A Study to Evaluate the Safety and Efficacy of Inactivate... | NCT01254630

ID	Type	Description
CTRI/2012/05/002673	Registry Identifier	CTRI
2010-023156-89	EudraCT Number
V212-011	Other Identifier	Merck Protocol Number

Label	Type	Description	Intervention Names
V212-STM	Experimental	Participants with STM receiving chemotherapy randomized to receive V212 vaccine given as a 4-dose regimen administered ~30 days apart.	Biological: V212
V212-HM	Experimental	Participants with HM randomized to receive V212 vaccine given as a 4-dose regimen administered ~30 days apart.	Biological: V212
Placebo-STM	Placebo Comparator	Participants with STM receiving chemotherapy randomized to receive placebo to V212 vaccine given as a 4-dose regimen administered ~30 days apart.	Biological: Placebo
Placebo-HM	Placebo Comparator	Participants with HM randomized to receive placebo to V212 vaccine given as a 4-dose regimen administered ~30 days apart.	Biological: Placebo

Name	Type	Description	Arm Group Labels	Other Names
V212	Biological	V212 viral antigen for HZ, 0.5 mL subcutaneous (SC) injection per dose, in a four dose regimen, approximately 30 days apart.	V212-HM V212-STM

Measure	Description	Time Frame
Incidence of Confirmed Herpes-Zoster	Clinical criteria for suspected HZ cases were the development of a papular or vesicular rash with a dermatomal or generalized distribution, or in the absence of a rash, clinical suspicion of VZV infection with or without the detection of VZV in diagnostic specimens from blood, cerebrospinal fluid, lung, liver, or other organ. All suspected cases of HZ were subjected to adjudication by the Clinical Adjudication Committee (CAC). Case confirmation was based on skin lesion polymerase chain reaction, if available, or by adjudication of the clinical case description by the CAC, conducted according to the CAC Standard Operations Procedure.	Up to approximately 5 years
Percentage of Participants With One or More Serious Adverse Events	An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. A serious adverse event (SAE) is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, is a cancer, is an overdose, or is another important medical event.	Up to 28 days after vaccination 4 (up to approximately 118 days)

Measure	Description	Time Frame
Incidence of Moderate to Severe Herpes-Zoster-Associated Pain	Moderate to severe HZ-associated pain was defined as 2 or more occurrences of a score of 3 or greater (0-to-10 scale, where 0 is no pain and 10 is pain as bad as you can imagine) on the Zoster Brief Pain Inventory (ZBPI) at any time from HZ onset through the end of the 6 month HZ-follow-up period.	Up to 6 months after onset of HZ (up to approximately 5 years)

Measure	Description	Time Frame
Percentage of Participants With Study Medication Withdrawn Due to an Adverse Event	An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. A serious adverse event (SAE) is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, is a cancer, is an overdose, or is another important medical event.

Name	Affiliation	Role
Medical Director	Merck Sharp & Dohme LLC	Study Director

PubMed Identifier	Type	Citation	Retractions
40396505	Derived	Zorger AM, Hirsch C, Baumann M, Feldmann M, Brockelmann PJ, Mellinghoff S, Monsef I, Skoetz N, Kreuzberger N. Vaccines for preventing infections in adults with haematological malignancies. Cochrane Database Syst Rev. 2025 May 21;5(5):CD015530. doi: 10.1002/14651858.CD015530.pub2.
40237463	Derived	Hirsch C, Zorger AM, Baumann M, Park YS, Brockelmann PJ, Mellinghoff S, Monsef I, Skoetz N, Kreuzberger N. Vaccines for preventing infections in adults with solid tumours. Cochrane Database Syst Rev. 2025 Apr 16;4(4):CD015551. doi: 10.1002/14651858.CD015551.pub2.

ID	Title	Description
FG000	V212-STM	Participants with STM receiving chemotherapy randomized to receive V212 vaccine given as a 4-dose regimen administered ~30 days apart.
FG001	V212-HM	Participants with HM randomized to receive V212 vaccine given as a 4-dose regimen administered ~30 days apart.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jun 30, 2015

ID	Title	Description
BG000	V212-STM	Participants with STM receiving chemotherapy randomized to receive V212 vaccine given as a 4-dose regimen administered ~30 days apart.
BG001	V212-HM	Participants with HM randomized to receive V212 vaccine given as a 4-dose regimen administered ~30 days apart.
BG002	Placebo-STM	Participants with STM receiving chemotherapy randomized to receive placebo to V212 vaccine given as a 4-dose regimen administered ~30 days apart.
BG003	Placebo-HM	Participants with HM randomized to receive placebo to V212 vaccine given as a 4-dose regimen administered ~30 days apart.
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG0001348 BG0011288 BG0021364 BG0031285 BG0045285

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG0009 events9 affected1,322 at risk EG00119 events16 affected1,274 at risk EG00225 events24 affected1,346 at risk EG00311 events11 affected1,274 at risk
Anaemia of chronic disease	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0023 events3 affected1,346 at risk EG003
Anaemia of malignant disease	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Autoimmune haemolytic anaemia	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0012 events2 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Bone marrow failure	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Coagulopathy	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG00023 events21 affected1,322 at risk EG00164 events44 affected1,274 at risk EG00237 events35 affected1,346 at risk EG003
Haematotoxicity	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Haemolysis	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Haemolytic anaemia	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Hypoprothrombinaemia	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Lymph node pain	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Lymphadenitis	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG0004 events4 affected1,322 at risk EG0014 events4 affected1,274 at risk EG0025 events5 affected1,346 at risk EG003
Pancytopenia	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG0008 events7 affected1,322 at risk EG0015 events5 affected1,274 at risk EG00212 events9 affected1,346 at risk EG003
Splenomegaly	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG0006 events5 affected1,322 at risk EG0015 events4 affected1,274 at risk EG0025 events5 affected1,346 at risk EG003
Acute coronary syndrome	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0016 events6 affected1,274 at risk EG0026 events6 affected1,346 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Angina unstable	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Aortic valve sclerosis	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Aortic valve stenosis	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Arrhythmia	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0008 events7 affected1,322 at risk EG00112 events9 affected1,274 at risk EG00211 events11 affected1,346 at risk EG003
Atrial flutter	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0013 events3 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Atrioventricular block second degree	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0008 events8 affected1,322 at risk EG0014 events4 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0006 events6 affected1,322 at risk EG0013 events3 affected1,274 at risk EG0024 events4 affected1,346 at risk EG003
Cardiac failure acute	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Cardiac failure chronic	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG00011 events9 affected1,322 at risk EG00112 events11 affected1,274 at risk EG0027 events6 affected1,346 at risk EG003
Cardiac tamponade	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0022 events1 affected1,346 at risk EG003
Cardiac valve disease	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Cardiac ventricular thrombosis	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Cardio-respiratory arrest	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0022 events2 affected1,346 at risk EG003
Cardiomyopathy	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Cardiomyopathy acute	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Cardiopulmonary failure	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Cardiorenal syndrome	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Congestive cardiomyopathy	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected1,322 at risk EG0013 events3 affected1,274 at risk EG0022 events2 affected1,346 at risk EG003
Coronary artery insufficiency	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0012 events2 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Mitral valve incompetence	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected1,322 at risk EG0014 events4 affected1,274 at risk EG0024 events4 affected1,346 at risk EG003
Myocardial ischaemia	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Palpitations	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Pericardial effusion	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Pericardial haemorrhage	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Pericarditis	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0022 events2 affected1,346 at risk EG003
Pulseless electrical activity	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Sinus node dysfunction	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Sinus tachycardia	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0022 events2 affected1,346 at risk EG003
Stress cardiomyopathy	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0012 events2 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Tachycardia	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Ventricular dyssynchrony	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Ventricular extrasystoles	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Ventricular fibrillation	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Ventricular tachycardia	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Dysplastic naevus syndrome	Congenital, familial and genetic disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Tracheo-oesophageal fistula	Congenital, familial and genetic disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0022 events2 affected1,346 at risk EG003
Inner ear disorder	Ear and labyrinth disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Neurosensory hypoacusis	Ear and labyrinth disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Vertigo positional	Ear and labyrinth disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Adrenal insufficiency	Endocrine disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Carcinoid syndrome	Endocrine disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Cushing's syndrome	Endocrine disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Goitre	Endocrine disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Hypercalcaemia of malignancy	Endocrine disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0012 events2 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Hyperthyroidism	Endocrine disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Inappropriate antidiuretic hormone secretion	Endocrine disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Thyroid mass	Endocrine disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Blindness transient	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Cataract	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Cortical visual impairment	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Myopia	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Necrotising retinitis	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Retinal detachment	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Ulcerative keratitis	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Abdominal hernia	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Abdominal hernia obstructive	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG00010 events9 affected1,322 at risk EG0013 events3 affected1,274 at risk EG0028 events7 affected1,346 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0024 events4 affected1,346 at risk EG003
Abdominal wall haematoma	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Anal fissure	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Anal fistula	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0022 events1 affected1,346 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0012 events2 affected1,274 at risk EG0023 events3 affected1,346 at risk EG003
Colitis ischaemic	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0022 events2 affected1,346 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0008 events7 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0028 events8 affected1,346 at risk EG003
Crohn's disease	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Cyclic vomiting syndrome	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG00020 events17 affected1,322 at risk EG0011 events1 affected1,274 at risk EG00215 events13 affected1,346 at risk EG003
Diarrhoea haemorrhagic	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Diverticular perforation	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Diverticulum	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Diverticulum intestinal	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Duodenal obstruction	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Duodenitis	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0025 events5 affected1,346 at risk EG003
Enteritis	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0022 events2 affected1,346 at risk EG003
Enterocutaneous fistula	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Eosinophilic colitis	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Erosive oesophagitis	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Faecaloma	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0022 events2 affected1,346 at risk EG003
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0022 events2 affected1,346 at risk EG003
Gastritis erosive	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0022 events2 affected1,346 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0008 events7 affected1,322 at risk EG0016 events6 affected1,274 at risk EG00213 events13 affected1,346 at risk EG003
Gastrointestinal hypomotility	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Gastrointestinal obstruction	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Gastrointestinal pain	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Gastrointestinal perforation	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Haematemesis	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Haematochezia	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Hiatus hernia	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0003 events2 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0025 events4 affected1,346 at risk EG003
Impaired gastric emptying	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Incarcerated inguinal hernia	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Inguinal hernia strangulated	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Intestinal fibrosis	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Intestinal ischaemia	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG00016 events12 affected1,322 at risk EG0014 events3 affected1,274 at risk EG00212 events10 affected1,346 at risk EG003
Intestinal perforation	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Intestinal prolapse	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Large intestinal obstruction	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Large intestine perforation	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Large intestine polyp	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0012 events2 affected1,274 at risk EG0023 events2 affected1,346 at risk EG003
Mallory-Weiss syndrome	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Mouth ulceration	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0004 events4 affected1,322 at risk EG0013 events1 affected1,274 at risk EG0026 events5 affected1,346 at risk EG003
Neutropenic colitis	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0013 events3 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Obstruction gastric	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Odynophagia	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Oesophageal perforation	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Oesophageal rupture	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Oesophageal spasm	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Oesophageal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Oesophageal varices haemorrhage	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Oesophagitis	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0022 events2 affected1,346 at risk EG003
Pancreatic cyst	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Pancreatic insufficiency	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Pancreatic mass	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0005 events4 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0022 events2 affected1,346 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0023 events3 affected1,346 at risk EG003
Pancreatitis chronic	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Proctalgia	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Proctitis	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0013 events3 affected1,274 at risk EG0023 events3 affected1,346 at risk EG003
Rectal ulcer	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Retroperitoneal haemorrhage	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Salivary gland calculus	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG00043 events21 affected1,322 at risk EG0014 events4 affected1,274 at risk EG00217 events12 affected1,346 at risk EG003
Small intestinal perforation	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0024 events4 affected1,346 at risk EG003
Subileus	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Umbilical hernia	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0013 events3 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Volvulus	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG00011 events11 affected1,322 at risk EG0014 events2 affected1,274 at risk EG00216 events13 affected1,346 at risk EG003
Adverse drug reaction	General disorders	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Asthenia	General disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0024 events4 affected1,346 at risk EG003
Chest discomfort	General disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Chest pain	General disorders	MedDRA 19.1	Systematic Assessment	EG0006 events6 affected1,322 at risk EG0014 events4 affected1,274 at risk EG00213 events12 affected1,346 at risk EG003
Chills	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Complication associated with device	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Death	General disorders	MedDRA 19.1	Systematic Assessment	EG00031 events31 affected1,322 at risk EG00113 events13 affected1,274 at risk EG00217 events17 affected1,346 at risk EG003
Drug withdrawal syndrome	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Fatigue	General disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Gait disturbance	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
General physical health deterioration	General disorders	MedDRA 19.1	Systematic Assessment	EG0005 events5 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0023 events3 affected1,346 at risk EG003
Generalised oedema	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Granuloma	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Impaired healing	General disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Incarcerated hernia	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0023 events3 affected1,346 at risk EG003
Malaise	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Medical device pain	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Mucosal haemorrhage	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Mucosal inflammation	General disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0023 events3 affected1,346 at risk EG003
Multiple organ dysfunction syndrome	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0012 events2 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Nodule	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0022 events2 affected1,346 at risk EG003
Oedema peripheral	General disorders	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Organ failure	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Pain	General disorders	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Polyserositis	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Pyrexia	General disorders	MedDRA 19.1	Systematic Assessment	EG00011 events11 affected1,322 at risk EG0015 events5 affected1,274 at risk EG00215 events15 affected1,346 at risk EG003
Sudden death	General disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Systemic inflammatory response syndrome	General disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Ulcer haemorrhage	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Vascular stent thrombosis	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Visceral pain	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Acute hepatic failure	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Bile duct obstruction	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0023 events3 affected1,346 at risk EG003
Bile duct stone	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Biliary colic	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Biloma	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Cholangitis	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0005 events4 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0028 events7 affected1,346 at risk EG003
Cholangitis acute	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0012 events2 affected1,274 at risk EG0022 events2 affected1,346 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Cholecystitis chronic	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0012 events2 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Cholestasis	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Drug-induced liver injury	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Gallbladder disorder	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Haemobilia	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Hepatic failure	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Hepatic haemorrhage	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Hepatitis cholestatic	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Hepatorenal syndrome	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Hepatotoxicity	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0002 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0022 events1 affected1,346 at risk EG003
Jaundice cholestatic	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0012 events1 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Liver injury	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Portal vein thrombosis	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Anaphylactic reaction	Immune system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA 19.1	Systematic Assessment	EG0004 events4 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0022 events2 affected1,346 at risk EG003
Graft versus host disease	Immune system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0023 events3 affected1,346 at risk EG003
Hypogammaglobulinaemia	Immune system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Sarcoidosis	Immune system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Abdominal abscess	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Abdominal infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Abdominal sepsis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Abdominal wall abscess	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Abscess	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Abscess jaw	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Abscess limb	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0022 events2 affected1,346 at risk EG003
Abscess soft tissue	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Anal abscess	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Appendicitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0012 events2 affected1,274 at risk EG0026 events6 affected1,346 at risk EG003
Appendicitis perforated	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Arthritis bacterial	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Arthritis infective	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Atypical pneumonia	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0022 events2 affected1,346 at risk EG003
Bacillus bacteraemia	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Bacteraemia	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0026 events6 affected1,346 at risk EG003
Bacterial sepsis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0013 events3 affected1,274 at risk EG0022 events2 affected1,346 at risk EG003
Bacterial tracheitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Biliary sepsis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Breast abscess	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Breast cellulitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Bronchiolitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Bronchitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG00110 events10 affected1,274 at risk EG0026 events6 affected1,346 at risk EG003
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0013 events3 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Campylobacter gastroenteritis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Cellulitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG00019 events12 affected1,322 at risk EG00118 events13 affected1,274 at risk EG00221 events19 affected1,346 at risk EG003
Cellulitis staphylococcal	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Cerebral aspergillosis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Chronic sinusitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Citrobacter sepsis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Clostridial infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Clostridial sepsis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Clostridium difficile colitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0009 events9 affected1,322 at risk EG0012 events2 affected1,274 at risk EG0026 events5 affected1,346 at risk EG003
Clostridium difficile infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0024 events4 affected1,346 at risk EG003
Cystitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Dengue fever	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Device related infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0007 events7 affected1,322 at risk EG0015 events4 affected1,274 at risk EG00210 events10 affected1,346 at risk EG003
Device related sepsis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Diarrhoea infectious	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0013 events3 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Disseminated cryptococcosis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Diverticulitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0025 events4 affected1,346 at risk EG003
Empyema	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Encephalitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Endocarditis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Endophthalmitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Enteritis infectious	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Enterococcal sepsis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0012 events2 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Epididymitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Erysipelas	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0024 events2 affected1,346 at risk EG003
Escherichia bacteraemia	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Escherichia infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Escherichia sepsis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0004 events4 affected1,322 at risk EG0012 events2 affected1,274 at risk EG0022 events2 affected1,346 at risk EG003
Escherichia urinary tract infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Extradural abscess	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Febrile infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Fungaemia	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Fungal oesophagitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0006 events6 affected1,322 at risk EG0015 events5 affected1,274 at risk EG0025 events5 affected1,346 at risk EG003
Gastroenteritis rotavirus	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Gastroenteritis salmonella	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Gastrointestinal infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0012 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Genital herpes	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Groin abscess	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
H1N1 influenza	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Haematoma infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Haemophilus bacteraemia	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Hepatitis B	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Hepatitis C	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Hepatosplenic candidiasis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Herpes virus infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0014 events4 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Herpes zoster disseminated	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0012 events2 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Herpes zoster oticus	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Implant site infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Infected bite	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0012 events2 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Infected fistula	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Infected seroma	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Infectious colitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Infectious pleural effusion	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Influenza	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected1,322 at risk EG0014 events4 affected1,274 at risk EG0023 events3 affected1,346 at risk EG003
Intestinal fistula infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Joint abscess	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Kidney infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Klebsiella bacteraemia	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0022 events2 affected1,346 at risk EG003
Klebsiella sepsis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Labyrinthitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Listeria sepsis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Lower respiratory tract infection bacterial	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Lower respiratory tract infection fungal	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Lung abscess	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Lung infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Lung infection pseudomonal	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Mediastinitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Meningitis aseptic	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Meningitis cryptococcal	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Meningoencephalitis herpetic	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Metapneumovirus infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Muscle abscess	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0012 events2 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Necrotising fasciitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0023 events3 affected1,346 at risk EG003
Neutropenic sepsis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Ophthalmic herpes zoster	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Orchitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Osteomyelitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Otitis media	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Paraspinal abscess	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Pelvic abscess	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0024 events4 affected1,346 at risk EG003
Pelvic inflammatory disease	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Periodontitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Periorbital cellulitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Perirectal abscess	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Peritonitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Peritonitis bacterial	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Peritonsillar abscess	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Pharyngitis streptococcal	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Pilonidal cyst	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Pleurisy viral	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0012 events2 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Pneumonia	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG00057 events49 affected1,322 at risk EG00183 events72 affected1,274 at risk EG00253 events49 affected1,346 at risk EG003
Pneumonia bacterial	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0012 events2 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Pneumonia cytomegaloviral	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Pneumonia fungal	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0012 events2 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Pneumonia influenzal	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Pneumonia klebsiella	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Pneumonia moraxella	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Pneumonia mycoplasmal	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Pneumonia necrotising	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0012 events2 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Pneumonia pneumococcal	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Pneumonia pseudomonal	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Pneumonia streptococcal	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0012 events2 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Post procedural cellulitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Post procedural infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Post procedural sepsis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Postoperative wound infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0023 events3 affected1,346 at risk EG003
Progressive multifocal leukoencephalopathy	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Pseudomembranous colitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Pseudomonal bacteraemia	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Pseudomonal sepsis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Psoas abscess	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Pulmonary sepsis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0022 events2 affected1,346 at risk EG003
Pyelonephritis acute	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Pyomyositis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Rectal abscess	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Renal abscess	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Respiratory moniliasis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Respiratory syncytial virus infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0023 events3 affected1,346 at risk EG003
Respiratory tract infection bacterial	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Rhinovirus infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Scrotal infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Sepsis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG00032 events28 affected1,322 at risk EG00118 events17 affected1,274 at risk EG00223 events21 affected1,346 at risk EG003
Sepsis syndrome	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Septic shock	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0006 events6 affected1,322 at risk EG0017 events7 affected1,274 at risk EG0027 events7 affected1,346 at risk EG003
Serratia bacteraemia	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Serratia sepsis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Sinusitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Skin infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Soft tissue infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Splenic abscess	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Staphylococcal abscess	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Staphylococcal bacteraemia	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0003 events2 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0022 events2 affected1,346 at risk EG003
Staphylococcal infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0012 events2 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Staphylococcal sepsis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Staphylococcal skin infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Stenotrophomonas sepsis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Subcutaneous abscess	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Tonsillitis bacterial	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Tooth abscess	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Tuberculosis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0012 events2 affected1,274 at risk EG0022 events2 affected1,346 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG00020 events19 affected1,322 at risk EG00111 events11 affected1,274 at risk EG00224 events24 affected1,346 at risk EG003
Urinary tract infection bacterial	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Urinary tract infection fungal	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Urinary tract infection staphylococcal	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Urosepsis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected1,322 at risk EG0015 events2 affected1,274 at risk EG0026 events6 affected1,346 at risk EG003
Varicella	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Varicella zoster pneumonia	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Viraemia	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Viral infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Vulval abscess	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
West Nile viral infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Wound abscess	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Wound infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0022 events2 affected1,346 at risk EG003
Abdominal wound dehiscence	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Accidental overdose	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Acetabulum fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Anastomotic stenosis	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0024 events4 affected1,346 at risk EG003
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Chemical peritonitis	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Compression fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0022 events2 affected1,346 at risk EG003
Concussion	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Cystitis radiation	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0012 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Eschar	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Eye contusion	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0013 events3 affected1,274 at risk EG0025 events5 affected1,346 at risk EG003
Fibula fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Foot fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Gastroenteritis radiation	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Gastrointestinal stoma complication	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0012 events1 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Head injury	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Heat exhaustion	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0005 events5 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0023 events3 affected1,346 at risk EG003
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Incarcerated incisional hernia	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Incisional hernia	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Intentional overdose	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Joint injury	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Laceration	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Ligament rupture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Muscle rupture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Osteoradionecrosis	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Overdose	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Periorbital haematoma	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Post procedural bile leak	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Post procedural discharge	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Post procedural fistula	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Post procedural haematuria	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0013 events3 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Postoperative fever	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Postoperative ileus	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0022 events2 affected1,346 at risk EG003
Postoperative respiratory distress	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Procedural hypotension	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Procedural pneumothorax	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0023 events3 affected1,346 at risk EG003
Radiation necrosis	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Radiation oesophagitis	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Radiation pericarditis	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Radiation pneumonitis	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Radius fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0012 events2 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Seroma	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Skin wound	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Spinal column injury	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected1,322 at risk EG0012 events2 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Sternal fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Stoma site haemorrhage	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Stomal hernia	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Stress fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Subarachnoid haemorrhage	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Subcutaneous haematoma	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0012 events2 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Subdural haemorrhage	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Thermal burn	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0013 events3 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Transplant dysfunction	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Traumatic haematoma	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Traumatic haemothorax	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Urinary retention postoperative	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Urostomy complication	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Wound	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
CSF test abnormal	Investigations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Oxygen saturation decreased	Investigations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Prothrombin time abnormal	Investigations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Troponin increased	Investigations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG00016 events16 affected1,322 at risk EG0012 events2 affected1,274 at risk EG00218 events17 affected1,346 at risk EG003
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0024 events3 affected1,346 at risk EG003
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Failure to thrive	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0023 events3 affected1,346 at risk EG003
Fluid overload	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0012 events2 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Food intolerance	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Gout	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0023 events3 affected1,346 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0022 events2 affected1,346 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0023 events2 affected1,346 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0005 events3 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0023 events3 affected1,346 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0019 events7 affected1,274 at risk EG0026 events6 affected1,346 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0012 events2 affected1,274 at risk EG0022 events2 affected1,346 at risk EG003
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Malnutrition	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0023 events3 affected1,346 at risk EG003
Metabolic alkalosis	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Tumour lysis syndrome	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Ankylosing spondylitis	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0004 events4 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0023 events3 affected1,346 at risk EG003
Bone cyst	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Fistula	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Fracture delayed union	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Haemarthrosis	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Muscle haemorrhage	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0022 events2 affected1,346 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0022 events2 affected1,346 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Myopathy	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0026 events5 affected1,346 at risk EG003
Osteolysis	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0022 events2 affected1,346 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0012 events2 affected1,274 at risk EG0023 events3 affected1,346 at risk EG003
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Polyarthritis	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Sacroiliitis	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Soft tissue mass	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Vertebral foraminal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Acute leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0012 events2 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Acute lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0014 events4 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Acute lymphocytic leukaemia recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0012 events2 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Acute monocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0015 events5 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Acute myeloid leukaemia recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Acute promyelocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Adenocarcinoma gastric	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0005 events5 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0023 events3 affected1,346 at risk EG003
Adenocarcinoma of appendix	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0009 events9 affected1,322 at risk EG0010 events0 affected1,274 at risk EG00211 events10 affected1,346 at risk EG003
Adenocarcinoma of salivary gland	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Adenocarcinoma pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0022 events2 affected1,346 at risk EG003
Anal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Anal cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Anal cancer stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Anaplastic large cell lymphoma T- and null-cell types	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Anaplastic oligodendroglioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Angiocentric lymphoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Appendix cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0023 events3 affected1,346 at risk EG003
B precursor type acute leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0019 events9 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
B-cell lymphoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0013 events3 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
B-cell lymphoma refractory	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
B-cell small lymphocytic lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
B-cell unclassifiable lymphoma low grade	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0012 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG00012 events9 affected1,322 at risk EG0017 events7 affected1,274 at risk EG00210 events9 affected1,346 at risk EG003
Basosquamous carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Benign renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Bile duct cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0005 events5 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0023 events3 affected1,346 at risk EG003
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Bowen's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Brain cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Brain neoplasm benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Brain neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG00098 events94 affected1,322 at risk EG0012 events2 affected1,274 at risk EG00289 events86 affected1,346 at risk EG003
Breast cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG00027 events27 affected1,322 at risk EG0010 events0 affected1,274 at risk EG00240 events40 affected1,346 at risk EG003
Breast cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected1,322 at risk EG0010 events0 affected1,274 at risk EG00212 events12 affected1,346 at risk EG003
Breast cancer stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Breast neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Bronchioloalveolar carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0022 events2 affected1,346 at risk EG003
Cervix cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Cervix carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0028 events8 affected1,346 at risk EG003
Cholangiocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0023 events3 affected1,346 at risk EG003
Cholesteatoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG00156 events54 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Chronic lymphocytic leukaemia recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0012 events2 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Chronic lymphocytic leukaemia transformation	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Chronic myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0015 events5 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Chronic myelomonocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0012 events2 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Clear cell renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Clear cell sarcoma of soft tissue	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG00061 events55 affected1,322 at risk EG0010 events0 affected1,274 at risk EG00271 events63 affected1,346 at risk EG003
Colon cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG00035 events33 affected1,322 at risk EG0010 events0 affected1,274 at risk EG00227 events24 affected1,346 at risk EG003
Colon cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Colon cancer stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Colon cancer stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Colon neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Colorectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Colorectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG00010 events10 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0028 events8 affected1,346 at risk EG003
Colorectal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0005 events5 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0025 events5 affected1,346 at risk EG003
Diffuse large B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0016 events6 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Diffuse large B-cell lymphoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Diffuse large B-cell lymphoma refractory	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Ductal adenocarcinoma of pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Duodenal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Endometrial adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0022 events2 affected1,346 at risk EG003
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0005 events5 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0027 events7 affected1,346 at risk EG003
Endometrial cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Endometrial cancer stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Ependymoma malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Epiglottic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Essential thrombocythaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Ewing's sarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Ewing's sarcoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Extranodal marginal zone B-cell lymphoma (MALT type)	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0012 events2 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Extranodal marginal zone B-cell lymphoma (MALT type) recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Fallopian tube cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Fibrous histiocytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Gallbladder adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0022 events2 affected1,346 at risk EG003
Gallbladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG00013 events12 affected1,322 at risk EG0010 events0 affected1,274 at risk EG00211 events11 affected1,346 at risk EG003
Gastric cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Gastrointestinal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Gastrointestinal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Gastrointestinal melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Gastrointestinal stromal tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Gastrooesophageal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Glioblastoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Glioblastoma multiforme	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0005 events5 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0028 events8 affected1,346 at risk EG003
Hairy cell leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0012 events2 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Head and neck cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Hepatic cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Hodgkin's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG00112 events11 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Hodgkin's disease lymphocyte depletion type stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Hodgkin's disease mixed cellularity recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Hodgkin's disease nodular sclerosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Hodgkin's disease nodular sclerosis recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Hodgkin's disease recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0013 events3 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Intestinal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Intraductal proliferative breast lesion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Invasive breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0006 events6 affected1,322 at risk EG0011 events1 affected1,274 at risk EG00210 events9 affected1,346 at risk EG003
Invasive lobular breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Keratinising squamous cell carcinoma of nasopharynx	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Keratoacanthoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Large granular lymphocytosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Laryngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0023 events3 affected1,346 at risk EG003
Laryngeal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Leiomyosarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Leiomyosarcoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Lentigo maligna	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Light chain disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Lip and/or oral cavity cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Liposarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Liposarcoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0003 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0006 events6 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0025 events5 affected1,346 at risk EG003
Lung adenocarcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0004 events2 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0022 events2 affected1,346 at risk EG003
Lung adenocarcinoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0006 events6 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0025 events5 affected1,346 at risk EG003
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG00052 events52 affected1,322 at risk EG0013 events3 affected1,274 at risk EG00251 events47 affected1,346 at risk EG003
Lung squamous cell carcinoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Lung squamous cell carcinoma stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Lymphocytic lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0014 events4 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Lymphoma transformation	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Lymphoplasmacytoid lymphoma/immunocytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Lymphoplasmacytoid lymphoma/immunocytoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Malignant ascites	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Malignant histiocytosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0026 events6 affected1,346 at risk EG003
Malignant melanoma in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Malignant neoplasm of ampulla of Vater	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0024 events4 affected1,346 at risk EG003
Malignant neoplasm of unknown primary site	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0025 events4 affected1,346 at risk EG003
Malignant peritoneal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0004 events3 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Malignant pleural effusion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0025 events4 affected1,346 at risk EG003
Mantle cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Mantle cell lymphoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Medullary carcinoma of breast	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Meningioma malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Mesothelioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Mesothelioma malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0022 events2 affected1,346 at risk EG003
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0022 events2 affected1,346 at risk EG003
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Metastases to lymph nodes	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Metastases to meninges	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Metastases to ovary	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Metastases to rectum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Metastatic carcinoma of the bladder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Metastatic gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0023 events3 affected1,346 at risk EG003
Metastatic malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0022 events2 affected1,346 at risk EG003
Metastatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Metastatic renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0023 events3 affected1,346 at risk EG003
Metastatic squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Mucinous adenocarcinoma of appendix	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0003 events2 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Mycosis fungoides	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Mycosis fungoides recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG00114 events12 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Myelodysplastic syndrome transformation	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0013 events3 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Myelofibrosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Myeloproliferative neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Nasopharyngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0022 events2 affected1,346 at risk EG003
Nasopharyngeal cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Neuroendocrine carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Neuroendocrine carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0026 events4 affected1,346 at risk EG003
Neuroendocrine carcinoma of the skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Neuroendocrine tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG00117 events17 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Non-Hodgkin's lymphoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Non-Hodgkin's lymphoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0013 events2 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Non-Hodgkin's lymphoma unspecified histology aggressive	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG00023 events22 affected1,322 at risk EG0011 events1 affected1,274 at risk EG00223 events18 affected1,346 at risk EG003
Non-small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0024 events4 affected1,346 at risk EG003
Non-small cell lung cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0022 events2 affected1,346 at risk EG003
Non-small cell lung cancer stage IIIB	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Oesophageal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0022 events2 affected1,346 at risk EG003
Oesophageal adenocarcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Oesophageal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0022 events2 affected1,346 at risk EG003
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0006 events5 affected1,322 at risk EG0010 events0 affected1,274 at risk EG00215 events15 affected1,346 at risk EG003
Oesophageal squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Oropharyngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Osteosarcoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Osteosarcoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Ovarian cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG00030 events27 affected1,322 at risk EG0010 events0 affected1,274 at risk EG00232 events29 affected1,346 at risk EG003
Ovarian cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0006 events6 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0024 events3 affected1,346 at risk EG003
Ovarian cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0006 events6 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0023 events3 affected1,346 at risk EG003
Ovarian epithelial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0022 events2 affected1,346 at risk EG003
Ovarian epithelial cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG00013 events13 affected1,322 at risk EG0012 events2 affected1,274 at risk EG00218 events17 affected1,346 at risk EG003
Pancreatic carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0025 events5 affected1,346 at risk EG003
Pancreatic carcinoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Pancreatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Pancreatic neuroendocrine tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Pancreatic neuroendocrine tumour metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Parathyroid tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Peripheral T-cell lymphoma unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0014 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Peripheral T-cell lymphoma unspecified recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Peritoneal carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Peritoneal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Pituitary tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG00154 events54 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Plasma cell myeloma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0018 events8 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Plasmablastic lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0012 events2 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Plasmacytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0012 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Precursor T-lymphoblastic lymphoma/leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0013 events3 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Precursor T-lymphoblastic lymphoma/leukaemia recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG00017 events15 affected1,322 at risk EG0015 events5 affected1,274 at risk EG00214 events10 affected1,346 at risk EG003
Prostate cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0004 events4 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0026 events6 affected1,346 at risk EG003
Rectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0025 events5 affected1,346 at risk EG003
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG00034 events25 affected1,322 at risk EG0010 events0 affected1,274 at risk EG00218 events17 affected1,346 at risk EG003
Rectal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0009 events9 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0027 events7 affected1,346 at risk EG003
Rectal cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Rectal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Rectosigmoid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Refractory anaemia with an excess of blasts	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Renal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0022 events2 affected1,346 at risk EG003
Renal cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0013 events3 affected1,274 at risk EG0022 events1 affected1,346 at risk EG003
Sarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Sarcoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0012 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Sarcoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Schwannoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Signet-ring cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Skin cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Skin cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Small cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0008 events7 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0026 events6 affected1,346 at risk EG003
Small cell lung cancer extensive stage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Small intestine adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Small intestine carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0022 events2 affected1,346 at risk EG003
Splenic marginal zone lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected1,322 at risk EG0016 events6 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Squamous cell carcinoma of head and neck	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Squamous cell carcinoma of lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0004 events4 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0024 events4 affected1,346 at risk EG003
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0016 events6 affected1,274 at risk EG0025 events4 affected1,346 at risk EG003
Squamous cell carcinoma of the hypopharynx	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Squamous cell carcinoma of the oral cavity	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0023 events3 affected1,346 at risk EG003
Squamous cell carcinoma of the tongue	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
T-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0016 events5 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
T-cell lymphoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
T-cell type acute leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Thymoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0022 events2 affected1,346 at risk EG003
Thyroid cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Tongue neoplasm malignant stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0023 events3 affected1,346 at risk EG003
Tonsil cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0022 events2 affected1,346 at risk EG003
Tonsillar neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0023 events3 affected1,346 at risk EG003
Tumour flare	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Ureteric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Urethral cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Uterine cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0024 events4 affected1,346 at risk EG003
Uterine leiomyosarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Vaginal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Vulval cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Waldenstrom's macroglobulinaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0012 events2 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Aphasia	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Autonomic nervous system imbalance	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Brain oedema	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Carotid artery aneurysm	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Carotid artery stenosis	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Cerebellar infarction	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Cerebral haematoma	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Cerebral haemorrhage	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Cerebral infarction	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Cerebral microangiopathy	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0008 events8 affected1,322 at risk EG0014 events4 affected1,274 at risk EG0025 events5 affected1,346 at risk EG003
Cervical cord compression	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Cognitive disorder	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Cubital tunnel syndrome	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Dementia	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0022 events2 affected1,346 at risk EG003
Dementia Alzheimer's type	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Depressed level of consciousness	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Diabetic coma	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Dizziness	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0022 events2 affected1,346 at risk EG003
Embolic stroke	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Encephalopathy	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0023 events3 affected1,346 at risk EG003
Epilepsy	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Facial paralysis	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0023 events3 affected1,346 at risk EG003
Guillain-Barre syndrome	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Haemorrhage intracranial	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Headache	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0013 events3 affected1,274 at risk EG0025 events5 affected1,346 at risk EG003
Hemiparesis	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Hepatic encephalopathy	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Hypoglycaemic coma	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Hypoxic-ischaemic encephalopathy	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Intensive care unit acquired weakness	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Intracranial haematoma	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Intraventricular haemorrhage	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0012 events2 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Lumbar radiculopathy	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Meningeal disorder	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Migraine	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Myelitis transverse	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Nervous system disorder	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Neuralgia	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0022 events2 affected1,346 at risk EG003
Parkinson's disease	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Polyneuropathy	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Post herpetic neuralgia	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Posterior reversible encephalopathy syndrome	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Presyncope	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Sciatica	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Seizure	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0006 events6 affected1,322 at risk EG0013 events2 affected1,274 at risk EG0025 events5 affected1,346 at risk EG003
Senile dementia	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Serotonin syndrome	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Simple partial seizures	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Spinal cord compression	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Syncope	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0005 events5 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0023 events3 affected1,346 at risk EG003
Toxic encephalopathy	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0023 events3 affected1,346 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0015 events5 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Vasogenic cerebral oedema	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Vocal cord paralysis	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Device dislocation	Product Issues	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0024 events3 affected1,346 at risk EG003
Device failure	Product Issues	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Device leakage	Product Issues	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Device malfunction	Product Issues	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0022 events2 affected1,346 at risk EG003
Device occlusion	Product Issues	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0023 events3 affected1,346 at risk EG003
Stent malfunction	Product Issues	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Thrombosis in device	Product Issues	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Adjustment disorder	Psychiatric disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Confusional state	Psychiatric disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Delirium	Psychiatric disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Depression	Psychiatric disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Major depression	Psychiatric disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Mania	Psychiatric disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Mental disorder	Psychiatric disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Mental status changes	Psychiatric disorders	MedDRA 19.1	Systematic Assessment	EG0005 events5 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0024 events4 affected1,346 at risk EG003
Mood altered	Psychiatric disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Somatic symptom disorder	Psychiatric disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Suicide attempt	Psychiatric disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG00012 events12 affected1,322 at risk EG00111 events10 affected1,274 at risk EG00220 events18 affected1,346 at risk EG003
Chronic kidney disease	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0013 events3 affected1,274 at risk EG0022 events2 affected1,346 at risk EG003
End stage renal disease	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0012 events2 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0023 events3 affected1,346 at risk EG003
Hydronephrosis	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0004 events4 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0024 events4 affected1,346 at risk EG003
Hypercalcaemic nephropathy	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Incontinence	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Micturition disorder	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0012 events2 affected1,274 at risk EG0023 events3 affected1,346 at risk EG003
Obstructive uropathy	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0005 events5 affected1,322 at risk EG0012 events2 affected1,274 at risk EG0026 events6 affected1,346 at risk EG003
Renal impairment	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Stag horn calculus	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Ureteric obstruction	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Ureterolithiasis	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Urinary bladder haemorrhage	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Urinary tract obstruction	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Adnexa uteri mass	Reproductive system and breast disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Cervical dysplasia	Reproductive system and breast disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Colpocele	Reproductive system and breast disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Dysfunctional uterine bleeding	Reproductive system and breast disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Endometrial hyperplasia	Reproductive system and breast disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Genital erosion	Reproductive system and breast disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Genital lesion	Reproductive system and breast disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Haemorrhagic ovarian cyst	Reproductive system and breast disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Metrorrhagia	Reproductive system and breast disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Ovarian cyst	Reproductive system and breast disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Ovarian disorder	Reproductive system and breast disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Ovarian mass	Reproductive system and breast disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Postmenopausal haemorrhage	Reproductive system and breast disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Prostatic disorder	Reproductive system and breast disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Prostatic dysplasia	Reproductive system and breast disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Testicular pain	Reproductive system and breast disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Vaginal disorder	Reproductive system and breast disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Acute interstitial pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0012 events2 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0009 events9 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0024 events3 affected1,346 at risk EG003
Alveolitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Apnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0024 events4 affected1,346 at risk EG003
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Bronchial hyperreactivity	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG00014 events10 affected1,322 at risk EG00119 events8 affected1,274 at risk EG00213 events10 affected1,346 at risk EG003
Chronic respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0022 events2 affected1,346 at risk EG003
Chylothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0005 events5 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0026 events6 affected1,346 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0023 events2 affected1,346 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0023 events3 affected1,346 at risk EG003
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0012 events2 affected1,274 at risk EG0022 events2 affected1,346 at risk EG003
Idiopathic pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0012 events2 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Nasal septum deviation	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Obstructive airways disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Organising pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Paranasal sinus mucosal hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG00012 events11 affected1,322 at risk EG0015 events5 affected1,274 at risk EG00214 events12 affected1,346 at risk EG003
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0028 events4 affected1,346 at risk EG003
Pneumonia lipoid	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0004 events4 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0022 events2 affected1,346 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0025 events5 affected1,346 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG00028 events28 affected1,322 at risk EG0017 events7 affected1,274 at risk EG00220 events19 affected1,346 at risk EG003
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Pulmonary infarction	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0022 events2 affected1,346 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Pulmonary toxicity	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Reactive airways dysfunction syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Respiration abnormal	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Respiratory acidosis	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0022 events2 affected1,346 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0006 events6 affected1,322 at risk EG0012 events2 affected1,274 at risk EG0028 events8 affected1,346 at risk EG003
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Tracheal stenosis	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Vocal cord thickening	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Brow ptosis	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Drug reaction with eosinophilia and systemic symptoms	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Eczema nummular	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Generalised erythema	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Pyoderma gangrenosum	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Rash vesicular	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Skin exfoliation	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Skin necrosis	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Skin reaction	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Stasis dermatitis	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Stevens-Johnson syndrome	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Swelling face	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Toxic epidermal necrolysis	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Accelerated hypertension	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Aortic aneurysm	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Aortic dissection	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Aortic stenosis	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Arterial thrombosis	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Circulatory collapse	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG00014 events14 affected1,322 at risk EG0016 events6 affected1,274 at risk EG00212 events12 affected1,346 at risk EG003
Embolism	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Haematoma	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Haemorrhage	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Hypertension	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Hypertensive crisis	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0002 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Hypertensive emergency	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Hypotension	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0024 events4 affected1,346 at risk EG003
Hypovolaemic shock	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Lymphoedema	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0023 events3 affected1,346 at risk EG003
Orthostatic hypotension	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0012 events2 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Pelvic venous thrombosis	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0021 events1 affected1,346 at risk EG003
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0013 events2 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Peripheral artery occlusion	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Peripheral embolism	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Peripheral ischaemia	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Peripheral venous disease	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Subclavian vein thrombosis	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0023 events3 affected1,346 at risk EG003
Superior vena cava syndrome	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003
Thrombosis	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0011 events1 affected1,274 at risk EG0022 events2 affected1,346 at risk EG003
Venous thrombosis limb	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected1,322 at risk EG0010 events0 affected1,274 at risk EG0020 events0 affected1,346 at risk EG003

ID	Term
D006562	Herpes Zoster
D019337	Hematologic Neoplasms

ID	Term
D000073618	Varicella Zoster Virus Infection
D006566	Herpesviridae Infections
D004266	DNA Virus Infections
D014777	Virus Diseases
D007239	Infections
D009371	Neoplasms by Site
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

ID	Term
D001688	Biological Products
D045424	Complex Mixtures

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	V212-STM	Participants with STM receiving chemotherapy randomized to receive V212 vaccine given as a 4-dose regimen administered ~30 days apart.	472	1,322	794	1,322	857	1,322
EG001	V212-HM	Participants with HM randomized to receive V212 vaccine given as a 4-dose regimen administered ~30 days apart.	159	1,274	500	1,274	779	1,274
EG002	Placebo-STM	Participants with STM receiving chemotherapy randomized to receive placebo to V212 vaccine given as a 4-dose regimen administered ~30 days apart.	488	1,346	808	1,346	759	1,346
EG003	Placebo-HM	Participants with HM randomized to receive placebo to V212 vaccine given as a 4-dose regimen administered ~30 days apart.	146	1,274	507	1,274	559	1,274