A Study of Clofarabine and Cytarabine for Older Patients... | NCT00317642

ID	Type	Description	Link
2008-001043-19	EudraCT Number

Label	Type	Description	Intervention Names
clofarabine (IV formulation) and cytarabine	Experimental	Participants received clofarabine (40 mg/m^2) administered as a 1-hour infusion followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour infusion. Participants could receive up to 3 cycles of treatment (induction, re-induction, and consolidation) Complete induction cycle = 5 consecutive days of treatment Re-induction cycle = 5 consecutive days of treatment at the original or modified dose Consolidation cycle = 4 consecutive days of treatment at the original or modified dose	Drug: clofarabine (IV formulation) Drug: cytarabine
placebo and cytarabine	Experimental	Participants received placebo administered as a 1-hour infusion followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour infusion. Patients could receive up to 3 cycles of treatment (induction, re-induction, and consolidation)	Drug: placebo Drug: cytarabine

Name	Type	Description	Arm Group Labels	Other Names
clofarabine (IV formulation)	Drug	clofarabine (IV formulation) infusion 40mg/m^2 / day up to 3 cycles	clofarabine (IV formulation) and cytarabine

Measure	Description	Time Frame
Overall Survival - Overall and by Calculated Strata (CSR 7-April-11)	Overall survival (OS) for the Full Analysis Set (FAS) and for the 2 calculated strata. OS was defined as the number of months from date of randomization until date of death due to any cause.	Day 1 (randomization) up to approximately 4 years
Overall Survival - Overall and by Randomized Strata (CSR 9-July-12)	Overall survival (OS) for the Full Analysis Set (FAS) and for the 2 randomized strata. OS was defined as the number of months from date of randomization until date of death due to any cause.	Day 1 (randomization) up to approximately 4 years

Measure	Description	Time Frame
Best Response Per Independent Response Review Panel (IRRP) Assessment - Overall and by Calculated Strata (CSR 7-April-11)	Percentage of participants whose best response was assessed by the IRRP as complete remission (CR) or complete remission with incomplete peripheral blood count recovery (CRi) using the revised International Working Group for Response Criteria (Cheson 2003). CR is defined on morphologic criteria at a single response assessment: a bone marrow aspirate or biopsy of <5% blasts, with evidence of normal hematopoiesis; absence of Auer rods in the blasts that are present; absence of extramedullary disease; absence of a unique phenotype determined at the pretreatment specimen, as assessed by immunophenotyping; only rare evidence of circulating blasts. If present, evidence of a regenerating bone marrow; recovery of peripheral counts (platelets ≥10010^9/L and absolute neutrophil count (ANC) ≥1.010^9/L). CRi met all criteria for CR except for either residual neutropenia (ANC <1.010^9/L) or thrombocytopenia (platelet count <10010^9/L).

Name	Affiliation	Role
Medical Monitor	Genzyme, a Sanofi Company	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinical Hospital		Scottsdale	Arizona		United States
Arizona Cancer Center

PubMed Identifier	Type	Citation
	Result	Clofarabine + Ara-c improves response rates and event-free survival, not overall survival, in older patients with relapsed/refractory AML compared to Ara-c alone: Updated CLASSIC I study results. H.M. Kantarjian, M. Wetzler, D. Rizzieri, G. J. Schiller, M. H. Jagasia, R. K. Stuart, S. Ganguly, D. Avigan, M. Craig, R. Collins, M. B. Maris, T. Kovacsovics, S. Goldberg, K. Seiter, P. Hari, J. Greiner, N. Vey, C. Recher, F. Ravandi, E.S. Wang, S. Eckert, D. Huebner and S. Faderl. Haematologica - 16th Congress of EHA Abstracts. 2011; 96(S2): 196.
	Result	Clofarabine plus cytarabine compared to cytarabine alone in older patients with relapsed or refractory (R/R) acute myelogenous leukemia (AML): Results from the phase III CLASSIC 1 trial. S. Faderl, M. Wetzler, D. Rizzieri, G. J. Schiller, M. H. Jagasia, R. K. Stuart, S. Ganguly, D. Avigan, M. Craig, R. Collins, M. B. Maris, T. Kovacsovics, S. Goldberg, K. Seiter, P. Hari, F. Ravandi, E. S. Wang, S. Eckert, D. Huebner, and H. Kantarjian JCO - ASCO Meeting Abstracts. 2011; 29:6503.
22585697	Result

ID	Title	Description
FG000	Clofarabine (IV Formulation) and Cytarabine	Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG00026 affected161 at risk EG00118 affected155 at risk EG00244 affected316 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG00010 affected161 at risk EG0011 affected155 at risk EG00211 affected316 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0010 affected155 at risk EG0022 affected316 at risk
Febrile bone marrow aplasia	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG00058 affected161 at risk EG00135 affected155 at risk EG00293 affected316 at risk
Haemoglobinaemia	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Hypercoagulation	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Hyperfibrinogenaemia	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0011 affected155 at risk EG0022 affected316 at risk
Hypofibrinogenaemia	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0012 affected155 at risk EG0022 affected316 at risk
Hypoprothrombinaemia	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0009 affected161 at risk EG0017 affected155 at risk EG00216 affected316 at risk
Lymph node pain	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0010 affected155 at risk EG0022 affected316 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected161 at risk EG0015 affected155 at risk EG0028 affected316 at risk
Lymphatic disorder	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Monocytosis	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0011 affected155 at risk EG0022 affected316 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG00017 affected161 at risk EG00110 affected155 at risk EG00227 affected316 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected161 at risk EG0010 affected155 at risk EG0023 affected316 at risk
Splenomegaly	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0012 affected155 at risk EG0023 affected316 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG00027 affected161 at risk EG00123 affected155 at risk EG00250 affected316 at risk
Angina pectoris	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0005 affected161 at risk EG0012 affected155 at risk EG0027 affected316 at risk
Aortic valve calcification	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0011 affected155 at risk EG0022 affected316 at risk
Aortic valve incompetence	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Arrhythmia	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0013 affected155 at risk EG0025 affected316 at risk
Arrhythmia supraventricular	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0010 affected155 at risk EG0022 affected316 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0006 affected161 at risk EG0013 affected155 at risk EG0029 affected316 at risk
Atrial flutter	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0005 affected161 at risk EG0010 affected155 at risk EG0025 affected316 at risk
Atrioventricular block	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0010 affected155 at risk EG0022 affected316 at risk
Atrioventricular block first degree	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected161 at risk EG0010 affected155 at risk EG0023 affected316 at risk
Bradycardia	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected161 at risk EG00114 affected155 at risk EG00217 affected316 at risk
Bundle branch block left	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0011 affected155 at risk EG0023 affected316 at risk
Bundle branch block right	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected161 at risk EG0010 affected155 at risk EG0023 affected316 at risk
Cardiac aneurysm	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Cardiac failure	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0012 affected155 at risk EG0022 affected316 at risk
Cardiac valve disease	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0011 affected155 at risk EG0022 affected316 at risk
Cardiomegaly	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0004 affected161 at risk EG0010 affected155 at risk EG0024 affected316 at risk
Conduction disorder	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Diastolic dysfunction	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0010 affected155 at risk EG0022 affected316 at risk
Dilatation atrial	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Dilatation ventricular	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Extrasystoles	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Heart valve incompetence	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Intracardiac thrombus	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Left atrial dilatation	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0011 affected155 at risk EG0023 affected316 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0012 affected155 at risk EG0023 affected316 at risk
Left ventricular hypertrophy	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0011 affected155 at risk EG0023 affected316 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0004 affected161 at risk EG0013 affected155 at risk EG0027 affected316 at risk
Myocardial infarction	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0014 affected155 at risk EG0025 affected316 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Nodal arrhythmia	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Palpitations	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0013 affected155 at risk EG0025 affected316 at risk
Pericardial effusion	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected161 at risk EG0016 affected155 at risk EG0029 affected316 at risk
Pulmonary valve incompetence	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Sinus arrhythmia	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected161 at risk EG0010 affected155 at risk EG0023 affected316 at risk
Sinus bradycardia	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected161 at risk EG0012 affected155 at risk EG0025 affected316 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG00012 affected161 at risk EG0016 affected155 at risk EG00218 affected316 at risk
Supraventricular extrasystoles	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0013 affected155 at risk EG0024 affected316 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Tachycardia	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG00025 affected161 at risk EG00114 affected155 at risk EG00239 affected316 at risk
Tricuspid valve incompetence	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected161 at risk EG0013 affected155 at risk EG0026 affected316 at risk
Ventricular arrhythmia	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0004 affected161 at risk EG0012 affected155 at risk EG0026 affected316 at risk
Ventricular hypertrophy	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Ventricular hypokinesia	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Atrial septal defect	Congenital, familial and genetic disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Hydrocele	Congenital, familial and genetic disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Cerumen impaction	Ear and labyrinth disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Ear congestion	Ear and labyrinth disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Ear pain	Ear and labyrinth disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0013 affected155 at risk EG0025 affected316 at risk
Hypoacusis	Ear and labyrinth disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0011 affected155 at risk EG0023 affected316 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0012 affected155 at risk EG0024 affected316 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 14.1	Systematic Assessment	EG0004 affected161 at risk EG0012 affected155 at risk EG0026 affected316 at risk
Adrenal disorder	Endocrine disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Cushingoid	Endocrine disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Hyperadrenalism	Endocrine disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Hypothyroidism	Endocrine disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Thyroid mass	Endocrine disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Blepharitis	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Cataract	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Conjunctival cyst	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Conjunctival haemorrhage	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0005 affected161 at risk EG0013 affected155 at risk EG0028 affected316 at risk
Conjunctival hyperaemia	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0011 affected155 at risk EG0023 affected316 at risk
Conjunctival pallor	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0010 affected155 at risk EG0022 affected316 at risk
Conjunctivitis	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0011 affected155 at risk EG0022 affected316 at risk
Diplopia	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Dry eye	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0007 affected161 at risk EG0017 affected155 at risk EG00214 affected316 at risk
Erythema of eyelid	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0011 affected155 at risk EG0022 affected316 at risk
Eye haemorrhage	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0011 affected155 at risk EG0023 affected316 at risk
Eye irritation	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected161 at risk EG0012 affected155 at risk EG0025 affected316 at risk
Eye pain	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected161 at risk EG0012 affected155 at risk EG0025 affected316 at risk
Eye swelling	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Eyelid oedema	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0012 affected155 at risk EG0023 affected316 at risk
Eyelid ptosis	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Gaze palsy	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Lacrimation increased	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0010 affected155 at risk EG0022 affected316 at risk
Miosis	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Ocular dysmetria	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Ocular hyperaemia	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0012 affected155 at risk EG0022 affected316 at risk
Ocular icterus	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Optic neuropathy	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0010 affected155 at risk EG0022 affected316 at risk
Papilloedema	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Periorbital oedema	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0004 affected161 at risk EG0011 affected155 at risk EG0025 affected316 at risk
Photophobia	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected161 at risk EG0011 affected155 at risk EG0024 affected316 at risk
Pupillary reflex impaired	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0012 affected155 at risk EG0022 affected316 at risk
Pupils unequal	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0010 affected155 at risk EG0022 affected316 at risk
Retinal haemorrhage	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Scleral disorder	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Scleral haemorrhage	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Scleral oedema	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Vision blurred	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0008 affected161 at risk EG0014 affected155 at risk EG00212 affected316 at risk
Visual acuity reduced	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Visual impairment	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0011 affected155 at risk EG0022 affected316 at risk
Vitreous detachment	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Vitreous floaters	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0012 affected155 at risk EG0023 affected316 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0005 affected161 at risk EG0013 affected155 at risk EG0028 affected316 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG00018 affected161 at risk EG00113 affected155 at risk EG00231 affected316 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG00030 affected161 at risk EG00118 affected155 at risk EG00248 affected316 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0012 affected155 at risk EG0023 affected316 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0005 affected161 at risk EG0016 affected155 at risk EG00211 affected316 at risk
Abdominal tenderness	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected161 at risk EG0012 affected155 at risk EG0025 affected316 at risk
Anal inflammation	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0011 affected155 at risk EG0022 affected316 at risk
Aphthous stomatitis	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Ascites	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected161 at risk EG0011 affected155 at risk EG0024 affected316 at risk
Caecitis	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0010 affected155 at risk EG0022 affected316 at risk
Chapped lips	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Cheilitis	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Colitis	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0011 affected155 at risk EG0023 affected316 at risk
Colonic polyp	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Colonic pseudo-obstruction	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Constipation	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG00066 affected161 at risk EG00172 affected155 at risk EG002138 affected316 at risk
Crohn's disease	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0010 affected155 at risk EG0022 affected316 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG000109 affected161 at risk EG00163 affected155 at risk EG002172 affected316 at risk
Diverticulum	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0009 affected161 at risk EG0016 affected155 at risk EG00215 affected316 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG00012 affected161 at risk EG00119 affected155 at risk EG00231 affected316 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0007 affected161 at risk EG0014 affected155 at risk EG00211 affected316 at risk
Epigastric discomfort	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0010 affected155 at risk EG0022 affected316 at risk
Eructation	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Faecal incontinence	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0005 affected161 at risk EG0015 affected155 at risk EG00210 affected316 at risk
Faeces discoloured	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Flatulence	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG00010 affected161 at risk EG0014 affected155 at risk EG00214 affected316 at risk
Gastric antral vascular ectasia	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Gastritis	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0011 affected155 at risk EG0023 affected316 at risk
Gastrointestinal inflammation	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Gastrointestinal sounds abnormal	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0011 affected155 at risk EG0022 affected316 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0015 affected155 at risk EG0027 affected316 at risk
Gingival bleeding	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0005 affected161 at risk EG0012 affected155 at risk EG0027 affected316 at risk
Gingival cyst	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Gingival pain	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0011 affected155 at risk EG0022 affected316 at risk
Gingivitis	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0006 affected161 at risk EG0011 affected155 at risk EG0027 affected316 at risk
Glossodynia	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0013 affected155 at risk EG0023 affected316 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0011 affected155 at risk EG0022 affected316 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0005 affected161 at risk EG0013 affected155 at risk EG0028 affected316 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0011 affected155 at risk EG0023 affected316 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG00013 affected161 at risk EG0019 affected155 at risk EG00222 affected316 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0011 affected155 at risk EG0023 affected316 at risk
Hypoaesthesia oral	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Ileus	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0011 affected155 at risk EG0023 affected316 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Intestinal dilatation	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Lip blister	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0011 affected155 at risk EG0022 affected316 at risk
Lip dry	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0004 affected161 at risk EG0015 affected155 at risk EG0029 affected316 at risk
Lip haemorrhage	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Lip ulceration	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0011 affected155 at risk EG0022 affected316 at risk
Melaena	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0012 affected155 at risk EG0023 affected316 at risk
Mouth haemorrhage	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG00011 affected161 at risk EG0017 affected155 at risk EG00218 affected316 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected161 at risk EG0019 affected155 at risk EG00212 affected316 at risk
Mucous stools	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Nausea	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG000117 affected161 at risk EG00182 affected155 at risk EG002199 affected316 at risk
Neutropenic colitis	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0010 affected155 at risk EG0022 affected316 at risk
Odynophagia	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0011 affected155 at risk EG0022 affected316 at risk
Oesophageal dilatation	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Oesophageal pain	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0011 affected155 at risk EG0023 affected316 at risk
Oral disorder	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0014 affected155 at risk EG0026 affected316 at risk
Oral mucosal discolouration	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0013 affected155 at risk EG0024 affected316 at risk
Oral mucosal erythema	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0012 affected155 at risk EG0023 affected316 at risk
Oral pain	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0011 affected155 at risk EG0023 affected316 at risk
Pancreatic mass	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0011 affected155 at risk EG0022 affected316 at risk
Parotid gland enlargement	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Poor dental condition	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Proctalgia	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0011 affected155 at risk EG0023 affected316 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0014 affected155 at risk EG0026 affected316 at risk
Rectal ulcer	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Retching	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected161 at risk EG0011 affected155 at risk EG0024 affected316 at risk
Salivary hypersecretion	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0011 affected155 at risk EG0023 affected316 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG00017 affected161 at risk EG00110 affected155 at risk EG00227 affected316 at risk
Tongue blistering	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Tongue coated	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Tongue discolouration	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0014 affected155 at risk EG0026 affected316 at risk
Tongue exfoliation	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Tongue haematoma	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0012 affected155 at risk EG0023 affected316 at risk
Tongue ulceration	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Tooth disorder	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Toothache	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0008 affected161 at risk EG0013 affected155 at risk EG00211 affected316 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Vomiting	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG00071 affected161 at risk EG00142 affected155 at risk EG002113 affected316 at risk
Adverse event	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Asthenia	General disorders	MedDRA 14.1	Systematic Assessment	EG00032 affected161 at risk EG00133 affected155 at risk EG00265 affected316 at risk
Catheter site discharge	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Catheter site erosion	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Catheter site erythema	General disorders	MedDRA 14.1	Systematic Assessment	EG0006 affected161 at risk EG00113 affected155 at risk EG00219 affected316 at risk
Catheter site haematoma	General disorders	MedDRA 14.1	Systematic Assessment	EG0004 affected161 at risk EG0010 affected155 at risk EG0024 affected316 at risk
Catheter site haemorrhage	General disorders	MedDRA 14.1	Systematic Assessment	EG0006 affected161 at risk EG0014 affected155 at risk EG00210 affected316 at risk
Catheter site inflammation	General disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0010 affected155 at risk EG0022 affected316 at risk
Catheter site oedema	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0011 affected155 at risk EG0022 affected316 at risk
Catheter site pain	General disorders	MedDRA 14.1	Systematic Assessment	EG00012 affected161 at risk EG0019 affected155 at risk EG00221 affected316 at risk
Catheter site pruritus	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Catheter site rash	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0012 affected155 at risk EG0023 affected316 at risk
Catheter site related reaction	General disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0015 affected155 at risk EG0027 affected316 at risk
Catheter site swelling	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0012 affected155 at risk EG0023 affected316 at risk
Chest discomfort	General disorders	MedDRA 14.1	Systematic Assessment	EG0004 affected161 at risk EG0014 affected155 at risk EG0028 affected316 at risk
Chest pain	General disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected161 at risk EG0012 affected155 at risk EG0025 affected316 at risk
Chills	General disorders	MedDRA 14.1	Systematic Assessment	EG00038 affected161 at risk EG00123 affected155 at risk EG00261 affected316 at risk
Crepitations	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Cyst	General disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Device occlusion	General disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected161 at risk EG0011 affected155 at risk EG0024 affected316 at risk
Discomfort	General disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Early satiety	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Face oedema	General disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0012 affected155 at risk EG0024 affected316 at risk
Facial pain	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0012 affected155 at risk EG0023 affected316 at risk
Fatigue	General disorders	MedDRA 14.1	Systematic Assessment	EG00057 affected161 at risk EG00149 affected155 at risk EG002106 affected316 at risk
Feeling cold	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0011 affected155 at risk EG0022 affected316 at risk
Feeling hot	General disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Gait disturbance	General disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0011 affected155 at risk EG0023 affected316 at risk
General physical health deterioration	General disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected161 at risk EG0012 affected155 at risk EG0025 affected316 at risk
Generalised oedema	General disorders	MedDRA 14.1	Systematic Assessment	EG0009 affected161 at risk EG0014 affected155 at risk EG00213 affected316 at risk
Hypothermia	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Infusion site discolouration	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Infusion site induration	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Injection site haemorrhage	General disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Injection site inflammation	General disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Injection site pain	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Injection site reaction	General disorders	MedDRA 14.1	Systematic Assessment	EG0004 affected161 at risk EG0011 affected155 at risk EG0025 affected316 at risk
Malaise	General disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0012 affected155 at risk EG0024 affected316 at risk
Mass	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Medical device complication	General disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Mucosal dryness	General disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Mucosal inflammation	General disorders	MedDRA 14.1	Systematic Assessment	EG00021 affected161 at risk EG00119 affected155 at risk EG00240 affected316 at risk
Nodule	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0011 affected155 at risk EG0022 affected316 at risk
Non-cardiac chest pain	General disorders	MedDRA 14.1	Systematic Assessment	EG0006 affected161 at risk EG0013 affected155 at risk EG0029 affected316 at risk
Oedema	General disorders	MedDRA 14.1	Systematic Assessment	EG0004 affected161 at risk EG0015 affected155 at risk EG0029 affected316 at risk
Oedema peripheral	General disorders	MedDRA 14.1	Systematic Assessment	EG00082 affected161 at risk EG00171 affected155 at risk EG002153 affected316 at risk
Pain	General disorders	MedDRA 14.1	Systematic Assessment	EG00022 affected161 at risk EG0018 affected155 at risk EG00230 affected316 at risk
Pyrexia	General disorders	MedDRA 14.1	Systematic Assessment	EG00053 affected161 at risk EG00139 affected155 at risk EG00292 affected316 at risk
Tenderness	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0012 affected155 at risk EG0023 affected316 at risk
Thrombosis in device	General disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected161 at risk EG0011 affected155 at risk EG0024 affected316 at risk
Visceral oedema	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0004 affected161 at risk EG0014 affected155 at risk EG0028 affected316 at risk
Dilatation intrahepatic duct acquired	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Gallbladder polyp	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Hepatic cyst	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0012 affected155 at risk EG0024 affected316 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Hepatic lesion	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0010 affected155 at risk EG0022 affected316 at risk
Hepatic steatosis	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0012 affected155 at risk EG0024 affected316 at risk
Hepatitis	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Hepatomegaly	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0013 affected155 at risk EG0023 affected316 at risk
Hepatosplenomegaly	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0010 affected155 at risk EG0022 affected316 at risk
Hepatotoxicity	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG00015 affected161 at risk EG00112 affected155 at risk EG00227 affected316 at risk
Jaundice	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0010 affected155 at risk EG0022 affected316 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 14.1	Systematic Assessment	EG0009 affected161 at risk EG0011 affected155 at risk EG00210 affected316 at risk
Hypogammaglobulinaemia	Immune system disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Abscess limb	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Acute sinusitis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Alpha haemolytic streptococcal infection	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0011 affected155 at risk EG0022 affected316 at risk
Anal abscess	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0011 affected155 at risk EG0022 affected316 at risk
Anorectal infection	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Bacteraemia	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0008 affected161 at risk EG0014 affected155 at risk EG00212 affected316 at risk
Bacterial infection	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0011 affected155 at risk EG0022 affected316 at risk
Bacterial sepsis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Bacteriuria	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0012 affected155 at risk EG0023 affected316 at risk
Bullous impetigo	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Candida pneumonia	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Candidiasis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0006 affected161 at risk EG0013 affected155 at risk EG0029 affected316 at risk
Catheter site cellulitis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Catheter site infection	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Cellulitis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0005 affected161 at risk EG0019 affected155 at risk EG00214 affected316 at risk
Clostridial infection	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0003 affected161 at risk EG0011 affected155 at risk EG0024 affected316 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0005 affected161 at risk EG0013 affected155 at risk EG0028 affected316 at risk
Cystitis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0010 affected155 at risk EG0022 affected316 at risk
Cystitis bacterial	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Cytomegalovirus infection	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Cytomegalovirus viraemia	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Device related infection	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0006 affected161 at risk EG0015 affected155 at risk EG00211 affected316 at risk
Diarrhoea infectious	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Diverticulitis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0012 affected155 at risk EG0024 affected316 at risk
Enterobacter bacteraemia	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0010 affected155 at risk EG0022 affected316 at risk
Enterococcal bacteraemia	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0009 affected161 at risk EG0013 affected155 at risk EG00212 affected316 at risk
Enterococcal infection	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0004 affected161 at risk EG0012 affected155 at risk EG0026 affected316 at risk
Enterococcal sepsis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Escherichia bacteraemia	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0012 affected155 at risk EG0024 affected316 at risk
Escherichia infection	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Escherichia sepsis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0011 affected155 at risk EG0022 affected316 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Eye infection	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Eye infection fungal	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Eye infection staphylococcal	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Folliculitis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0016 affected155 at risk EG0027 affected316 at risk
Fungal infection	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Fungal skin infection	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Furuncle	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0003 affected161 at risk EG0011 affected155 at risk EG0024 affected316 at risk
Gastroenteritis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Genital herpes	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Hepatosplenic candidiasis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Herpes simplex	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0014 affected155 at risk EG0026 affected316 at risk
Herpes zoster	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Infection	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Klebsiella bacteraemia	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0004 affected161 at risk EG0011 affected155 at risk EG0025 affected316 at risk
Lobar pneumonia	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0011 affected155 at risk EG0022 affected316 at risk
Localised infection	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0012 affected155 at risk EG0023 affected316 at risk
Lung infection	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0003 affected161 at risk EG0011 affected155 at risk EG0024 affected316 at risk
Lung infection pseudomonal	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Micrococcus infection	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Nasopharyngitis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0010 affected155 at risk EG0022 affected316 at risk
Oesophageal candidiasis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Onychomycosis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Oral candidiasis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG00010 affected161 at risk EG0018 affected155 at risk EG00218 affected316 at risk
Oral fungal infection	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Oral herpes	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0009 affected161 at risk EG0014 affected155 at risk EG00213 affected316 at risk
Osteomyelitis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0010 affected155 at risk EG0022 affected316 at risk
Otitis externa	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Parainfluenzae virus infection	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Paronychia	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Pharyngitis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0011 affected155 at risk EG0022 affected316 at risk
Pharyngitis streptococcal	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Pneumonia	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG00014 affected161 at risk EG0019 affected155 at risk EG00223 affected316 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Pneumonia fungal	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0005 affected161 at risk EG0012 affected155 at risk EG0027 affected316 at risk
Pseudomonal bacteraemia	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Pseudomonal sepsis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0010 affected155 at risk EG0022 affected316 at risk
Pseudomonas infection	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Pulmonary mycosis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0013 affected155 at risk EG0025 affected316 at risk
Respiratory syncytial virus infection	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0011 affected155 at risk EG0023 affected316 at risk
Rhinitis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Sepsis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0011 affected155 at risk EG0023 affected316 at risk
Septic embolus	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0010 affected155 at risk EG0022 affected316 at risk
Serratia bacteraemia	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Sinusitis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0012 affected155 at risk EG0024 affected316 at risk
Sinusitis fungal	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Skin candida	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Skin infection	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0011 affected155 at risk EG0022 affected316 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0009 affected161 at risk EG00115 affected155 at risk EG00224 affected316 at risk
Staphylococcal infection	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0004 affected161 at risk EG0011 affected155 at risk EG0025 affected316 at risk
Staphylococcal scalded skin syndrome	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0003 affected161 at risk EG0011 affected155 at risk EG0024 affected316 at risk
Staphylococcal skin infection	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Stenotrophomonas infection	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Streptococcal bacteraemia	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0003 affected161 at risk EG0014 affected155 at risk EG0027 affected316 at risk
Streptococcal sepsis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0010 affected155 at risk EG0022 affected316 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0011 affected155 at risk EG0022 affected316 at risk
Tooth abscess	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0013 affected155 at risk EG0023 affected316 at risk
Tooth infection	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0014 affected155 at risk EG0026 affected316 at risk
Urinary tract infection	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0003 affected161 at risk EG0010 affected155 at risk EG0023 affected316 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0013 affected155 at risk EG0025 affected316 at risk
Urinary tract infection enterococcal	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0004 affected161 at risk EG0011 affected155 at risk EG0025 affected316 at risk
Urinary tract infection pseudomonal	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0010 affected155 at risk EG0022 affected316 at risk
Urinary tract infection staphylococcal	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Viral skin infection	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Vulvovaginal candidiasis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Anal injury	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Bite	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Compression fracture	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG00012 affected161 at risk EG00117 affected155 at risk EG00229 affected316 at risk
Corneal abrasion	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Eschar	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0012 affected155 at risk EG0022 affected316 at risk
Excoriation	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0009 affected161 at risk EG0013 affected155 at risk EG00212 affected316 at risk
Eye injury	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Face injury	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0005 affected161 at risk EG0011 affected155 at risk EG0026 affected316 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0005 affected161 at risk EG0015 affected155 at risk EG00210 affected316 at risk
Lip injury	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Nail avulsion	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Nail injury	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0011 affected155 at risk EG0022 affected316 at risk
Periorbital haematoma	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Post procedural complication	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0013 affected155 at risk EG0023 affected316 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0012 affected155 at risk EG0024 affected316 at risk
Post procedural haematuria	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0003 affected161 at risk EG0011 affected155 at risk EG0024 affected316 at risk
Post procedural swelling	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Post-traumatic pain	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Procedural hypotension	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG00012 affected161 at risk EG00119 affected155 at risk EG00231 affected316 at risk
Procedural site reaction	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Refractoriness to platelet transfusion	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Scratch	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Skin injury	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Tongue injury	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Tooth fracture	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0012 affected155 at risk EG0023 affected316 at risk
Transfusion reaction	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0009 affected161 at risk EG0017 affected155 at risk EG00216 affected316 at risk
Traumatic haematoma	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Urethral injury	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Wound	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Wound haemorrhage	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Wound secretion	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Activated partial thromboplastin time prolonged	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Alanine aminotransferase increased	Investigations	MedDRA 14.1	Systematic Assessment	EG00040 affected161 at risk EG00113 affected155 at risk EG00253 affected316 at risk
Ammonia increased	Investigations	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 14.1	Systematic Assessment	EG00036 affected161 at risk EG0018 affected155 at risk EG00244 affected316 at risk
Bacterial test	Investigations	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Bacterial test positive	Investigations	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0012 affected155 at risk EG0024 affected316 at risk
Blast cells present	Investigations	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Blood albumin decreased	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 14.1	Systematic Assessment	EG00011 affected161 at risk EG0016 affected155 at risk EG00217 affected316 at risk
Blood amylase increased	Investigations	MedDRA 14.1	Systematic Assessment	EG0009 affected161 at risk EG0012 affected155 at risk EG00211 affected316 at risk
Blood beta-D-glucan increased	Investigations	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Blood bicarbonate decreased	Investigations	MedDRA 14.1	Systematic Assessment	EG0005 affected161 at risk EG0010 affected155 at risk EG0025 affected316 at risk
Blood bicarbonate increased	Investigations	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Blood bilirubin increased	Investigations	MedDRA 14.1	Systematic Assessment	EG00012 affected161 at risk EG0011 affected155 at risk EG00213 affected316 at risk
Blood calcium decreased	Investigations	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Blood chloride decreased	Investigations	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0010 affected155 at risk EG0022 affected316 at risk
Blood chloride increased	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Blood creatinine increased	Investigations	MedDRA 14.1	Systematic Assessment	EG0006 affected161 at risk EG0013 affected155 at risk EG0029 affected316 at risk
Blood culture positive	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0011 affected155 at risk EG0022 affected316 at risk
Blood glucose increased	Investigations	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0012 affected155 at risk EG0024 affected316 at risk
Blood iron increased	Investigations	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA 14.1	Systematic Assessment	EG0009 affected161 at risk EG0014 affected155 at risk EG00213 affected316 at risk
Blood magnesium decreased	Investigations	MedDRA 14.1	Systematic Assessment	EG0003 affected161 at risk EG0010 affected155 at risk EG0023 affected316 at risk
Blood magnesium increased	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Blood osmolarity increased	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Blood phosphorus decreased	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0011 affected155 at risk EG0022 affected316 at risk
Blood phosphorus increased	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Blood potassium decreased	Investigations	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0012 affected155 at risk EG0024 affected316 at risk
Blood potassium increased	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Blood pressure increased	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0011 affected155 at risk EG0022 affected316 at risk
Blood urea increased	Investigations	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0013 affected155 at risk EG0025 affected316 at risk
Blood uric acid increased	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Blood urine present	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0011 affected155 at risk EG0022 affected316 at risk
Breath sounds abnormal	Investigations	MedDRA 14.1	Systematic Assessment	EG0005 affected161 at risk EG0017 affected155 at risk EG00212 affected316 at risk
Cardiac murmur	Investigations	MedDRA 14.1	Systematic Assessment	EG0006 affected161 at risk EG0019 affected155 at risk EG00215 affected316 at risk
Catheter culture positive	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Clostridium test positive	Investigations	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Crystal urine present	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Culture stool positive	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0012 affected155 at risk EG0023 affected316 at risk
Culture throat positive	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Culture urine positive	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Cytomegalovirus test positive	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Diagnostic procedure	Investigations	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Electrocardiogram PR shortened	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0012 affected155 at risk EG0023 affected316 at risk
Electrocardiogram QT prolonged	Investigations	MedDRA 14.1	Systematic Assessment	EG0004 affected161 at risk EG0015 affected155 at risk EG0029 affected316 at risk
Electrocardiogram ST-T segment abnormal	Investigations	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0012 affected155 at risk EG0022 affected316 at risk
Electrocardiogram T wave abnormal	Investigations	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0011 affected155 at risk EG0023 affected316 at risk
Electrocardiogram abnormal	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0012 affected155 at risk EG0023 affected316 at risk
Enterococcus test positive	Investigations	MedDRA 14.1	Systematic Assessment	EG0005 affected161 at risk EG0013 affected155 at risk EG0028 affected316 at risk
Escherichia test positive	Investigations	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Fungal test positive	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Gallop rhythm present	Investigations	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 14.1	Systematic Assessment	EG0003 affected161 at risk EG0010 affected155 at risk EG0023 affected316 at risk
Glucose urine present	Investigations	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Haematocrit decreased	Investigations	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0010 affected155 at risk EG0022 affected316 at risk
Haemoglobin decreased	Investigations	MedDRA 14.1	Systematic Assessment	EG0003 affected161 at risk EG0011 affected155 at risk EG0024 affected316 at risk
Heart rate decreased	Investigations	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Heart rate increased	Investigations	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0010 affected155 at risk EG0022 affected316 at risk
Hepatic enzyme increased	Investigations	MedDRA 14.1	Systematic Assessment	EG0003 affected161 at risk EG0010 affected155 at risk EG0023 affected316 at risk
International normalised ratio increased	Investigations	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0010 affected155 at risk EG0022 affected316 at risk
Lipase increased	Investigations	MedDRA 14.1	Systematic Assessment	EG00010 affected161 at risk EG0013 affected155 at risk EG00213 affected316 at risk
Liver function test abnormal	Investigations	MedDRA 14.1	Systematic Assessment	EG0003 affected161 at risk EG0017 affected155 at risk EG00210 affected316 at risk
Liver scan abnormal	Investigations	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Lymph node palpable	Investigations	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Monocyte count increased	Investigations	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Neutrophil count decreased	Investigations	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Nitrite urine present	Investigations	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Platelet count decreased	Investigations	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0010 affected155 at risk EG0022 affected316 at risk
Protein total decreased	Investigations	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0010 affected155 at risk EG0022 affected316 at risk
Protein total increased	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Protein urine present	Investigations	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Prothrombin time prolonged	Investigations	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0011 affected155 at risk EG0023 affected316 at risk
Pulmonary function test decreased	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
QRS axis abnormal	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Red blood cell count decreased	Investigations	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0010 affected155 at risk EG0022 affected316 at risk
Red blood cells urine positive	Investigations	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Right ventricular systolic pressure increased	Investigations	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Serum ferritin increased	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Spleen palpable	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Staphylococcus test positive	Investigations	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Streptococcus test positive	Investigations	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0011 affected155 at risk EG0023 affected316 at risk
Total lung capacity decreased	Investigations	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Transaminases increased	Investigations	MedDRA 14.1	Systematic Assessment	EG00010 affected161 at risk EG0011 affected155 at risk EG00211 affected316 at risk
Troponin I increased	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Urinary sediment present	Investigations	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Urine leukocyte esterase positive	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Urine output decreased	Investigations	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0012 affected155 at risk EG0022 affected316 at risk
Weight decreased	Investigations	MedDRA 14.1	Systematic Assessment	EG00024 affected161 at risk EG00111 affected155 at risk EG00235 affected316 at risk
Weight increased	Investigations	MedDRA 14.1	Systematic Assessment	EG00013 affected161 at risk EG0017 affected155 at risk EG00220 affected316 at risk
White blood cell count decreased	Investigations	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0011 affected155 at risk EG0023 affected316 at risk
White blood cell count increased	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
White blood cells urine positive	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
pH urine increased	Investigations	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Acidosis	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0010 affected155 at risk EG0022 affected316 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG00057 affected161 at risk EG00137 affected155 at risk EG00294 affected316 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0008 affected161 at risk EG0014 affected155 at risk EG00212 affected316 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0008 affected161 at risk EG0014 affected155 at risk EG00212 affected316 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG00022 affected161 at risk EG00117 affected155 at risk EG00239 affected316 at risk
Fluid retention	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0009 affected161 at risk EG0017 affected155 at risk EG00216 affected316 at risk
Folate deficiency	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Glucose tolerance impaired	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Gout	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0011 affected155 at risk EG0022 affected316 at risk
Hyperamylasaemia	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0011 affected155 at risk EG0022 affected316 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0012 affected155 at risk EG0022 affected316 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG00017 affected161 at risk EG00117 affected155 at risk EG00234 affected316 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0005 affected161 at risk EG0011 affected155 at risk EG0026 affected316 at risk
Hyperlipasaemia	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0011 affected155 at risk EG0022 affected316 at risk
Hypermagnesaemia	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0012 affected155 at risk EG0024 affected316 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0004 affected161 at risk EG0011 affected155 at risk EG0025 affected316 at risk
Hyperphosphataemia	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0007 affected161 at risk EG0017 affected155 at risk EG00214 affected316 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0013 affected155 at risk EG0024 affected316 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG00022 affected161 at risk EG0018 affected155 at risk EG00230 affected316 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG00014 affected161 at risk EG0015 affected155 at risk EG00219 affected316 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0005 affected161 at risk EG0013 affected155 at risk EG0028 affected316 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG00061 affected161 at risk EG00129 affected155 at risk EG00290 affected316 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG00026 affected161 at risk EG00113 affected155 at risk EG00239 affected316 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG00015 affected161 at risk EG0015 affected155 at risk EG00220 affected316 at risk
Hypophagia	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG00012 affected161 at risk EG0017 affected155 at risk EG00219 affected316 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0011 affected155 at risk EG0022 affected316 at risk
Iron overload	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0004 affected161 at risk EG0011 affected155 at risk EG0025 affected316 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0004 affected161 at risk EG0011 affected155 at risk EG0025 affected316 at risk
Polydipsia	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Tumour lysis syndrome	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Vitamin K deficiency	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG00016 affected161 at risk EG0017 affected155 at risk EG00223 affected316 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG00029 affected161 at risk EG00116 affected155 at risk EG00245 affected316 at risk
Bone loss	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0004 affected161 at risk EG0013 affected155 at risk EG0027 affected316 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0010 affected155 at risk EG0022 affected316 at risk
Chondritis	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Coccydynia	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0004 affected161 at risk EG0011 affected155 at risk EG0025 affected316 at risk
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected161 at risk EG0012 affected155 at risk EG0025 affected316 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Joint effusion	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Joint range of motion decreased	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0012 affected155 at risk EG0023 affected316 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0012 affected155 at risk EG0022 affected316 at risk
Limb discomfort	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0012 affected155 at risk EG0022 affected316 at risk
Muscle atrophy	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0008 affected161 at risk EG0015 affected155 at risk EG00213 affected316 at risk
Muscle tightness	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG00011 affected161 at risk EG0011 affected155 at risk EG00212 affected316 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected161 at risk EG0016 affected155 at risk EG0029 affected316 at risk
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0012 affected155 at risk EG0022 affected316 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG00014 affected161 at risk EG0019 affected155 at risk EG00223 affected316 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0009 affected161 at risk EG0017 affected155 at risk EG00216 affected316 at risk
Myopathy	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0005 affected161 at risk EG0017 affected155 at risk EG00212 affected316 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Osteolysis	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Osteosclerosis	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0011 affected155 at risk EG0022 affected316 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG00027 affected161 at risk EG00112 affected155 at risk EG00239 affected316 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected161 at risk EG0012 affected155 at risk EG0025 affected316 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Scoliosis	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Benign neoplasm of eye	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Eye naevus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Lip neoplasm malignant stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0011 affected155 at risk EG0022 affected316 at risk
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Neurilemmoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Seborrhoeic keratosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Amnesia	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Apraxia	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Ataxia	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0011 affected155 at risk EG0023 affected316 at risk
Burning sensation	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0011 affected155 at risk EG0023 affected316 at risk
Carotid arteriosclerosis	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0010 affected155 at risk EG0022 affected316 at risk
Central nervous system lesion	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Cerebral atrophy	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Cerebral infarction	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Cerebrovascular disorder	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Convulsion	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected161 at risk EG0010 affected155 at risk EG0023 affected316 at risk
Cranial nerve disorder	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Dizziness	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG00019 affected161 at risk EG00128 affected155 at risk EG00247 affected316 at risk
Dizziness postural	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Dysaesthesia	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Dysgeusia	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG00010 affected161 at risk EG0014 affected155 at risk EG00214 affected316 at risk
Dyskinesia	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Encephalitis toxic	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Encephalopathy	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0012 affected155 at risk EG0023 affected316 at risk
Headache	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG00068 affected161 at risk EG00144 affected155 at risk EG002112 affected316 at risk
Hemiparesis	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Hepatic encephalopathy	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Hyperaesthesia	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected161 at risk EG0014 affected155 at risk EG0027 affected316 at risk
Hypogeusia	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Hypokinesia	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Hyporeflexia	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Intention tremor	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Lethargy	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected161 at risk EG0014 affected155 at risk EG0027 affected316 at risk
Loss of consciousness	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Memory impairment	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0011 affected155 at risk EG0022 affected316 at risk
Migraine	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0011 affected155 at risk EG0022 affected316 at risk
Myoclonus	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0004 affected161 at risk EG0012 affected155 at risk EG0026 affected316 at risk
Nystagmus	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Paraesthesia	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected161 at risk EG0012 affected155 at risk EG0025 affected316 at risk
Peroneal nerve palsy	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Polyneuropathy	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Presyncope	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0010 affected155 at risk EG0022 affected316 at risk
Restless legs syndrome	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0012 affected155 at risk EG0023 affected316 at risk
Sciatica	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Sensory disturbance	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Sinus headache	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected161 at risk EG0014 affected155 at risk EG0027 affected316 at risk
Slow speech	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Somnolence	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0009 affected161 at risk EG0017 affected155 at risk EG00216 affected316 at risk
Speech disorder	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Syncope	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0006 affected161 at risk EG0014 affected155 at risk EG00210 affected316 at risk
Tension headache	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0011 affected155 at risk EG0022 affected316 at risk
Tremor	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0009 affected161 at risk EG0017 affected155 at risk EG00216 affected316 at risk
Aggression	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Agitation	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0009 affected161 at risk EG0012 affected155 at risk EG00211 affected316 at risk
Anger	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Anxiety	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG00035 affected161 at risk EG00120 affected155 at risk EG00255 affected316 at risk
Confusional state	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG00030 affected161 at risk EG00113 affected155 at risk EG00243 affected316 at risk
Delirium	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0011 affected155 at risk EG0022 affected316 at risk
Depressed mood	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Depression	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG00020 affected161 at risk EG0018 affected155 at risk EG00228 affected316 at risk
Disorientation	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0012 affected155 at risk EG0022 affected316 at risk
Dysphoria	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Fear	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Flat affect	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0011 affected155 at risk EG0022 affected316 at risk
Hallucination	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected161 at risk EG0013 affected155 at risk EG0026 affected316 at risk
Hallucination, visual	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Insomnia	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG00051 affected161 at risk EG00142 affected155 at risk EG00293 affected316 at risk
Mental status changes	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0008 affected161 at risk EG0014 affected155 at risk EG00212 affected316 at risk
Mood altered	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Nightmare	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0010 affected155 at risk EG0022 affected316 at risk
Panic attack	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0010 affected155 at risk EG0022 affected316 at risk
Restlessness	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0013 affected155 at risk EG0025 affected316 at risk
Bladder dilatation	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Bladder mass	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Bladder spasm	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0011 affected155 at risk EG0022 affected316 at risk
Chromaturia	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Dysuria	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0008 affected161 at risk EG0013 affected155 at risk EG00211 affected316 at risk
Enuresis	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Haematuria	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0008 affected161 at risk EG00111 affected155 at risk EG00219 affected316 at risk
Incontinence	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Kidney enlargement	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Nocturia	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0013 affected155 at risk EG0025 affected316 at risk
Oliguria	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0005 affected161 at risk EG0016 affected155 at risk EG00211 affected316 at risk
Polyuria	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0011 affected155 at risk EG0022 affected316 at risk
Proteinuria	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Renal cyst	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0004 affected161 at risk EG0014 affected155 at risk EG0028 affected316 at risk
Renal disorder	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Renal failure	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0004 affected161 at risk EG0014 affected155 at risk EG0028 affected316 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0005 affected161 at risk EG0012 affected155 at risk EG0027 affected316 at risk
Renal failure chronic	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Renal tubular necrosis	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0010 affected155 at risk EG0022 affected316 at risk
Urethritis noninfective	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0009 affected161 at risk EG0016 affected155 at risk EG00215 affected316 at risk
Urinary retention	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0019 affected155 at risk EG00210 affected316 at risk
Urine abnormality	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Urine flow decreased	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Balanitis	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Breast haematoma	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Breast pain	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0011 affected155 at risk EG0022 affected316 at risk
Gynaecomastia	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Pelvic pain	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0010 affected155 at risk EG0022 affected316 at risk
Penile blister	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Penile haemorrhage	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0012 affected155 at risk EG0024 affected316 at risk
Penile pain	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Prostatomegaly	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Scrotal oedema	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0011 affected155 at risk EG0023 affected316 at risk
Testicular pain	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0011 affected155 at risk EG0022 affected316 at risk
Vulvovaginal rash	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Vulvovaginal swelling	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0008 affected161 at risk EG0014 affected155 at risk EG00212 affected316 at risk
Bronchial wall thickening	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0010 affected155 at risk EG0022 affected316 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected161 at risk EG0012 affected155 at risk EG0025 affected316 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG00034 affected161 at risk EG00126 affected155 at risk EG00260 affected316 at risk
Dry throat	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0012 affected155 at risk EG0024 affected316 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG00030 affected161 at risk EG00118 affected155 at risk EG00248 affected316 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0008 affected161 at risk EG0014 affected155 at risk EG00212 affected316 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG00030 affected161 at risk EG00119 affected155 at risk EG00249 affected316 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0006 affected161 at risk EG00110 affected155 at risk EG00216 affected316 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0009 affected161 at risk EG0012 affected155 at risk EG00211 affected316 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0009 affected161 at risk EG0013 affected155 at risk EG00212 affected316 at risk
Increased bronchial secretion	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Laryngospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0008 affected161 at risk EG0014 affected155 at risk EG00212 affected316 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0007 affected161 at risk EG0013 affected155 at risk EG00210 affected316 at risk
Nasal dryness	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0012 affected155 at risk EG0023 affected316 at risk
Nasal mucosal disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0012 affected155 at risk EG0022 affected316 at risk
Nasal ulcer	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Oropharyngeal blistering	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected161 at risk EG0013 affected155 at risk EG0026 affected316 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG00010 affected161 at risk EG00111 affected155 at risk EG00221 affected316 at risk
Oropharyngeal plaque	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Orthopnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0012 affected155 at risk EG0023 affected316 at risk
Paranasal cyst	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Paranasal sinus hypersecretion	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Pharyngeal erythema	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0011 affected155 at risk EG0022 affected316 at risk
Pharyngeal inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG00016 affected161 at risk EG00115 affected155 at risk EG00231 affected316 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected161 at risk EG0012 affected155 at risk EG0025 affected316 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0013 affected155 at risk EG0023 affected316 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected161 at risk EG0010 affected155 at risk EG0023 affected316 at risk
Pulmonary alveolar haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0011 affected155 at risk EG0023 affected316 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0010 affected155 at risk EG0022 affected316 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0008 affected161 at risk EG0012 affected155 at risk EG00210 affected316 at risk
Rales	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0009 affected161 at risk EG0019 affected155 at risk EG00218 affected316 at risk
Respiratory alkalosis	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected161 at risk EG0010 affected155 at risk EG0023 affected316 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0011 affected155 at risk EG0022 affected316 at risk
Respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Rhinalgia	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected161 at risk EG0013 affected155 at risk EG0026 affected316 at risk
Rhonchi	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected161 at risk EG0012 affected155 at risk EG0025 affected316 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected161 at risk EG0012 affected155 at risk EG0025 affected316 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0013 affected155 at risk EG0023 affected316 at risk
Sputum discoloured	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Stridor	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Tachypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0015 affected155 at risk EG0026 affected316 at risk
Throat lesion	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0011 affected155 at risk EG0022 affected316 at risk
Upper-airway cough syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Vocal cord polyp	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0007 affected161 at risk EG0012 affected155 at risk EG0029 affected316 at risk
Actinic keratosis	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG00014 affected161 at risk EG0013 affected155 at risk EG00217 affected316 at risk
Blister	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0007 affected161 at risk EG0013 affected155 at risk EG00210 affected316 at risk
Blood blister	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected161 at risk EG0011 affected155 at risk EG0024 affected316 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0008 affected161 at risk EG0011 affected155 at risk EG0029 affected316 at risk
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0013 affected155 at risk EG0024 affected316 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0012 affected155 at risk EG0022 affected316 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG00024 affected161 at risk EG00113 affected155 at risk EG00237 affected316 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0009 affected161 at risk EG00120 affected155 at risk EG00229 affected316 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG00019 affected161 at risk EG00122 affected155 at risk EG00241 affected316 at risk
Exfoliative rash	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0006 affected161 at risk EG0012 affected155 at risk EG0028 affected316 at risk
Generalised erythema	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected161 at risk EG0010 affected155 at risk EG0023 affected316 at risk
Heat rash	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Hidradenitis	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG00012 affected161 at risk EG0016 affected155 at risk EG00218 affected316 at risk
Hyperkeratosis	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Increased tendency to bruise	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Ingrowing nail	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Lentigo	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Leukocytoclastic vasculitis	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Nail disorder	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Nail dystrophy	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0005 affected161 at risk EG00110 affected155 at risk EG00215 affected316 at risk
Pain of skin	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected161 at risk EG0011 affected155 at risk EG0024 affected316 at risk
Palmar erythema	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0010 affected155 at risk EG0022 affected316 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG00030 affected161 at risk EG0012 affected155 at risk EG00232 affected316 at risk
Papule	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Pemphigoid	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Petechiae	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG00022 affected161 at risk EG00124 affected155 at risk EG00246 affected316 at risk
Photodermatosis	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Pigmentation disorder	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG00019 affected161 at risk EG0015 affected155 at risk EG00224 affected316 at risk
Pruritus generalised	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected161 at risk EG0012 affected155 at risk EG0025 affected316 at risk
Purpura	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0013 affected155 at risk EG0025 affected316 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG00040 affected161 at risk EG00122 affected155 at risk EG00262 affected316 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG00014 affected161 at risk EG0013 affected155 at risk EG00217 affected316 at risk
Rash follicular	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected161 at risk EG0010 affected155 at risk EG0023 affected316 at risk
Rash generalised	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG00017 affected161 at risk EG0017 affected155 at risk EG00224 affected316 at risk
Rash macular	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected161 at risk EG0011 affected155 at risk EG0024 affected316 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0004 affected161 at risk EG0014 affected155 at risk EG0028 affected316 at risk
Rash papular	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0006 affected161 at risk EG0011 affected155 at risk EG0027 affected316 at risk
Rash vesicular	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Rosacea	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Scab	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Skin discolouration	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Skin disorder	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0010 affected155 at risk EG0022 affected316 at risk
Skin exfoliation	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG00023 affected161 at risk EG0013 affected155 at risk EG00226 affected316 at risk
Skin haemorrhage	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0011 affected155 at risk EG0022 affected316 at risk
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0012 affected155 at risk EG0024 affected316 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0005 affected161 at risk EG0018 affected155 at risk EG00213 affected316 at risk
Skin mass	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0010 affected155 at risk EG0022 affected316 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0010 affected155 at risk EG0022 affected316 at risk
Stasis dermatitis	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Subcutaneous nodule	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Swelling face	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0014 affected155 at risk EG0025 affected316 at risk
Toxic skin eruption	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0015 affected155 at risk EG0027 affected316 at risk
Andropause	Social circumstances	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Aortic aneurysm	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Aortic arteriosclerosis	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0011 affected155 at risk EG0022 affected316 at risk
Aortic calcification	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0012 affected155 at risk EG0022 affected316 at risk
Aortic disorder	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Arteriosclerosis	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0006 affected161 at risk EG0013 affected155 at risk EG0029 affected316 at risk
Flushing	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG00019 affected161 at risk EG00111 affected155 at risk EG00230 affected316 at risk
Haematoma	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0004 affected161 at risk EG0013 affected155 at risk EG0027 affected316 at risk
Hot flush	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected161 at risk EG0012 affected155 at risk EG0025 affected316 at risk
Hypertension	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG00029 affected161 at risk EG00121 affected155 at risk EG00250 affected316 at risk
Hypotension	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG00037 affected161 at risk EG00133 affected155 at risk EG00270 affected316 at risk
Infarction	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Jugular vein distension	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Jugular vein thrombosis	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0011 affected155 at risk EG0023 affected316 at risk
Lymphoedema	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0009 affected161 at risk EG0014 affected155 at risk EG00213 affected316 at risk
Pallor	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected161 at risk EG0019 affected155 at risk EG00211 affected316 at risk
Subclavian vein thrombosis	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0011 affected155 at risk EG0022 affected316 at risk
Thrombosis	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected161 at risk EG0011 affected155 at risk EG0024 affected316 at risk
Vascular stenosis	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected161 at risk EG0011 affected155 at risk EG0021 affected316 at risk
Vasculitis	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Vena cava thrombosis	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0011 affected155 at risk EG0022 affected316 at risk
Venous insufficiency	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0010 affected155 at risk EG0021 affected316 at risk
Venous thrombosis limb	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected161 at risk EG0013 affected155 at risk EG0024 affected316 at risk

ID	Term
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

ID	Term
D000227	Adenine Nucleotides
D011685	Purine Nucleotides
D011687	Purines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D001087	Arabinonucleosides
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides
D009711	Nucleotides
D012265	Ribonucleotides
D004364	Pharmaceutical Preparations
D013678	Technology, Pharmaceutical
D008919	Investigative Techniques
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring

ID	Title	Description
BG000	Clofarabine (IV Formulation) and Cytarabine	Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
BG001	Placebo and Cytarabine	Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
BG002	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Clofarabine (IV Formulation) and Cytarabine	Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.	97	161	161	161
EG001	Placebo and Cytarabine	Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.	76	155	154	155
EG002	Overall	Combined total for the two Arms/Groups	173	316	315	316