Study of Voreloxin (Vosaroxin) in Older Patients With Unt... | NCT00607997

Label	Type	Description	Intervention Names
All Study Patients	Experimental	Schedule A: 72 mg/m2 vosaroxin Days 1, 8 and 15 Schedule B: 72 mg/m2 vosaroxin on Days 1 and 8 Schedule C: 72 mg/m2 on Days 1 and 4, or Schedule C: 90 mg/m2 on Days 1 and 4	Drug: vosaroxin

Name	Type	Description	Arm Group Labels	Other Names
vosaroxin	Drug	Vosaroxin was administered by slow intravenous (IV) infusion or via syringe pump within 10 minutes.Patients could have completed up to 4 treatment cycles consisting of 1 or 2 induction treatment cycles and up to 2 consolidation treatment cycles. For Schedule A, an induction cycle was a minimum of 21 days during which patients received vosaroxin on Days 1, 8, and 15, followed by weekly observations until hematologic recovery for patients with aplastic marrow after the postinduction bone marrow assessment. For Schedules B and C, an induction cycle was a minimum of 15 days, during which patients received vosaroxin on Days 1 and 8 (Schedule B), or Days 1 and 4 (Schedule C), followed by the same weekly observations until hematologic recovery as for Schedule A.

Measure	Description	Time Frame
Remission Rate Defined as the Percentage of Patients Whose Respnse is CR or CRp Based on International Working Group (IWG) Response Criteria and Treatment Outcomes Definitions	Combined remission rate (complete remission [CR] + complete remission with incomplete platelet recovery [CRp]) of vosaroxin of patients ≥ 60 years old with previously untreated (de novo or secondary) AML are presented by treatment group for all treated analysis set. Per IWG criteria, a CR requires bone marrow blasts < 5%, absolute neutrophil count (ANC) > 1000 cells/uL, and platelet (plt) count > 100,000 plt/uL. The criteria for CRp are the same as those for CR, except for platelet count <= 100,000 lt/uL. Investigators were to determine a response category for each patient by examination of bone marrow and blood counts at the time of hematologic recovery after induction or reinduction. Investigator assessment categories included CR, CRp, CRi (Morphologic CR with incomplete blood count recovery), PR (partial remission), treatment failure, and relapse.	2 years

Measure	Description	Time Frame
Leukemia-free Survival (LFS)	The censor date was the last known alive date without report of relapse.	2 years
Overall Survival		2 years

Name	Affiliation	Role
Adam Craig, MD	Sunesis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic Hospital		Phoenix	Arizona	85054	United States
Mayo Clinic Scottsdale

PubMed Identifier	Type	Citation	Retractions
25403830	Derived	Stuart RK, Cripe LD, Maris MB, Cooper MA, Stone RM, Dakhil SR, Turturro F, Stock W, Mason J, Shami PJ, Strickland SA, Costa LJ, Borthakur G, Michelson GC, Fox JA, Leavitt RD, Ravandi F. REVEAL-1, a phase 2 dose regimen optimization study of vosaroxin in older poor-risk patients with previously untreated acute myeloid leukaemia. Br J Haematol. 2015 Mar;168(6):796-805. doi: 10.1111/bjh.13214. Epub 2014 Nov 17.

ID	Title	Description
FG000	Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15	The original Schedule A used a single arm Green Dahlberg design (Green 1992) with 30 patients planned to be treated in Stage I.
FG001	Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8

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

Remission Rate Defined as the Percentage of Patients Whose Respnse is CR or CRp Based on International Working Group (IWG) Response Criteria and Treatment Outcomes Definitions

Combined remission rate (complete remission [CR] + complete remission with incomplete platelet recovery [CRp]) of vosaroxin of patients ≥ 60 years old with previously untreated (de novo or secondary) AML are presented by treatment group for all treated analysis set.

Per IWG criteria, a CR requires bone marrow blasts < 5%, absolute neutrophil count (ANC) > 1000 cells/uL, and platelet (plt) count > 100,000 plt/uL. The criteria for CRp are the same as those for CR, except for platelet count <= 100,000 lt/uL. Investigators were to determine a response category for each patient by examination of bone marrow and blood counts at the time of hematologic recovery after induction or reinduction. Investigator assessment categories included CR, CRp, CRi (Morphologic CR with incomplete blood count recovery), PR (partial remission), treatment failure, and relapse.

The all treated analysis set Included all enrolled patients who received any amount of vosaroxin.

Posted

Number

95% Confidence Interval

percentage of patients

2 years

ID	Title	Description
OG000	Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15	The original Schedule A used a single arm Green Dahlberg design (Green 1992) with 30 patients planned to be treated in Stage I.
OG001	Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8	Schedule B was to use a single arm Green Dahlberg 2 stage design with 30 patients planned to be treated in Stage I and 25 patients in Stage II.
OG002	Schedule C: 72 mg/m2 on Days 1 and 4	Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
OG003	Schedule C: 90 mg/m2 on Days 1 and 4	Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.
OG004	Total	Schedule A, B and C combined

Units	Counts
Participants	OG00029 OG00135 OG00229 OG003

Title

Denominators

Categories

Title	Measurements
	OG00041.4(23.5 to 61.1) OG00125.7(12.5 to 43.3) OG00234.5(17.9 to 54.3) OG003

Secondary

Leukemia-free Survival (LFS)

The censor date was the last known alive date without report of relapse.

All treated analysis set

Posted

Median

95% Confidence Interval

Months

2 years

ID	Title	Description
OG000	Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15	The original Schedule A used a single arm Green Dahlberg design (Green 1992) with 30 patients planned to be treated in Stage I.
OG001	Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8	Schedule B was to use a single arm Green Dahlberg 2 stage design with 30 patients planned to be treated in Stage I and 25 patients in Stage II.
OG002	Schedule C: 72 mg/m2 on Days 1 and 4	Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
OG003	Schedule C: 90 mg/m2 on Days 1 and 4	Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.

Secondary

Overall Survival

All treated patients

Posted

Median

95% Confidence Interval

Months

2 years

ID	Title	Description
OG000	Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15	The original Schedule A used a single arm Green Dahlberg design (Green 1992) with 30 patients planned to be treated in Stage I.
OG001	Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8	Schedule B was to use a single arm Green Dahlberg 2 stage design with 30 patients planned to be treated in Stage I and 25 patients in Stage II.
OG002	Schedule C: 72 mg/m2 on Days 1 and 4	Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
OG003	Schedule C: 90 mg/m2 on Days 1 and 4	Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.
OG004

Secondary

Pharmacokinetics Day 1 - Cmax (ng/mL)

Pharmacokinetic Parameters (Cmax) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 1

Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. The standard deviation is really CV% in the table.

Patients Treated with Vosaroxin as a Single Agent (SPO-0014) on Day 1. Of 113 patients treated, PK data were available for 33 patients who received at least 1 dose of vosaroxin, PK profiles were evaluated for 10 patients in Schedule A, for 9 patients in Schedule B, for 6 patients in Schedule C, and for 8 patients in Schedule C.

Posted

Mean

Standard Deviation

ng/mL

1 Day

ID	Title	Description
OG000	Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15	The original Schedule A used a single arm Green Dahlberg design (Green 1992) with 30 patients planned to be treated in Stage I.
OG001	Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8	Schedule B was to use a single arm Green Dahlberg 2 stage design with 30 patients planned to be treated in Stage I and 25 patients in Stage II.
OG002	Schedule C: 72 mg/m2 on Days 1 and 4	Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose

Secondary

Pharmacokinetics Day 4 Cmax (ng/mL)

Pharmacokinetic Parameters by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) on Day 4

Please note that N, mean and CV% are reported, but CV% is not an option in the drop down menu. So Standard Deviation is really CV% in the table.

Patients Treated with Vosaroxin as a Single Agent (SPO-0014) Day 4. Of 113 patients treated, PK data were available for 33 patients who received at least 1 dose of vosaroxin, PK profiles were evaluated for patients with data on Day 4 for 5 patients in Schedule C, and for 8 patients in Schedule C .

Posted

Mean

Standard Deviation

ng/mL

Day 4

ID	Title	Description
OG000	Schedule C: 72 mg/m2 on Days 1 and 4	Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
OG001	Schedule C: 90 mg/m2 on Days 1 and 4	Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.

Units	Counts
Participants

Secondary

All Cause Mortality

Mortality of those patients enrolled in the study and receiving intervention

All treated analysis set

Posted

Count of Participants

Participants

30 and 60 days

ID	Title	Description
OG000	Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15	The original Schedule A used a single arm Green Dahlberg design (Green 1992) with 30 patients planned to be treated in Stage I.
OG001	Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8	Schedule B was to use a single arm Green Dahlberg 2 stage design with 30 patients planned to be treated in Stage I and 25 patients in Stage II.
OG002	Schedule C: 72 mg/m2 on Days 1 and 4	Schedule C (implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
OG003	Schedule C: 90 mg/m2 on Days 1 and 4	Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.

Secondary

Pharmacokinetics Day 1 - AUC0-72 and AUCinf (hr*ng/mL)

Pharmacokinetic Parameters (AUC0-72 and AUCinf ) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 1

Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. The standard deviation is really CV% in the table.

Posted

Mean

Standard Deviation

hr*ng/mL

1 Day

ID	Title	Description
OG000	Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15	The original Schedule A used a single arm Green Dahlberg design (Green 1992) with 30 patients planned to be treated in Stage I.
OG001	Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8	Schedule B was to use a single arm Green Dahlberg 2 stage design with 30 patients planned to be treated in Stage I and 25 patients in Stage II.
OG002	Schedule C: 72 mg/m2 on Days 1 and 4

Secondary

Pharmacokinetics Day 1 - t1/2 (hr) and MRTinf (hr)

Pharmacokinetic Parameters (t1/2 and and MRTinf) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 1

Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. The standard deviation is really CV% in the table.

Patients Treated with Vosaroxin as a Single Agent (SPO-0014) on Day 1. Of 113 patients treated, PK data were available for 33 patients who received at least 1 dose of vosaroxin, PK profiles were evaluated for 10 patients in Schedule A, for 8 patients in Schedule B, for 6 patients in Schedule C, and for 8 patients in Schedule C.

Posted

Mean

Standard Deviation

1 Day

ID	Title	Description
OG000	Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15	The original Schedule A used a single arm Green Dahlberg design (Green 1992) with 30 patients planned to be treated in Stage I.
OG001	Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8	Schedule B was to use a single arm Green Dahlberg 2 stage design with 30 patients planned to be treated in Stage I and 25 patients in Stage II.
OG002	Schedule C: 72 mg/m2 on Days 1 and 4

Secondary

Pharmacokinetics Day 1 - CL (L/hr)

Pharmacokinetic Parameters (CL) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 1

Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. The standard deviation is really CV% in the table.

Patients Treated with Vosaroxin as a Single Agent (SPO-0014) on Day 1. Of 113 patients treated, PK data were available for 33 patients who received at least 1 dose of vosaroxin, PK profiles were evaluated for 10 patients in Schedule A, for 8 patients in Schedule B, for 6 patients in Schedule C, and for 8 patients in Schedule C.

Posted

Mean

Standard Deviation

L/hr

1 Day

ID	Title	Description
OG000	Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15	The original Schedule A used a single arm Green Dahlberg design (Green 1992) with 30 patients planned to be treated in Stage I.
OG001	Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8	Schedule B was to use a single arm Green Dahlberg 2 stage design with 30 patients planned to be treated in Stage I and 25 patients in Stage II.
OG002	Schedule C: 72 mg/m2 on Days 1 and 4	Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose

Secondary

Pharmacokinetics Day 1 - Vss (L)

Pharmacokinetic Parameters (Vss ) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 1

Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. The standard deviation is really CV% in the table.

Patients Treated with Vosaroxin as a Single Agent (SPO-0014) on Day 1. Of 113 patients treated, PK data were available for 33 patients who received at least 1 dose of vosaroxin, PK profiles were evaluated for 10 patients in Schedule A, for 8 patients in Schedule B, for 6 patients in Schedule C, and for 8 patients in Schedule C.

Posted

Mean

Standard Deviation

1 Day

ID	Title	Description
OG000	Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15	The original Schedule A used a single arm Green Dahlberg design (Green 1992) with 30 patients planned to be treated in Stage I.
OG001	Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8	Schedule B was to use a single arm Green Dahlberg 2 stage design with 30 patients planned to be treated in Stage I and 25 patients in Stage II.
OG002	Schedule C: 72 mg/m2 on Days 1 and 4	Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose

Secondary

Pharmacokinetics Day 4 - AUC0-72 and AUCinf (hr*ng/mL)

Pharmacokinetic Parameters (AUC0-72 and AUCinf ) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 4

Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. Standard Deviation is really CV% in the table.

Patients Treated with Vosaroxin as a Single Agent (SPO-0014) on Day 4. Of 113 patients treated, PK data were available for 33 patients who received at least 1 dose of vosaroxin, PK profiles were evaluated for patients with data on Day 4, for 5 patients in Schedule C, and for 8 patients in Schedule C.

Posted

Mean

Standard Deviation

hr*ng/mL

Day 4

ID	Title	Description
OG000	Schedule C: 72 mg/m2 on Days 1 and 4	Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
OG001	Schedule C: 90 mg/m2 on Days 1 and 4	Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.

Units	Counts

Secondary

Pharmacokinetics Day 4 - t1/2 (hr) and MRTinf (hr)

Pharmacokinetic Parameters (t1/2 and and MRTinf) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 4

Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. The Standard Deviation is really CV% in the table.

Patients Treated with Vosaroxin as a Single Agent (SPO-0014) on Day 4. Of 113 patients treated, PK data were available for 33 patients who received at least 1 dose of vosaroxin, PK profiles were evaluated for patients with data, for 5 patients in Schedule C, and for 7 patients in Schedule C.

Posted

Mean

Standard Deviation

Day 4

ID	Title	Description
OG000	Schedule C: 72 mg/m2 on Days 1 and 4	Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
OG001	Schedule C: 90 mg/m2 on Days 1 and 4	Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.

Units	Counts

Secondary

Pharmacokinetics Day 4 - CL (L/hr)

Pharmacokinetic Parameters (CL) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 4

Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. The standard deviation is really CV% in the table.

Posted

Mean

Standard Deviation

L/hr

Day 4

ID	Title	Description
OG000	Schedule C: 72 mg/m2 on Days 1 and 4	Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
OG001	Schedule C: 90 mg/m2 on Days 1 and 4	Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.

Units	Counts

Secondary

Pharmacokinetics Day 4 - Vss (L)

Pharmacokinetic Parameters (Vss ) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 4

Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. The standard deviation is really CV% in the table.

Patients Treated with Vosaroxin as a Single Agent (SPO-0014) on Day 4. Of 113 patients treated, PK data were available for 33 patients who received at least 1 dose of vosaroxin, PK profiles were evaluated for patients with data for Day 4, for 5 patients in Schedule C, and for 7 patients in Schedule C.

Posted

Mean

Standard Deviation

Day 4

ID	Title	Description
OG000	Schedule C: 72 mg/m2 on Days 1 and 4	Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
OG001	Schedule C: 90 mg/m2 on Days 1 and 4	Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Disseminated Intravascular Coagulation	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG0030 affected20 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0006 affected29 at risk EG0016 affected35 at risk EG0026 affected29 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Pancytopenia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0021 affected29 at risk EG003
Cardio-Respiratory arrest	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Cardiomyopathy	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Myocardial ischaemia	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Ventricular extrasystoles	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0012 affected35 at risk EG0021 affected29 at risk EG003
Intestinal functional disorder	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Neutropenic colitis	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Oesophagitis	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected29 at risk EG0013 affected35 at risk EG0022 affected29 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Death	General disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Multi-Organ failure	General disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Non-Cardiac chest pain	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Pyrexia	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Bile duct obstruction	Hepatobiliary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Bacteraemia	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0002 affected29 at risk EG0013 affected35 at risk EG0022 affected29 at risk EG003
Cellulitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Cellulitis orbital	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Clostridium difficile colitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Enterococcal bacteraemia	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Escherichia bacteraemia	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Neutropenic sepsis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0021 affected29 at risk EG003
Perirectal abscess	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Pneumonia	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0005 affected29 at risk EG00111 affected35 at risk EG0027 affected29 at risk EG003
Pneumonia fungal	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Pseudomonal bacteraemia	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Pseudomonal sepsis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0002 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Sepsis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0013 affected35 at risk EG0022 affected29 at risk EG003
Septic shock	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Sinusitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Sinusitis fungal	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Staphylococcal bacteraemia	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0002 affected29 at risk EG0011 affected35 at risk EG0021 affected29 at risk EG003
Staphylococcal infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Staphylococcal sepsis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Streptococcal bacteraemia	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Streptococcal sepsis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
subdural haemorrhage	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0012 affected35 at risk EG0020 affected29 at risk EG003
Therapeutic agent toxicity	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Ejection fraction decreased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0022 affected29 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Failure to thrive	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Fluid overload	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Myositis	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Leukaemia recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Tumour lysis syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0021 affected29 at risk EG003
Convulsion	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Grand mal convulsion	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Confusional state	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Suicidal ideation	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Renal failure acute	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected29 at risk EG0011 affected35 at risk EG0021 affected29 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0012 affected35 at risk EG0020 affected29 at risk EG003
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0011 affected35 at risk EG0021 affected29 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG00012 affected29 at risk EG00119 affected35 at risk EG00219 affected29 at risk EG00312 affected20 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0014 affected35 at risk EG0022 affected29 at risk EG003
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG00010 affected29 at risk EG00119 affected35 at risk EG00214 affected29 at risk EG003
Hilar lymphadenopathy	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected29 at risk EG0015 affected35 at risk EG0020 affected29 at risk EG003
Lymph node calcification	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Lymphadenopathy mediastinal	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Microcytic anaemia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG00012 affected29 at risk EG0019 affected35 at risk EG0028 affected29 at risk EG003
Pancytopenia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Splenomegaly	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0021 affected29 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG00012 affected29 at risk EG00124 affected35 at risk EG00220 affected29 at risk EG003
Acute myocardial infraction	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0011 affected35 at risk EG0024 affected29 at risk EG003
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0004 affected29 at risk EG0014 affected35 at risk EG0026 affected29 at risk EG003
Atrial flutter	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Atrioventricular block	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Bradycardia	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0022 affected29 at risk EG003
Bundle branch block	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Bundle branch block left	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Cardiac disorder	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected29 at risk EG0011 affected35 at risk EG0022 affected29 at risk EG003
Cardiomegaly	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Left ventricular failure	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0022 affected29 at risk EG003
Mitral valve Disease	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Mitral valve incompetence	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Myocardial infraction	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Palpitations	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0022 affected29 at risk EG003
Pericardial cyst	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Pericardial effusion	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0011 affected35 at risk EG0021 affected29 at risk EG003
Pericarditis	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Sinus bradycardia	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Sinus Tachycardia	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0015 affected35 at risk EG0023 affected29 at risk EG003
Supraventricular extrasystoles	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Supraventricular Tachycardia	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Tachycardia	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG00011 affected29 at risk EG00114 affected35 at risk EG0025 affected29 at risk EG003
Tricuspid valve incompetence	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Ventricular arrhythmia	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Ventricular extrasystoles	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0011 affected35 at risk EG0021 affected29 at risk EG003
Spondylolisthesis	Congenital, familial and genetic disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Cerumen impaction	Ear and labyrinth disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Deafness bilateral	Ear and labyrinth disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Ear congestion	Ear and labyrinth disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Ear pain	Ear and labyrinth disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Eustachian tube patulous	Ear and labyrinth disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Tinnitus	Ear and labyrinth disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Conjunctival discolouration	Eye disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Conjunctival haemorrhage	Eye disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Conjunctivitis	Eye disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Dry eye	Eye disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0011 affected35 at risk EG0021 affected29 at risk EG003
Erythema of eyelid	Eye disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Eye haemorrhage	Eye disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Eye Oedema	Eye disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Eye Pruritus	Eye disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Eyelid disorder	Eye disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Eyelid oedema	Eye disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Eyelid ptosis	Eye disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0021 affected29 at risk EG003
Lacrimation increased	Eye disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Madarosis	Eye disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Ocular hyperaemia	Eye disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Ocular icterus	Eye disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Retinal haemorrhage	Eye disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Vision blurred	Eye disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Visual disturbance	Eye disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Vitreous detachment	Eye disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0021 affected29 at risk EG003
Vitreous floaters	Eye disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0011 affected35 at risk EG0022 affected29 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected29 at risk EG0015 affected35 at risk EG0025 affected29 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0009 affected29 at risk EG0016 affected35 at risk EG0026 affected29 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0015 affected35 at risk EG0020 affected29 at risk EG003
Abdominal tenderness	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Anorectal disorder	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Aptyalism	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Bowel sounds abnormal	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0013 affected35 at risk EG0020 affected29 at risk EG003
Breath odour	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Caecitis	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Chapped lips	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0013 affected35 at risk EG0020 affected29 at risk EG003
Colonic Pseudo-obstruction	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG00012 affected29 at risk EG00113 affected35 at risk EG0025 affected29 at risk EG003
Dental discomfort	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG00024 affected29 at risk EG00127 affected35 at risk EG00220 affected29 at risk EG003
Diverticulum	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0006 affected29 at risk EG0015 affected35 at risk EG0024 affected29 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0005 affected29 at risk EG0013 affected35 at risk EG0026 affected29 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0005 affected29 at risk EG0019 affected35 at risk EG0026 affected29 at risk EG003
Enlarged uvula	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Enterocolitis	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Faecal incontinence	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0013 affected35 at risk EG0020 affected29 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected29 at risk EG0012 affected35 at risk EG0020 affected29 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Gingival bleeding	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Gingival disorder	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Gingival pain	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0015 affected35 at risk EG0020 affected29 at risk EG003
Gingival swelling	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Gingivitis	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Glossitis	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Glossodynia	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Haematochezia	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0005 affected29 at risk EG0017 affected35 at risk EG0022 affected29 at risk EG003
Hiatus Hernia	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0021 affected29 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Ileus paralytic	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Inguinal Hernia	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Leukoplakia oral	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Lip blister	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Lip disorder	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Lip dry	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected29 at risk EG0011 affected35 at risk EG0021 affected29 at risk EG003
Lip haemorrhage	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Lip pain	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Lip ulceration	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Malabsorption	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Melaena	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0013 affected35 at risk EG0020 affected29 at risk EG003
Mouth haemorrhage	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0012 affected35 at risk EG0020 affected29 at risk EG003
Mouth ulceration	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG00022 affected29 at risk EG00121 affected35 at risk EG00225 affected29 at risk EG003
Odynophagia	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0004 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Oedema mouth	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Oesophageal disorder	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Oesophageal Spasm	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Oesophageal stenosis	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Oesophagitis	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0021 affected29 at risk EG003
Oral discomfort	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Oral mucosal blistering	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Oral mucosal discolouration	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Oral mucosal petechiae	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Oral pain	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected29 at risk EG0015 affected35 at risk EG0025 affected29 at risk EG003
Oral soft tissue disorder	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Palatal disorder	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Perianal erythema	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0023 affected29 at risk EG003
Periodontal disease	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Poor dental condition	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Proctalgia	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0011 affected35 at risk EG0023 affected29 at risk EG003
Rectal fissure	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Rectal spasm	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Retching	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Salivary gland disorder	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Salivary hypersecretion	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG00018 affected29 at risk EG00119 affected35 at risk EG00215 affected29 at risk EG003
Tongue blistering	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Tongue discolouration	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Tongue haematoma	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Tongue haemorrhage	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Tongue oedema	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0011 affected35 at risk EG0021 affected29 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG00016 affected29 at risk EG00110 affected35 at risk EG00215 affected29 at risk EG003
Application site hypersensitivity	General disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Asthenia	General disorders	MedDRA (10.0)	Systematic Assessment	EG0009 affected29 at risk EG00114 affected35 at risk EG0026 affected29 at risk EG003
Axillary pain	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Catheter related complication	General disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected29 at risk EG0011 affected35 at risk EG0023 affected29 at risk EG003
Catheter site erythema	General disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0013 affected35 at risk EG0021 affected29 at risk EG003
Catheter site excoriation	General disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Catheter site haematoma	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Catheter site haemorrhage	General disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Catheter site inflammation	General disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Catheter site oedema	General disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Catheter site pain	General disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0013 affected35 at risk EG0025 affected29 at risk EG003
Catheter site related reaction	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0022 affected29 at risk EG003
Catheter Thrombosis	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Chest discomfort	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Chest pain	General disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected29 at risk EG0013 affected35 at risk EG0024 affected29 at risk EG003
Chills	General disorders	MedDRA (10.0)	Systematic Assessment	EG0008 affected29 at risk EG00112 affected35 at risk EG0028 affected29 at risk EG003
Discomfort	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Early Satiety	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Face Oedema	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Facial pain	General disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Fatigue	General disorders	MedDRA (10.0)	Systematic Assessment	EG00015 affected29 at risk EG00120 affected35 at risk EG00212 affected29 at risk EG003
Feeling cold	General disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Gait disturbance	General disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0012 affected35 at risk EG0020 affected29 at risk EG003
Generalized oedema	General disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0014 affected35 at risk EG0021 affected29 at risk EG003
Induration	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0022 affected29 at risk EG003
Infusion site pain	General disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Injection site bruising	General disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Injection site reaction	General disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Malaise	General disorders	MedDRA (10.0)	Systematic Assessment	EG0006 affected29 at risk EG0012 affected35 at risk EG0022 affected29 at risk EG003
Mucosal Inflammation	General disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0012 affected35 at risk EG0020 affected29 at risk EG003
Mucous membrane disorder	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Multi-Organ failure	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Nodule	General disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Non-Cardiac chest pain	General disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0011 affected35 at risk EG0022 affected29 at risk EG003
Oedema	General disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Oedema peripheral	General disorders	MedDRA (10.0)	Systematic Assessment	EG00017 affected29 at risk EG00117 affected35 at risk EG00215 affected29 at risk EG003
Pain	General disorders	MedDRA (10.0)	Systematic Assessment	EG0005 affected29 at risk EG0012 affected35 at risk EG0027 affected29 at risk EG003
Performance status decreased	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Peripheral coldness	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0022 affected29 at risk EG003
Pyrexia	General disorders	MedDRA (10.0)	Systematic Assessment	EG0005 affected29 at risk EG0019 affected35 at risk EG0027 affected29 at risk EG003
Suprapubic pain	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Swelling	General disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Tenderness	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Jaundice	Hepatobiliary disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Abscess	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Acinetobacter bacteraemia	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Anorectal infection bacterial	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0022 affected29 at risk EG003
Bacteraemia	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0002 affected29 at risk EG0013 affected35 at risk EG0020 affected29 at risk EG003
Bacterial infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Bacteroides bacteraemia	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Bronchiolitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Bronchitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Candidiasis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0003 affected29 at risk EG0014 affected35 at risk EG0021 affected29 at risk EG003
Catheter related infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Catheter site cellulitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Catheter site infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Cellulitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0002 affected29 at risk EG0012 affected35 at risk EG0021 affected29 at risk EG003
Central line infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Chronic Sinusitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Clostridial infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0021 affected29 at risk EG003
Clostridium difficile colitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Diverticulitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0002 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Enterococcal bacteraemia	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0003 affected29 at risk EG0013 affected35 at risk EG0020 affected29 at risk EG003
Enterococcal infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0002 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Epiglottitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Folliculitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0022 affected29 at risk EG003
Fungaemia	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Fungal infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0022 affected29 at risk EG003
Fungal rash	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Fusarium infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Gingival infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Herpes simplex	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0002 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Herpes zoster	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Lobar pneumonia	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Localized infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Lung infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0021 affected29 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0022 affected29 at risk EG003
Oral Candidiasis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0021 affected29 at risk EG003
Oral fungal infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Parotitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Pharyngitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Pneumonia	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0005 affected29 at risk EG0013 affected35 at risk EG0024 affected29 at risk EG003
Pneumonia fungal	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Pseudomonal sepsis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Pseudomonas infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Rectal abscess	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Rhinitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Sinusitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0011 affected35 at risk EG0022 affected29 at risk EG003
Skin infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Staphylococcal bacteraemia	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0003 affected29 at risk EG0013 affected35 at risk EG0021 affected29 at risk EG003
Staphylococcal infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Stenotrophomonas infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Tooth abscess	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0011 affected35 at risk EG0021 affected29 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0002 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Urinary tract infection enterococcal	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0002 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Urinary tract infection fungal	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Urinary tract infection pseudomonal	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Urinary tract infection staphylococcal	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Vaginal candidiasis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Allergic transfusion reaction	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Anaphylactic transfusion reaction	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0003 affected29 at risk EG0012 affected35 at risk EG0022 affected29 at risk EG003
Excoriation	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0023 affected29 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0003 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Head injury	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Incision site erythema	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Incision site haemorrhage	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Injury	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Joint Injury	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Post procedural complication	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0015 affected35 at risk EG0023 affected29 at risk EG003
Skin injury	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Skin laceration	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0003 affected29 at risk EG0012 affected35 at risk EG0020 affected29 at risk EG003
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Tooth fracture	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Tracheal deviation	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Transfusion reaction	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0003 affected29 at risk EG0011 affected35 at risk EG0023 affected29 at risk EG003
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Wound	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0002 affected29 at risk EG0012 affected35 at risk EG0022 affected29 at risk EG003
Wound complication	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0012 affected35 at risk EG0020 affected29 at risk EG003
Bacteria sputum identified	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0012 affected35 at risk EG0020 affected29 at risk EG003
Bacteria urine identified	Investigations	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Bacterial culture positive	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Blood creatinine increased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0003 affected29 at risk EG0013 affected35 at risk EG0020 affected29 at risk EG003
Blood culture positive	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Blood glucose increased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Blood lactate dehydrogenase increased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Blood testosterone decreased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Blood urea increased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Blood uric acid increased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Body temperature decreased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Breath sounds abnormal	Investigations	MedDRA (10.0)	Systematic Assessment	EG0007 affected29 at risk EG0016 affected35 at risk EG0023 affected29 at risk EG003
C-Reactive protein increased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Cardiac murmur	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0014 affected35 at risk EG0020 affected29 at risk EG003
Chest x-ray abnormal	Investigations	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0012 affected35 at risk EG0021 affected29 at risk EG003
Clostridium difficile toxin test positive	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Culture urine positive	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Ejection fraction decreased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0002 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Electrocardiogram qrs complex abnormal	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Electrocardiogram qt corrected interval prolonged	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Electrocardiogram qt prolonged	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Electrocardiogram st segment abnormal	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Electrocardiogram st segment depression	Investigations	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Electrocardiogram st-t change	Investigations	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Electrocardiogram st-t segment abnormal	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Electrocardiogram t wave abnormal	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Electrocardiogram t wave inversion	Investigations	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Heart rate irregular	Investigations	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Helicobacter pylori identification test positive	Investigations	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Hepatic enzyme increased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Hepatitis a antibody positive	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
International normalised ratio increased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0004 affected29 at risk EG0012 affected35 at risk EG0022 affected29 at risk EG003
Liver function test abnormal	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0021 affected29 at risk EG003
Liver scan abnormal	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Lymph node palpable	Investigations	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Nuclear magnetic resonance imaging brain abnormal	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Oxygen consumption increased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Oxygen saturation decreased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0012 affected35 at risk EG0021 affected29 at risk EG003
Prostate examination abnormal	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0022 affected29 at risk EG003
Prothrombin level increased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Prothrombin time prolonged	Investigations	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Pulse pressure decreased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0012 affected35 at risk EG0021 affected29 at risk EG003
Pulse pressure increased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Radial pulse abnormal	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0012 affected35 at risk EG0020 affected29 at risk EG003
Respiratory rate increased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Skin turgor decreased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0014 affected35 at risk EG0020 affected29 at risk EG003
Sputum culture positive	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Transaminases increased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0012 affected35 at risk EG0020 affected29 at risk EG003
Troponin i increased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Urine analysis abnormal	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Urine colour abnormal	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0012 affected35 at risk EG0020 affected29 at risk EG003
Urine output decreased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Weight decreased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0006 affected29 at risk EG0013 affected35 at risk EG0023 affected29 at risk EG003
Weight increased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
White blood cell count decreased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
X-Ray abnormal	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Xanthochromia	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Acidosis	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Anorexia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG00021 affected29 at risk EG00118 affected35 at risk EG00217 affected29 at risk EG003
Cachexia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0014 affected35 at risk EG0022 affected29 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0007 affected29 at risk EG0017 affected35 at risk EG0023 affected29 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Diabetes mellitus insulin-dependent	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Fluid retention	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Fluid overload	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected29 at risk EG0013 affected35 at risk EG0024 affected29 at risk EG003
Gout	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected29 at risk EG0017 affected35 at risk EG0026 affected29 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0013 affected35 at risk EG0021 affected29 at risk EG003
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Hypermagnesaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Hypernatraemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Hyperphosphataemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected29 at risk EG0014 affected35 at risk EG0022 affected29 at risk EG003
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0022 affected29 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0011 affected35 at risk EG0021 affected29 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0008 affected29 at risk EG0015 affected35 at risk EG0029 affected29 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0012 affected35 at risk EG0021 affected29 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG00021 affected29 at risk EG00119 affected35 at risk EG00217 affected29 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG00015 affected29 at risk EG00114 affected35 at risk EG00214 affected29 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected29 at risk EG0016 affected35 at risk EG0022 affected29 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG00013 affected29 at risk EG0018 affected35 at risk EG0026 affected29 at risk EG003
Hypovolaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Malnutrition	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected29 at risk EG0012 affected35 at risk EG0021 affected29 at risk EG003
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Oral intake reduced	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected29 at risk EG0015 affected35 at risk EG0024 affected29 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0005 affected29 at risk EG0017 affected35 at risk EG0025 affected29 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0011 affected35 at risk EG0022 affected29 at risk EG003
Chondrocalcinosis pyrophosphate	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0012 affected35 at risk EG0020 affected29 at risk EG003
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Joint range of motion decreased	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Joint stiffness	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0022 affected29 at risk EG003
Limb discomfort	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0004 affected29 at risk EG0014 affected35 at risk EG0023 affected29 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected29 at risk EG0012 affected35 at risk EG0023 affected29 at risk EG003
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0004 affected29 at risk EG0015 affected35 at risk EG0024 affected29 at risk EG003
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected29 at risk EG0014 affected35 at risk EG0022 affected29 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0012 affected35 at risk EG0021 affected29 at risk EG003
Osteitis	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Osteopenia	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Osteosclerosis	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0004 affected29 at risk EG0015 affected35 at risk EG0027 affected29 at risk EG003
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0022 affected29 at risk EG003
Scoliosis	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Spondylolysis	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Temporomandibular joint syndrome	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Tumour lysis syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Ageusia	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Aphasia	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Carotid artery occlusion	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Cerebral ischaemia	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Convulsion	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Coordination abnormal	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Dizziness	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0006 affected29 at risk EG0017 affected35 at risk EG0027 affected29 at risk EG003
Dysarthria	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0004 affected29 at risk EG0015 affected35 at risk EG0023 affected29 at risk EG003
Encephalopathy	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Extrapyramidal disorder	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Headache	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG00010 affected29 at risk EG0019 affected35 at risk EG0029 affected29 at risk EG003
Hemiparesis	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Hypogeusia	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0022 affected29 at risk EG003
Hyporeflexia	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Hyposmia	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Intention tremor	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Lethargy	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0012 affected35 at risk EG0024 affected29 at risk EG003
Memory impairment	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Nervous system disorder	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Neuralgia	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Neuropathy	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0011 affected35 at risk EG0022 affected29 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Parosmia	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Periventricular leukomalacia	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Restless legs syndrome	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Somnolence	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0004 affected29 at risk EG0014 affected35 at risk EG0022 affected29 at risk EG003
Speech disorder	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0012 affected35 at risk EG0020 affected29 at risk EG003
Syncope	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0012 affected35 at risk EG0020 affected29 at risk EG003
Syncope vasovagal	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Tremor	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0012 affected35 at risk EG0022 affected29 at risk EG003
Agitation	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0006 affected29 at risk EG0010 affected35 at risk EG0024 affected29 at risk EG003
Anxiety	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0007 affected29 at risk EG00114 affected35 at risk EG00212 affected29 at risk EG003
Apathy	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Confusional state	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0008 affected29 at risk EG0019 affected35 at risk EG0027 affected29 at risk EG003
Delirium	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Delusion	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Depressed mood	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Depression	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0005 affected29 at risk EG0015 affected35 at risk EG0026 affected29 at risk EG003
Disorientation	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0021 affected29 at risk EG003
Dysthymic disorder	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Flat affect	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Hallucination	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Insomnia	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG00012 affected29 at risk EG00113 affected35 at risk EG00211 affected29 at risk EG003
Mental disorder	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Mental status changes	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0013 affected35 at risk EG0022 affected29 at risk EG003
Mood altered	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Psychotic disorder	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Restlessness	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected29 at risk EG0013 affected35 at risk EG0020 affected29 at risk EG003
Suicidal ideation	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Bladder diverticulum	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Bladder pain	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Bladder spasm	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0004 affected29 at risk EG00111 affected35 at risk EG0022 affected29 at risk EG003
Haemorrhage urinary tract	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Incontinence	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected29 at risk EG0013 affected35 at risk EG0020 affected29 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0022 affected29 at risk EG003
Nocturia	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0011 affected35 at risk EG0021 affected29 at risk EG003
Oliguria	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected29 at risk EG0011 affected35 at risk EG0022 affected29 at risk EG003
Renal cyst	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0021 affected29 at risk EG003
Renal failure acute	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0013 affected35 at risk EG0022 affected29 at risk EG003
Renal mass	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Residual urine	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Stress urinary incontinence	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Urinary incontinence	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected29 at risk EG0014 affected35 at risk EG0021 affected29 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Breast pain	Reproductive system and breast disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Pelvic fluid collection	Reproductive system and breast disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Penile oedema	Reproductive system and breast disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Penile pain	Reproductive system and breast disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Scrotal erythema	Reproductive system and breast disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Scrotal oedema	Reproductive system and breast disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Vulval disorder	Reproductive system and breast disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Vulvovaginal pruritus	Reproductive system and breast disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected29 at risk EG0014 affected35 at risk EG0025 affected29 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG00013 affected29 at risk EG00111 affected35 at risk EG00211 affected29 at risk EG003
Diaphragmalgia	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0012 affected35 at risk EG0021 affected29 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG00011 affected29 at risk EG00114 affected35 at risk EG00211 affected29 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Epiglottic oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0007 affected29 at risk EG00113 affected35 at risk EG0028 affected29 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected29 at risk EG0018 affected35 at risk EG0022 affected29 at risk EG003
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Hypoventilation	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected29 at risk EG0016 affected35 at risk EG0026 affected29 at risk EG003
Lung consolidation	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected29 at risk EG0011 affected35 at risk EG0022 affected29 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0013 affected35 at risk EG0020 affected29 at risk EG003
Nasal dryness	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0012 affected35 at risk EG0021 affected29 at risk EG003
Obstructive airways disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Orthopnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Pharyngeal inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Pharyngeal oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Pharyngolaryngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected29 at risk EG0014 affected35 at risk EG0024 affected29 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0007 affected29 at risk EG0016 affected35 at risk EG00211 affected29 at risk EG003
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected29 at risk EG0013 affected35 at risk EG0020 affected29 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected29 at risk EG0014 affected35 at risk EG0023 affected29 at risk EG003
Pulmonary alveolar haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Pulmonary granuloma	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected29 at risk EG0014 affected35 at risk EG0024 affected29 at risk EG003
Rales	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG00010 affected29 at risk EG0018 affected35 at risk EG0022 affected29 at risk EG003
Respiratory alkalosis	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0016 affected35 at risk EG0020 affected29 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0023 affected29 at risk EG003
Rhonchi	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected29 at risk EG0013 affected35 at risk EG0020 affected29 at risk EG003
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Sinus disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Tachypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0012 affected35 at risk EG0020 affected29 at risk EG003
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Upper respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected29 at risk EG0014 affected35 at risk EG0022 affected29 at risk EG003
Acne	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG00012 affected29 at risk EG0018 affected35 at risk EG00213 affected29 at risk EG003
Blister	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected29 at risk EG0015 affected35 at risk EG0023 affected29 at risk EG003
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0008 affected29 at risk EG0017 affected35 at risk EG0024 affected29 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected29 at risk EG0013 affected35 at risk EG0028 affected29 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0004 affected29 at risk EG0015 affected35 at risk EG0025 affected29 at risk EG003
Leukocytoclastic vasculitis	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Leukoplakia	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Nail disorder	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Night sweats	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Penile ulceration	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Periorbital oedema	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0023 affected29 at risk EG003
Perivascular dermatitis	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Petechiae	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0008 affected29 at risk EG00111 affected35 at risk EG0024 affected29 at risk EG003
Pigmentation disorder	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0005 affected29 at risk EG0015 affected35 at risk EG0026 affected29 at risk EG003
Purpura	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0007 affected29 at risk EG0018 affected35 at risk EG0029 affected29 at risk EG003
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected29 at risk EG0011 affected35 at risk EG0022 affected29 at risk EG003
Rash follicular	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Rash generalised	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Rash macular	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected29 at risk EG0011 affected35 at risk EG0021 affected29 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Red man syndrome	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Scab	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Skin discolouration	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Skin disorder	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0011 affected35 at risk EG0021 affected29 at risk EG003
Skin exfoliation	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0021 affected29 at risk EG003
Skin Hypopigmentation	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Skin irritation	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected29 at risk EG0012 affected35 at risk EG0021 affected29 at risk EG003
Skin nodule	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Skin reaction	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Sinus operation	Surgical and medical procedures	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Aortic arteriosclerosis	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Arterial disorder	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0012 affected35 at risk EG0020 affected29 at risk EG003
Flushing	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0012 affected35 at risk EG0022 affected29 at risk EG003
Haematoma	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected29 at risk EG0012 affected35 at risk EG0024 affected29 at risk EG003
Haemorrhage	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Hot flush	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0022 affected29 at risk EG003
Hypertension	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0006 affected29 at risk EG0014 affected35 at risk EG0023 affected29 at risk EG003
Hypertensive crisis	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Hypotension	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG00011 affected29 at risk EG00111 affected35 at risk EG00210 affected29 at risk EG003
Orthostatic hypotension	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected29 at risk EG0011 affected35 at risk EG0022 affected29 at risk EG003
Pallor	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0004 affected29 at risk EG0013 affected35 at risk EG0022 affected29 at risk EG003
Phlebitis	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Raynaud's phenomenon	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0020 affected29 at risk EG003
Thrombophlebitis superficial	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected35 at risk EG0021 affected29 at risk EG003
Thrombosis	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0021 affected29 at risk EG003
Bacteria tissue specimen identified	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003
Hypoacusis	Ear and labyrinth disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected35 at risk EG0020 affected29 at risk EG003

ID	Term
D007938	Leukemia
D000208	Acute Disease
D015470	Leukemia, Myeloid, Acute
D009190	Myelodysplastic Syndromes
D009369	Neoplasms
D006402	Hematologic Diseases

ID	Term
D009370	Neoplasms by Histologic Type
D006425	Hemic and Lymphatic Diseases
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D007951	Leukemia, Myeloid
D001855	Bone Marrow Diseases

ID	Title	Description
BG000	Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15	The original Schedule A used a single arm Green Dahlberg design (Green 1992) with 30 patients planned to be treated in Stage I.
BG001	Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8	Schedule B was to use a single arm Green Dahlberg 2 stage design with 30 patients planned to be treated in Stage I and 25 patients in Stage II.
BG002	Schedule C: 72 mg/m2 on Days 1 and 4	Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
BG003	Schedule C: 90 mg/m2 on Days 1 and 4	Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.
BG004	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15	The original Schedule A used a single arm Green Dahlberg design (Green 1992) with 30 patients planned to be treated in Stage I.	25	29	25	29	29	29
EG001	Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8	Schedule B was to use a single arm Green Dahlberg 2 stage design with 30 patients planned to be treated in Stage I and 25 patients in Stage II.	31	35	29	35	35	35
EG002	Schedule C: 72 mg/m2 on Days 1 and 4	Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose	28	29	21	29	29	29
EG003	Schedule C: 90 mg/m2 on Days 1 and 4	Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.	19	20	17	20	20	20