Comparison of Treatment Regimens Using Ranibizumab: Inten... | NCT01972789

Label	Type	Description	Intervention Names
Intensive retinal fluid regimen	Experimental	Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of any IRF or SRF on OCT.	Drug: Ranibizumab
Relaxed retinal fluid regimen	Experimental	Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of IRF or SRF >200 um on OCT.	Drug: Ranibizumab

Name	Type	Description	Arm Group Labels	Other Names
Ranibizumab	Drug	Ranibizumab solution for injection is commercially supplied in two presentations: as a pre-filled syringe (containing 1.65 mg of ranibizumab in 0.165 mL solution) and as a vial (containing 2.3 mg of ranibizumab in 0.23 mL solution) corresponding to a recommended dose of 0.5 mg (0.05 mL) given as a single intravitreal injection. It will be prescribed and administered by the investigator or designee

Measure	Description	Time Frame
Mean Change in Best-corrected Visual Acuity (BCVA) From Baseline to 24 Months.	Best-corrected visual acuity (BCVA) with refraction will be taken using a logMAR chart at a distance of 3 metres in the study eye at baseline and month 24.	Baseline to month 24

Measure	Description	Time Frame
Mean Change in BCVA From Baseline to Month 12.	Best-corrected visual acuity (BCVA) with refraction will be taken using a logMAR chart at a distance of 3 metres in the study eye at baseline and month 12.	Baseline to month 12
Mean Change in Central Retinal Thickness (CRT) From Baseline to Month 12 and 24.

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Albury	New South Wales	2640	Australia
Novartis Investigative Site

PubMed Identifier	Type	Citation	Retractions
27009515	Derived	Arnold JJ, Markey CM, Kurstjens NP, Guymer RH. The role of sub-retinal fluid in determining treatment outcomes in patients with neovascular age-related macular degeneration--a phase IV randomised clinical trial with ranibizumab: the FLUID study. BMC Ophthalmol. 2016 Mar 24;16:31. doi: 10.1186/s12886-016-0207-3.

ID	Title	Description
FG000	Intensive Retinal Fluid Regimen	Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of any IRF or SRF on OCT.
FG001	Relaxed Retinal Fluid Regimen

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 19, 2017	Feb 22, 2018

ID	Title	Description
BG000	Intensive Retinal Fluid Regimen	Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of any IRF or SRF on OCT.
BG001	Relaxed Retinal Fluid Regimen	Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of IRF or SRF >200 um on OCT.
BG002	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Mean Change in Best-corrected Visual Acuity (BCVA) From Baseline to 24 Months.

Best-corrected visual acuity (BCVA) with refraction will be taken using a logMAR chart at a distance of 3 metres in the study eye at baseline and month 24.

Full Analysis Set (FAS): The Full Analysis Set (FAS) compromises all subjects randomised and whom have at least one post-Baseline efficacy value for the primary endpoint

Posted

Mean

Standard Deviation

Letters

Baseline to month 24

ID	Title	Description
OG000	Intensive Retinal Fluid Regimen	Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of any IRF or SRF on OCT.
OG001	Relaxed Retinal Fluid Regimen	Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of IRF or SRF >200 um on OCT.

Units	Counts
Participants	OG000172 OG001173

Title

Denominators

Categories

Title	Measurements
	OG0003.2± 16.51 OG0012.5± 16.56

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Mixed Models Analysis		0.787		Odds Ratio (OR)	0.40			2-Sided	95	-2.51	3.32					Non-Inferiority	This is a non-inferiority study design, with a pre-specified non-inferiority margin of 5 letters between intensive and relaxed groups. That is, if the change from Baseline in BCVA at Month 24 in the intensive group is not more than 5 letters higher than the relaxed group, then the relaxed group is regarded not inferior to the intensive group

Secondary

Mean Change in BCVA From Baseline to Month 12.

Best-corrected visual acuity (BCVA) with refraction will be taken using a logMAR chart at a distance of 3 metres in the study eye at baseline and month 12.

Full Analysis Set (FAS): The Full Analysis Set (FAS) compromises all subjects randomised and whom have at least one post-Baseline efficacy value for the primary endpoint

Posted

Mean

Standard Deviation

Letters

Baseline to month 12

ID	Title	Description
OG000	Intensive Retinal Fluid Regimen	Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of any IRF or SRF on OCT.
OG001	Relaxed Retinal Fluid Regimen	Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of IRF or SRF >200 um on OCT.

Units	Counts
Participants

Secondary

Mean Change in Central Retinal Thickness (CRT) From Baseline to Month 12 and 24.

Central retinal thickness will be measured by Optical Coherence Tomography (OCT) at every visit.

Full Analysis Set (FAS): The Full Analysis Set (FAS) compromises all subjects randomised and whom have at least one post-Baseline efficacy value for the primary endpoint

Posted

Mean

Standard Deviation

μm

Baseline to month 12 and month 24

ID	Title	Description
OG000	Intensive Retinal Fluid Regimen	Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of any IRF or SRF on OCT.
OG001	Relaxed Retinal Fluid Regimen	Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of IRF or SRF >200 um on OCT.

Units	Counts
Participants

Secondary

Mean Number of Injections From Baseline to Month 12 and 24

The number of injections will be determined by the individual patient response to ranibizumab therapy and potential for extension between injections based on specific criteria: loss of visual acuity, new retinal haemorrhage, and presence of IRF or SRF on OCT.

Full Analysis Set (FAS): The Full Analysis Set (FAS) compromises all subjects randomised and whom have at least one post-Baseline efficacy value for the primary endpoint

Posted

Mean

Standard Deviation

Injections

Baseline to month 12 to month 24.

ID	Title	Description
OG000	Intensive Retinal Fluid Regimen	Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of any IRF or SRF on OCT.
OG001	Relaxed Retinal Fluid Regimen	Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of IRF or SRF >200 um on OCT.

Units	Counts

Secondary

Mean Change in Area of New and Existing Geographic Atrophy From Baseline to Month 12 and 24.

Autofluorescence will be measured by multimodal imaging to assess the presence and development of geographic atrophy in the study at baseline, and month 12 and 24.

Full Analysis Set (FAS): The Full Analysis Set (FAS) compromises all subjects randomised and whom have at least one post-Baseline efficacy value for the primary endpoint

Posted

Mean

Standard Deviation

mm^2

Baseline to months 12 and 24.

ID	Title	Description
OG000	Intensive Retinal Fluid Regimen	Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of any IRF or SRF on OCT.
OG001	Relaxed Retinal Fluid Regimen	Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of IRF or SRF >200 um on OCT.

Units	Counts
Participants

Secondary

Proportion of Patients Showing Newly Developed Geographic Atrophy (GA) at Months 12 and 24

A multimodal imaging approach will be used to assess the presence of new geographic atrophy (defined as incorporating both geographic atrophy and atrophy associated with the CNV) in the study eye at baseline, and month 12 and 24. Image modalities will include fundus autofluorescence (AF) imaging, infrared imaging, OCT and colour fundus (CF) photographs. Atrophy will be diagnosed if FA and one other modality confirm the presence of macular atrophy

Full Analysis Set (FAS): The Full Analysis Set (FAS) compromises all subjects randomized and whom have at least one post-Baseline efficacy value for the primary endpoint

Posted

Number

Participants

Months 12 and 24

ID	Title	Description
OG000	Intensive Retinal Fluid Regimen	Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of any IRF or SRF on OCT.
OG001	Relaxed Retinal Fluid Regimen	Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of IRF or SRF >200 um on OCT.

Secondary

Proportion of Patients Showing no IRF and SRF at Months 2, 12 and 24.

Assessed by Optical Coherence Tomography (OCT) and confirmed by a central reading centre.

Full Analysis Set (FAS): The Full Analysis Set (FAS) compromises all subjects randomized and whom have at least one post-Baseline efficacy value for the primary endpoint

Posted

Number

Participants

Months 2, 12 and 24.

ID	Title	Description
OG000	Intensive Retinal Fluid Regimen	Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of any IRF or SRF on OCT.
OG001	Relaxed Retinal Fluid Regimen	Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of IRF or SRF >200 um on OCT.

Units	Counts
Participants

Secondary

Proportion of Patients Showing Greater Than or Equal to 15 Letters Early Treatment Diabetic Retinopathy (ETDRS) Gain From Baseline to Month 12 and 24.

Best-corrected visual acuity (BCVA) with refraction will be taken using a logMAR chart at a distance of 3 metres in the study eye at baseline and months 2, 12 and 24.

Full Analysis Set (FAS): The Full Analysis Set (FAS) compromises all subjects randomized and whom have at least one post-Baseline efficacy value for the primary endpoint

Posted

Number

Participants

Baseline to months 12 and 24.

ID	Title	Description
OG000	Intensive Retinal Fluid Regimen	Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of any IRF or SRF on OCT.
OG001	Relaxed Retinal Fluid Regimen	Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of IRF or SRF >200 um on OCT.

Units	Counts

Secondary

Proportion of Patients Showing Less Than 15 Letters ETDRS Loss From Baseline to Month 12 and 24.

Best-corrected visual acuity with refraction will be taken using a logMAR chart at a distance of 3 metres in the study eye at baseline and months 2, 12 and 24.

Full Analysis Set (FAS): The Full Analysis Set (FAS) compromises all subjects randomized and whom have at least one post-Baseline efficacy value for the primary endpoint

Posted

Number

Participants

Baseline to months 12 and 24

ID	Title	Description
OG000	Intensive Retinal Fluid Regimen	Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of any IRF or SRF on OCT.
OG001	Relaxed Retinal Fluid Regimen	Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of IRF or SRF >200 um on OCT.

Units	Counts
Participants

Secondary

Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.

DNA will be extracted from saliva and genotyping performed on the significantly associated single nucleotide polymorphisms (SNPs) identified by the AMD Gene Consortium (Nature Genetics, March 2013). Genotypes will be derived through the use of a Sequenom Iplex protocol. No correlation analyses were performed.

Full Analysis Set (FAS): The Full Analysis Set (FAS) compromises all subjects randomized and whom have at least one post-Baseline efficacy value for the primary endpoint

Posted

Number

Participants

Baseline or following consent

ID	Title	Description
OG000	Intensive Retinal Fluid Regimen	Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of any IRF or SRF on OCT.
OG001	Relaxed Retinal Fluid Regimen	Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of IRF or SRF >200 um on OCT.

Secondary

Proportion of Patients With Both SRF (Sub-retinal Fluid) and IRF (Intra-retinal Fluid) Who Despite Monthly Treatment do Not Resolve Their SRF

Assessed by Optical Coherence Tomography (OCT) and confirmed by a central reading centre.

Full Analysis Set (FAS): The Full Analysis Set (FAS) compromises all subjects randomized and whom have at least one post-Baseline efficacy value for the primary endpoint

Posted

Number

Participants

Month 12 and 24

ID	Title	Description
OG000	Intensive Retinal Fluid Regimen	Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of any IRF or SRF on OCT.
OG001	Relaxed Retinal Fluid Regimen	Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of IRF or SRF >200 um on OCT.

Units	Counts
Participants

Secondary

The Number of Times a Participant Needs to Return to Monthly Treatments During the 24 Months.

Treatment requirements will be determined by the individual patient disease activity as measured by OCT, BCVA, colour fundus photography and fluorescein angiography (FA). Analysis was not performed.

Full Analysis Set (FAS): The Full Analysis Set (FAS) compromises all subjects randomized and whom have at least one post-Baseline efficacy value for the primary endpoint.

Posted

Mean

Standard Deviation

Visits

Month 24

ID	Title	Description
OG000	Intensive Retinal Fluid Regimen	Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of any IRF or SRF on OCT.
OG001	Relaxed Retinal Fluid Regimen	Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of IRF or SRF >200 um on OCT.

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected173 at risk EG0010 affected174 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Normochromic normocytic anaemia	Blood and lymphatic system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0012 affected174 at risk
Arrhythmia	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected173 at risk EG0017 affected174 at risk
Bradycardia	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Cardiac failure	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected173 at risk EG0011 affected174 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Cardiogenic shock	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Coronary artery disease	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Myocardial infarction	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0011 affected174 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Pericarditis	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Tachycardia	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Phimosis	Congenital, familial and genetic disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Meniere's disease	Ear and labyrinth disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Macular hole	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Retinal artery occlusion	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Retinal pigment epithelial tear	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Alcoholic pancreatitis	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Barrett's oesophagus	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Dysphagia	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Gastrointestinal oedema	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Haematemesis	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Peptic ulcer	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Vomiting	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Catheter site extravasation	General disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Chest pain	General disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0011 affected174 at risk
Death	General disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected173 at risk EG0012 affected174 at risk
Disease progression	General disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0012 affected174 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0012 affected174 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Jaundice cholestatic	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Drug hypersensitivity	Immune system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Appendicitis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Arthritis infective	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Bacteraemia	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Bronchitis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Cystitis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0002 affected173 at risk EG0010 affected174 at risk
Endophthalmitis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Escherichia bacteraemia	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Gastroenteritis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0011 affected174 at risk
Gastroenteritis viral	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Herpes zoster	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Influenza	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0002 affected173 at risk EG0010 affected174 at risk
Klebsiella infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Localised infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0013 affected174 at risk
Pertussis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Pneumonia	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG00010 affected173 at risk EG0015 affected174 at risk
Sepsis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Skin graft infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Urinary tract infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0012 affected174 at risk
Urosepsis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Cataract operation complication	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0004 affected173 at risk EG0012 affected174 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0011 affected174 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Pulmonary contusion	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0002 affected173 at risk EG0010 affected174 at risk
Skull fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Blood sodium decreased	Investigations	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected173 at risk EG0010 affected174 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Colon cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0012 affected174 at risk
Diffuse large B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Ductal adenocarcinoma of pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Gastrointestinal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0003 affected173 at risk EG0010 affected174 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Mesothelioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Metastases to abdominal cavity	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0011 affected174 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0012 affected174 at risk
Squamous cell carcinoma of lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0003 affected173 at risk EG0014 affected174 at risk
Convulsion	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Dementia Alzheimer's type	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Dizziness	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Neuralgia	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Presyncope	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Syncope	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected173 at risk EG0010 affected174 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0004 affected173 at risk EG0012 affected174 at risk
Confusional state	Psychiatric disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Delirium	Psychiatric disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Haematuria	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0011 affected174 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Renal disorder	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Renal failure acute	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Renal impairment	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Renal injury	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Urinary retention	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected173 at risk EG0010 affected174 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Hospitalisation	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0011 affected174 at risk
Percutaneous coronary intervention	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Arteriovenous fistula	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Blood pressure fluctuation	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Haemorrhage	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Hypertension	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Hypotension	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Orthostatic hypotension	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0012 affected174 at risk
Anaemia(Non-ocular)	Blood and lymphatic system disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected173 at risk EG0010 affected174 at risk
Iron deficiency anaemia(Non-ocular)	Blood and lymphatic system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Normochromic normocytic anaemia(Non-ocular)	Blood and lymphatic system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Acute myocardial infarction(Non-ocular)	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0012 affected174 at risk
Arrhythmia(Non-ocular)	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Atrial fibrillation(Non-ocular)	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected173 at risk EG0017 affected174 at risk
Bradycardia(Non-ocular)	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Cardiac failure congestive(Non-ocular)	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Cardiac failure(Non-ocular)	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected173 at risk EG0011 affected174 at risk
Cardiogenic shock(Non-ocular)	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Coronary artery disease(Non-ocular)	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Myocardial infarction(Non-ocular)	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0011 affected174 at risk
Myocardial ischaemia(Non-ocular)	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Pericarditis(Non-ocular)	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Tachycardia(Non-ocular)	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Ventricular tachycardia(Non-ocular)	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Phimosis(Non-ocular)	Congenital, familial and genetic disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Meniere's disease(Non-ocular)	Ear and labyrinth disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Vertigo positional(Non-ocular)	Ear and labyrinth disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Macular hole(Left eye)	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Retinal artery occlusion(Right eye)	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Retinal pigment epithelial tear(Left eye)	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Abdominal pain upper(Non-ocular)	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Alcoholic pancreatitis(Non-ocular)	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Barrett's oesophagus(Non-ocular)	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Dysphagia(Non-ocular)	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Gastric ulcer(Non-ocular)	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Gastrointestinal oedema(Non-ocular)	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Haematemesis(Non-ocular)	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Intestinal perforation(Non-ocular)	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Pancreatitis(Non-ocular)	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Peptic ulcer(Non-ocular)	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Vomiting(Non-ocular)	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Catheter site extravasation(Non-ocular)	General disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Chest pain(Non-ocular)	General disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0011 affected174 at risk
Death(Non-ocular)	General disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected173 at risk EG0012 affected174 at risk
Disease progression(Non-ocular)	General disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0012 affected174 at risk
Cholecystitis acute(Non-ocular)	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0012 affected174 at risk
Cholecystitis chronic(Non-ocular)	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Cholelithiasis(Non-ocular)	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Hepatic cirrhosis(Non-ocular)	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Jaundice cholestatic(Non-ocular)	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Drug hypersensitivity(Non-ocular)	Immune system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Appendicitis(Non-ocular)	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Arthritis infective(Non-ocular)	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Bacteraemia(Non-ocular)	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Bronchitis(Non-ocular)	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Cystitis()	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Cystitis(Non-ocular)	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Endophthalmitis(Right eye)	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Escherichia bacteraemia(Non-ocular)	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Gastroenteritis viral(Non-ocular)	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Gastroenteritis(Non-ocular)	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0011 affected174 at risk
Herpes zoster(Non-ocular)	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Infective exacerbation of chronic obstructive airways disease(Non-ocular)	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Influenza(Non-ocular)	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0002 affected173 at risk EG0010 affected174 at risk
Klebsiella infection(Non-ocular)	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Localised infection(Non-ocular)	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Lower respiratory tract infection(Non-ocular)	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0013 affected174 at risk
Pertussis(Left eye)	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Pneumonia(Non-ocular)	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG00010 affected173 at risk EG0015 affected174 at risk
Sepsis(Non-ocular)	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Skin graft infection(Non-ocular)	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Urinary tract infection(Non-ocular)	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0012 affected174 at risk
Urosepsis(Non-ocular)	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Accidental overdose(Non-ocular)	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Cataract operation complication(Right eye)	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Clavicle fracture(Non-ocular)	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Fall(Non-ocular)	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0004 affected173 at risk EG0012 affected174 at risk
Femoral neck fracture(Non-ocular)	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0011 affected174 at risk
Foot fracture(Non-ocular)	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Head injury(Non-ocular)	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Hip fracture(Non-ocular)	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Humerus fracture(Non-ocular)	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Joint dislocation(Non-ocular)	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Joint injury(Non-ocular)	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Laceration(Non-ocular)	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Pelvic fracture(Non-ocular)	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Pulmonary contusion(Non-ocular)	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Rib fracture(Non-ocular)	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0002 affected173 at risk EG0010 affected174 at risk
Skull fracture(Non-ocular)	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Vascular pseudoaneurysm(Non-ocular)	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Blood sodium decreased(Non-ocular)	Investigations	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Fluid overload(Non-ocular)	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Hyponatraemia(Non-ocular)	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected173 at risk EG0010 affected174 at risk
Back pain(Non-ocular)	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Myalgia(Non-ocular)	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Rotator cuff syndrome(Non-ocular)	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Bladder cancer(Non-ocular)	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Breast cancer(Non-ocular)	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Colon cancer metastatic(Non-ocular)	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0012 affected174 at risk
Colon cancer(Non-ocular)	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Diffuse large B-cell lymphoma(Non-ocular)	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Ductal adenocarcinoma of pancreas(Non-ocular)	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Gastrointestinal carcinoma(Non-ocular)	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0003 affected173 at risk EG0010 affected174 at risk
Lung neoplasm malignant(Non-ocular)	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Mesothelioma(Non-ocular)	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Metastases to abdominal cavity(Non-ocular)	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Metastases to liver(Non-ocular)	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Metastases to lung(Non-ocular)	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Neoplasm malignant(Non-ocular)	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Plasma cell myeloma(Non-ocular)	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Prostate cancer(Non-ocular)	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0011 affected174 at risk
Squamous cell carcinoma of lung(Non-ocular)	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Squamous cell carcinoma(Non-ocular)	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0012 affected174 at risk
Cerebral haemorrhage(Non-ocular)	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Cerebrovascular accident(Non-ocular)	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0003 affected173 at risk EG0014 affected174 at risk
Convulsion(Non-ocular)	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Dementia Alzheimer's type(Non-ocular)	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Dizziness(Non-ocular)	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Neuralgia(Non-ocular)	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Presyncope(Non-ocular)	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Syncope(Non-ocular)	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected173 at risk EG0010 affected174 at risk
Transient ischaemic attack(Non-ocular)	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0004 affected173 at risk EG0012 affected174 at risk
Confusional state(Non-ocular)	Psychiatric disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Delirium(Non-ocular)	Psychiatric disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Haematuria(Non-ocular)	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0011 affected174 at risk
Nephrolithiasis(Non-ocular)	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Renal disorder(Non-ocular)	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Renal failure acute(Non-ocular)	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Renal impairment(Non-ocular)	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Renal injury(Non-ocular)	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Urinary retention(Non-ocular)	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Acute pulmonary oedema(Non-ocular)	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Asthma(Non-ocular)	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected173 at risk EG0010 affected174 at risk
Chronic obstructive pulmonary disease(Non-ocular)	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Pneumothorax(Non-ocular)	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Pulmonary embolism(Non-ocular)	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Pulmonary fibrosis(Non-ocular)	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Pulmonary hypertension(Non-ocular)	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Skin ulcer(Non-ocular)	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Hospitalisation()	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Hospitalisation(Non-ocular)	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Percutaneous coronary intervention(Non-ocular)	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Arteriovenous fistula(Non-ocular)	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Blood pressure fluctuation(Non-ocular)	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Haemorrhage(Non-ocular)	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Hypertension(Non-ocular)	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected173 at risk EG0011 affected174 at risk
Hypotension(Non-ocular)	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0010 affected174 at risk
Orthostatic hypotension(Non-ocular)	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected173 at risk EG0012 affected174 at risk

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Intensive	Intensive	7	173	58	173	109	173
EG001	Relaxed	Relaxed	5	174	58	174	114	174

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Age-related macular degeneration	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG00018 affected173 at risk EG00117 affected174 at risk
Cataract	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0004 affected173 at risk EG00113 affected174 at risk
Conjunctival haemorrhage	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0008 affected173 at risk EG00113 affected174 at risk
Dry eye	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0008 affected173 at risk EG0019 affected174 at risk
Eye pain	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG00028 affected173 at risk EG00124 affected174 at risk
Eye pruritus	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0009 affected173 at risk EG0015 affected174 at risk
Foreign body sensation in eyes	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0008 affected173 at risk EG00111 affected174 at risk
Lacrimation increased	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG00017 affected173 at risk EG0018 affected174 at risk
Retinal haemorrhage	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0007 affected173 at risk EG00112 affected174 at risk
Vision blurred	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG00016 affected173 at risk EG00110 affected174 at risk
Visual acuity reduced	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0009 affected173 at risk EG00111 affected174 at risk
Vitreous detachment	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG00011 affected173 at risk EG00111 affected174 at risk
Vitreous floaters	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG00021 affected173 at risk EG00111 affected174 at risk
Nausea	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0008 affected173 at risk EG00110 affected174 at risk
Disease progression	General disorders	MedDRA (19.1)	Systematic Assessment	EG0009 affected173 at risk EG0016 affected174 at risk
Injection site pain	General disorders	MedDRA (19.1)	Systematic Assessment	EG00014 affected173 at risk EG0018 affected174 at risk
Influenza	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG00026 affected173 at risk EG00116 affected174 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG00010 affected173 at risk EG00111 affected174 at risk
Nasopharyngitis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG00023 affected173 at risk EG00129 affected174 at risk
Urinary tract infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG00011 affected173 at risk EG00113 affected174 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG00021 affected173 at risk EG00115 affected174 at risk
Dizziness	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG00011 affected173 at risk EG0019 affected174 at risk
Headache	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG00016 affected173 at risk EG0019 affected174 at risk
Depression	Psychiatric disorders	MedDRA (19.1)	Systematic Assessment	EG0003 affected173 at risk EG00111 affected174 at risk
Cataract operation	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0006 affected173 at risk EG00110 affected174 at risk
Age-related macular degeneration(Left eye)	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0008 affected173 at risk EG00114 affected174 at risk
Age-related macular degeneration(Right eye)	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG00011 affected173 at risk EG0015 affected174 at risk
Cataract(Left eye)	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected173 at risk EG0019 affected174 at risk
Eye pain(Left eye)	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG00012 affected173 at risk EG00111 affected174 at risk
Eye pain(Right eye)	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG00011 affected173 at risk EG00113 affected174 at risk
Lacrimation increased(Right eye)	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0009 affected173 at risk EG0014 affected174 at risk
Retinal haemorrhage(Left eye)	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0006 affected173 at risk EG0019 affected174 at risk
Vision blurred(Right eye)	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0009 affected173 at risk EG0013 affected174 at risk
Vitreous floaters(Left eye)	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG00014 affected173 at risk EG0015 affected174 at risk
Nausea(Non-ocular)	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0008 affected173 at risk EG00110 affected174 at risk
Injection site pain(Right eye)	General disorders	MedDRA (19.1)	Systematic Assessment	EG0009 affected173 at risk EG0014 affected174 at risk
Influenza(Non-ocular)	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG00026 affected173 at risk EG00116 affected174 at risk
Lower respiratory tract infection(Non-ocular)	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG00010 affected173 at risk EG00111 affected174 at risk
Nasopharyngitis(Non-ocular)	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG00023 affected173 at risk EG00129 affected174 at risk
Urinary tract infection(Non-ocular)	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG00011 affected173 at risk EG00113 affected174 at risk
Fall(Non-ocular)	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG00021 affected173 at risk EG00115 affected174 at risk
Dizziness(Non-ocular)	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG00011 affected173 at risk EG0019 affected174 at risk
Headache(Non-ocular)	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG00015 affected173 at risk EG0018 affected174 at risk
Depression(Non-ocular)	Psychiatric disorders	MedDRA (19.1)	Systematic Assessment	EG0003 affected173 at risk EG00111 affected174 at risk