An Extension Study to Evaluate the Safety and Tolerabilit... | NCT00379795

Label	Type	Description	Intervention Names
Ranibizumad 0.5 mg	Experimental	Ranibizumab 0.5 mg intravitreal injection 0.5 mg in the study eye on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment.	Drug: Ranibizumab 0.5 mg

Name	Type	Description	Arm Group Labels	Other Names
Ranibizumab 0.5 mg	Drug	Ranibizumab intravitreal injection 0.5 mg in a single-dose regimen given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Ocular Adverse Events	Number of participants with ocular adverse events in the following categories: any adverse events, serious adverse events, adverse events leading to study discontinuation, endophthalmitis and intraocular inflammation that occurred in the study eye (the eye that received all study drug injections) and the fellow eye (other eye). Only adverse events that occurred during this extension study are reported. For subjects in the crossover groups who started their first ranibizumab injection in this extension study, adverse events that occurred prior to any ranibizumab injection were also excluded.	36 months
Number of Participants With Non-ocular Adverse Events	Number of participants with non-ocular adverse events (not occurring in the eye) in the following categories: any adverse events, serious adverse events, adverse events leading to study discontinuation and death. Only adverse events that occurred during this extension study are reported. For subjects in the crossover groups who started their first ranibizumab injection in this extension study, adverse events that occurred prior to any ranibizumab injection were also excluded. Additional information about adverse events can be found in the adverse events section.	36 months
Number of Participants With Positive Serum Antibodies to Ranibizumab at Month 12 and Month 24	Serum samples for the evaluation of antibodies to Ranibizumab were collected at Month 12 and Month 24 and were sent to a reference laboratory for analysis. If an injection of Ranibizumab was required at the visit, the samples were collected prior to the injection.	Month 12 and 24

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in Best Corrected Visual Acuity (BCVA) at a Starting Test Distance of 2 Meters	Change from baseline in Best corrected visual acuity (BCVA) was assessed by the number of letters a patient could read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) Eye Chart at a starting test distance of 2 meters. An increase in the number of letters read indicates improvement in visual acuity.

Eligibility Module

Name	Affiliation	Role
Lisa Tuomi, M.D.	Genentech, Inc.	Study Director

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	RanibizumabTreated Initial Mono	In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Participants in this group received ranibizumab monotherapy (Mono) in previous studies, that is, ranibizumab alone in study FVF2598g or ranibizumab in combination with sham photodynamic therapy (PDT) in study FVF2587g.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	RanibizumabTreated Initial Mono	In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Participants in this group received ranibizumab 0.5 mg monotherapy, that is, ranibizumab alone in study FVF2598g or ranibizumab in combination with sham photodynamic therapy (PDT) in study FVF2587g.
BG001	RanibizumabTreated Initial + PDT	In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. This group includes participants who received ranibizumab 0.5 mg intravitreal injections in combination with photodynamic therapy in Study FVF2428g.
BG002	RanibizumabTreated Sham XO	In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated Sham Crossover (XO) includes participants who received sham intravitreal injections before crossing over to receive ranibizumab 0.5mg intravitreal injections in previous study FVF2598g or in this extension study.
BG003	Ranibizumab Treated PDT XO	In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated PDT XO includes participants who received sham intravitreal injections in combination with photodynamic therapy in study FVF2428g or study FVF2587g before crossing over to receive ranibizumab 0.5 mg intravitreal injections in previous studies FVF2428g, study FVF2587g or this extension study.
BG004	Ranibizumab Untreated Group	In this extension study participants did not receive Ranibizumab. Participants in this group were previously enrolled in one of the following studies: FVF2428g (NCT00056823), FVF2587g (NCT00061594), FVF2598g (NCT0056823) but did not receive treatment with Ranibizumab in that study or in this extension study (FVF3426g).
BG005	Total	Total of all reporting groups

Units	Counts
Participants	BG000526 BG00174 BG002116 BG00374 BG00463 BG005853

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

Number of Participants With Ocular Adverse Events

Number of participants with ocular adverse events in the following categories: any adverse events, serious adverse events, adverse events leading to study discontinuation, endophthalmitis and intraocular inflammation that occurred in the study eye (the eye that received all study drug injections) and the fellow eye (other eye).

Only adverse events that occurred during this extension study are reported. For subjects in the crossover groups who started their first ranibizumab injection in this extension study, adverse events that occurred prior to any ranibizumab injection were also excluded.

All enrolled participants treated with Ranibizumab in this extension study or in one of the previous studies.

Posted

Number

participants

36 months

ID	Title	Description
OG000	Ranibizumab Treated Initial Mono	In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Participants in this group previously received ranibizumab monotherapy (Mono), that is, ranibizumab 0.5 mg intravitreal injection alone in previous study FVF2598g or ranibizumab 0.5 mg intravitreal injection in combination with sham photodynamic therapy (PDT) in previous study FVF2587g.
OG001	Ranibizumab Treated Initial + PDT	In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. This group includes participants who received ranibizumab 0.5 mg intravitreal injection in combination with photodynamic therapy in previous Study FVF2428g.
OG002	Ranibizumab Treated Sham XO	In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated Sham Crossover (XO) includes participants who received sham intravitreal injections before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2598g or this extension study.
OG003	Ranibizumab Treated PDT XO	In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated PDT XO includes participants who received sham intravitreal injections in combination with photodynamic therapy in previous study FVF2428g or previous study FVF2587g before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2428g, previous study FVF2587g or this extension study.

Units	Counts
Participants	OG000526 OG00174 OG002116 OG003

Title

Denominators

Categories

Any adverse event in study eye

Title	Measurements
	OG000418 OG00156 OG00296 OG003

Primary

Number of Participants With Non-ocular Adverse Events

Number of participants with non-ocular adverse events (not occurring in the eye) in the following categories: any adverse events, serious adverse events, adverse events leading to study discontinuation and death.

Additional information about adverse events can be found in the adverse events section.

Enrolled participants treated with Ranibizumab in this extension study or in one of the previous studies.

Posted

Number

participants

36 months

ID	Title	Description
OG000	Ranibizumab Treated Initial Mono	In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Participants in this group previously received ranibizumab monotherapy (Mono), that is, ranibizumab 0.5 mg intravitreal injection alone in previous study FVF2598g or ranibizumab 0.5 mg intravitreal injection in combination with sham photodynamic therapy (PDT) in previous study FVF2587g.
OG001	Ranibizumab Treated Initial + PDT

Secondary

Change From Baseline in Best Corrected Visual Acuity (BCVA) at a Starting Test Distance of 2 Meters

Change from baseline in Best corrected visual acuity (BCVA) was assessed by the number of letters a patient could read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) Eye Chart at a starting test distance of 2 meters. An increase in the number of letters read indicates improvement in visual acuity.

Enrolled participants. Observed data were used with no imputation. The number of participants for whom data was available for analyses is represented by "n".

Posted

Mean

Standard Deviation

letters

Extension study baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24

ID	Title	Description
OG000	Ranibizumab Initial Group	In this extension study participants received Ranibizumab injection 0.5 mg in a single-dose regimen given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Participants in this group were initially enrolled and received treatment with Ranibizumab in one of the following studies: FVF2428g (NCT00056823), FVF2587g (NCT00061594) or FVF2598g (NCT0056823).
OG001	Ranibizumab Crossover Group	In this extension study participants received Ranibizumab injection 0.5 mg in a single-dose regimen given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Participants in this group were enrolled but did not initially receive Ranibizumab in Study FVF2428g (NCT00056823), Study FVF2587g (NCT00061594) or Study FVF2598g (NCT00056836) and then crossed over to receive Ranibizumab either in that initial study or this extension study.

Secondary

Change From Baseline in Best Corrected Visual Acuity at a Starting Test Distance of 4 Meters

Change from baseline in Best corrected visual acuity (BCVA) was assessed by the number of letters a patient could read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) Eye Chart at a starting test distance of 4 meters. An increase in the number of letters read indicates improvement in visual acuity.

Enrolled participants. Observed data were used with no imputation. The number of participants for whom data was available for analyses is represented by "n".

Posted

Mean

Standard Deviation

letters

Extension study baseline, Months 12 and 24

ID	Title	Description
OG000	Ranibizumab Initial Group	In this extension study participants received Ranibizumab injection 0.5 mg in a single-dose regimen given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Participants in this group were initially enrolled and received treatment with Ranibizumab in one of the following studies: FVF2428g (NCT00056823), FVF2587g (NCT00061594) or FVF2598g (NCT0056823).
OG001	Ranibizumab Crossover Group	In this extension study participants received Ranibizumab injection 0.5 mg in a single-dose regimen given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Participants in this group were enrolled but did not initially receive Ranibizumab in Study FVF2428g (NCT00056823), Study FVF2587g (NCT00061594) or Study FVF2598g (NCT00056836) and then crossed over to receive Ranibizumab either in the initial study or this extension study.

Primary

Number of Participants With Positive Serum Antibodies to Ranibizumab at Month 12 and Month 24

Serum samples for the evaluation of antibodies to Ranibizumab were collected at Month 12 and Month 24 and were sent to a reference laboratory for analysis. If an injection of Ranibizumab was required at the visit, the samples were collected prior to the injection.

Population included all enrolled participants treated with Ranibizumab in the extension study or in one of the initial studies. The number of participants for whom data was available at Month 12 and Month 24 are represented by "n"

Posted

Number

participants

Month 12 and 24

ID	Title	Description
OG000	Ranibizumab Treated Initial Mono	In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Participants in this group previously received ranibizumab monotherapy (Mono), that is, ranibizumab 0.5 mg intravitreal injection alone in previous study FVF2598g or ranibizumab 0.5 mg intravitreal injection in combination with sham photodynamic therapy (PDT) in previous study FVF2587g.
OG001	Ranibizumab Treated Initial + PDT	In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. This group includes participants who received ranibizumab 0.5 mg intravitreal injection in combination with photodynamic therapy in previous Study FVF2428g.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Ranibizumab Treated Initial Mono	In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Participants in this group previously received ranibizumab monotherapy (Mono), that is, ranibizumab 0.5 mg intravitreal injection alone in previous study FVF2598g or ranibizumab 0.5 mg intravitreal injection in combination with sham photodynamic therapy (PDT) in previous study FVF2587g.	213	526	491	526
EG001	Ranibizumab Treated Initial + PDT	In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. This group includes participants who received ranibizumab 0.5 mg intravitreal injection in combination with photodynamic therapy in previous Study FVF2428g.	26	74	70	74
EG002	Ranibizumab Treated Sham XO	In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated Sham Crossover (XO) includes participants who received sham intravitreal injections before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2428g or this extension study.	43	116	110	116
EG003	Ranibizumab Treated PDT XO	In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated PDT XO includes participants who received sham intravitreal injections in combination with photodynamic therapy in previous study FVF2428g or previous study FVF2587g before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2428g, previous study FVF2587g or this extension study.	24	74	71	74

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG0030 affected74 at risk
CORONARY ARTERY OCCLUSION	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected526 at risk EG0010 affected74 at risk EG0021 affected116 at risk EG003
ISCHAEMIC CARDIOMYOPATHY	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
PALPITATIONS	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
SICK SINUS SYNDROME	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
TACHYCARDIA	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected526 at risk EG0010 affected74 at risk EG0021 affected116 at risk EG003
VENTRICULAR TACHYCARDIA	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
VERTIGO	Ear and labyrinth disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
HYPOPARATHYROIDISM	Endocrine disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
MACULAR DEGENERATION	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG00021 affected526 at risk EG0012 affected74 at risk EG0025 affected116 at risk EG003
CHOROIDAL NEOVASCULARISATION	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG0007 affected526 at risk EG0012 affected74 at risk EG0022 affected116 at risk EG003
VISUAL ACUITY REDUCED	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG00011 affected526 at risk EG0011 affected74 at risk EG0020 affected116 at risk EG003
RETINAL HAEMORRHAGE	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG0008 affected526 at risk EG0010 affected74 at risk EG0022 affected116 at risk EG003
VITREOUS HAEMORRHAGE	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG0003 affected526 at risk EG0010 affected74 at risk EG0021 affected116 at risk EG003
CATARACT	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG0003 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
MACULAR OEDEMA	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
OPTIC ISCHAEMIC NEUROPATHY	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
POSTERIOR CAPSULE OPACIFICATION	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0021 affected116 at risk EG003
RETINAL DEGENERATION	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
ANGLE CLOSURE GLAUCOMA	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
PAPILLOEDEMA	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected526 at risk EG0011 affected74 at risk EG0020 affected116 at risk EG003
RETINAL ARTERY OCCLUSION	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
RETINAL PIGMENT EPITHELIAL TEAR	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
SUBRETINAL FIBROSIS	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
UVEITIS	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
VITRITIS	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0005 affected526 at risk EG0010 affected74 at risk EG0021 affected116 at risk EG003
SMALL INTESTINAL OBSTRUCTION	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0003 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
INTESTINAL OBSTRUCTION	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
ABDOMINAL COMPARTMENT SYNDROME	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
COLITIS ISCHAEMIC	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
COLONIC OBSTRUCTION	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
COLONIC STENOSIS	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
DIARRHOEA	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected526 at risk EG0010 affected74 at risk EG0021 affected116 at risk EG003
DIVERTICULUM	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
DUODENAL ULCER	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
ILEUS	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
INTESTINAL ISCHAEMIA	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
INTESTINAL PERFORATION	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
PANCREATITIS	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
PHARYNGOESOPHAGEAL DIVERTICULUM	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
RECTAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
VARICES OESOPHAGEAL	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
CHEST PAIN	General disorders	MedDRA (12.0)	Systematic Assessment	EG0004 affected526 at risk EG0010 affected74 at risk EG0021 affected116 at risk EG003
DEATH	General disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected526 at risk EG0010 affected74 at risk EG0021 affected116 at risk EG003
ASTHENIA	General disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected526 at risk EG0010 affected74 at risk EG0021 affected116 at risk EG003
GRANULOMA	General disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
HERNIA OBSTRUCTIVE	General disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
IDIOSYNCRATIC DRUG REACTION	General disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected526 at risk EG0011 affected74 at risk EG0020 affected116 at risk EG003
PYREXIA	General disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected526 at risk EG0010 affected74 at risk EG0021 affected116 at risk EG003
CHOLECYSTITIS	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
CHOLELITHIASIS	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
BILE DUCT STONE	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
CHOLECYSTITIS CHRONIC	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
PNEUMONIA	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG00013 affected526 at risk EG0011 affected74 at risk EG0024 affected116 at risk EG003
BRONCHITIS	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0005 affected526 at risk EG0010 affected74 at risk EG0021 affected116 at risk EG003
CELLULITIS	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0003 affected526 at risk EG0011 affected74 at risk EG0020 affected116 at risk EG003
LOBAR PNEUMONIA	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0002 affected526 at risk EG0011 affected74 at risk EG0020 affected116 at risk EG003
DIVERTICULITIS	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0003 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
GASTROENTERITIS	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0022 affected116 at risk EG003
DEVICE RELATED INFECTION	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0002 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
OSTEOMYELITIS	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0021 affected116 at risk EG003
CLOSTRIDIUM DIFFICILE COLITIS	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
HERPES ZOSTER	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
INFLUENZA	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
INTERVERTEBRAL DISCITIS	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
KERATITIS HERPETIC	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
KLEBSIELLA BACTERAEMIA	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
PYELONEPHRITIS ACUTE	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 affected526 at risk EG0010 affected74 at risk EG0021 affected116 at risk EG003
SEPTIC SHOCK	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
STAPHYLOCOCCAL INFECTION	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
URINARY TRACT INFECTION	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
UROSEPSIS	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
VIRAL MYOCARDITIS	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
HIP FRACTURE	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0008 affected526 at risk EG0011 affected74 at risk EG0021 affected116 at risk EG003
FALL	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0008 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
PELVIC FRACTURE	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0002 affected526 at risk EG0010 affected74 at risk EG0021 affected116 at risk EG003
SUBDURAL HAEMATOMA	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0002 affected526 at risk EG0010 affected74 at risk EG0021 affected116 at risk EG003
FEMORAL NECK FRACTURE	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0002 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
OVERDOSE	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
PATELLA FRACTURE	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0011 affected74 at risk EG0020 affected116 at risk EG003
PUBIC RAMI FRACTURE	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0002 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
ANKLE FRACTURE	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
ARTERIAL INJURY	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
DEVICE FAILURE	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0000 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
FEMUR FRACTURE	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
HEAD INJURY	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0000 affected526 at risk EG0010 affected74 at risk EG0021 affected116 at risk EG003
MEDICATION ERROR	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
MULTIPLE FRACTURES	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
POST PROCEDURAL HAEMATOMA	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0000 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
RIB FRACTURE	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0000 affected526 at risk EG0011 affected74 at risk EG0020 affected116 at risk EG003
SPINAL FRACTURE	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
STRESS FRACTURE	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
THERAPEUTIC AGENT TOXICITY	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
INTRAOCULAR PRESSURE INCREASED	Investigations	MedDRA (12.0)	Systematic Assessment	EG0002 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
DEHYDRATION	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0023 affected116 at risk EG003
HYPONATRAEMIA	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected526 at risk EG0010 affected74 at risk EG0021 affected116 at risk EG003
DIABETES MELLITUS	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected526 at risk EG0011 affected74 at risk EG0020 affected116 at risk EG003
FAILURE TO THRIVE	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
HYPERKALAEMIA	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected526 at risk EG0010 affected74 at risk EG0021 affected116 at risk EG003
OSTEOARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0006 affected526 at risk EG0010 affected74 at risk EG0021 affected116 at risk EG003
SPINAL COLUMN STENOSIS	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected526 at risk EG0010 affected74 at risk EG0023 affected116 at risk EG003
LUMBAR SPINAL STENOSIS	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0003 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
ARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
INTERVERTEBRAL DISC PROTRUSION	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
MUSCULAR WEAKNESS	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
RHEUMATOID ARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
SACROILIITIS	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
SYNOVITIS	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
LUNG NEOPLASM MALIGNANT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0002 affected526 at risk EG0012 affected74 at risk EG0021 affected116 at risk EG003
COLON CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0000 affected526 at risk EG0010 affected74 at risk EG0021 affected116 at risk EG003
RENAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0003 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
BREAST CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0011 affected74 at risk EG0020 affected116 at risk EG003
NON-HODGKIN'S LYMPHOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0002 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
PANCREATIC CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0011 affected74 at risk EG0020 affected116 at risk EG003
PROSTATE CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0002 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
PROSTATE CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0002 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
ACUTE MYELOID LEUKAEMIA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0000 affected526 at risk EG0011 affected74 at risk EG0020 affected116 at risk EG003
BASAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
BLADDER CANCER RECURRENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
BRAIN NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
BREAST CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
COLON ADENOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
ENDOMETRIAL CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
GASTROINTESTINAL TRACT ADENOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
LUNG ADENOCARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
LYMPHOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0000 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
MALIGNANT MELANOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0000 affected526 at risk EG0010 affected74 at risk EG0021 affected116 at risk EG003
OVARIAN EPITHELIAL CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
PANCREATIC NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0000 affected526 at risk EG0010 affected74 at risk EG0021 affected116 at risk EG003
SARCOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
SMALL CELL LUNG CANCER STAGE UNSPECIFIED	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
SQUAMOUS CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
CEREBROVASCULAR ACCIDENT	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0006 affected526 at risk EG0011 affected74 at risk EG0021 affected116 at risk EG003
TRANSIENT ISCHAEMIC ATTACK	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0004 affected526 at risk EG0011 affected74 at risk EG0021 affected116 at risk EG003
CAROTID ARTERY STENOSIS	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0003 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
SYNCOPE	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
CEREBRAL INFARCTION	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
DIZZINESS	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
HEADACHE	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
ISCHAEMIC STROKE	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0011 affected74 at risk EG0020 affected116 at risk EG003
SUBARACHNOID HAEMORRHAGE	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
APHASIA	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
BRAIN MASS	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
BRAIN STEM INFARCTION	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected526 at risk EG0011 affected74 at risk EG0020 affected116 at risk EG003
CAROTID ARTERY DISEASE	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
CEREBELLAR HAEMORRHAGE	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected526 at risk EG0010 affected74 at risk EG0021 affected116 at risk EG003
CEREBRAL HAEMATOMA	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected526 at risk EG0011 affected74 at risk EG0020 affected116 at risk EG003
COMPLEX REGIONAL PAIN SYNDROME	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
CONVULSION	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected526 at risk EG0010 affected74 at risk EG0021 affected116 at risk EG003
DEMENTIA	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
DEMENTIA ALZHEIMER'S TYPE	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
ISCHAEMIC CEREBRAL INFARCTION	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
SPONDYLITIC MYELOPATHY	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
THROMBOTIC STROKE	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
BIPOLAR DISORDER	Psychiatric disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
MENTAL STATUS CHANGES	Psychiatric disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
RENAL FAILURE	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
RENAL FAILURE ACUTE	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
HAEMATURIA	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
RENAL ARTERY STENOSIS	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
RENAL DISORDER	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
URINARY RETENTION	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
URINARY TRACT OBSTRUCTION	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected526 at risk EG0011 affected74 at risk EG0020 affected116 at risk EG003
BENIGN PROSTATIC HYPERPLASIA	Reproductive system and breast disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
PELVIC PROLAPSE	Reproductive system and breast disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
CHRONIC OBSTRUCTIVE PULMONARY DISEASE	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0008 affected526 at risk EG0012 affected74 at risk EG0021 affected116 at risk EG003
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0004 affected526 at risk EG0010 affected74 at risk EG0022 affected116 at risk EG003
PLEURAL EFFUSION	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected526 at risk EG0010 affected74 at risk EG0021 affected116 at risk EG003
PULMONARY FIBROSIS	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
ACUTE RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
ASTHMA	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
EMPHYSEMA	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected526 at risk EG0011 affected74 at risk EG0020 affected116 at risk EG003
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected526 at risk EG0010 affected74 at risk EG0021 affected116 at risk EG003
PNEUMOTHORAX	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected526 at risk EG0011 affected74 at risk EG0020 affected116 at risk EG003
RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected526 at risk EG0011 affected74 at risk EG0020 affected116 at risk EG003
RASH	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
AORTIC ANEURYSM	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0003 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
AORTIC STENOSIS	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected526 at risk EG0011 affected74 at risk EG0020 affected116 at risk EG003
ARTERIAL OCCLUSIVE DISEASE	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
DEEP VEIN THROMBOSIS	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
HYPOTENSION	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
ORTHOSTATIC HYPOTENSION	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
PERIPHERAL ISCHAEMIA	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0021 affected116 at risk EG003
PERIPHERAL VASCULAR DISORDER	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0021 affected116 at risk EG003
ANEURYSM	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
AORTIC ANEURYSM RUPTURE	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
AORTIC DISSECTION	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
HAEMORRHAGE	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
INTERMITTENT CLAUDICATION	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
COAGULOPATHY	Blood and lymphatic system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
HAEMOLYTIC ANAEMIA	Blood and lymphatic system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0008 affected526 at risk EG0010 affected74 at risk EG0024 affected116 at risk EG003
MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0007 affected526 at risk EG0010 affected74 at risk EG0022 affected116 at risk EG003
ACUTE MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0003 affected526 at risk EG0011 affected74 at risk EG0020 affected116 at risk EG003
CARDIAC FAILURE CONGESTIVE	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0004 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
CORONARY ARTERY DISEASE	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0011 affected74 at risk EG0021 affected116 at risk EG003
ANGINA PECTORIS	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0002 affected526 at risk EG0011 affected74 at risk EG0020 affected116 at risk EG003
CARDIO-RESPIRATORY ARREST	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0021 affected116 at risk EG003
BRADYCARDIA	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0011 affected74 at risk EG0020 affected116 at risk EG003
ACUTE CORONARY SYNDROME	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected526 at risk EG0011 affected74 at risk EG0020 affected116 at risk EG003
ANGINA UNSTABLE	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003
ARRHYTHMIA	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected526 at risk EG0010 affected74 at risk EG0021 affected116 at risk EG003
CARDIAC ARREST	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 affected526 at risk EG0010 affected74 at risk EG0020 affected116 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA (12.0)	Systematic Assessment	EG00027 affected526 at risk EG0013 affected74 at risk EG0023 affected116 at risk EG0033 affected74 at risk
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG00014 affected526 at risk EG0014 affected74 at risk EG0023 affected116 at risk EG003
MACULAR DEGENERATION	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG000236 affected526 at risk EG00118 affected74 at risk EG00253 affected116 at risk EG003
RETINAL HAEMORRHAGE	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG000197 affected526 at risk EG00121 affected74 at risk EG00247 affected116 at risk EG003
CONJUNCTIVAL HAEMORRHAGE	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG000124 affected526 at risk EG00120 affected74 at risk EG00233 affected116 at risk EG003
CHOROIDAL NEOVASCULARISATION	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG00063 affected526 at risk EG00115 affected74 at risk EG00216 affected116 at risk EG003
MACULAR OEDEMA	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG00070 affected526 at risk EG0016 affected74 at risk EG00215 affected116 at risk EG003
CATARACT	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG00061 affected526 at risk EG00112 affected74 at risk EG0028 affected116 at risk EG003
EYE PAIN	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG00056 affected526 at risk EG0014 affected74 at risk EG00213 affected116 at risk EG003
MYODESOPSIA	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG00056 affected526 at risk EG0013 affected74 at risk EG0029 affected116 at risk EG003
VISUAL ACUITY REDUCED	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG00032 affected526 at risk EG0014 affected74 at risk EG0023 affected116 at risk EG003
DETACHMENT OF RETINAL PIGMENT EPITHELIUM	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG00033 affected526 at risk EG0013 affected74 at risk EG00212 affected116 at risk EG003
MACULOPATHY	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG00030 affected526 at risk EG0014 affected74 at risk EG0024 affected116 at risk EG003
VISION BLURRED	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG00031 affected526 at risk EG0014 affected74 at risk EG0025 affected116 at risk EG003
EYE IRRITATION	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG00029 affected526 at risk EG0011 affected74 at risk EG0027 affected116 at risk EG003
POSTERIOR CAPSULE OPACIFICATION	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG00029 affected526 at risk EG0011 affected74 at risk EG0026 affected116 at risk EG003
FOREIGN BODY SENSATION IN EYES	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG00021 affected526 at risk EG0015 affected74 at risk EG0028 affected116 at risk EG003
BLEPHARITIS	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG00025 affected526 at risk EG0015 affected74 at risk EG0023 affected116 at risk EG003
EYE PRURITUS	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG00023 affected526 at risk EG0014 affected74 at risk EG0027 affected116 at risk EG003
RETINAL DISORDER	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG00024 affected526 at risk EG0011 affected74 at risk EG0029 affected116 at risk EG003
RETINAL DEGENERATION	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG00023 affected526 at risk EG0011 affected74 at risk EG0026 affected116 at risk EG003
DRY EYE	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG00016 affected526 at risk EG0013 affected74 at risk EG0025 affected116 at risk EG003
PHOTOPSIA	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG00014 affected526 at risk EG0014 affected74 at risk EG0023 affected116 at risk EG003
GASTROOESOPHAGEAL REFLUX DISEASE	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG00031 affected526 at risk EG0015 affected74 at risk EG0025 affected116 at risk EG003
NAUSEA	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG00027 affected526 at risk EG0011 affected74 at risk EG0025 affected116 at risk EG003
CONSTIPATION	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG00022 affected526 at risk EG0010 affected74 at risk EG0026 affected116 at risk EG003
NASOPHARYNGITIS	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG00048 affected526 at risk EG0019 affected74 at risk EG0029 affected116 at risk EG003
BRONCHITIS	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG00043 affected526 at risk EG0013 affected74 at risk EG0027 affected116 at risk EG003
URINARY TRACT INFECTION	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG00038 affected526 at risk EG0013 affected74 at risk EG0028 affected116 at risk EG003
INFLUENZA	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG00025 affected526 at risk EG0012 affected74 at risk EG0025 affected116 at risk EG003
SINUSITIS	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG00022 affected526 at risk EG0014 affected74 at risk EG0027 affected116 at risk EG003
EAR INFECTION	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0004 affected526 at risk EG0014 affected74 at risk EG0021 affected116 at risk EG003
CONTUSION	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG00020 affected526 at risk EG0011 affected74 at risk EG0026 affected116 at risk EG003
INTRAOCULAR PRESSURE INCREASED	Investigations	MedDRA (12.0)	Systematic Assessment	EG00073 affected526 at risk EG0016 affected74 at risk EG00215 affected116 at risk EG003
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG00031 affected526 at risk EG00110 affected74 at risk EG0026 affected116 at risk EG003
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG00036 affected526 at risk EG0011 affected74 at risk EG0024 affected116 at risk EG003
ARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG00026 affected526 at risk EG0013 affected74 at risk EG0027 affected116 at risk EG003
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG00022 affected526 at risk EG0011 affected74 at risk EG0024 affected116 at risk EG003
OSTEOARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG00013 affected526 at risk EG0011 affected74 at risk EG0023 affected116 at risk EG003
BASAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG00021 affected526 at risk EG0010 affected74 at risk EG0026 affected116 at risk EG003
DEPRESSION	Psychiatric disorders	MedDRA (12.0)	Systematic Assessment	EG00023 affected526 at risk EG0016 affected74 at risk EG0023 affected116 at risk EG003
ANXIETY	Psychiatric disorders	MedDRA (12.0)	Systematic Assessment	EG00023 affected526 at risk EG0015 affected74 at risk EG0022 affected116 at risk EG003
BENIGN PROSTATIC HYPERPLASIA	Reproductive system and breast disorders	MedDRA (12.0)	Systematic Assessment	EG0007 affected526 at risk EG0012 affected74 at risk EG0022 affected116 at risk EG003
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG00015 affected526 at risk EG0011 affected74 at risk EG0022 affected116 at risk EG003
HYPERTENSION	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG00043 affected526 at risk EG0019 affected74 at risk EG0029 affected116 at risk EG003
SUBMACULAR FLUID	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG0000 affected526 at risk EG0014 affected74 at risk EG0020 affected116 at risk EG003

ID	Term
D020256	Choroidal Neovascularization
D008268	Macular Degeneration

ID	Term
D015862	Choroid Diseases
D014603	Uveal Diseases
D005128	Eye Diseases
D009389	Neovascularization, Pathologic
D008679	Metaplasia
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D012162	Retinal Degeneration
D012164	Retinal Diseases

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