Study of Belatacept in Subjects Who Are Undergoing a Rena... | NCT00114777

NCT00114777

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Cyclosporin A	Active Comparator	Drug: Cyclosporin A
Belatacept Less Intensive Regimen (LI)	Experimental	Drug: Belatacept Less Intensive Regimen (LI)
Belatacept More Intensive Regimen (MI)	Experimental	Drug: Belatacept More Intensive Regimen (MI)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cyclosporin A	Drug	tablet, oral, 1st month target: 150-300 ng/mL, after 1st month target: 100-250 ng/mL, daily, 36 months, 100-250 ng/mL, daily, 84 months	Cyclosporin A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants Who Survived With a Graft at 12 Months Post-Transplant	Participant and graft survival at 12 months was summarized within each treatment group. Graft loss was defined as either functional loss or physical loss (nephrectomy). Functional loss was defined as a sustained level of serum creatinine ≥ 6.0 mg/dL (530 μmol/L) as determined by central laboratory for ≥4 weeks or 56 or more consecutive days of dialysis.	Month 12 post-transplant
Percentage of Participants With a Measured Glomerular Filtration Rate (GFR) <60 mL/Min Per 1.73 m^2 at Month 12 or a Decrease in Measured GFR >=10 mL/Min Per 1.73 m^2 From Month 3 to Month 12	GFR was assessed using a true measure of glomerular filtration via non-radiolabeled iothalamate clearance test using a validated procedure.	From Month 3 to Month 12

Secondary Outcomes

Measure	Description	Time Frame
Measured Glomerular Filtration Rate (GFR) by Month 12 and 24	GFR was assessed using a true measure of glomerular filtration via nonradiolabeled iothalamate clearance test using a validated procedure. Missing measured GFR assessments were imputed. Here, 'n' signifies the number of evaluable participants for the reporting arm at the given time point. Missing measured GFR assessments were imputed to a GFR of zero.

Eligibility Module

Contacts/Locations Module

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

Facility	Status	City	State	ZIP	Country	Contacts
University Of Alabama At Birmingham		Birmingham	Alabama	35294	United States
Ucla Kidney & Kidney-Pancreas Transplant Research Office

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24831918	Derived	Dobbels F, Wong S, Min Y, Sam J, Kalsekar A. Beneficial effect of belatacept on health-related quality of life and perceived side effects: results from the BENEFIT and BENEFIT-EXT trials. Transplantation. 2014 Nov 15;98(9):960-8. doi: 10.1097/TP.0000000000000159.
22300431	Derived	Pestana JO, Grinyo JM, Vanrenterghem Y, Becker T, Campistol JM, Florman S, Garcia VD, Kamar N, Lang P, Manfro RC, Massari P, Rial MD, Schnitzler MA, Vitko S, Duan T, Block A, Harler MB, Durrbach A. Three-year outcomes from BENEFIT-EXT: a phase III study of belatacept versus cyclosporine in recipients of extended criteria donor kidneys. Am J Transplant. 2012 Mar;12(3):630-9. doi: 10.1111/j.1600-6143.2011.03914.x. Epub 2012 Feb 2.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Belatacept More Intensive (MI) Regimen	Belatacept 10 mg/kg intravenous solution on Days 1 and 5 during the first week, and then every other week through 3 months (Weeks 2, 4, 8, and 12) and then every 4 weeks through 6 months (Weeks 16, 20 and 24), followed by a maintenance dose of belatacept, 5 mg/kg intravenously every 4 weeks thereafter for up to 84 months

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

Arm/Group Information

ID	Title	Description
BG000	Belatacept More Intensive (MI) Regimen	Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
BG001	Belatacept Less Intensive (LI) Regimen	Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
BG002	Cyclosporin A (CsA)	Cyclosporine A 410 mg/kg was capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00056.7± 12.6 BG00156.1± 12.4 BG00255.7± 12.2 BG003

Age, Customized

Number

participants

Title

Denominators

Categories

18 to 45 years

Title	Measurements
	BG00032 BG00135 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00065 BG00146 BG002

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

Percentage of Participants Who Survived With a Graft at 12 Months Post-Transplant

Participant and graft survival at 12 months was summarized within each treatment group. Graft loss was defined as either functional loss or physical loss (nephrectomy). Functional loss was defined as a sustained level of serum creatinine ≥ 6.0 mg/dL (530 μmol/L) as determined by central laboratory for ≥4 weeks or 56 or more consecutive days of dialysis.

All randomized and transplanted participants

Posted

Number

95% Confidence Interval

percentage of participants

Month 12 post-transplant

ID	Title	Description
OG000	Belatacept More Intensive (MI) Regimen	Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
OG001	Belatacept Less Intensive (LI) Regimen	Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
OG002	Cyclosporin A (CsA)	Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.

Units	Counts
Participants	OG000184 OG001175 OG002184

Title

Denominators

Categories

Title	Measurements
	OG00085.9(80.8 to 90.9) OG00188.0(83.2 to 92.8) OG00284.8(79.6 to 90.0)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002						Treament Difference	1.1			2-Sided	97.3	-7.2	9.4			The treatment differences between each belatacept treatment group and cyclosporin group was tested at the 0.027 significance level for participant and graft survival (based on 10% non-inferiority margin).		Superiority or Other
OG001 OG002

Primary

Percentage of Participants With a Measured Glomerular Filtration Rate (GFR) <60 mL/Min Per 1.73 m^2 at Month 12 or a Decrease in Measured GFR >=10 mL/Min Per 1.73 m^2 From Month 3 to Month 12

GFR was assessed using a true measure of glomerular filtration via non-radiolabeled iothalamate clearance test using a validated procedure.

All randomized and transplanted participants

Posted

Number

95% Confidence Interval

percentage of participants

From Month 3 to Month 12

ID	Title	Description
OG000	Belatacept More Intensive (MI) Regimen	Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
OG001	Belatacept Less Intensive (LI) Regimen	Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
OG002	Cyclosporin A (CsA)	Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.

Secondary

Measured Glomerular Filtration Rate (GFR) by Month 12 and 24

GFR was assessed using a true measure of glomerular filtration via nonradiolabeled iothalamate clearance test using a validated procedure. Missing measured GFR assessments were imputed. Here, 'n' signifies the number of evaluable participants for the reporting arm at the given time point. Missing measured GFR assessments were imputed to a GFR of zero.

All randomized and transplanted participants

Posted

Mean

Standard Deviation

mL/min/1.73 m^2

At Month 12 and Month 24

ID	Title	Description
OG000	Belatacept More Intensive (MI) Regimen	Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
OG001	Belatacept Less Intensive (LI) Regimen	Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
OG002	Cyclosporin A (CsA)	Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.

Secondary

Percentage of Participants With Chronic Allograft Nephropathy (CAN) at Month 12

Biopsy-proven CAN was determined by a blinded central histopathologist using the Banff 97 working classification of kidney transplant pathology. Onset of CAN was determined by the biopsy date when it was observed. Participants were considered as having CAN at 12 months if: CAN observed in a biopsy either prior to 12 months (including baseline biopsy) or first post 12 months biopsy; Participant had graft loss during the first year post transplant; no biopsy available post 12 months and CAN not observed in biopsies prior to 12 months; no biopsy available either prior to or post 12 months; and the measured glomerular filtration rate from Month 3 to Month 12 decreases at least 10 mL/min/1.73m^2. All other participants with missing 12 month biopsy were considered having no CAN observed at 12 months.

All randomized and transplanted participants

Posted

Number

95% Confidence Interval

percentage of participants

At Month 12

ID	Title	Description
OG000	Belatacept More Intensive (MI) Regimen	Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
OG001	Belatacept Less Intensive (LI) Regimen	Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.

Secondary

Percentage of Participants Who Survived With a Graft at 24 and 36 Months Post-Transplant

Participant and graft survival at 12 months was summarized within each treatment group. Graft loss was defined as either functional loss or physical loss (nephrectomy). Functional loss will be defined as a sustained level of serum creatinine ≥ 6.0 mg/dL (530 μmol/L) as determined by central laboratory for ≥ 4 weeks or 56 or more consecutive days of dialysis.

All randomized and transplanted participants

Posted

Number

95% Confidence Interval

percentage of participants

Month 24 and Month 36 post-transplant

ID	Title	Description
OG000	Belatacept More Intensive (MI) Regimen	Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
OG001	Belatacept Less Intensive (LI) Regimen	Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
OG002	Cyclosporin A (CsA)	Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.

Secondary

Calculated Glomerular Filtration Rate (GFR) at 6, 12, 24, 36 and 84 Months

GFR was assessed using a true measure of glomerular filtration via nonradiolabeled iothalamate clearance test using a validated procedure. Missing measured GFR assessments were imputed. Here 'n' signifies those participants evaluable for this measure at specified time points for each arm, respectively.

All randomized and transplanted participants

Posted

Mean

Standard Deviation

participants

Months 6, 12, 24, 36 and 84

ID	Title	Description
OG000	Belatacept More Intensive (MI) Regimen	Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
OG001	Belatacept Less Intensive (LI) Regimen	Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
OG002	Cyclosporin A (CsA)	Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.

Secondary

Change in Calculated GFR at Months 12, 24, 36 and 84

GFR was assessed using a true measure of glomerular filtration via nonradiolabeled iothalamate clearance test using a validated procedure. Missing measured GFR assessments were imputed. Here 'n' signifies those participants evaluable for this measure at specified time points for each arm, respectively.

All randomized and transplanted participants

Posted

Mean

Standard Deviation

mL/min/1.73 m^2

Baseline and Months 12, 24, 36 and 84

ID	Title	Description
OG000	Belatacept More Intensive (MI) Regimen	Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
OG001	Belatacept Less Intensive (LI) Regimen	Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
OG002	Cyclosporin A (CsA)	Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.

Secondary

Number of Participants With Anti-Hypertensive Medications Used to Control Hypertension at 12, 24 and 36 Months

Participants were determined to have hypertension at a particular time point if standardized systolic blood pressure ≥ 130 mm Hg or standardized diastolic blood pressure ≥ 80 mm Hg or participant had received an antihypertensive medication(s) for hypertension. Here 'n' signifies those participants evaluable for this measure at specified time points for each arm, respectively.

All randomized and transplanted participants

Posted

Number

participants

Baseline and Months 12, 24 and 36

ID	Title	Description
OG000	Belatacept More Intensive (MI) Regimen	Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
OG001	Belatacept Less Intensive (LI) Regimen	Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
OG002	Cyclosporin A (CsA)	Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.

Secondary

Percentage of Subjects Who Used Anti-Hypertensive Medications to Control Hypertension at Months 12, 24 and 36

Participants were determined to have hypertension at a particular time point if standardized systolic blood pressure ≥ 130 mm Hg or standardized diastolic blood pressure ≥ 80 mm Hg or subject had received an anti-hypertensive medication(s) for hypertension. Here 'n' signifies those participants evaluable for this measure at specified time points for each arm, respectively.

All randomized and transplanted participants

Posted

Number

95% Confidence Interval

percentage of participants

Months 12, 24 and 36

ID	Title	Description
OG000	Belatacept More Intensive (MI) Regimen	Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
OG001	Belatacept Less Intensive (LI) Regimen	Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
OG002	Cyclosporin A (CsA)	Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.

Secondary

Percentage of Participants With New Onset Diabetes Mellitus (NODM) at 12, 24 and 36 Months.

NODM was defined as participant who did not have diabetes prior to randomization. Participants were determined for NODM if the participant received an antidiabetic medication for a duration of at least 30 days, or at least two fasting plasma glucose (FPG) tests indicate that FPG is ≥ 126 mg/dL (7.0 mmol/L).

All randomized and transplanted participants

Posted

Number

95% Confidence Interval

percentage of participants

Months 12, 24 and 36

ID	Title	Description
OG000	Belatacept More Intensive (MI) Regimen	Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
OG001	Belatacept Less Intensive (LI) Regimen	Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
OG002	Cyclosporin A (CsA)	Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.

Secondary

Systolic and Diastolic Blood Pressure (BP) at 12, 24 and 36 Months

Participants were determined to have hypertension at a particular time point if standardized systolic blood pressure ≥ 130 mm Hg or standardized diastolic blood pressure ≥ 80 mm Hg or participant had received an anti-hypertensive medication(s) for hypertension. Here 'n' signifies those participants evaluable for this measure at specified time points for each arm, respectively.

All randomized and transplanted participants

Posted

Mean

Standard Deviation

mmHg

Months 12, 24 and 36

ID	Title	Description
OG000	Belatacept More Intensive (MI) Regimen	Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
OG001	Belatacept Less Intensive (LI) Regimen	Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
OG002	Cyclosporin A (CsA)	Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.

Secondary

Mean Framingham Risk Score From Baseline to Months 12, 24 and 36

The risk score was calculated based on the total points from six variables: Age, Level of LDL-cholesterol, Level of HDL-cholesterol, Presence and severity of systolic or diastolic hypertension, Presence or absence of a history of diabetes mellitus and Presence or absence of a history recent cigarette smoking. Total scores can range from <-3 to >14, which translate to a 1% to 56% risk of developing coronary heart disease in 10 years. Totals in the 4 to 6 point range translate to a 7 to 11% risk and 8 to 10 point range translate to a 18 to 27% risk.

All randomized and transplanted participants

Posted

Mean

Standard Deviation

units on a scale

Baseline and Months 12, 24 and 36

ID	Title	Description
OG000	Belatacept More Intensive (MI) Regimen	Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
OG001	Belatacept Less Intensive (LI) Regimen	Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84months.
OG002	Cyclosporin A (CsA)

Secondary

Percentage of Participants Using Lipid-Lowering Therapy at 12, 24, and 36 Months

Dyslipidemia was defined as triglyceride ≥ 500 mg/dL [5.65 mmol/L], low density lipoprotein (LDL) ≥ 100 mg/dL [2.59 mmol/L], and non-elevated high density lipoprotein (HDL) ≥ 130 mg/dL [3.36 mmol/L]. Here 'n' signifies those participants evaluable for this measure at specified time points for each arm, respectively.

All randomized and transplanted participants

Posted

Number

95% Confidence Interval

percentage of participants

Months 12, 24 and 36

ID	Title	Description
OG000	Belatacept More Intensive (MI) Regimen	Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
OG001	Belatacept Less Intensive (LI) Regimen	Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
OG002	Cyclosporin A (CsA)	Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.

Secondary

Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36

Dyslipidemia was defined as triglyceride ≥ 500 mg/dL [5.65 mmol/L], low density lipoprotein (LDL) ≥ 100 mg/dL [2.59 mmol/L], and elevated non-high density lipoprotein (HDL) ≥ 130 mg/dL [3.36 mmol/L]. Here 'n' signifies those participants evaluable for this measure at specified time points for each arm, respectively.

All randomized and transplanted participants

Posted

Mean

Standard Deviation

mg/dL

Months 12, 24 and 36

ID	Title	Description
OG000	Belatacept More Intensive (MI) Regimen	Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
OG001	Belatacept Less Intensive (LI) Regimen	Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
OG002	Cyclosporin A (CsA)	Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.

Secondary

Percentage of Participants Who Have an Acute Rejection by Months 6, 12, 24, 36 and 84

Acute rejection was defined as central biopsy proven rejection that was either clinically suspected by protocol defined reasons or clinically suspected by other reasons and treated. Clinically suspected acute rejection was defined as an unexplained rise of serum creatinine ≥ 25% from baseline creatinine or an unexplained decreased urine output or fever and graft tenderness or serum creatinine that remains elevated within 14 days post--transplantation and clinical suspicion of acute rejection exists.

All randomized and transplanted participants

Posted

Number

95% Confidence Interval

percentage of participants

Months 6, 12, 24, 36 and 84

ID	Title	Description
OG000	Belatacept More Intensive (MI) Regimen	Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
OG001	Belatacept Less Intensive (LI) Regimen	Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
OG002	Cyclosporin A (CsA)

Secondary

Number of Participants Using Lymphocyte Depleting Therapy and Steroid-Resistant for Acute Rejection by Months 6, 12, 24, and 36.

Acute rejection was defined as central biopsy proven rejection that was either clinically suspected by protocol defined reasons or clinically suspected by other reasons and treated. Lymphocyte -depletion therapy for treatment of an episode of acute was defined as a participant treated with therapy and provided not treated with steroids earlier while steroid resistant acute rejection was defined as participants initially treated with steroids alone for suspected acute rejection for at least 2 days and then followed by the start of lymphocyte -depletion therapy.

All randomized and transplanted participants

Posted

Number

participants

Months 6, 12, 24 and 36

ID	Title	Description
OG000	Belatacept More Intensive (MI) Regimen	Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
OG001	Belatacept Less Intensive (LI) Regimen	Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
OG002	Cyclosporin A (CsA)

Secondary

Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84

All randomized and transplanted participants

Posted

Number

participants

Months 6, 12, 24, 36 and 84

ID	Title	Description
OG000	Belatacept More Intensive (MI) Regimen	Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
OG001	Belatacept Less Intensive (LI) Regimen	Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
OG002	Cyclosporin A (CsA)

Secondary

Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36

The SF-36 is a 36-item self-administered questionnaire developed to assess health-related quality of life (QOL) and comprises 8 domains, including 4 physical (physical health, bodily pain, physical functioning and physical role limitations) and 4 mental (mental health, vitality, social functioning, and emotional role limitation) subscales. Responses are used to derive physical and mental component summary scores, ranging from 0 to 100, with higher scores indicating better QOL (0=Poorest Health; 100=Best Health). Mean change from baseline = post-baseline value - baseline value; a higher value signifies improvement.

Randomized and transplanted participants

Posted

Mean

Standard Error

units on SF-36 scale

Baseline and Months 12, 24 and 36

ID	Title	Description
OG000	Belatacept More Intensive (MI) Regimen	Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
OG001	Belatacept Less Intensive (LI) Regimen	Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.

Secondary

Number of Participants With Clinically Significant Changes in Vital Signs up to 36 Months

Participants with abnormal blood pressure, body weight and body temperature outside the defined normal range were graded as clinically significant vital signs by the investigator.

All randomized and transplanted participants

Posted

Number

participants

Day 1 to Month 36

ID	Title	Description
OG000	Belatacept More Intensive (MI) Regimen	Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
OG001	Belatacept Less Intensive (LI) Regimen	Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
OG002	Cyclosporin A (CsA)	Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.

Secondary

Number of Participants With Laboratory Test Abnormalities up to 36 Months

Participants with laboratory values outside the defined normal range were graded as clinically significant laboratory abnormalities by the investigator. Subjects were analyzed for Alkaline phosphatase (ALP), Alanine aminotransferase (ALT), Aspartate aminotransferase(AST), Hemoglobin, Platelet Count, Leukocytes, Bilirubin, Creatinine, Calcium, Bicarbonate, Potassium, Magnesium, Sodium, Phosphorus, Albumin, Uric Acid and Protein. Laboratory abnormalities were assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3. Here 'n' signifies those subjects evaluable for this measure at specified time points for each arm, respectively.

All randomized and transplanted participants.

Posted

Number

participants

Day 1 to Month 36

ID	Title	Description
OG000	Belatacept More Intensive (MI) Regimen	Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
OG001	Belatacept Less Intensive (LI) Regimen	Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
OG002

Secondary

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 36

AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.

All randomized and transplanted participants

Posted

Number

participants

Day 1 to Month 36

ID	Title	Description
OG000	Belatacept More Intensive (MI) Regimen	Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
OG001	Belatacept Less Intensive (LI) Regimen	Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
OG002

Secondary

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 84

All randomized and transplanted participants who completed 36 months of treatment and continued into long-term extension phase

Posted

Number

participants

Day 1 to Month 84

ID	Title	Description
OG000	Belatacept More Intensive (MI) Regimen	Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
OG001	Belatacept Less Intensive (LI) Regimen	Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.

Secondary

Percentage of Participants With Graft Loss or Death to Month 84

Participant and graft survival at 84 months was summarized within each treatment group.

All randomized and transplanted participants

Posted

Number

percentage of participants

Randomization to date of death, up to 84 months

ID	Title	Description
OG000	Belatacept More Intensive (MI) Regimen	Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
OG001	Belatacept Less Intensive (LI) Regimen	Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
OG002	Cyclosporin A (CsA)	Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Belatacept More Intensive (MI) Regimen	Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.	162	184	177	184
EG001	Belatacept Less Intensive (LI) Regimen	Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.	157	175	171	175
EG002	Cyclosporin (CsA)	Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.	152	184	179	184

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal hernia	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected184 at risk EG0013 affected175 at risk EG0022 affected184 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Abscess limb	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0002 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Anaemia postoperative	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Arterial occlusive disease	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Aspergillus infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0009 affected184 at risk EG0016 affected175 at risk EG00212 affected184 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected184 at risk EG0012 affected175 at risk EG0021 affected184 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG00010 affected184 at risk EG0015 affected175 at risk EG0024 affected184 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0022 affected184 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Chronic allograft nephropathy	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0003 affected184 at risk EG0011 affected175 at risk EG0025 affected184 at risk
Colon cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Constipation	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Cyst	General disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Cytomegalovirus gastritis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Cytomegalovirus hepatitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Cytomegalovirus infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG00018 affected184 at risk EG00116 affected175 at risk EG00213 affected184 at risk
Death	General disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Diarrhoea infectious	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Endocarditis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0021 affected184 at risk
Erysipelas	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Gastritis	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0024 affected184 at risk
Gastroduodenal ulcer	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Gingival hypertrophy	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Hepatic mass	Hepatobiliary disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Herpes zoster	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0008 affected184 at risk EG0013 affected175 at risk EG0023 affected184 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Hypercoagulation	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Hyperparathyroidism	Endocrine disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Hypertensive crisis	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0011 affected175 at risk EG0023 affected184 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0003 affected184 at risk EG0014 affected175 at risk EG0022 affected184 at risk
Ileus	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0012 affected175 at risk EG0021 affected184 at risk
Incision site complication	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Incorrect dose administered	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0021 affected184 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Jugular vein thrombosis	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Lymphangitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Mediastinal disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Muscle rupture	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Non-cardiac chest pain	General disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Obesity	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Oral fungal infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0012 affected175 at risk EG0021 affected184 at risk
Peritoneal disorder	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Pneumonia cryptococcal	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Pneumonia klebsiella	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0021 affected184 at risk
Prostatism	Reproductive system and breast disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Pseudomonas infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0012 affected175 at risk EG0020 affected184 at risk
Rectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Renal failure	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected184 at risk EG0010 affected175 at risk EG0022 affected184 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 17.1	Systematic Assessment	EG0003 affected184 at risk EG0011 affected175 at risk EG0021 affected184 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0008 affected184 at risk EG0016 affected175 at risk EG0024 affected184 at risk
Synovitis	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Thrombotic microangiopathy	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0021 affected184 at risk
Ureteric dilatation	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Ureteric obstruction	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Ureteric stenosis	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0004 affected184 at risk EG0013 affected175 at risk EG0024 affected184 at risk
Urinary fistula	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0026 affected184 at risk
Urinary tract infection enterococcal	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0012 affected175 at risk EG0020 affected184 at risk
Varicella	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Vesical fistula	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Viral infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0021 affected184 at risk
Wound evisceration	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0012 affected175 at risk EG0022 affected184 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Acquired hydrocele	Reproductive system and breast disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0021 affected184 at risk
Alanine aminotransferase increased	Investigations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Antibody test positive	Investigations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Appendicitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0012 affected175 at risk EG0020 affected184 at risk
Appendicitis perforated	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Arterial stenosis	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Arteriovenous fistula occlusion	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
BK virus infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Bronchitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0003 affected184 at risk EG0013 affected175 at risk EG0023 affected184 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Cerebral aspergillosis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Chorioretinitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Cognitive disorder	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Cytomegalovirus chorioretinitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0007 affected184 at risk EG00110 affected175 at risk EG0026 affected184 at risk
Diastasis recti abdominis	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Diverticulum	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Duodenal perforation	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0002 affected184 at risk EG0011 affected175 at risk EG0025 affected184 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Hepatic cyst infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0011 affected175 at risk EG0023 affected184 at risk
Hydrocele	Congenital, familial and genetic disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0022 affected184 at risk
Hypercreatinaemia	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0014 affected175 at risk EG0022 affected184 at risk
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Leishmaniasis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0013 affected175 at risk EG0020 affected184 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Malaise	General disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0021 affected184 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Metrorrhagia	Reproductive system and breast disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Mitral valve stenosis	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Myopathy	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Nephritis	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Oedema	General disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Oesophageal candidiasis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Pericarditis	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0022 affected184 at risk
Perirenal haematoma	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0002 affected184 at risk EG0013 affected175 at risk EG0021 affected184 at risk
Phlebitis	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Post transplant lymphoproliferative disorder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0013 affected175 at risk EG0020 affected184 at risk
Proteinuria	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0011 affected175 at risk EG0022 affected184 at risk
Pseudomonal sepsis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0002 affected184 at risk EG0011 affected175 at risk EG0021 affected184 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected184 at risk EG0011 affected175 at risk EG0025 affected184 at risk
Renal cyst infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0022 affected184 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Sinusitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0002 affected184 at risk EG0011 affected175 at risk EG0023 affected184 at risk
Skin cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Transplant dysfunction	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0009 affected184 at risk EG0016 affected175 at risk EG00211 affected184 at risk
Tuberculosis of eye	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Urethral disorder	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Uveitis	Eye disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Vascular stenosis	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Volvulus	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Weight increased	Investigations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Wound	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0015 affected175 at risk EG0022 affected184 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0012 affected175 at risk EG0023 affected184 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0022 affected184 at risk
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG00011 affected184 at risk EG0019 affected175 at risk EG0026 affected184 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0012 affected175 at risk EG0020 affected184 at risk
Aortic aneurysm rupture	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Aphthous stomatitis	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0003 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Arteriovenous fistula	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0021 affected184 at risk
Atrioventricular block	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0021 affected184 at risk
Blood creatine increased	Investigations	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0011 affected175 at risk EG0023 affected184 at risk
Bowen's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0004 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Bronchial secretion retention	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Bronchopneumopathy	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Cardiac arrest	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected184 at risk EG0011 affected175 at risk EG0024 affected184 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0022 affected184 at risk
Cholestasis	Hepatobiliary disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected184 at risk EG0012 affected175 at risk EG0020 affected184 at risk
Device malfunction	General disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG00018 affected184 at risk EG00114 affected175 at risk EG00210 affected184 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Duodenitis	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected184 at risk EG0014 affected175 at risk EG0022 affected184 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Erosive oesophagitis	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Escherichia sepsis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0002 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Fatigue	General disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Fungal infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0012 affected175 at risk EG0023 affected184 at risk
Gingival hyperplasia	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Graft loss	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0004 affected184 at risk EG0017 affected175 at risk EG0026 affected184 at risk
Haematoma	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected184 at risk EG0013 affected175 at risk EG0024 affected184 at risk
Haemorrhagic infarction	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Hepatitis B	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0021 affected184 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0011 affected175 at risk EG0021 affected184 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Hypoxic-ischaemic encephalopathy	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Incarcerated hernia	General disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0021 affected184 at risk
Incision site haemorrhage	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Influenza	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Intestinal fistula	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Kidney rupture	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected184 at risk EG0011 affected175 at risk EG0021 affected184 at risk
Lung infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Macular oedema	Eye disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Nasopharyngitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Neurotoxicity	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0002 affected184 at risk EG0011 affected175 at risk EG0021 affected184 at risk
Pancreatic enzymes increased	Investigations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Perinephric effusion	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Peripheral artery stenosis	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Pneumonia cytomegaloviral	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Pneumonia fungal	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Post procedural complication	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0002 affected184 at risk EG0011 affected175 at risk EG0021 affected184 at risk
Procedural complication	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Prostatic adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Purulent discharge	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Renal infarct	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Renal vein thrombosis	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0006 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Respiratory tract infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0003 affected184 at risk EG0013 affected175 at risk EG0022 affected184 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Septic shock	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0002 affected184 at risk EG0012 affected175 at risk EG0026 affected184 at risk
Shunt occlusion	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0012 affected175 at risk EG0020 affected184 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0003 affected184 at risk EG0010 affected175 at risk EG0022 affected184 at risk
Strongyloidiasis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0012 affected175 at risk EG0020 affected184 at risk
Supraventricular tachyarrhythmia	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Thrombophlebitis	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0012 affected175 at risk EG0020 affected184 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0003 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Ulna fracture	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0012 affected175 at risk EG0022 affected184 at risk
Urinary tract infection pseudomonal	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0013 affected175 at risk EG0022 affected184 at risk
Venous thrombosis	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0013 affected175 at risk EG0020 affected184 at risk
Weight decreased	Investigations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0012 affected175 at risk EG0020 affected184 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Anal fistula	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Angiopathy	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Arterial haemorrhage	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Asymptomatic bacteriuria	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Atrial thrombosis	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Azotaemia	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0021 affected184 at risk
Bladder prolapse	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Cataract operation complication	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Cerebral fungal infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Clostridium difficile infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Complications of transplant surgery	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Cytomegalovirus colitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0011 affected175 at risk EG0021 affected184 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0007 affected184 at risk EG0014 affected175 at risk EG0022 affected184 at risk
Dementia	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0011 affected175 at risk EG0021 affected184 at risk
Dry gangrene	Skin and subcutaneous tissue disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Dysentery	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Dyspnoea paroxysmal nocturnal	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Dysuria	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Emphysematous cystitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Enterococcus test positive	Investigations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Epilepsy	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Escherichia bacteraemia	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0021 affected184 at risk
Eyelid ptosis	Eye disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0022 affected184 at risk
Haemolysis	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Haemorrhage	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Haemorrhagic cyst	General disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0022 affected184 at risk
Hepatic cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Hepatic steatosis	Hepatobiliary disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected184 at risk EG0011 affected175 at risk EG0022 affected184 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Ileus paralytic	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Impaired healing	General disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Influenza like illness	General disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Intraductal proliferative breast lesion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Large intestinal obstruction	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Laryngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Liver function test abnormal	Investigations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Lobar pneumonia	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Lymphoedema	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0022 affected184 at risk
Muscle haemorrhage	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Mycoplasma infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Myocardial infarction	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0007 affected184 at risk EG0013 affected175 at risk EG0023 affected184 at risk
Obstructive uropathy	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected184 at risk EG0011 affected175 at risk EG0021 affected184 at risk
Osteitis	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0011 affected175 at risk EG0021 affected184 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0012 affected175 at risk EG0020 affected184 at risk
Perirectal abscess	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0003 affected184 at risk EG0012 affected175 at risk EG0021 affected184 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Posterior reversible encephalopathy syndrome	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0003 affected184 at risk EG0013 affected175 at risk EG0022 affected184 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0003 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Renal cyst	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0023 affected184 at risk
Renal failure chronic	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Renal tubular atrophy	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Respiratory tract infection fungal	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Retinal detachment	Eye disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Sepsis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0008 affected184 at risk EG00110 affected175 at risk EG00215 affected184 at risk
Seroma	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0022 affected184 at risk
Sinusitis bacterial	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Sudden death	General disorders	MedDRA 17.1	Systematic Assessment	EG0003 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Suicide attempt	Psychiatric disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Ulcer haemorrhage	General disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Venous stenosis	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Wound infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0002 affected184 at risk EG0011 affected175 at risk EG0022 affected184 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Abdominal wall haematoma	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Abscess rupture	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Acetabulum fracture	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Adenocarcinoma gastric	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Anastomotic haemorrhage	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Aortic dissection	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Aortic stenosis	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Aortic valve disease	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Arteriovenous fistula thrombosis	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0011 affected175 at risk EG0021 affected184 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0011 affected175 at risk EG0022 affected184 at risk
Bacterial pyelonephritis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0002 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Bladder neck sclerosis	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Bladder obstruction	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Cardiac death	General disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Cardiovascular disorder	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0006 affected184 at risk EG0011 affected175 at risk EG0024 affected184 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0011 affected175 at risk EG0021 affected184 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0012 affected175 at risk EG0021 affected184 at risk
Convulsion	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0012 affected175 at risk EG0023 affected184 at risk
Cystitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Cytomegalovirus enteritis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Diabetic gangrene	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Diffuse large B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Diverticular perforation	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Diverticulum intestinal haemorrhagic	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Drug intolerance	General disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Dupuytren's contracture	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Endocarditis bacterial	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Enterobacter infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0012 affected175 at risk EG0020 affected184 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0022 affected184 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0003 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Gout	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0021 affected184 at risk
Granulocytopenia	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Guillain-Barre syndrome	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Haematuria	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0004 affected184 at risk EG0012 affected175 at risk EG0023 affected184 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Helicobacter infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Hernia	General disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0022 affected184 at risk
Human polyomavirus infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Hypercreatininaemia	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected184 at risk EG0011 affected175 at risk EG0022 affected184 at risk
Hypertonic bladder	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0012 affected175 at risk EG0020 affected184 at risk
Hypovolaemic shock	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Infectious pleural effusion	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0021 affected184 at risk
Klebsiella infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Microalbuminuria	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Multi-organ failure	General disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0012 affected175 at risk EG0023 affected184 at risk
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Organising pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Orthopnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Osteomyelitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0004 affected184 at risk EG0011 affected175 at risk EG0021 affected184 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Perinephric collection	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0012 affected175 at risk EG0023 affected184 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Polyomavirus test positive	Investigations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Post procedural haematuria	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0012 affected175 at risk EG0021 affected184 at risk
Post procedural urine leak	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0002 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Progressive multifocal leukoencephalopathy	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Prostatic obstruction	Reproductive system and breast disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0004 affected184 at risk EG0011 affected175 at risk EG0027 affected184 at risk
Renal artery dissection	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Renal tubular disorder	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0022 affected184 at risk
Retinal vein thrombosis	Eye disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected184 at risk EG0010 affected175 at risk EG0022 affected184 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Tenosynovitis	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Testicular swelling	Reproductive system and breast disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0023 affected184 at risk
Tracheobronchitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0012 affected175 at risk EG0020 affected184 at risk
Uterine malposition	Reproductive system and breast disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Vascular graft complication	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0011 affected175 at risk EG0021 affected184 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Venous thrombosis limb	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Vocal cord disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Vomiting	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected184 at risk EG0012 affected175 at risk EG0026 affected184 at risk
White blood cells urine positive	Investigations	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Abdominal abscess	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0021 affected184 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0013 affected175 at risk EG0021 affected184 at risk
Acute psychosis	Psychiatric disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Adrenal mass	Endocrine disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Agranulocytosis	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0011 affected175 at risk EG0021 affected184 at risk
Anal abscess	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Angina unstable	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0012 affected175 at risk EG0021 affected184 at risk
Aplasia pure red cell	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Asthenia	General disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Blister	Skin and subcutaneous tissue disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Blood creatinine increased	Investigations	MedDRA 17.1	Systematic Assessment	EG00014 affected184 at risk EG00111 affected175 at risk EG00217 affected184 at risk
Blood glucose abnormal	Investigations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Blood pressure increased	Investigations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
C-reactive protein increased	Investigations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Cardiac failure	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0003 affected184 at risk EG0013 affected175 at risk EG0024 affected184 at risk
Cerebellar syndrome	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Cerebral infarction	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Chest pain	General disorders	MedDRA 17.1	Systematic Assessment	EG0005 affected184 at risk EG0013 affected175 at risk EG0024 affected184 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0012 affected175 at risk EG0024 affected184 at risk
Completed suicide	Psychiatric disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Confusional state	Psychiatric disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Coronary artery disease	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected184 at risk EG0012 affected175 at risk EG0021 affected184 at risk
Cytomegalovirus gastroenteritis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Cytomegalovirus syndrome	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Cytomegalovirus viraemia	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0023 affected184 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Diabetic bullosis	Skin and subcutaneous tissue disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0012 affected175 at risk EG0021 affected184 at risk
Diabetic nephropathy	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Enterocolitis haemorrhagic	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0012 affected175 at risk EG0021 affected184 at risk
Gastroenteritis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0008 affected184 at risk EG0016 affected175 at risk EG0028 affected184 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0002 affected184 at risk EG0011 affected175 at risk EG0021 affected184 at risk
Gastrointestinal obstruction	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Glaucoma	Eye disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Hepatitis	Hepatobiliary disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Herpes zoster disseminated	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0021 affected184 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Hypotension	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0004 affected184 at risk EG0014 affected175 at risk EG0022 affected184 at risk
Infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Joint tuberculosis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Kaposi's sarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0011 affected175 at risk EG0023 affected184 at risk
Kidney infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0022 affected184 at risk
Laryngeal oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Localised infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Malignant pleural effusion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Meningitis cryptococcal	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0002 affected184 at risk EG0012 affected175 at risk EG0020 affected184 at risk
Mononeuropathy	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG0003 affected184 at risk EG0012 affected175 at risk EG0023 affected184 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Optic neuritis	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Oral candidiasis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0012 affected175 at risk EG0020 affected184 at risk
Peripheral swelling	General disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Pharyngeal oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Pneumonia	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG00015 affected184 at risk EG00114 affected175 at risk EG00211 affected184 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Polyomavirus-associated nephropathy	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0003 affected184 at risk EG0011 affected175 at risk EG0021 affected184 at risk
Postoperative ileus	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Pyelocaliectasis	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0007 affected184 at risk EG00112 affected175 at risk EG00211 affected184 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Sickle cell anaemia with crisis	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Staphylococcal infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Subcutaneous haematoma	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Thrombophlebitis superficial	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Tooth abscess	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Transplant abscess	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0012 affected175 at risk EG0021 affected184 at risk
Transplant failure	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0021 affected184 at risk
Tuberculosis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0012 affected175 at risk EG0020 affected184 at risk
Ureteral necrosis	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0012 affected175 at risk EG0021 affected184 at risk
Urinary retention	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0022 affected184 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0013 affected175 at risk EG0023 affected184 at risk
Urosepsis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0006 affected184 at risk EG0017 affected175 at risk EG0026 affected184 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Aneurysm ruptured	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Arrhythmia	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Arrhythmia supraventricular	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Arteriovenous fistula aneurysm	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0011 affected175 at risk EG0021 affected184 at risk
Bacterial infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Biliary dilatation	Hepatobiliary disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Bradycardia	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0011 affected175 at risk EG0021 affected184 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Bronchopneumonia	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0014 affected175 at risk EG0020 affected184 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Cataract	Eye disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Central nervous system lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0012 affected175 at risk EG0020 affected184 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Cholangiocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Cholangitis acute	Hepatobiliary disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Colitis	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0012 affected175 at risk EG0020 affected184 at risk
Complications of transplanted kidney	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0003 affected184 at risk EG0018 affected175 at risk EG0026 affected184 at risk
Cystitis bacterial	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Cytomegalovirus gastrointestinal infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Device related sepsis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Disseminated cytomegaloviral infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Disseminated tuberculosis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0012 affected175 at risk EG0020 affected184 at risk
Diverticulitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0011 affected175 at risk EG0022 affected184 at risk
Encephalitis toxic	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Encephalomyelitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Enterococcal bacteraemia	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0021 affected184 at risk
Enterococcal infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Epididymitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Epiglottic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Escherichia test positive	Investigations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Extremity necrosis	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0021 affected184 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0022 affected184 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Gastrointestinal ulcer	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Helicobacter gastritis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Hepatic cyst	Hepatobiliary disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Hernial eventration	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0022 affected184 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected184 at risk EG0013 affected175 at risk EG0021 affected184 at risk
Hypertension	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected184 at risk EG0015 affected175 at risk EG0023 affected184 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Incision site infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Infected cyst	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Infected lymphocele	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0021 affected184 at risk
International normalised ratio increased	Investigations	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Intestinal haemorrhage	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Intracardiac thrombus	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Iron deficiency	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Joint effusion	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG0008 affected184 at risk EG0012 affected175 at risk EG0025 affected184 at risk
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0012 affected175 at risk EG0022 affected184 at risk
Lymphocele	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected184 at risk EG0015 affected175 at risk EG00211 affected184 at risk
Macular fibrosis	Eye disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Nephropathy	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0011 affected175 at risk EG0021 affected184 at risk
Nephropathy toxic	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Nephrotic syndrome	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Oedema peripheral	General disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Partial seizures	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Pituitary tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Pleural mesothelioma malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Postrenal failure	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0013 affected175 at risk EG0021 affected184 at risk
Pyelonephritis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG00012 affected184 at risk EG0016 affected175 at risk EG00214 affected184 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0012 affected175 at risk EG0024 affected184 at risk
Rectal prolapse	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Rectocele	Reproductive system and breast disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Renal artery thrombosis	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0011 affected175 at risk EG0021 affected184 at risk
Renal cyst haemorrhage	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Renal impairment	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected184 at risk EG0013 affected175 at risk EG0029 affected184 at risk
Renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0022 affected184 at risk
Renal transplant failure	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0022 affected184 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Sciatica	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Scrotal oedema	Reproductive system and breast disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Shock haemorrhagic	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Thrombosis	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Tuberculous laryngitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Urethral obstruction	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0023 affected184 at risk
Urinary tract infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG00025 affected184 at risk EG00128 affected175 at risk EG00226 affected184 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Vesicoureteric reflux	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0022 affected184 at risk
Abscess	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0003 affected184 at risk EG0010 affected175 at risk EG0022 affected184 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected184 at risk EG0014 affected175 at risk EG0022 affected184 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Adverse drug reaction	General disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Anastomotic complication	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Angina pectoris	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0003 affected184 at risk EG0011 affected175 at risk EG0024 affected184 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0003 affected184 at risk EG0011 affected175 at risk EG0021 affected184 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0009 affected184 at risk EG00111 affected175 at risk EG0023 affected184 at risk
Atrial flutter	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Atrial tachycardia	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0022 affected184 at risk
Bacteraemia	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0003 affected184 at risk EG0011 affected175 at risk EG0025 affected184 at risk
Bacterial prostatitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Brain mass	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Cardiomyopathy	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Cellulitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0005 affected184 at risk EG0014 affected175 at risk EG0020 affected184 at risk
Cerebral haematoma	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Cryptococcosis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0013 affected175 at risk EG0020 affected184 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Device related infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0002 affected184 at risk EG0011 affected175 at risk EG0022 affected184 at risk
Dizziness	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Extravasation	General disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Fistula	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Gallbladder perforation	Hepatobiliary disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Gangrene	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0004 affected184 at risk EG0012 affected175 at risk EG0020 affected184 at risk
Graft complication	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0003 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Graft thrombosis	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0013 affected175 at risk EG0021 affected184 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Hyperparathyroidism tertiary	Endocrine disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected184 at risk EG0010 affected175 at risk EG0023 affected184 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0012 affected175 at risk EG0020 affected184 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Malabsorption	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Mobility decreased	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Necrotising fasciitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Oral disorder	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected184 at risk EG0011 affected175 at risk EG0023 affected184 at risk
Peritoneal haemorrhage	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Platelet count decreased	Investigations	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Post transplant distal limb syndrome	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Postoperative wound infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0003 affected184 at risk EG0012 affected175 at risk EG0021 affected184 at risk
Prerenal failure	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Priapism	Reproductive system and breast disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0002 affected184 at risk EG0014 affected175 at risk EG0020 affected184 at risk
Psoas abscess	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Pyrexia	General disorders	MedDRA 17.1	Systematic Assessment	EG00017 affected184 at risk EG00110 affected175 at risk EG00212 affected184 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0021 affected184 at risk
Renal artery stenosis	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected184 at risk EG0015 affected175 at risk EG0027 affected184 at risk
Renal haemorrhage	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Renal tubular necrosis	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0004 affected184 at risk EG0013 affected175 at risk EG0022 affected184 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0012 affected175 at risk EG0021 affected184 at risk
Shock	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0022 affected184 at risk
Type 1 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0022 affected184 at risk
Ureteric fistula	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Urine abnormality	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0021 affected184 at risk
Visual acuity reduced	Eye disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected175 at risk EG0020 affected184 at risk
Visual impairment	Eye disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0020 affected184 at risk
White blood cell count decreased	Investigations	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0022 affected184 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Chills	General disorders	MedDRA 17.1	Systematic Assessment	EG0009 affected184 at risk EG0016 affected175 at risk EG0029 affected184 at risk
Chronic allograft nephropathy	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG00014 affected184 at risk EG0019 affected175 at risk EG00222 affected184 at risk
Conjunctivitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG00015 affected184 at risk EG0019 affected175 at risk EG0027 affected184 at risk
Constipation	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG00061 affected184 at risk EG00163 affected175 at risk EG00279 affected184 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0008 affected184 at risk EG00111 affected175 at risk EG0024 affected184 at risk
Cytomegalovirus infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG00022 affected184 at risk EG00118 affected175 at risk EG00217 affected184 at risk
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG00034 affected184 at risk EG00129 affected175 at risk EG00241 affected184 at risk
Gastritis	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0008 affected184 at risk EG0017 affected175 at risk EG0029 affected184 at risk
Gingival hypertrophy	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected175 at risk EG0029 affected184 at risk
Herpes zoster	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG00021 affected184 at risk EG00117 affected175 at risk EG00213 affected184 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG00021 affected184 at risk EG00120 affected175 at risk EG00223 affected184 at risk
Hyperparathyroidism	Endocrine disorders	MedDRA 17.1	Systematic Assessment	EG0007 affected184 at risk EG0015 affected175 at risk EG00212 affected184 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG00010 affected184 at risk EG00112 affected175 at risk EG00213 affected184 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG00015 affected184 at risk EG00112 affected175 at risk EG0029 affected184 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0008 affected184 at risk EG0011 affected175 at risk EG00210 affected184 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG00013 affected184 at risk EG00115 affected175 at risk EG00210 affected184 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG00013 affected184 at risk EG00113 affected175 at risk EG00219 affected184 at risk
Bronchitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG00037 affected184 at risk EG00136 affected175 at risk EG00225 affected184 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG00013 affected184 at risk EG00110 affected175 at risk EG0028 affected184 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG00022 affected184 at risk EG00116 affected175 at risk EG00220 affected184 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 17.1	Systematic Assessment	EG00013 affected184 at risk EG0014 affected175 at risk EG0029 affected184 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0009 affected184 at risk EG0016 affected175 at risk EG00213 affected184 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG00016 affected184 at risk EG00113 affected175 at risk EG0028 affected184 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG00016 affected184 at risk EG00116 affected175 at risk EG00231 affected184 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0005 affected184 at risk EG0011 affected175 at risk EG0029 affected184 at risk
Oedema	General disorders	MedDRA 17.1	Systematic Assessment	EG00026 affected184 at risk EG00123 affected175 at risk EG00230 affected184 at risk
Proteinuria	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG00040 affected184 at risk EG00136 affected175 at risk EG00229 affected184 at risk
Sinusitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG00019 affected184 at risk EG00123 affected175 at risk EG00220 affected184 at risk
Transplant dysfunction	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG00065 affected184 at risk EG00164 affected175 at risk EG00285 affected184 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 17.1	Systematic Assessment	EG0005 affected184 at risk EG00114 affected175 at risk EG0028 affected184 at risk
Weight increased	Investigations	MedDRA 17.1	Systematic Assessment	EG00015 affected184 at risk EG00113 affected175 at risk EG00211 affected184 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0003 affected184 at risk EG0015 affected175 at risk EG00210 affected184 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG00030 affected184 at risk EG00139 affected175 at risk EG00233 affected184 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG00098 affected184 at risk EG00193 affected175 at risk EG002103 affected184 at risk
Aphthous stomatitis	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG00010 affected184 at risk EG00113 affected175 at risk EG0024 affected184 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG00053 affected184 at risk EG00156 affected175 at risk EG00241 affected184 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG000103 affected184 at risk EG00194 affected175 at risk EG00274 affected184 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG00033 affected184 at risk EG00140 affected175 at risk EG00237 affected184 at risk
Fatigue	General disorders	MedDRA 17.1	Systematic Assessment	EG00026 affected184 at risk EG00122 affected175 at risk EG00219 affected184 at risk
Gingival hyperplasia	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected175 at risk EG0029 affected184 at risk
Haematoma	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG00016 affected184 at risk EG00116 affected175 at risk EG00218 affected184 at risk
Hyperkeratosis	Skin and subcutaneous tissue disorders	MedDRA 17.1	Systematic Assessment	EG0008 affected184 at risk EG0019 affected175 at risk EG0025 affected184 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG00047 affected184 at risk EG00140 affected175 at risk EG00240 affected184 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG00015 affected184 at risk EG00113 affected175 at risk EG00212 affected184 at risk
Incision site pain	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG00026 affected184 at risk EG00122 affected175 at risk EG00236 affected184 at risk
Influenza	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG00017 affected184 at risk EG00116 affected175 at risk EG00218 affected184 at risk
Nasopharyngitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG00045 affected184 at risk EG00144 affected175 at risk EG00238 affected184 at risk
Pain	General disorders	MedDRA 17.1	Systematic Assessment	EG00013 affected184 at risk EG00113 affected175 at risk EG00214 affected184 at risk
Post procedural discharge	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0012 affected175 at risk EG0029 affected184 at risk
Respiratory tract infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0006 affected184 at risk EG00113 affected175 at risk EG0026 affected184 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG00024 affected184 at risk EG00113 affected175 at risk EG00211 affected184 at risk
Tremor	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG00017 affected184 at risk EG00121 affected175 at risk EG00231 affected184 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG00035 affected184 at risk EG00129 affected175 at risk EG00223 affected184 at risk
Weight decreased	Investigations	MedDRA 17.1	Systematic Assessment	EG00017 affected184 at risk EG00121 affected175 at risk EG00213 affected184 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG00014 affected184 at risk EG00118 affected175 at risk EG00219 affected184 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG00015 affected184 at risk EG00110 affected175 at risk EG0028 affected184 at risk
Dysuria	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG00025 affected184 at risk EG00123 affected175 at risk EG00216 affected184 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0009 affected184 at risk EG0019 affected175 at risk EG0029 affected184 at risk
Headache	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG00037 affected184 at risk EG00141 affected175 at risk EG00247 affected184 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0009 affected184 at risk EG0012 affected175 at risk EG00211 affected184 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0015 affected175 at risk EG00216 affected184 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG00021 affected184 at risk EG00114 affected175 at risk EG00226 affected184 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG00015 affected184 at risk EG00116 affected175 at risk EG00216 affected184 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG00017 affected184 at risk EG00117 affected175 at risk EG00219 affected184 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG00011 affected184 at risk EG0019 affected175 at risk EG00217 affected184 at risk
Oral herpes	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG00013 affected184 at risk EG00114 affected175 at risk EG0029 affected184 at risk
Polycythaemia	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG0004 affected184 at risk EG00110 affected175 at risk EG0027 affected184 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 17.1	Systematic Assessment	EG00016 affected184 at risk EG0018 affected175 at risk EG0026 affected184 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG00021 affected184 at risk EG00125 affected175 at risk EG00227 affected184 at risk
Arteriovenous fistula thrombosis	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0004 affected184 at risk EG0017 affected175 at risk EG0029 affected184 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG00033 affected184 at risk EG00143 affected175 at risk EG00234 affected184 at risk
Fungal skin infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0008 affected184 at risk EG0019 affected175 at risk EG0028 affected184 at risk
Gout	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0003 affected184 at risk EG00111 affected175 at risk EG0027 affected184 at risk
Haematuria	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG00041 affected184 at risk EG00139 affected175 at risk EG00236 affected184 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG00043 affected184 at risk EG00147 affected175 at risk EG00244 affected184 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG00035 affected184 at risk EG00137 affected175 at risk EG00222 affected184 at risk
Insomnia	Psychiatric disorders	MedDRA 17.1	Systematic Assessment	EG00037 affected184 at risk EG00131 affected175 at risk EG00239 affected184 at risk
Leukocyturia	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG00013 affected184 at risk EG00114 affected175 at risk EG00212 affected184 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG00013 affected184 at risk EG0017 affected175 at risk EG0025 affected184 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG00035 affected184 at risk EG00134 affected175 at risk EG00242 affected184 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0009 affected184 at risk EG00118 affected175 at risk EG0026 affected184 at risk
Sinus bradycardia	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0008 affected184 at risk EG0014 affected175 at risk EG0029 affected184 at risk
Tachycardia	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG00014 affected184 at risk EG00122 affected175 at risk EG00212 affected184 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 affected184 at risk EG0011 affected175 at risk EG00218 affected184 at risk
Vomiting	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG00037 affected184 at risk EG00151 affected175 at risk EG00244 affected184 at risk
Wound complication	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0003 affected184 at risk EG0015 affected175 at risk EG0029 affected184 at risk
Anxiety	Psychiatric disorders	MedDRA 17.1	Systematic Assessment	EG00027 affected184 at risk EG00120 affected175 at risk EG00230 affected184 at risk
Asthenia	General disorders	MedDRA 17.1	Systematic Assessment	EG00023 affected184 at risk EG00117 affected175 at risk EG00223 affected184 at risk
Blood creatinine increased	Investigations	MedDRA 17.1	Systematic Assessment	EG00029 affected184 at risk EG00129 affected175 at risk EG00231 affected184 at risk
Blood pressure increased	Investigations	MedDRA 17.1	Systematic Assessment	EG0008 affected184 at risk EG0015 affected175 at risk EG00210 affected184 at risk
C-reactive protein increased	Investigations	MedDRA 17.1	Systematic Assessment	EG00012 affected184 at risk EG00114 affected175 at risk EG00211 affected184 at risk
Chest pain	General disorders	MedDRA 17.1	Systematic Assessment	EG00022 affected184 at risk EG00124 affected175 at risk EG00224 affected184 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG00015 affected184 at risk EG00116 affected175 at risk EG00217 affected184 at risk
Flatulence	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0005 affected184 at risk EG0015 affected175 at risk EG00210 affected184 at risk
Gastroenteritis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0008 affected184 at risk EG00118 affected175 at risk EG00222 affected184 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG00024 affected184 at risk EG00116 affected175 at risk EG00222 affected184 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG00013 affected184 at risk EG00113 affected175 at risk EG00213 affected184 at risk
Hyperphosphataemia	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG00016 affected184 at risk EG00115 affected175 at risk EG00215 affected184 at risk
Hypotension	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG00038 affected184 at risk EG00152 affected175 at risk EG00229 affected184 at risk
Left ventricular hypertrophy	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0005 affected184 at risk EG0019 affected175 at risk EG0026 affected184 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG00012 affected184 at risk EG00110 affected175 at risk EG00212 affected184 at risk
Onychomycosis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG00014 affected184 at risk EG0016 affected175 at risk EG0028 affected184 at risk
Oral candidiasis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG00014 affected184 at risk EG00110 affected175 at risk EG00213 affected184 at risk
Peripheral swelling	General disorders	MedDRA 17.1	Systematic Assessment	EG00010 affected184 at risk EG00114 affected175 at risk EG00212 affected184 at risk
Pneumonia	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0007 affected184 at risk EG00115 affected175 at risk EG00211 affected184 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0004 affected184 at risk EG0017 affected175 at risk EG0029 affected184 at risk
Urinary retention	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0005 affected184 at risk EG0016 affected175 at risk EG00211 affected184 at risk
Bradycardia	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG00010 affected184 at risk EG0017 affected175 at risk EG00212 affected184 at risk
Cataract	Eye disorders	MedDRA 17.1	Systematic Assessment	EG00020 affected184 at risk EG00113 affected175 at risk EG00216 affected184 at risk
Complications of transplanted kidney	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG00010 affected184 at risk EG00120 affected175 at risk EG00217 affected184 at risk
Cushingoid	Endocrine disorders	MedDRA 17.1	Systematic Assessment	EG0006 affected184 at risk EG0017 affected175 at risk EG0029 affected184 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG00016 affected184 at risk EG0018 affected175 at risk EG00211 affected184 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG00011 affected184 at risk EG0015 affected175 at risk EG0025 affected184 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG00035 affected184 at risk EG00129 affected175 at risk EG00237 affected184 at risk
Hypertension	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG00063 affected184 at risk EG00163 affected175 at risk EG00280 affected184 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG00035 affected184 at risk EG00134 affected175 at risk EG00222 affected184 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG00051 affected184 at risk EG00140 affected175 at risk EG00248 affected184 at risk
Lymphocele	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0009 affected184 at risk EG0017 affected175 at risk EG00215 affected184 at risk
Oedema peripheral	General disorders	MedDRA 17.1	Systematic Assessment	EG00092 affected184 at risk EG00181 affected175 at risk EG00296 affected184 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG00016 affected184 at risk EG0019 affected175 at risk EG00211 affected184 at risk
Osteopenia	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG00010 affected184 at risk EG0017 affected175 at risk EG0026 affected184 at risk
Renal impairment	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG00013 affected184 at risk EG00113 affected175 at risk EG00219 affected184 at risk
Rhinitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG00011 affected184 at risk EG0018 affected175 at risk EG00211 affected184 at risk
Sciatica	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0007 affected184 at risk EG00111 affected175 at risk EG0028 affected184 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 17.1	Systematic Assessment	EG00018 affected184 at risk EG00115 affected175 at risk EG00211 affected184 at risk
Skin papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG00011 affected184 at risk EG0016 affected175 at risk EG00211 affected184 at risk
Urinary tract infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG00079 affected184 at risk EG00176 affected175 at risk EG00286 affected184 at risk
Acidosis	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG00016 affected184 at risk EG00114 affected175 at risk EG00215 affected184 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA 17.1	Systematic Assessment	EG0007 affected184 at risk EG00112 affected175 at risk EG00215 affected184 at risk
Angina pectoris	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0005 affected184 at risk EG0018 affected175 at risk EG00212 affected184 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG00016 affected184 at risk EG00111 affected175 at risk EG00212 affected184 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG00041 affected184 at risk EG00144 affected175 at risk EG00239 affected184 at risk
Depression	Psychiatric disorders	MedDRA 17.1	Systematic Assessment	EG0008 affected184 at risk EG00116 affected175 at risk EG00218 affected184 at risk
Dizziness	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG00026 affected184 at risk EG00118 affected175 at risk EG00218 affected184 at risk
Erectile dysfunction	Reproductive system and breast disorders	MedDRA 17.1	Systematic Assessment	EG00012 affected184 at risk EG0019 affected175 at risk EG0025 affected184 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG00010 affected184 at risk EG00112 affected175 at risk EG0028 affected184 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0004 affected184 at risk EG0014 affected175 at risk EG00210 affected184 at risk
Nausea	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG00054 affected184 at risk EG00149 affected175 at risk EG00252 affected184 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0005 affected184 at risk EG0015 affected175 at risk EG0029 affected184 at risk
Paraesthesia	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG00011 affected184 at risk EG00113 affected175 at risk EG00216 affected184 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG00036 affected184 at risk EG00138 affected175 at risk EG00237 affected184 at risk
Pyrexia	General disorders	MedDRA 17.1	Systematic Assessment	EG00056 affected184 at risk EG00164 affected175 at risk EG00252 affected184 at risk
Renal tubular necrosis	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG00017 affected184 at risk EG00121 affected175 at risk EG00230 affected184 at risk
Tinea versicolour	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0002 affected184 at risk EG0013 affected175 at risk EG0029 affected184 at risk

Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.

ID	Term
D003524	Cyclosporins
D010456	Peptides, Cyclic
D047028	Macrocyclic Compounds
D011083	Polycyclic Compounds
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins