at risk EG00127 affected480 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG000141 affected748 at risk EG00196 affected480 at risk
VOMITING	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG00073 affected748 at risk EG00144 affected480 at risk
NAUSEA	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG00059 affected748 at risk EG00141 affected480 at risk
CONSTIPATION	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG00052 affected748 at risk EG00141 affected480 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG00046 affected748 at risk EG00122 affected480 at risk
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG00037 affected748 at risk EG00127 affected480 at risk
MUSCLE SPASMS	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG00075 affected748 at risk EG00156 affected480 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG00074 affected748 at risk EG00144 affected480 at risk
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG00076 affected748 at risk EG00141 affected480 at risk
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG00065 affected748 at risk EG00142 affected480 at risk
MUSCULOSKELETAL PAIN	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG00055 affected748 at risk EG00130 affected480 at risk
OSTEOARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG00044 affected748 at risk EG00124 affected480 at risk
PROCEDURAL HYPOTENSION	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG00097 affected748 at risk EG00156 affected480 at risk
ARTERIOVENOUS FISTULA SITE COMPLICATION	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG00083 affected748 at risk EG00136 affected480 at risk
ARTERIOVENOUS FISTULA THROMBOSIS	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG00056 affected748 at risk EG00124 affected480 at risk
ARTERIOVENOUS GRAFT THROMBOSIS	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG00053 affected748 at risk EG00126 affected480 at risk
CONTUSION	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG00034 affected748 at risk EG00127 affected480 at risk
VASCULAR GRAFT COMPLICATION	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG00039 affected748 at risk EG00122 affected480 at risk
HYPERTENSION	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG000167 affected748 at risk EG001109 affected480 at risk
HYPOTENSION	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG00031 affected748 at risk EG00126 affected480 at risk
FLUID OVERLOAD	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG00083 affected748 at risk EG00138 affected480 at risk
HYPERKALAEMIA	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG00047 affected748 at risk EG00137 affected480 at risk
HYPERPHOSPHATAEMIA	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG00047 affected748 at risk EG00122 affected480 at risk
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG00079 affected748 at risk EG00158 affected480 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG00062 affected748 at risk EG00141 affected480 at risk
HEADACHE	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG00083 affected748 at risk EG00143 affected480 at risk
INSOMNIA	Psychiatric disorders	MedDRA (12.1)	Systematic Assessment	EG00039 affected748 at risk EG00133 affected480 at risk
DEPRESSION	Psychiatric disorders	MedDRA (12.1)	Systematic Assessment	EG00038 affected748 at risk EG00121 affected480 at risk
HYPERPARATHYROIDISM SECONDARY	Endocrine disorders	MedDRA (12.1)	Systematic Assessment	EG00057 affected748 at risk EG00144 affected480 at risk
PRURITUS	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Systematic Assessment	EG00059 affected748 at risk EG00135 affected480 at risk
PYREXIA	General disorders	MedDRA (12.1)	Systematic Assessment	EG00052 affected748 at risk EG00127 affected480 at risk
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG00042 affected748 at risk EG00130 affected480 at risk
ANAEMIA	Blood and lymphatic system disorders	MedDRA (12.1)	Systematic Assessment	EG00041 affected748 at risk EG00125 affected480 at risk
RENAL FAILURE CHRONIC	Renal and urinary disorders	MedDRA (12.1)	Systematic Assessment	EG00022 affected748 at risk EG00128 affected480 at risk

ID	Term
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

ID	Term
C508420	continuous erythropoietin receptor activator
D000068817	Epoetin Alfa
C103998	epoetin beta
D000068256	Darbepoetin alfa

ID	Term
D004921	Erythropoietin
D003115	Colony-Stimulating Factors
D006023	Glycoproteins
D006001	Glycoconjugates
D002241	Carbohydrates
D016298	Hematopoietic Cell Growth Factors
D016207	Cytokines
D036341	Intercellular Signaling Peptides and Proteins
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D011506	Proteins
D001685	Biological Factors