A Study of Two Fabrazyme (Agalsidase Beta) Dosing Regimen... | NCT00701415

ID	Type	Description	Link
2007-005668-28	EudraCT Number
EFC12821	Other Identifier	Sanofi

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fabrazyme 0.5 mg/kg	Experimental	Fabrazyme 0.5 mg/kg was administered every 2 weeks (up to 131 infusion) up to 260 weeks, the total infusion time was not less than 45 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.	Biological: Agalsidase beta
Fabrazyme 1.0 mg/kg	Experimental	Fabrazyme 1.0 mg/kg was administered every 4 weeks (up to 66 infusion) up to 260 weeks, the total infusion time was not less than 90 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.	Biological: Agalsidase beta

Name	Type	Description	Arm Group Labels	Other Names
Agalsidase beta	Biological	Powder for concentrate for solution for infusion 1.0 mg/kg/4 weeks	Fabrazyme 0.5 mg/kg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Skin Globotriaosylceramide (GL-3) Clearance From Superficial Skin Capillary Endothelium	Skin biopsies were taken at Baseline, Week 52, Week 156 and Week 260 or early withdrawal and analyzed for cellular GL-3 accumulation (inclusions) by light microscopy. Each biopsy was scored for GL-3 accumulation on a severity score-scale of none, mild, moderate, severe (0-1-2-3). Scores are categorized as normal (score = 0) or abnormal (score = 1, 2 or 3). Data was summarized in terms of number of participants with none/trace, mild, moderate and severe biopsy scores.	Baseline, Week 52, Week 156 and Week 260

Secondary Outcomes

Measure	Description	Time Frame
Percent Change From Baseline in GL-3 Clearance From Plasma	Plasma samples were assayed for GL-3 clearance using a validated tandem mass spectrometry with an upper limit of normal plasma GL-3 level of 7.0 μg/mL. Number of participants analyzed=participants with both baseline and post-baseline GL-3 plasma clearance assessment. Here 'n' signifies number of participants with available data for specified category.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The participant and/or participant's parent(s)/legal guardian(s) must provide written informed assent/consent prior to any protocol-related procedures being performed.
The participant must had a confirmed diagnosis of Fabry disease as documented by leukocyte α-Galactosidase A (αGAL) activity of <4 nmol/hr/mg leukocyte (preferred assay; resulted from a central laboratory). If the leukocyte αGAL activity assay was difficult to obtain, the participant might be enrolled based on documented plasma αGAL <1.5 nmol/hr/mL, with the agreement of the Medical Monitor (resulted from a central laboratory).
The participant must had evidence of globotriaosylceramide (GL-3) accumulation as documented by plasma GL-3 (>7.0 µg/mL) or urinary GL-3 (>0.3 mg GL-3/mmol creatinine) levels (results from a central laboratory).
The participant must be male ≥5 and ≤18 years of age.

Exclusion Criteria:

Participant had albuminuria (first morning void urinary albumin/creatinine ratio >30 mg/g on at least 2 out of 3 consecutive samples, each at least 1 week apart).
Participant had a Glomerular Filtration Rate (GFR) by iohexol <90 L/min/1.73m^2. In case of properly documented low protein intake, values as low as 80 mL/min/1.73 m^2 might be acceptable, after consultation with the Medical Monitor.
Participant had documented evidence of stroke or transient ischemic attack (TIA), or if a brain magnetic resonance imaging (MRI) had been performed, bright lesions >2 mm on T2- or fluid attenuated inversion recovery (FLAIR)- weighted images within the white matter or the basal ganglia.
Participant had severe and recurrent acroparesthesia, judged by the physician as frequent (more than once a week) pain episodes for at least 3 months that influenced daily activities, irrespective of medication.
Participant had an end-diastolic left ventricular posterior wall thickness (LVPWTd) and/or an end-diastolic interventricular septum thickness (IVSTd)≥2 standard deviations (SD) compared to normal (based on body surface area [BSA] normal ranges from Kampmann, et al 2000) as read at the study site.
Participant had received prior treatment specific to Fabry Disease.
Participant had participated in a study employing an investigational drug within 30 days of the start of their participation in this study.
Participant had any medical condition or extenuating circumstance, which in the opinion of the Study Investigator, could interfere with study compliance.
Participant had any medical condition or extenuating circumstance, for example diabetes mellitus, which in the opinion of the Study Investigator, could interfere with the interpretation of study results.
Participant was on treatment with angiotensin converting enzyme inhibitors/angiotensin receptor blockers (ACEIs/ARBs).
Participant had any contra-indication mentioned in the labeling of Fabrazyme and/or iohexol (Omnipaque).
Participant or parent(s)/legal guardian(s) was unwilling to comply with the requirements of the protocol.

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

PubMed Identifier	Type	Citation	Retractions
25955246	Derived	Wijburg FA, Benichou B, Bichet DG, Clarke LA, Dostalova G, Fainboim A, Fellgiebel A, Forcelini C, An Haack K, Hopkin RJ, Mauer M, Najafian B, Scott CR, Shankar SP, Thurberg BL, Tondel C, Tylki-Szymanska A, Ramaswami U. Characterization of early disease status in treatment-naive male paediatric patients with Fabry disease enrolled in a randomized clinical trial. PLoS One. 2015 May 8;10(5):e0124987. doi: 10.1371/journal.pone.0124987. eCollection 2015.
23531228

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Fabrazyme 0.5 mg/kg	Fabrazyme 0.5 mg/kg was administered every 2 weeks (up to 131 infusions) up to 260 weeks, the total infusion time was not less than 45 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
FG001	Fabrazyme 1.0 mg/kg

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

ID	Title	Description
BG000	Fabrazyme 0.5 mg/kg	Fabrazyme 0.5 mg/kg was administered every 2 weeks (up to 131 infusion) up to 260 weeks, the total infusion time was not less than 45 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
BG001	Fabrazyme 1.0 mg/kg	Fabrazyme 1.0 mg/kg was administered every 4 weeks (up to 66 infusion) up to 260 weeks, the total infusion time was not less than 90 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00016 BG00115 BG00231

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

Skin Globotriaosylceramide (GL-3) Clearance From Superficial Skin Capillary Endothelium

Skin biopsies were taken at Baseline, Week 52, Week 156 and Week 260 or early withdrawal and analyzed for cellular GL-3 accumulation (inclusions) by light microscopy. Each biopsy was scored for GL-3 accumulation on a severity score-scale of none, mild, moderate, severe (0-1-2-3). Scores are categorized as normal (score = 0) or abnormal (score = 1, 2 or 3). Data was summarized in terms of number of participants with none/trace, mild, moderate and severe biopsy scores.

Analysis was performed on Full analysis set (FAS), which included all randomized participants who received at least 1 infusion of study treatment.

Posted

Number

Percentage of participants

Baseline, Week 52, Week 156 and Week 260

ID	Title	Description
OG000	Fabrazyme 0.5 mg/kg	Fabrazyme 0.5 mg/kg was administered every 2 weeks (up to 131 infusions) up to 260 weeks, the total infusion time was not less than 45 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
OG001	Fabrazyme 1.0 mg/kg	Fabrazyme 1.0 mg/kg was administered every 4 weeks (up to 66 infusions) up to 260 weeks, the total infusion time was not less than 90 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.

Units	Counts
Participants	OG00016 OG00115

Title

Denominators

Categories

Zero (0) Skin GL-3 Score at Baseline

Title	Measurements
	OG00018.8 OG00133.3

Zero (0) Skin GL-3 Score at Week 52

Title	Measurements
	OG000

Secondary

Percent Change From Baseline in GL-3 Clearance From Plasma

Plasma samples were assayed for GL-3 clearance using a validated tandem mass spectrometry with an upper limit of normal plasma GL-3 level of 7.0 μg/mL. Number of participants analyzed=participants with both baseline and post-baseline GL-3 plasma clearance assessment. Here 'n' signifies number of participants with available data for specified category.

Analysis was performed on FAS.

Posted

Mean

Standard Deviation

Percent change

Baseline, Week 12, 28, 40, 52, 80, 104, 132, 156, 184, 208, 236 and 260

ID	Title	Description
OG000	Fabrazyme 0.5 mg/kg	Fabrazyme 0.5 mg/kg was administered every 2 weeks (up to 131 infusions) up to 260 weeks, the total infusion time was not less than 45 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
OG001	Fabrazyme 1.0 mg/kg	Fabrazyme 1.0 mg/kg was administered every 4 weeks (up to 66 infusions) up to 260 weeks, the total infusion time was not less than 90 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.

Units	Counts

Secondary

Percent Change From Baseline in GL-3 Clearance From Urine

Plasma samples were assayed for total urine GL-3 clearance using a validated tandem mass spectrometry with an upper limit of normal of <0.030 mg/mmoL of creatinine. Number of participants analyzed=participants with both baseline and post-baseline GL-3 urine clearance assessment. Here 'n' signifies number of participants with available data for specified category.

Analysis was performed on FAS.

Posted

Mean

Standard Deviation

Percent change

Baseline, Week 12, 28, 40, 52, 80, 104, 132, 156, 184, 208, 236 and 260

ID	Title	Description
OG000	Fabrazyme 0.5 mg/kg	Fabrazyme 0.5 mg/kg was administered every 2 weeks (up to 131 infusions) up to 260 weeks, the total infusion time was not less than 45 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
OG001	Fabrazyme 1.0 mg/kg	Fabrazyme 1.0 mg/kg was administered every 4 weeks (up to 66 infusions) up to 260 weeks, the total infusion time was not less than 90 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.

Units	Counts

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
MEDICAL DEVICE COMPLICATION	General disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
PYREXIA	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0011 affected15 at risk
CELLULITIS	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
ERYSIPELAS	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
OTITIS MEDIA	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
PNEUMONIA	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
SEPSIS	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
TINEA PEDIS	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
MULTIPLE INJURIES	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
OVERDOSE	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
BODY MASS INDEX DECREASED	Investigations	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
PARAESTHESIA	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0011 affected15 at risk
TREMOR	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
SUICIDAL IDEATION	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
MICROALBUMINURIA	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0011 affected15 at risk
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
DERMATITIS	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
CENTRAL VENOUS CATHETERISATION	Surgical and medical procedures	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
ELECTIVE SURGERY	Surgical and medical procedures	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
CHILLS	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0011 affected15 at risk
EOSINOPHILIA	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
LEUKOPENIA	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0012 affected15 at risk
LYMPHADENOPATHY	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected16 at risk EG0010 affected15 at risk
MONOCYTOPENIA	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
ARRHYTHMIA	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
TACHYCARDIA	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected16 at risk EG0011 affected15 at risk
CONDUCTIVE DEAFNESS	Ear and labyrinth disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0012 affected15 at risk
DEAFNESS	Ear and labyrinth disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
DEAFNESS BILATERAL	Ear and labyrinth disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
DEAFNESS NEUROSENSORY	Ear and labyrinth disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
DEAFNESS UNILATERAL	Ear and labyrinth disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0012 affected15 at risk
MIDDLE EAR EFFUSION	Ear and labyrinth disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
OTORRHOEA	Ear and labyrinth disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
TINNITUS	Ear and labyrinth disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected16 at risk EG0014 affected15 at risk
TYMPANIC MEMBRANE HYPERAEMIA	Ear and labyrinth disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
HYPERPARATHYROIDISM SECONDARY	Endocrine disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0011 affected15 at risk
CONJUNCTIVAL HYPERAEMIA	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0012 affected15 at risk
CORNEAL DEPOSITS	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
DRY EYE	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
LACRIMATION INCREASED	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
OCULAR VASCULAR DISORDER	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
PHOTOPHOBIA	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
VISION BLURRED	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
VISUAL ACUITY REDUCED	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0009 affected16 at risk EG0016 affected15 at risk
ABDOMINAL PAIN LOWER	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0004 affected16 at risk EG0014 affected15 at risk
CONSTIPATION	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected16 at risk EG0010 affected15 at risk
DENTAL CARIES	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0011 affected15 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG00010 affected16 at risk EG0018 affected15 at risk
EPIGASTRIC DISCOMFORT	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
FOOD POISONING	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
FREQUENT BOWEL MOVEMENTS	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
GASTROINTESTINAL DISORDER	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected16 at risk EG0011 affected15 at risk
NAUSEA	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0009 affected16 at risk EG0017 affected15 at risk
ORAL MUCOSAL ERYTHEMA	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
SALIVARY HYPERSECRETION	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
STOMATITIS	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
TOOTHACHE	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
VOMITING	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0009 affected16 at risk EG0017 affected15 at risk
ASTHENIA	General disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected16 at risk EG0011 affected15 at risk
CATHETER SITE PAIN	General disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
CHEST DISCOMFORT	General disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0012 affected15 at risk
CHILLS	General disorders	MedDRA 18.0	Systematic Assessment	EG0006 affected16 at risk EG0012 affected15 at risk
FACE OEDEMA	General disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected16 at risk EG0010 affected15 at risk
FATIGUE	General disorders	MedDRA 18.0	Systematic Assessment	EG0005 affected16 at risk EG0012 affected15 at risk
FEELING COLD	General disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected16 at risk EG0011 affected15 at risk
FEELING HOT	General disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0013 affected15 at risk
FEELING OF BODY TEMPERATURE CHANGE	General disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
INFLUENZA LIKE ILLNESS	General disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected16 at risk EG0010 affected15 at risk
INFUSION SITE PAIN	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
INJECTION SITE HAEMORRHAGE	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
MALAISE	General disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected16 at risk EG0011 affected15 at risk
MEDICAL DEVICE COMPLICATION	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0011 affected15 at risk
OEDEMA PERIPHERAL	General disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected16 at risk EG0012 affected15 at risk
PAIN	General disorders	MedDRA 18.0	Systematic Assessment	EG0004 affected16 at risk EG0013 affected15 at risk
PYREXIA	General disorders	MedDRA 18.0	Systematic Assessment	EG00012 affected16 at risk EG0018 affected15 at risk
SOFT TISSUE INFLAMMATION	General disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
ALLERGY TO ARTHROPOD BITE	Immune system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
ACUTE SINUSITIS	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
BRONCHITIS	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0011 affected15 at risk
CATHETER SITE INFECTION	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
CHLAMYDIAL INFECTION	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
CONJUNCTIVITIS	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
COXSACKIE VIRAL INFECTION	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
EAR INFECTION	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0005 affected16 at risk EG0011 affected15 at risk
ENTEROBIASIS	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
ERYSIPELAS	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
GASTROENTERITIS	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0002 affected16 at risk EG0012 affected15 at risk
GASTROENTERITIS VIRAL	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0003 affected16 at risk EG0011 affected15 at risk
HERPES SIMPLEX	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0011 affected15 at risk
HERPES VIRUS INFECTION	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
IMPETIGO	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0002 affected16 at risk EG0011 affected15 at risk
INFLUENZA	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0003 affected16 at risk EG0013 affected15 at risk
LOWER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
MOLLUSCUM CONTAGIOSUM	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
NASOPHARYNGITIS	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0007 affected16 at risk EG0015 affected15 at risk
ORAL HERPES	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0002 affected16 at risk EG0010 affected15 at risk
OTITIS MEDIA CHRONIC	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
PARASITIC GASTROENTERITIS	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
PHARYNGITIS	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0002 affected16 at risk EG0010 affected15 at risk
PHARYNGITIS STREPTOCOCCAL	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0002 affected16 at risk EG0010 affected15 at risk
PNEUMONIA	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0012 affected15 at risk
RESPIRATORY TRACT INFECTION VIRAL	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
RHINITIS	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0005 affected16 at risk EG0013 affected15 at risk
SINUSITIS	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0003 affected16 at risk EG0011 affected15 at risk
STAPHYLOCOCCAL INFECTION	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
TINEA INFECTION	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
TINEA VERSICOLOUR	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
TONSILLITIS	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
TOOTH INFECTION	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0006 affected16 at risk EG0015 affected15 at risk
VIRAL INFECTION	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0002 affected16 at risk EG0011 affected15 at risk
VIRAL PHARYNGITIS	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
VIRAL RHINITIS	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
VIRAL UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0011 affected15 at risk
ANIMAL BITE	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0011 affected15 at risk
ARTHROPOD BITE	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
ARTHROPOD STING	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0012 affected15 at risk
CONCUSSION	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
CONTUSION	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0002 affected16 at risk EG0011 affected15 at risk
EAR INJURY	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
EXCORIATION	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
FALL	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
FROSTBITE	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
GENITAL INJURY	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
HAND FRACTURE	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
HEAD INJURY	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
HUMERUS FRACTURE	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
JOINT INJURY	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
LACERATION	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
LIGAMENT RUPTURE	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
LIGAMENT SPRAIN	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0011 affected15 at risk
LIMB INJURY	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0011 affected15 at risk
MUSCLE RUPTURE	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
MUSCLE STRAIN	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
OVERDOSE	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
POST-TRAUMATIC PAIN	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
PROCEDURAL PAIN	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0012 affected15 at risk
ROAD TRAFFIC ACCIDENT	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0011 affected15 at risk
SKIN ABRASION	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0011 affected15 at risk
SOFT TISSUE INJURY	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
TOOTH FRACTURE	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0012 affected15 at risk
WOUND COMPLICATION	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
WOUND DEHISCENCE	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
BETA 2 MICROGLOBULIN INCREASED	Investigations	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
BLOOD PRESSURE INCREASED	Investigations	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
BODY TEMPERATURE INCREASED	Investigations	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
EOSINOPHIL COUNT INCREASED	Investigations	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
HEART RATE INCREASED	Investigations	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
NEUTROPHIL COUNT INCREASED	Investigations	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0011 affected15 at risk
URINE ALBUMIN/CREATININE RATIO ABNORMAL	Investigations	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
VITAMIN B12 DECREASED	Investigations	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0012 affected15 at risk
VITAMIN D DECREASED	Investigations	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0011 affected15 at risk
FAILURE TO THRIVE	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
HYPOPHOSPHATAEMIA	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
IRON DEFICIENCY	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
OBESITY	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
UNDERWEIGHT	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0011 affected15 at risk
VITAMIN D DEFICIENCY	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0004 affected16 at risk EG0011 affected15 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected16 at risk EG0012 affected15 at risk
FOOT DEFORMITY	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
GROIN PAIN	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
HAEMARTHROSIS	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
INTERVERTEBRAL DISC PROTRUSION	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
JOINT RANGE OF MOTION DECREASED	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
MUSCLE SPASMS	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
MUSCULOSKELETAL PAIN	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
MYALGIA	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected16 at risk EG0010 affected15 at risk
NECK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected16 at risk EG0010 affected15 at risk
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0008 affected16 at risk EG0015 affected15 at risk
TENDONITIS	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
BURNING SENSATION	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0011 affected15 at risk
DISTURBANCE IN ATTENTION	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
DIZZINESS	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0004 affected16 at risk EG0014 affected15 at risk
DYSGEUSIA	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
HEADACHE	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0008 affected16 at risk EG0014 affected15 at risk
MIGRAINE	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0011 affected15 at risk
PARAESTHESIA	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0006 affected16 at risk EG0013 affected15 at risk
PRESYNCOPE	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected16 at risk EG0011 affected15 at risk
SLOW RESPONSE TO STIMULI	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
SPEECH DISORDER	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
TREMOR	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
ABNORMAL BEHAVIOUR	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
ANXIETY	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0011 affected15 at risk
CONFUSIONAL STATE	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
DEPRESSION	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
DEPRESSIVE SYMPTOM	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
DISORIENTATION	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
DYSPHORIA	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
HALLUCINATION	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
INSOMNIA	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected16 at risk EG0010 affected15 at risk
LISTLESS	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
PANIC ATTACK	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
SLEEP DISORDER	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected16 at risk EG0010 affected15 at risk
HAEMATURIA	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected16 at risk EG0011 affected15 at risk
HYDRONEPHROSIS	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
HYDROURETER	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
MICROALBUMINURIA	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
PENILE DISCHARGE	Reproductive system and breast disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
PENILE PAIN	Reproductive system and breast disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
SCROTAL ANGIOKERATOMA	Reproductive system and breast disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected16 at risk EG0011 affected15 at risk
ALLERGIC COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
ALLERGIC RESPIRATORY SYMPTOM	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
BRONCHIAL OBSTRUCTION	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0011 affected15 at risk
BRONCHOSPASM	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0011 affected15 at risk
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0008 affected16 at risk EG0015 affected15 at risk
DRY THROAT	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected16 at risk EG0012 affected15 at risk
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected16 at risk EG0011 affected15 at risk
NASAL CONGESTION	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0005 affected16 at risk EG0011 affected15 at risk
OROPHARYNGEAL PAIN	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected16 at risk EG0016 affected15 at risk
PHARYNGEAL ERYTHEMA	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
RESPIRATORY TRACT CONGESTION	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
RHINITIS ALLERGIC	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
RHINORRHOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0011 affected15 at risk
SINUS CONGESTION	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0011 affected15 at risk
SNEEZING	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
TACHYPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
THROAT IRRITATION	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
TONSILLAR HYPERTROPHY	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
UPPER RESPIRATORY TRACT CONGESTION	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
WHEEZING	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
ACNE	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
ANGIOKERATOMA	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0009 affected16 at risk EG0015 affected15 at risk
BLISTER	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
DERMATITIS	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
DERMATITIS CONTACT	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected16 at risk EG0012 affected15 at risk
DRY SKIN	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
ECZEMA	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0011 affected15 at risk
ERYTHEMA	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0004 affected16 at risk EG0011 affected15 at risk
HYPERHIDROSIS	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
MILIARIA	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
NIGHT SWEATS	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
PETECHIAE	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
RASH	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0004 affected16 at risk EG0011 affected15 at risk
RASH ERYTHEMATOUS	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
RASH MACULAR	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0011 affected15 at risk
SWELLING FACE	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected16 at risk EG0011 affected15 at risk
TELANGIECTASIA	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
UMBILICAL ERYTHEMA	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
SINUS OPERATION	Surgical and medical procedures	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
ANGIOPATHY	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
FLUSHING	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
HYPOTENSION	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0011 affected15 at risk
PALLOR	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected16 at risk EG0011 affected15 at risk
RAYNAUD'S PHENOMENON	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected16 at risk EG0011 affected15 at risk
GENERAL PHYSICAL HEALTH DETERIORATION	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
INFUSION SITE EXTRAVASATION	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
TENDON RUPTURE	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
PROTEIN URINE PRESENT	Investigations	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
CATARRH	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
HYPOAESTHESIA	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
PERIORBITAL OEDEMA	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
ABDOMINAL TENDERNESS	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
IRRITABLE BOWEL SYNDROME	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
PRURITUS	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0012 affected15 at risk
JOINT SWELLING	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
MUSCULAR WEAKNESS	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
MUSCULOSKELETAL CHEST PAIN	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0011 affected15 at risk
VITAMIN B12 DEFICIENCY	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk
HORDEOLUM	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected16 at risk EG0010 affected15 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Decatur	Georgia		United States

ID	Term
D013106	Sphingolipidoses
D020140	Lysosomal Storage Diseases, Nervous System
D020739	Brain Diseases, Metabolic, Inborn
D001928	Brain Diseases, Metabolic
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D059345	Cerebral Small Vessel Diseases
D002561	Cerebrovascular Disorders
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D040181	Genetic Diseases, X-Linked
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D008661	Metabolism, Inborn Errors
D008064	Lipidoses
D008052	Lipid Metabolism, Inborn Errors
D016464	Lysosomal Storage Diseases
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D052439	Lipid Metabolism Disorders

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Fabrazyme 0.5 mg/kg	Fabrazyme 0.5 mg/kg was administered every 2 weeks (up to 131 infusion) up to 260 weeks, the total infusion time was not less than 45 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.			6	16	16	16
EG001	Fabrazyme 1.0 mg/kg	Fabrazyme 1.0 mg/kg was administered every 4 weeks (up to 66 infusion) up to 260 weeks, the total infusion time was not less than 90 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.			5	15	15	15