Efficacy and Safety of Everolimus in Recipients of Heart... | NCT00300274

Label	Type	Description	Intervention Names
everolimus 1.5 mg	Experimental	Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.	Drug: everolimus Drug: cyclosporine Drug: corticosteroids
everolimus 3.0 mg	Experimental	Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL. Randomization of new patients in this arm was prematurely stopped as of 27 March 2008 due to high mortality rate, as per Data Monitoring Committee.	Drug: everolimus Drug: cyclosporine Drug: corticosteroids
mycophenolate mofetil	Active Comparator	Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.	Drug: mycophenolate mofetil Drug: cyclosporine Drug: corticosteroids

Name	Type	Description	Arm Group Labels	Other Names
everolimus	Drug	Everolimus supplied as 0.75 mg tablets. Everolimus was also supplied in 0.25 mg and 0.5 mg tablets for dose adjustments.	everolimus 1.5 mg everolimus 3.0 mg

Measure	Description	Time Frame
Percentage of Participants With Composite Efficacy Failure at 12 Months	Composite efficacy failure was defined as Biopsy Proven Acute Rejection(BPAR) of International Society for Heart and Lung Transplantation(ISHLT) grade ≥3A, Acute Rejection associated with Hemodynamic Compromise, Graft loss/Retransplant, Death or Loss to follow-up. Identification of acute rejection was based on the local pathologist's evaluation of endomyocardial biopsy slides. Hemodynamic compromise was present if 1 or more of the following were met: Ejection fraction ≤30% or 25% lower than Baseline or Fractional shortening ≤20% or 25% lower than Baseline and/or use of inotropic treatment.	12 Months

Measure	Description	Time Frame
Percentage of Participants With Graft Loss/Re-transplant, Death or Loss to Follow-up at 12 Months	Loss to follow-up for this composite endpoint included participants who did not experience graft loss/re-transplant or death and whose last day of contact was prior to Day 316 (start day of the Month 12 visit window).	12 Months

Name	Affiliation	Role
Novartis	Novartis	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
UCLA Medical Center		Los Angeles	California		United States
California Pacific Medical Center

ID	Title	Description
FG000	Everolimus 1.5 mg	Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.

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 With Composite Efficacy Failure at 12 Months

Composite efficacy failure was defined as Biopsy Proven Acute Rejection(BPAR) of International Society for Heart and Lung Transplantation(ISHLT) grade ≥3A, Acute Rejection associated with Hemodynamic Compromise, Graft loss/Retransplant, Death or Loss to follow-up.

Identification of acute rejection was based on the local pathologist's evaluation of endomyocardial biopsy slides.

Hemodynamic compromise was present if 1 or more of the following were met: Ejection fraction ≤30% or 25% lower than Baseline or Fractional shortening ≤20% or 25% lower than Baseline and/or use of inotropic treatment.

Intent-to-treat population included all randomized participants.

Posted

Number

Percentage of participants

12 Months

ID	Title	Description
OG000	Everolimus 1.5 mg	Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
OG001	Everolimus 3.0 mg	Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
OG002	Mycophenolate Mofetil	Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.

Units	Counts
Participants	OG000282 OG001168 OG002271

Title

Denominators

Categories

Title	Measurements
	OG00035.1 OG00135.1 OG00233.6

Secondary

Percentage of Participants With Graft Loss/Re-transplant, Death or Loss to Follow-up at 12 Months

Loss to follow-up for this composite endpoint included participants who did not experience graft loss/re-transplant or death and whose last day of contact was prior to Day 316 (start day of the Month 12 visit window).

Intent-to-treat population included all randomized participants.

Posted

Number

Percentage of participants

12 Months

ID	Title	Description
OG000	Everolimus 1.5 mg	Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
OG001	Everolimus 3.0 mg	Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
OG002	Mycophenolate Mofetil

Secondary

Renal Function Measured by Glomerular Filtration Rate (GFR) at 12 Months

GFR was calculated using the Modification of Diet and Renal Disease (MDRD) formula:

GFR [mL/min/1.73m^2] = 186.3*(C^-1.154)*(A^-0.203)*G*R where C is the serum concentration of creatinine [mg/dL] A is age [years] G=0.742 when gender is female, otherwise G=1 R=1.21 when race is black, otherwise R=1

Participants from the intent-to-treat population (all randomized participants) with data available for analysis.

Posted

Mean

Standard Deviation

mL/min/1.73^2

12 Months

ID	Title	Description
OG000	Everolimus 1.5 mg	Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
OG001	Everolimus 3.0 mg	Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
OG002	Mycophenolate Mofetil

Secondary

Change From Baseline in the Average Maximum Intimal Thickness at Month 12

Maximum intimal thickness was assessed using Intravascular Ultrasound (IVUS). IVUS is a technique for taking ultrasound pictures of the wall of an artery from inside the artery itself. It shows the thickness of the artery wall and any narrowing of the artery.

IVUS population consisted of randomized patients who had a minimum of 11 matched slices between IVUS images from Baseline and from Month 12 (IVUS Centers).

Posted

Mean

Standard Deviation

Baseline, Month 12

ID	Title	Description
OG000	Everolimus 1.5 mg	Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
OG001	Everolimus 3.0 mg	Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
OG002	Mycophenolate Mofetil

Secondary

Percentage of Participants With Cardiac Allograft Vasculopathy (CAV) at Month 12

Cardiac allograft vasculopathy is defined as a 0.5 mm increase in maximum intimal thickness as measured by Intravascular Ultrasound (IVUS) in at least one matched slice between baseline and Month 12.

IVUS population consisted of randomized patients who had a minimum of 11 matched slices between IVUS images from Baseline and from Month 12 (IVUS centers).

Posted

Number

Percentage of participants

12 Months

ID	Title	Description
OG000	Everolimus 1.5 mg	Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
OG001	Everolimus 3.0 mg	Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
OG002	Mycophenolate Mofetil

Secondary

Percentage of Participants With Biopsy-proven Acute Rejection (BPAR of ISHLT Grade ≥ 3A), Acute Rejection Associated With Hemodynamic Compromise (HDC), Graft Loss/Re-transplant and Death at Month 12

Identification of acute rejections was based on the local pathologist's evaluation of endomyocardial biopsy slides.

Hemodynamic compromise was present if 1 or more of the following were met: Ejection fraction ≤ 30% or 25% lower than Baseline or Fractional shortening ≤ 20% or 25% lower than Baseline, and/or use of inotropic treatment.

Intent-to-treat population includes all randomized participants.

Posted

Number

Percentage of participants

12 Months

ID	Title	Description
OG000	Everolimus 1.5 mg	Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
OG001	Everolimus 3.0 mg	Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.

Secondary

Percentage of Participants With Composite Efficacy Failure at 24 Months

Composite efficacy failure was defined as Biopsy Proven Acute Rejection (BPAR) of International Society for Heart and Lung Transplantation grade ≥ 3A, Acute Rejection associated with Hemodynamic Compromise, Graft loss/Retransplant, Death or Loss to follow-up.

Identification of acute rejections was based on the local pathologist's evaluation of endomyocardial biopsy slides.

Hemodynamic compromise was present if 1 or more of the following were met: Ejection fraction ≤ 30% or 25% lower than Baseline or Fractional shortening ≤ 20% or 25% lower than Baseline and/or use of inotropic treatment.

Intent-to-treat population included all randomized participants.

Posted

Number

Percentage of participants

24 Months

ID	Title	Description
OG000	Everolimus 1.5 mg	Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
OG001	Everolimus 3.0 mg	Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.

Secondary

Percentage of Participants With Graft Loss/Re-transplant, Death or Loss to Follow-up at 24 Months

Loss to follow-up for this composite endpoint included participants who did not experience graft loss/re-transplant or death and whose last day of contact was prior to Day 631 (start day of 24 Month visit window).

Intent-to-treat population included all randomized participants.

Posted

Number

Percentage of participants

24 Months

ID	Title	Description
OG000	Everolimus 1.5 mg	Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
OG001	Everolimus 3.0 mg	Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
OG002	Mycophenolate Mofetil	Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.

Secondary

Renal Function Calculated by Glomerular Filtration Rate (GFR) at 24 Months

GFR was calculated using the Modification of Diet and Renal Disease (MDRD) formula:

GFR [mL/min/1.73m^2] = 186.3*(C^-1.154)*(A^-0.203)*G*R

C is the serum concentration of creatinine [mg/dL] A is age [years] G=0.742 when gender is female, otherwise G=1 R=1.21 when race is black, otherwise R=1

Participants from the intent-to-treat population (all randomized participants) with data available for analysis.

Posted

Mean

Standard Deviation

mL/min/1.73^2

24 Months

ID	Title	Description
OG000	Everolimus 1.5 mg	Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
OG001	Everolimus 3.0 mg	Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
OG002	Mycophenolate Mofetil

Secondary

Percentage of Participants With Biopsy-proven Acute Rejection (BPAR of ISHLT Grade ≥ 3A), Acute Rejection (AR) Associated With Hemodynamic Compromise (HDC), Graft Loss/Re-transplant and Death at Month 24

Identification of acute rejections was based on the local pathologist's evaluation of endomyocardial biopsy slides.

Hemodynamic compromise was present if 1 or more of the following were met: Ejection fraction ≤ 30% or 25% lower than Baseline or Fractional shortening ≤ 20% or 25% lower than Baseline, and/ or use of inotropic treatment.

Intent-to-treat population included all randomized participants.

Posted

Number

Percentage of participants

24 Months

ID	Title	Description
OG000	Everolimus 1.5 mg	Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
OG001	Everolimus 3.0 mg	Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 14.0	Systematic Assessment	EG0005 affected279 at risk EG0015 affected167 at risk EG0024 affected268 at risk
Bone marrow failure	Blood and lymphatic system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Haemolytic anaemia	Blood and lymphatic system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0022 affected268 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0014 affected167 at risk EG0022 affected268 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0022 affected268 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0021 affected268 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0012 affected167 at risk EG0021 affected268 at risk
Thrombotic microangiopathy	Blood and lymphatic system disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Thrombotic thrombocytopenic purpura	Blood and lymphatic system disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Angina pectoris	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0004 affected279 at risk EG0012 affected167 at risk EG0020 affected268 at risk
Aortic valve incompetence	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Arrhythmia	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0022 affected268 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0007 affected279 at risk EG0013 affected167 at risk EG00210 affected268 at risk
Atrial flutter	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0004 affected279 at risk EG0011 affected167 at risk EG0025 affected268 at risk
Atrial tachycardia	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0022 affected268 at risk
Atrial thrombosis	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0012 affected167 at risk EG0022 affected268 at risk
Atrioventricular block	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0012 affected167 at risk EG0021 affected268 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Bradycardia	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Cardiac arrest	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0003 affected279 at risk EG0015 affected167 at risk EG0023 affected268 at risk
Cardiac failure	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0011 affected167 at risk EG0022 affected268 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0022 affected268 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0004 affected279 at risk EG0011 affected167 at risk EG0024 affected268 at risk
Cardiac perforation	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Cardiac tamponade	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0005 affected279 at risk EG0013 affected167 at risk EG0024 affected268 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected279 at risk EG0011 affected167 at risk EG0026 affected268 at risk
Cardiomegaly	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Coronary artery disease	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Coronary artery dissection	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Dilatation atrial	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected279 at risk EG0010 affected167 at risk EG0022 affected268 at risk
Nodal arrhythmia	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Nodal rhythm	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Palpitations	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0005 affected279 at risk EG0010 affected167 at risk EG0024 affected268 at risk
Pericardial cyst	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Pericardial effusion	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG00038 affected279 at risk EG00118 affected167 at risk EG00212 affected268 at risk
Pericardial haemorrhage	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Pericarditis	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0012 affected167 at risk EG0020 affected268 at risk
Pericarditis constrictive	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Pulseless electrical activity	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Right ventricular dysfunction	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected279 at risk EG0013 affected167 at risk EG0020 affected268 at risk
Right ventricular failure	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Sick sinus syndrome	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0021 affected268 at risk
Sinus arrest	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected279 at risk EG0010 affected167 at risk EG0022 affected268 at risk
Tachycardia	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0023 affected268 at risk
Tricuspid valve incompetence	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0003 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Ventricular arrhythmia	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0022 affected268 at risk
Ventricular asystole	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Ventricular dysfunction	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Blindness	Eye disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Retinal artery thrombosis	Eye disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Vision blurred	Eye disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Visual impairment	Eye disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0012 affected167 at risk EG0021 affected268 at risk
Vitreous haemorrhage	Eye disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0004 affected279 at risk EG0013 affected167 at risk EG0021 affected268 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected279 at risk EG0012 affected167 at risk EG0023 affected268 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0022 affected268 at risk
Ascites	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Colitis	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Colitis ulcerative	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0005 affected279 at risk EG0012 affected167 at risk EG0025 affected268 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Enteritis	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Epigastric discomfort	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0023 affected268 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Gingival hyperplasia	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Hernial eventration	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Ileitis	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Ileus	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Ileus paralytic	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Large intestinal ulcer	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Megacolon	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Melaena	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Nausea	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0003 affected279 at risk EG0014 affected167 at risk EG0027 affected268 at risk
Odynophagia	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Oral disorder	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Paraesthesia oral	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Reflux oesophagitis	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0021 affected268 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Stomatitis necrotising	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Vomiting	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0004 affected279 at risk EG0013 affected167 at risk EG0025 affected268 at risk
Asthenia	General disorders	MedDRA 14.0	Systematic Assessment	EG0003 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Cardiac death	General disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Catheter site haematoma	General disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Chest pain	General disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Chills	General disorders	MedDRA 14.0	Systematic Assessment	EG0003 affected279 at risk EG0014 affected167 at risk EG0022 affected268 at risk
Concomitant disease progression	General disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Crepitations	General disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Device breakage	General disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Device malfunction	General disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Fatigue	General disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected279 at risk EG0012 affected167 at risk EG0026 affected268 at risk
Feeling hot	General disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Generalised oedema	General disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Hyperpyrexia	General disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Hyperthermia	General disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Hypothermia	General disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Impaired healing	General disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0022 affected268 at risk
Malaise	General disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Multi-organ failure	General disorders	MedDRA 14.0	Systematic Assessment	EG0006 affected279 at risk EG0013 affected167 at risk EG0025 affected268 at risk
Non-cardiac chest pain	General disorders	MedDRA 14.0	Systematic Assessment	EG0008 affected279 at risk EG0012 affected167 at risk EG0023 affected268 at risk
Oedema	General disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Oedema peripheral	General disorders	MedDRA 14.0	Systematic Assessment	EG0006 affected279 at risk EG0015 affected167 at risk EG0024 affected268 at risk
Pyrexia	General disorders	MedDRA 14.0	Systematic Assessment	EG00012 affected279 at risk EG00114 affected167 at risk EG00210 affected268 at risk
Sudden cardiac death	General disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Sudden death	General disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected279 at risk EG0011 affected167 at risk EG0021 affected268 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 14.0	Systematic Assessment	EG0003 affected279 at risk EG0012 affected167 at risk EG0021 affected268 at risk
Cholestasis	Hepatobiliary disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0022 affected268 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0022 affected268 at risk
Hepatitis acute	Hepatobiliary disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Hepatorenal syndrome	Hepatobiliary disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Ischaemic hepatitis	Hepatobiliary disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Allergy to animal	Immune system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Anaphylactic shock	Immune system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Heart transplant rejection	Immune system disorders	MedDRA 14.0	Systematic Assessment	EG00020 affected279 at risk EG00113 affected167 at risk EG00226 affected268 at risk
Hypersensitivity	Immune system disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Transplant rejection	Immune system disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected279 at risk EG0011 affected167 at risk EG0022 affected268 at risk
Abscess intestinal	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Abscess limb	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0021 affected268 at risk
Abscess neck	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Acute pulmonary histoplasmosis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Acute sinusitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Appendicitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0002 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Aspergillosis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0002 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Bacteraemia	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0012 affected167 at risk EG0021 affected268 at risk
Bacterial diarrhoea	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Brain abscess	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0012 affected167 at risk EG0020 affected268 at risk
Bronchiolitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Bronchitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0012 affected167 at risk EG0022 affected268 at risk
Bronchitis bacterial	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0002 affected279 at risk EG0011 affected167 at risk EG0022 affected268 at risk
Candida pneumonia	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Cellulitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0002 affected279 at risk EG0012 affected167 at risk EG0022 affected268 at risk
Cerebral aspergillosis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0022 affected268 at risk
Chlamydial infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Clostridial infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0012 affected167 at risk EG0021 affected268 at risk
Cytomegalovirus colitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0022 affected268 at risk
Cytomegalovirus gastritis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0022 affected268 at risk
Cytomegalovirus infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0003 affected279 at risk EG0015 affected167 at risk EG00210 affected268 at risk
Cytomegalovirus syndrome	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0023 affected268 at risk
Cytomegalovirus viraemia	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0012 affected167 at risk EG0028 affected268 at risk
Device related infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0002 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Device related sepsis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Diarrhoea infectious	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Endocarditis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Enterobacter bacteraemia	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Enterobacter infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Enterobacter pneumonia	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Enterococcal infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Escherichia infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Escherichia sepsis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Fungal abscess central nervous system	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Fungal infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Fungal peritonitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Fungal sepsis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Gastroenteritis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0004 affected279 at risk EG0011 affected167 at risk EG0024 affected268 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0003 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Gastrointestinal infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
H1N1 influenza	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Herpes simplex	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Herpes virus infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Herpes zoster	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0002 affected279 at risk EG0010 affected167 at risk EG0023 affected268 at risk
Herpes zoster disseminated	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Incision site infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Infected lymphocele	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0002 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Influenza	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0021 affected268 at risk
Intraspinal abscess	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Listeriosis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Lobar pneumonia	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0011 affected167 at risk EG0023 affected268 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0012 affected167 at risk EG0021 affected268 at risk
Lung abscess	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Lung infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0005 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Lung infection pseudomonal	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Mediastinitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0004 affected279 at risk EG0011 affected167 at risk EG0022 affected268 at risk
Meningitis cryptococcal	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Mycobacterium avium complex infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Mycobacterium chelonei infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Myocarditis mycotic	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Necrotising fasciitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Oral herpes	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Osteomyelitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0013 affected167 at risk EG0022 affected268 at risk
Pericarditis fungal	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Pneumococcal sepsis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Pneumocystis jiroveci pneumonia	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0012 affected167 at risk EG0020 affected268 at risk
Pneumonia	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG00015 affected279 at risk EG00111 affected167 at risk EG0028 affected268 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Pneumonia cryptococcal	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Pneumonia cytomegaloviral	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0023 affected268 at risk
Pneumonia escherichia	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0002 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Pneumonia haemophilus	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Pneumonia klebsiella	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0011 affected167 at risk EG0021 affected268 at risk
Pneumonia legionella	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Pneumonia pneumococcal	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0003 affected279 at risk EG0011 affected167 at risk EG0021 affected268 at risk
Pneumonia primary atypical	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0002 affected279 at risk EG0011 affected167 at risk EG0022 affected268 at risk
Pneumonia respiratory syncytial viral	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Post procedural pneumonia	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Postoperative wound infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0005 affected279 at risk EG0015 affected167 at risk EG0022 affected268 at risk
Pseudomembranous colitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Pseudomonas bronchitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Purulent pericarditis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Pyelonephritis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Pyothorax	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Respiratory tract infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0021 affected268 at risk
Respiratory tract infection viral	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Rhinovirus infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Salmonella sepsis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Sepsis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0007 affected279 at risk EG0016 affected167 at risk EG0022 affected268 at risk
Sepsis syndrome	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Septic embolus	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Septic shock	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0004 affected279 at risk EG0013 affected167 at risk EG0022 affected268 at risk
Sinusitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0003 affected279 at risk EG0012 affected167 at risk EG0022 affected268 at risk
Skin infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Spinal cord infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Staphylococcal mediastinitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0003 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Stenotrophomonas infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Tonsillitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Tooth infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Tracheobronchitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Tuberculosis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0003 affected279 at risk EG0012 affected167 at risk EG0021 affected268 at risk
Urinary tract infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0005 affected279 at risk EG0010 affected167 at risk EG0025 affected268 at risk
Urosepsis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Varicella	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Viral infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0003 affected279 at risk EG0012 affected167 at risk EG0020 affected268 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0005 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Wound infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0012 affected167 at risk EG0020 affected268 at risk
Wound infection staphylococcal	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0022 affected268 at risk
Alcohol poisoning	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Arterial injury	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Complications of transplanted heart	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0002 affected279 at risk EG0010 affected167 at risk EG0022 affected268 at risk
Contrast media reaction	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Dislocation of sternum	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Extradural haematoma	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0002 affected279 at risk EG0010 affected167 at risk EG0022 affected268 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0002 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0021 affected268 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Gastrointestinal anastomotic leak	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Incision site pain	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0003 affected279 at risk EG0012 affected167 at risk EG0020 affected268 at risk
Jaw fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Ligament rupture	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Post procedural complication	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Post procedural diarrhoea	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Post procedural discharge	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0012 affected167 at risk EG0021 affected268 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Post procedural swelling	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Post-traumatic pain	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Postoperative thoracic procedure complication	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0002 affected279 at risk EG0010 affected167 at risk EG0024 affected268 at risk
Postoperative wound complication	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Seroma	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0004 affected279 at risk EG0012 affected167 at risk EG0020 affected268 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0022 affected268 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0011 affected167 at risk EG0021 affected268 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0012 affected167 at risk EG0021 affected268 at risk
Atrial pressure increased	Investigations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Blood creatinine increased	Investigations	MedDRA 14.0	Systematic Assessment	EG0004 affected279 at risk EG0012 affected167 at risk EG0021 affected268 at risk
Blood potassium increased	Investigations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Blood pressure increased	Investigations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Catheterisation cardiac	Investigations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Cells in urine	Investigations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Central venous pressure increased	Investigations	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Culture wound positive	Investigations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Cytomegalovirus test positive	Investigations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0012 affected167 at risk EG0022 affected268 at risk
Ejection fraction decreased	Investigations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Haemoglobin decreased	Investigations	MedDRA 14.0	Systematic Assessment	EG0002 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Immunosuppressant drug level	Investigations	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Immunosuppressant drug level decreased	Investigations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Immunosuppressant drug level increased	Investigations	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Left ventricular end-diastolic pressure increased	Investigations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Liver function test abnormal	Investigations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Red blood cell count decreased	Investigations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Sputum culture positive	Investigations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Troponin increased	Investigations	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Weight increased	Investigations	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
White blood cell count decreased	Investigations	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0022 affected268 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0004 affected279 at risk EG0012 affected167 at risk EG0022 affected268 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0003 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Diabetic foot	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0006 affected279 at risk EG0016 affected167 at risk EG0026 affected268 at risk
Fluid retention	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Gout	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0022 affected268 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0003 affected279 at risk EG0011 affected167 at risk EG0021 affected268 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0012 affected167 at risk EG0024 affected268 at risk
Hypervolaemia	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0003 affected279 at risk EG0012 affected167 at risk EG0022 affected268 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0003 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected279 at risk EG0012 affected167 at risk EG0020 affected268 at risk
Metabolic disorder	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0013 affected167 at risk EG0024 affected268 at risk
Bone lesion	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Compartment syndrome	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Fistula	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Haemarthrosis	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Intervertebral disc compression	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0012 affected167 at risk EG0022 affected268 at risk
Mobility decreased	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0021 affected268 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Myopathy	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Osteochondrosis	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0012 affected167 at risk EG0020 affected268 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0011 affected167 at risk EG0021 affected268 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Spondylitis	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0004 affected279 at risk EG0013 affected167 at risk EG0022 affected268 at risk
Benign neoplasm of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Diffuse large B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Epstein-Barr virus associated lymphoproliferative disorder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0022 affected268 at risk
Haemangioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Ovarian cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0002 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Small cell lung cancer stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0012 affected167 at risk EG0021 affected268 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Amnesia	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Aphasia	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Ataxia	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Basal ganglia haemorrhage	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Brain injury	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Brain stem infarction	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Cerebral artery occlusion	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected279 at risk EG0012 affected167 at risk EG0021 affected268 at risk
Cerebral infarction	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected279 at risk EG0012 affected167 at risk EG0021 affected268 at risk
Cerebrovascular insufficiency	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Cognitive disorder	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Coma	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Convulsion	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0004 affected279 at risk EG0011 affected167 at risk EG0022 affected268 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Dizziness	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected279 at risk EG0013 affected167 at risk EG0022 affected268 at risk
Encephalopathy	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Grand mal convulsion	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Headache	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Hemiparesis	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Hypoxic-ischaemic encephalopathy	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Loss of consciousness	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0022 affected268 at risk
Migraine	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0012 affected167 at risk EG0021 affected268 at risk
Neurological symptom	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Paraesthesia	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0022 affected268 at risk
Polyneuropathy	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected279 at risk EG0011 affected167 at risk EG0024 affected268 at risk
Sciatica	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Syncope	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0005 affected279 at risk EG0011 affected167 at risk EG0026 affected268 at risk
Thalamic infarction	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0013 affected167 at risk EG0021 affected268 at risk
Tremor	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Abnormal behaviour	Psychiatric disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Alcohol abuse	Psychiatric disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Anxiety	Psychiatric disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0011 affected167 at risk EG0023 affected268 at risk
Confusional state	Psychiatric disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0022 affected268 at risk
Delirium	Psychiatric disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0012 affected167 at risk EG0021 affected268 at risk
Depression	Psychiatric disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0011 affected167 at risk EG0022 affected268 at risk
Drug abuse	Psychiatric disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Hallucination	Psychiatric disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Mental disorder	Psychiatric disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Mental status changes	Psychiatric disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0023 affected268 at risk
Suicide attempt	Psychiatric disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Azotaemia	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Calculus ureteric	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Haematuria	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Nephropathy toxic	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Nephrosclerosis	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Polyuria	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Proteinuria	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Renal failure	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG00010 affected279 at risk EG0010 affected167 at risk EG0023 affected268 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG00012 affected279 at risk EG00113 affected167 at risk EG00213 affected268 at risk
Renal failure chronic	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0012 affected167 at risk EG0020 affected268 at risk
Renal impairment	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0003 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Renal tubular necrosis	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Colpocele	Reproductive system and breast disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Epididymitis	Reproductive system and breast disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Oedema genital	Reproductive system and breast disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Apnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Bronchial haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0022 affected268 at risk
Chylothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected279 at risk EG0013 affected167 at risk EG0020 affected268 at risk
Diaphragmatic paralysis	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG00014 affected279 at risk EG0018 affected167 at risk EG0028 affected268 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0022 affected268 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0012 affected167 at risk EG0020 affected268 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0003 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0012 affected167 at risk EG0021 affected268 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Mediastinal haematoma	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Mediastinal mass	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Nasal polyps	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Orthopnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG00013 affected279 at risk EG0014 affected167 at risk EG0026 affected268 at risk
Pleural haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0005 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0005 affected279 at risk EG0014 affected167 at risk EG0022 affected268 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Pulmonary infarction	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Pulmonary toxicity	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0004 affected279 at risk EG0012 affected167 at risk EG0022 affected268 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Sputum discoloured	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Tracheal stenosis	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Blood blister	Skin and subcutaneous tissue disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Diabetic ulcer	Skin and subcutaneous tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Excessive granulation tissue	Skin and subcutaneous tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Rash macular	Skin and subcutaneous tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Subcutaneous emphysema	Skin and subcutaneous tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Incisional drainage	Surgical and medical procedures	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Angiodysplasia	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Arteriovenous fistula	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0003 affected279 at risk EG0012 affected167 at risk EG0023 affected268 at risk
Femoral artery aneurysm	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Flushing	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Haematoma	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Haemodynamic instability	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Hypertension	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0004 affected279 at risk EG0012 affected167 at risk EG0020 affected268 at risk
Hypertensive crisis	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Hypotension	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0003 affected279 at risk EG0015 affected167 at risk EG0024 affected268 at risk
Intermittent claudication	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Intra-abdominal haemorrhage	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Jugular vein thrombosis	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Lymphocele	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0005 affected279 at risk EG0011 affected167 at risk EG0021 affected268 at risk
Lymphoedema	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0011 affected167 at risk EG0020 affected268 at risk
Lymphorrhoea	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Malignant hypertension	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0022 affected268 at risk
Phlebitis	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Subclavian vein thrombosis	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0020 affected268 at risk
Thrombosis	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected279 at risk EG0010 affected167 at risk EG0021 affected268 at risk
Venous thrombosis limb	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected279 at risk EG0010 affected167 at risk EG0022 affected268 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 14.0	Systematic Assessment	EG000105 affected279 at risk EG00160 affected167 at risk EG00274 affected268 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 14.0	Systematic Assessment	EG00037 affected279 at risk EG00127 affected167 at risk EG00227 affected268 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 14.0	Systematic Assessment	EG00036 affected279 at risk EG00129 affected167 at risk EG00267 affected268 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 14.0	Systematic Assessment	EG0008 affected279 at risk EG0014 affected167 at risk EG00215 affected268 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 14.0	Systematic Assessment	EG00026 affected279 at risk EG00125 affected167 at risk EG00225 affected268 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG00020 affected279 at risk EG00113 affected167 at risk EG00222 affected268 at risk
Left ventricular hypertrophy	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG00016 affected279 at risk EG0015 affected167 at risk EG00212 affected268 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG00015 affected279 at risk EG0017 affected167 at risk EG00218 affected268 at risk
Palpitations	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG00012 affected279 at risk EG00114 affected167 at risk EG00214 affected268 at risk
Pericardial effusion	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG00093 affected279 at risk EG00151 affected167 at risk EG00269 affected268 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG00013 affected279 at risk EG0019 affected167 at risk EG0027 affected268 at risk
Tachycardia	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG00020 affected279 at risk EG00114 affected167 at risk EG00223 affected268 at risk
Tricuspid valve incompetence	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG00028 affected279 at risk EG00117 affected167 at risk EG00224 affected268 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG00011 affected279 at risk EG0018 affected167 at risk EG00217 affected268 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG00029 affected279 at risk EG00117 affected167 at risk EG00226 affected268 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG00017 affected279 at risk EG0019 affected167 at risk EG00217 affected268 at risk
Constipation	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG00070 affected279 at risk EG00142 affected167 at risk EG00263 affected268 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG00062 affected279 at risk EG00143 affected167 at risk EG00267 affected268 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG00017 affected279 at risk EG0019 affected167 at risk EG00216 affected268 at risk
Nausea	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG00064 affected279 at risk EG00152 affected167 at risk EG00272 affected268 at risk
Vomiting	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG00033 affected279 at risk EG00121 affected167 at risk EG00245 affected268 at risk
Asthenia	General disorders	MedDRA 14.0	Systematic Assessment	EG00016 affected279 at risk EG00112 affected167 at risk EG00221 affected268 at risk
Chills	General disorders	MedDRA 14.0	Systematic Assessment	EG00012 affected279 at risk EG00112 affected167 at risk EG00213 affected268 at risk
Fatigue	General disorders	MedDRA 14.0	Systematic Assessment	EG00039 affected279 at risk EG00122 affected167 at risk EG00250 affected268 at risk
Non-cardiac chest pain	General disorders	MedDRA 14.0	Systematic Assessment	EG00038 affected279 at risk EG00110 affected167 at risk EG00226 affected268 at risk
Oedema peripheral	General disorders	MedDRA 14.0	Systematic Assessment	EG000133 affected279 at risk EG00169 affected167 at risk EG002119 affected268 at risk
Pyrexia	General disorders	MedDRA 14.0	Systematic Assessment	EG00047 affected279 at risk EG00122 affected167 at risk EG00238 affected268 at risk
Heart transplant rejection	Immune system disorders	MedDRA 14.0	Systematic Assessment	EG0006 affected279 at risk EG0012 affected167 at risk EG00215 affected268 at risk
Bronchitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0007 affected279 at risk EG0017 affected167 at risk EG00215 affected268 at risk
Cytomegalovirus infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG00014 affected279 at risk EG0017 affected167 at risk EG00225 affected268 at risk
Herpes zoster	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0008 affected279 at risk EG0014 affected167 at risk EG00223 affected268 at risk
Nasopharyngitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG00035 affected279 at risk EG00112 affected167 at risk EG00232 affected268 at risk
Oral candidiasis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG00010 affected279 at risk EG0013 affected167 at risk EG00214 affected268 at risk
Oral herpes	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0007 affected279 at risk EG0019 affected167 at risk EG00215 affected268 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG00034 affected279 at risk EG00116 affected167 at risk EG00232 affected268 at risk
Urinary tract infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG00018 affected279 at risk EG00119 affected167 at risk EG00220 affected268 at risk
Incision site pain	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG00020 affected279 at risk EG00119 affected167 at risk EG00220 affected268 at risk
Post procedural discharge	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG00014 affected279 at risk EG0016 affected167 at risk EG0027 affected268 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG00035 affected279 at risk EG00124 affected167 at risk EG00232 affected268 at risk
Blood creatinine increased	Investigations	MedDRA 14.0	Systematic Assessment	EG00025 affected279 at risk EG00117 affected167 at risk EG00218 affected268 at risk
Blood triglycerides increased	Investigations	MedDRA 14.0	Systematic Assessment	EG00013 affected279 at risk EG0019 affected167 at risk EG0027 affected268 at risk
Cytomegalovirus test positive	Investigations	MedDRA 14.0	Systematic Assessment	EG0004 affected279 at risk EG0019 affected167 at risk EG00218 affected268 at risk
Haemoglobin decreased	Investigations	MedDRA 14.0	Systematic Assessment	EG00019 affected279 at risk EG0016 affected167 at risk EG00222 affected268 at risk
Weight increased	Investigations	MedDRA 14.0	Systematic Assessment	EG00014 affected279 at risk EG0015 affected167 at risk EG00215 affected268 at risk
White blood cell count decreased	Investigations	MedDRA 14.0	Systematic Assessment	EG00011 affected279 at risk EG00112 affected167 at risk EG00235 affected268 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG00010 affected279 at risk EG00111 affected167 at risk EG0028 affected268 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG00020 affected279 at risk EG0018 affected167 at risk EG00222 affected268 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG00047 affected279 at risk EG00130 affected167 at risk EG00243 affected268 at risk
Gout	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG00015 affected279 at risk EG0016 affected167 at risk EG0027 affected268 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG00038 affected279 at risk EG00122 affected167 at risk EG00223 affected268 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG00032 affected279 at risk EG00121 affected167 at risk EG00231 affected268 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG00034 affected279 at risk EG00117 affected167 at risk EG00234 affected268 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG00022 affected279 at risk EG0019 affected167 at risk EG00210 affected268 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG00041 affected279 at risk EG00123 affected167 at risk EG00230 affected268 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG00015 affected279 at risk EG00110 affected167 at risk EG00218 affected268 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG00039 affected279 at risk EG00125 affected167 at risk EG00232 affected268 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG00021 affected279 at risk EG00120 affected167 at risk EG00237 affected268 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG00023 affected279 at risk EG00113 affected167 at risk EG00230 affected268 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG00051 affected279 at risk EG00117 affected167 at risk EG00242 affected268 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG00041 affected279 at risk EG00121 affected167 at risk EG00236 affected268 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG00019 affected279 at risk EG0016 affected167 at risk EG00210 affected268 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG00016 affected279 at risk EG0014 affected167 at risk EG00213 affected268 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG00014 affected279 at risk EG0019 affected167 at risk EG00218 affected268 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG00024 affected279 at risk EG00111 affected167 at risk EG00218 affected268 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG00028 affected279 at risk EG0019 affected167 at risk EG00225 affected268 at risk
Dizziness	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG00037 affected279 at risk EG00119 affected167 at risk EG00227 affected268 at risk
Headache	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG00085 affected279 at risk EG00139 affected167 at risk EG00270 affected268 at risk
Paraesthesia	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG00023 affected279 at risk EG00110 affected167 at risk EG00217 affected268 at risk
Tremor	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG00058 affected279 at risk EG00133 affected167 at risk EG00260 affected268 at risk
Anxiety	Psychiatric disorders	MedDRA 14.0	Systematic Assessment	EG00041 affected279 at risk EG00122 affected167 at risk EG00235 affected268 at risk
Depression	Psychiatric disorders	MedDRA 14.0	Systematic Assessment	EG00027 affected279 at risk EG00114 affected167 at risk EG00226 affected268 at risk
Insomnia	Psychiatric disorders	MedDRA 14.0	Systematic Assessment	EG00077 affected279 at risk EG00132 affected167 at risk EG00260 affected268 at risk
Renal failure	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG00044 affected279 at risk EG00125 affected167 at risk EG00227 affected268 at risk
Renal impairment	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG00023 affected279 at risk EG0018 affected167 at risk EG00213 affected268 at risk
Erectile dysfunction	Reproductive system and breast disorders	MedDRA 14.0	Systematic Assessment	EG00016 affected279 at risk EG0016 affected167 at risk EG0029 affected268 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG00015 affected279 at risk EG0017 affected167 at risk EG00220 affected268 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG00067 affected279 at risk EG00123 affected167 at risk EG00251 affected268 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG00054 affected279 at risk EG00125 affected167 at risk EG00247 affected268 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG00013 affected279 at risk EG0019 affected167 at risk EG00216 affected268 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG00017 affected279 at risk EG00111 affected167 at risk EG0029 affected268 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG00014 affected279 at risk EG0019 affected167 at risk EG0029 affected268 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG00021 affected279 at risk EG0019 affected167 at risk EG00216 affected268 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG00065 affected279 at risk EG00137 affected167 at risk EG00257 affected268 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG00015 affected279 at risk EG0014 affected167 at risk EG0028 affected268 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG00015 affected279 at risk EG0015 affected167 at risk EG00210 affected268 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG00011 affected279 at risk EG00110 affected167 at risk EG00218 affected268 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA 14.0	Systematic Assessment	EG00023 affected279 at risk EG00118 affected167 at risk EG00228 affected268 at risk
Hirsutism	Skin and subcutaneous tissue disorders	MedDRA 14.0	Systematic Assessment	EG0008 affected279 at risk EG0019 affected167 at risk EG0026 affected268 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 14.0	Systematic Assessment	EG00015 affected279 at risk EG00117 affected167 at risk EG00217 affected268 at risk
Hypertension	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG000132 affected279 at risk EG00172 affected167 at risk EG002125 affected268 at risk
Hypotension	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG00023 affected279 at risk EG00113 affected167 at risk EG00227 affected268 at risk
Jugular vein thrombosis	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG00014 affected279 at risk EG0014 affected167 at risk EG0025 affected268 at risk

ID	Term
D000068338	Everolimus
D009173	Mycophenolic Acid
D016572	Cyclosporine
D000305	Adrenal Cortex Hormones

ID	Term
D020123	Sirolimus
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals
D002208	Caproates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D005227	Fatty Acids
D008055	Lipids
D003524	Cyclosporins
D010456	Peptides, Cyclic
D047028	Macrocyclic Compounds
D011083	Polycyclic Compounds
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists

ID	Title	Description
BG000	Everolimus 1.5 mg	Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
BG001	Everolimus 3.0 mg	Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
BG002	Mycophenolate Mofetil	Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Everolimus 1.5 mg	Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.	209	279	275	279
EG001	Everolimus 3.0 mg	Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.	119	167	165	167
EG002	Mycophenolate Mofetil	Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.	168	268	262	268