Phase 3 Extension Study of the Safety and Efficacy of Ald... | NCT00146770

Name	Class
BioMarin/Genzyme LLC	INDUSTRY

Label	Type	Description	Intervention Names
Placebo/Aldurazyme	Active Comparator	Patients received placebo for 26 weeks in the Double-Blind Study then received 182 weeks of Aldurazyme (0.58 mg/kg every week) in this Extension Study; patients received a total of 182 weeks of Aldurazyme.	Biological: Aldurazyme Biological: placebo
Aldurazyme/Aldurazyme	Active Comparator	Patients received 26 weeks of Aldurazyme in the Double-Blind Study and then received 182 weeks of Aldurazyme in this Extension Study; patients received a total of 208 weeks of Aldurazyme.	Biological: Aldurazyme

Name	Type	Description	Arm Group Labels	Other Names
Aldurazyme	Biological	Placebo for 26 weeks then 0.58 mg/kg Aldurazyme every week for 182 weeks	Placebo/Aldurazyme

Measure	Description	Time Frame
Change From Baseline to Week 182 in Percent Predicted Forced Vital Capacity (FVC)	Percent Predicted Forced Vital Capacity: the maximal exhaled breath volume following a maximal inhaled breath. Overall change from Baseline to Week 182 in percent predicted FVC = (observed value)/(predicted value) * 100%). A higher value indicates a greater response.	Baseline to Week 182
Change From Baseline to Week 182 in Six Minute Walk Test (6MWT)	Six Minute Walk Test: Distance walked (measured in Meters) in 6 minutes. A longer distance indicates a greater response.	Baseline to Week 182

Measure	Description	Time Frame
Change From Baseline to Week 182 in Apnea/Hypopnea Index (AHI)	Apnea/Hypopnea Index (AHI): Number of absent (apnea) and shallow (hypopnea) breaths per hour of sleep. A greater decrease in events indicates a greater response.	Baseline to Week 182
Change From Baseline to Week 182 in Liver Volume

Measure	Description	Time Frame
Change From Baseline to Week 182 in Urinary GAG Level	Urinary Glycosaminoglycan (GAG) Levels: >> Concentration of GAG relative to creatinine in urine. A greater decrease in GAG level indicates a greater response.	Baseline to Week 182

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

Facility	Status	City	State	ZIP	Country	Contacts
University of South Alabama		Mobile	Alabama	36604	United States
Emory University School of Medicine

PubMed Identifier	Type	Citation	Retractions
33874971	Derived	Tandon PK, Kakkis ED. The multi-domain responder index: a novel analysis tool to capture a broader assessment of clinical benefit in heterogeneous complex rare diseases. Orphanet J Rare Dis. 2021 Apr 19;16(1):183. doi: 10.1186/s13023-021-01805-5.
19117887	Derived	Clarke LA, Wraith JE, Beck M, Kolodny EH, Pastores GM, Muenzer J, Rapoport DM, Berger KI, Sidman M, Kakkis ED, Cox GF. Long-term efficacy and safety of laronidase in the treatment of mucopolysaccharidosis I. Pediatrics. 2009 Jan;123(1):229-40. doi: 10.1542/peds.2007-3847.

ID	Title	Description
FG000	Placebo/Aldurazyme	Patients received placebo for 26 weeks in the Double-Blind Study then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 182 weeks of Aldurazyme treatment. "Baseline" for this group is the last measurement in the Double-Bind Study prior to enrollment in this Extension Study.

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

Change From Baseline to Week 182 in Percent Predicted Forced Vital Capacity (FVC)

Percent Predicted Forced Vital Capacity: the maximal exhaled breath volume following a maximal inhaled breath. Overall change from Baseline to Week 182 in percent predicted FVC = (observed value)/(predicted value) * 100%). A higher value indicates a greater response.

This study enrolled patients who completed the Phase 3 Double-Blind Study and wished to receive open-label treatment with Aldurazyme. The analysis method was intention to treat with last value carried forward.

Posted

Mean

Standard Deviation

percent predicted FVC

Baseline to Week 182

ID	Title	Description
OG000	Placebo/Aldurazyme	Patients received placebo for 26 weeks in the Double-Blind Study then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 182 weeks of Aldurazyme treatment. "Baseline" for this group is the last measurement in the Double-Bind Study prior to enrollment in this Extension Study.
OG001	Aldurazyme/Aldurazyme	Patients received 26 weeks of Aldurazyme treatment in the Double-Blind Study and then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 208 weeks of Aldurazyme treatment. "Baseline" for this group is the last measurement prior to randomization in the Double-Blind Study.

Units	Counts
Participants	OG00023 OG00122

Title

Denominators

Categories

Baseline percentage points FVC

Title	Measurements
	OG00051.0± 13.15 OG00148.4± 14.85

Week 182 percentage points FVC

Title	Measurements
	OG000

Primary

Change From Baseline to Week 182 in Six Minute Walk Test (6MWT)

Six Minute Walk Test: Distance walked (measured in Meters) in 6 minutes. A longer distance indicates a greater response.

The study enrolled patients who completed the Phase 3 double-blind study and wished to receive open-label treatment with Aldurazyme. The analysis method was intention to treat with last value carried forward.

Posted

Mean

Standard Deviation

Meters

Baseline to Week 182

ID	Title	Description
OG000	Placebo/Aldurazyme	Patients received placebo for 26 weeks in the Double-Blind Study then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 182 weeks of Aldurazyme treatment. "Baseline" for this group is the last measurement in the Double-Bind Study prior to enrollment in this Extension Study.
OG001	Aldurazyme/Aldurazyme	Patients received 26 weeks of Aldurazyme treatment in the Double-Blind Study and then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 208 weeks of Aldurazyme treatment. "Baseline" for this group is the last measurement prior to randomization in the Double-Blind Study.

Units	Counts

Secondary

Change From Baseline to Week 182 in Apnea/Hypopnea Index (AHI)

Apnea/Hypopnea Index (AHI): Number of absent (apnea) and shallow (hypopnea) breaths per hour of sleep. A greater decrease in events indicates a greater response.

The study enrolled patients who completed the Phase 3 double-blind study and wished to receive open-label treatment with Aldurazyme. The analysis method was intention to treat.

Posted

Mean

Standard Deviation

Events per Hour

Baseline to Week 182

ID	Title	Description
OG000	Placebo/Aldurazyme	Patients received placebo for 26 weeks in the Double-Blind Study then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 182 weeks of Aldurazyme treatment. "Baseline" for this group is the last measurement in the Double-Bind Study prior to enrollment in this Extension Study.
OG001	Aldurazyme/Aldurazyme	Patients received 26 weeks of Aldurazyme treatment in the Double-Blind Study and then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 208 weeks of Aldurazyme treatment. "Baseline" for this group is the last measurement prior to randomization in the Double-Blind Study.

Units

Secondary

Change From Baseline to Week 182 in Liver Volume

Liver Organ Volume: Volume of liver measured by Magnetic Resonance Imaging (MRI). Greater decrease in volume indicates a greater response.

The study enrolled patients who completed the Phase 3 double-blind study and wished to receive open-label treatment with Aldurazyme. The analysis method was intention to treat.

Posted

Mean

Standard Deviation

Cubic centimeters (cm3)

Baseline to Week 182

ID	Title	Description
OG000	Placebo/Aldurazyme	Patients received placebo for 26 weeks in the Double-Blind Study then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 182 weeks of Aldurazyme treatment. "Baseline" for this group is the last measurement in the Double-Bind Study prior to enrollment in this Extension Study.
OG001	Aldurazyme/Aldurazyme	Patients received 26 weeks of Aldurazyme treatment in the Double-Blind Study and then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 208 weeks of Aldurazyme treatment. "Baseline" for this group is the last measurement prior to randomization in the Double-Blind Study.

Units	Counts

Secondary

Change From Baseline to Week 182 in Child Health Assessment Questionnaire/Health Assessment Questionnaire (CHAQ/HAQ) Disability Index Score

CHAQ/HAQ = Patient questionnaire that measures the degree of disability on a scale of 0 (no disability) to 3 (maximal disability). A lower score indicates a greater response.

The study enrolled patients who completed the Phase 3 double-blind study and wished to receive open-label treatment with Aldurazyme. The analysis method was intention to treat.

Posted

Mean

Standard Deviation

Units on a scale

Baseline to Week 182

ID	Title	Description
OG000	Placebo/Aldurazyme	Patients received placebo for 26 weeks in the Double-Blind Study then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 182 weeks of Aldurazyme treatment. "Baseline" for this group is the last measurement in the Double-Bind Study prior to enrollment in this Extension Study.
OG001	Aldurazyme/Aldurazyme	Patients received 26 weeks of Aldurazyme treatment in the Double-Blind Study and then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 208 weeks of Aldurazyme treatment. "Baseline" for this group is the last measurement prior to randomization in the Double-Blind Study.

Secondary

Change From Baseline to Week 182 in Active Joint Range of Motion (ROM)

Active Joint Range of Motion (ROM): Shoulder Flexion Ability to maximally raise one's arm overhead without assistance. Shoulder range of motion (mean of left and right arms) measured in degrees (0-180) by goniometry. Greater degree of flexion indicates greater response.

The study enrolled patients who completed the Phase 3 double-blind study and wished to receive open-label treatment with Aldurazyme. The analysis method was intention to treat.

Posted

Mean

Standard Deviation

Degrees

Baseline to Week182

ID	Title	Description
OG000	Placebo/Aldurazyme	Patients received placebo for 26 weeks in the Double-Blind Study then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 182 weeks of Aldurazyme treatment. "Baseline" for this group is the last measurement in the Double-Bind Study prior to enrollment in this Extension Study.
OG001	Aldurazyme/Aldurazyme	Patients received 26 weeks of Aldurazyme treatment in the Double-Blind Study and then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 208 weeks of Aldurazyme treatment. "Baseline" for this group is the last measurement prior to randomization in the Double-Blind Study.

Other Pre-specified

Change From Baseline to Week 182 in Urinary GAG Level

Urinary Glycosaminoglycan (GAG) Levels: >> Concentration of GAG relative to creatinine in urine. A greater decrease in GAG level indicates a greater response.

The study enrolled patients who completed the Phase 3 double-blind study and wished to receive open-label treatment with Aldurazyme. The analysis method was intention to treat.

Posted

Mean

Standard Deviation

ug GAG/mg Creatinine

Baseline to Week 182

ID	Title	Description
OG000	Placebo/Aldurazyme	Patients received placebo for 26 weeks in the Double-Blind Study then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 182 weeks of Aldurazyme treatment. "Baseline" for this group is the last measurement in the Double-Bind Study prior to enrollment in this Extension Study.
OG001	Aldurazyme/Aldurazyme	Patients received 26 weeks of Aldurazyme treatment in the Double-Blind Study and then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 208 weeks of Aldurazyme treatment. "Baseline" for this group is the last measurement prior to randomization in the Double-Blind Study.

Units

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Arrhythmia	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Atrial flutter	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Palpitations	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Arnold-Chiari malformation	Congenital, familial and genetic disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Talipes	Congenital, familial and genetic disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Corneal opacity	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0011 affected22 at risk
Visual acuity reduced	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0011 affected22 at risk
Constipation	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0011 affected22 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Small intestinal perforation	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected23 at risk EG0010 affected22 at risk
Vomiting	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Catheter related complication	General disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Granuloma	General disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Hernia pain	General disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Pyrexia	General disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Heart transplant rejection	Immune system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Bacteraemia	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Bronchitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Catheter sepsis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Herpes virus infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Lobar pneumonia	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Otitis media	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Pneumonia	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Sepsis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Tracheitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Blood pressure increased	Investigations	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Electroencephalogram abnormal	Investigations	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Oxygen saturation decreased	Investigations	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0011 affected22 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Tendon disorder	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0012 affected22 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Cervical cord compression	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Convulsion	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0012 affected22 at risk
Extensor plantar response	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Grand mal convulsion	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Hydrocephalus	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Intracranial pressure increased	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Myoclonus	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Spinal cord compression	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Bipolar disorder	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Major depression	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Mental status changes	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Psychotic disorder	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Testicular torsion	Reproductive system and breast disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Choking	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0012 affected22 at risk
Tachypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Carpal tunnel decompression	Surgical and medical procedures	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Catheterisation venous	Surgical and medical procedures	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Central venous catheterisation	Surgical and medical procedures	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0011 affected22 at risk
Hypotension	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Poor venous access	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Thrombosis	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG0005 affected23 at risk EG0012 affected22 at risk
Splenomegaly	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected23 at risk EG0014 affected22 at risk
Angina pectoris	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Aortic valve incompetence	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected23 at risk EG0012 affected22 at risk
Arrhythmia	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0012 affected22 at risk
Atrioventricular block first degree	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected23 at risk EG0012 affected22 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Bradycardia	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Cyanosis	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Extrasystoles	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0012 affected22 at risk
Left atrial dilatation	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0012 affected22 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected23 at risk EG0010 affected22 at risk
Left ventricular hypertrophy	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected23 at risk EG0010 affected22 at risk
Mitral valve disease	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0011 affected22 at risk
Mitral valve stenosis	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Myocarditis	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Palpitations	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0012 affected22 at risk
Pericardial disease	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected23 at risk EG0010 affected22 at risk
Sinus arrhythmia	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Tachycardia	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected23 at risk EG0011 affected22 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Hip dysplasia	Congenital, familial and genetic disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Odontogenic cyst	Congenital, familial and genetic disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Talipes	Congenital, familial and genetic disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected23 at risk EG0012 affected22 at risk
Cerumen impaction	Ear and labyrinth disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected23 at risk EG0012 affected22 at risk
Deafness	Ear and labyrinth disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Deafness bilateral	Ear and labyrinth disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Deafness unilateral	Ear and labyrinth disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Ear discomfort	Ear and labyrinth disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0012 affected22 at risk
Ear disorder	Ear and labyrinth disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Ear haemorrhage	Ear and labyrinth disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0012 affected22 at risk
Ear pain	Ear and labyrinth disorders	MedDRA 11.1	Systematic Assessment	EG0007 affected23 at risk EG00111 affected22 at risk
Ear pruritus	Ear and labyrinth disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0011 affected22 at risk
Hypoacusis	Ear and labyrinth disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0011 affected22 at risk
Inner ear inflammation	Ear and labyrinth disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0012 affected22 at risk
Middle ear effusion	Ear and labyrinth disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Motion sickness	Ear and labyrinth disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Otorrhoea	Ear and labyrinth disorders	MedDRA 11.1	Systematic Assessment	EG0004 affected23 at risk EG0013 affected22 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected23 at risk EG0010 affected22 at risk
Tympanic membrane hyperaemia	Ear and labyrinth disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Tympanic membrane perforation	Ear and labyrinth disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0011 affected22 at risk
Tympanic membrane scarring	Ear and labyrinth disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected23 at risk EG0012 affected22 at risk
Cushingoid	Endocrine disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Hypothyroidism	Endocrine disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Abnormal sensation in eye	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Anisometropia	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Astigmatism	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0011 affected22 at risk
Blepharospasm	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Conjunctival hyperaemia	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Conjunctivitis	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0013 affected22 at risk
Corneal oedema	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Corneal opacity	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected23 at risk EG0015 affected22 at risk
Dry eye	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Eye allergy	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Eye inflammation	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Eye irritation	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0012 affected22 at risk
Eye movement disorder	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Eye oedema	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Eye pain	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected23 at risk EG0012 affected22 at risk
Eye pruritus	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected23 at risk EG0011 affected22 at risk
Eye swelling	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Eyelid oedema	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Hypermetropia	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0011 affected22 at risk
Hypoaesthesia eye	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Lacrimation increased	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected23 at risk EG0014 affected22 at risk
Myodesopsia	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Myopia	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Ocular hyperaemia	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Optic atrophy	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Papilloedema	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Photophobia	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Pseudopapilloedema	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Pterygium	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Retinal degeneration	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0011 affected22 at risk
Retinal pigment epitheliopathy	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected23 at risk EG0011 affected22 at risk
Strabismus	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0011 affected22 at risk
Vision blurred	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected23 at risk EG0011 affected22 at risk
Visual acuity reduced	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0012 affected22 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected23 at risk EG0011 affected22 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0014 affected22 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0007 affected23 at risk EG0019 affected22 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected23 at risk EG0013 affected22 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0007 affected23 at risk EG0018 affected22 at risk
Abdominal strangulated hernia	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Aphthous stomatitis	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Constipation	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected23 at risk EG0015 affected22 at risk
Dental caries	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG00014 affected23 at risk EG00110 affected22 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0011 affected22 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0012 affected22 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0012 affected22 at risk
Faecal incontinence	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Faeces discoloured	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Flatulence	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected23 at risk EG0011 affected22 at risk
Gastrointestinal hypermotility	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Gingival cyst	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0011 affected22 at risk
Gingival hyperplasia	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected23 at risk EG0011 affected22 at risk
Lip blister	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Lip swelling	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Lip ulceration	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Megacolon	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Nausea	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG00016 affected23 at risk EG00112 affected22 at risk
Oesophageal disorder	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Oral pain	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0011 affected22 at risk
Salivary hypersecretion	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0011 affected22 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Stomach discomfort	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected23 at risk EG0010 affected22 at risk
Teething	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Tongue disorder	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Tooth disorder	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected23 at risk EG0011 affected22 at risk
Tooth loss	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Toothache	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0006 affected23 at risk EG0012 affected22 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected23 at risk EG0013 affected22 at risk
Vomiting	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG00013 affected23 at risk EG00112 affected22 at risk
Application site erythema	General disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Application site pruritus	General disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Application site rash	General disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Asthenia	General disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected23 at risk EG0011 affected22 at risk
Catheter related complication	General disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected23 at risk EG0010 affected22 at risk
Catheter site discharge	General disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Catheter site erythema	General disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Catheter site inflammation	General disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected23 at risk EG0011 affected22 at risk
Catheter site pain	General disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected23 at risk EG0013 affected22 at risk
Catheter site pruritus	General disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0011 affected22 at risk
Catheter site rash	General disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0012 affected22 at risk
Catheter site related reaction	General disorders	MedDRA 11.1	Systematic Assessment	EG0004 affected23 at risk EG0011 affected22 at risk
Catheter site swelling	General disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Catheter site urticaria	General disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Chest discomfort	General disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected23 at risk EG0012 affected22 at risk
Chest pain	General disorders	MedDRA 11.1	Systematic Assessment	EG0006 affected23 at risk EG0017 affected22 at risk
Chills	General disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected23 at risk EG0012 affected22 at risk
Cyst	General disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0012 affected22 at risk
Fatigue	General disorders	MedDRA 11.1	Systematic Assessment	EG0006 affected23 at risk EG0019 affected22 at risk
Feeling cold	General disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected23 at risk EG0011 affected22 at risk
Feeling hot	General disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected23 at risk EG0013 affected22 at risk
Feeling of body temperature change	General disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected23 at risk EG0010 affected22 at risk
Gait disturbance	General disorders	MedDRA 11.1	Systematic Assessment	EG0006 affected23 at risk EG0013 affected22 at risk
Granuloma	General disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Hangover	General disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Hernia pain	General disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0012 affected22 at risk
Hyperthermia	General disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Hypothermia	General disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Inflammation	General disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0012 affected22 at risk
Influenza like illness	General disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected23 at risk EG0015 affected22 at risk
Infusion site erythema	General disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected23 at risk EG0011 affected22 at risk
Infusion site extravasation	General disorders	MedDRA 11.1	Systematic Assessment	EG0004 affected23 at risk EG0014 affected22 at risk
Infusion site pain	General disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected23 at risk EG0012 affected22 at risk
Infusion site reaction	General disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Injection site haematoma	General disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0011 affected22 at risk
Irritability	General disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Local swelling	General disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0011 affected22 at risk
Malaise	General disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0012 affected22 at risk
Oedema peripheral	General disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected23 at risk EG0014 affected22 at risk
Pain	General disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected23 at risk EG0014 affected22 at risk
Pyrexia	General disorders	MedDRA 11.1	Systematic Assessment	EG00016 affected23 at risk EG00118 affected22 at risk
Secretion discharge	General disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Hepatomegaly	Hepatobiliary disorders	MedDRA 11.1	Systematic Assessment	EG0005 affected23 at risk EG0018 affected22 at risk
Hepatosplenomegaly	Hepatobiliary disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Corneal graft rejection	Immune system disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected23 at risk EG0011 affected22 at risk
Food allergy	Immune system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Multiple allergies	Immune system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Seasonal allergy	Immune system disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected23 at risk EG0013 affected22 at risk
Bronchiolitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Bronchitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0002 affected23 at risk EG0011 affected22 at risk
Central line infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Conjunctivitis infective	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Cystitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0002 affected23 at risk EG0010 affected22 at risk
Dacryocystitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Ear infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG00010 affected23 at risk EG0017 affected22 at risk
Enterobiasis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Eye infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0011 affected22 at risk
Fungal infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Fungal skin infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Furuncle	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Gastroenteritis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0003 affected23 at risk EG0010 affected22 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0004 affected23 at risk EG0011 affected22 at risk
Herpangina	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Herpes virus infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Herpes zoster	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Hordeolum	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0003 affected23 at risk EG0010 affected22 at risk
Infectious mononucleosis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Influenza	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0006 affected23 at risk EG0011 affected22 at risk
Laryngitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Lice infestation	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0011 affected22 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0003 affected23 at risk EG0014 affected22 at risk
Lymph gland infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Myringitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Nasopharyngitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG00019 affected23 at risk EG00117 affected22 at risk
Oral herpes	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0011 affected22 at risk
Otitis externa	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0005 affected23 at risk EG0013 affected22 at risk
Otitis media	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0005 affected23 at risk EG0016 affected22 at risk
Otitis media acute	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0012 affected22 at risk
Otitis media chronic	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0002 affected23 at risk EG0010 affected22 at risk
Paronychia	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Pharyngitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0003 affected23 at risk EG0012 affected22 at risk
Pharyngitis streptococcal	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0003 affected23 at risk EG0011 affected22 at risk
Pneumonia	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0002 affected23 at risk EG0013 affected22 at risk
Postoperative wound infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0002 affected23 at risk EG0010 affected22 at risk
Respiratory tract infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0011 affected22 at risk
Rhinitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0004 affected23 at risk EG0016 affected22 at risk
Sialoadenitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0011 affected22 at risk
Sinusitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0004 affected23 at risk EG0012 affected22 at risk
Skin infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0011 affected22 at risk
Tinea pedis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0012 affected22 at risk
Tooth abscess	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0002 affected23 at risk EG0011 affected22 at risk
Tracheobronchitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0006 affected23 at risk EG0017 affected22 at risk
Upper respiratory tract infection bacterial	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Urinary tract infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0004 affected23 at risk EG0013 affected22 at risk
Viral diarrhoea	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Viral infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0002 affected23 at risk EG0012 affected22 at risk
Viral pharyngitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Viral skin infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0003 affected23 at risk EG0013 affected22 at risk
Vulvovaginal candidiasis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0011 affected22 at risk
Back injury	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Bite	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0004 affected23 at risk EG0015 affected22 at risk
Device migration	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Endotracheal intubation complication	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Excoriation	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0002 affected23 at risk EG0013 affected22 at risk
Extrusion of device	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0006 affected23 at risk EG0013 affected22 at risk
Incision site pain	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0012 affected22 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0012 affected22 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Medical device complication	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Mouth injury	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0011 affected22 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0012 affected22 at risk
Nail avulsion	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Neck injury	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Post procedural complication	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Post-traumatic pain	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Procedural nausea	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0007 affected23 at risk EG0019 affected22 at risk
Procedural vomiting	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0012 affected22 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Respiratory fume inhalation disorder	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0002 affected23 at risk EG0010 affected22 at risk
Scratch	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0012 affected22 at risk
Shunt malfunction	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0012 affected22 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0011 affected22 at risk
Soft tissue injury	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Stress fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Sunburn	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0011 affected22 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Tooth fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0011 affected22 at risk
Traumatic haematoma	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Vena cava injury	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Wound	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0002 affected23 at risk EG0011 affected22 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Bacteria urine	Investigations	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Blood bilirubin increased	Investigations	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Blood calcium increased	Investigations	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Blood cholesterol increased	Investigations	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Blood iron decreased	Investigations	MedDRA 11.1	Systematic Assessment	EG0004 affected23 at risk EG0010 affected22 at risk
Blood pressure decreased	Investigations	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0012 affected22 at risk
Blood pressure diastolic decreased	Investigations	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Body temperature increased	Investigations	MedDRA 11.1	Systematic Assessment	EG0004 affected23 at risk EG0014 affected22 at risk
Breath sounds abnormal	Investigations	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0012 affected22 at risk
Cardiac murmur	Investigations	MedDRA 11.1	Systematic Assessment	EG0005 affected23 at risk EG0018 affected22 at risk
Electrocardiogram PR prolongation	Investigations	MedDRA 11.1	Systematic Assessment	EG0003 affected23 at risk EG0011 affected22 at risk
Electrocardiogram QRS complex abnormal	Investigations	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Electrocardiogram QT prolonged	Investigations	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0013 affected22 at risk
Eosinophil count increased	Investigations	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Fungus stool identified	Investigations	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Grip strength decreased	Investigations	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Heart sounds abnormal	Investigations	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Intraocular pressure increased	Investigations	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Mean cell haemoglobin decreased	Investigations	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Oxygen saturation decreased	Investigations	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0012 affected22 at risk
Renal function test abnormal	Investigations	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Respiratory rate increased	Investigations	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Tandem gait test abnormal	Investigations	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Urine analysis abnormal	Investigations	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Urine leukocyte esterase positive	Investigations	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Weight decreased	Investigations	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0011 affected22 at risk
Weight increased	Investigations	MedDRA 11.1	Systematic Assessment	EG0003 affected23 at risk EG0011 affected22 at risk
White blood cells urine positive	Investigations	MedDRA 11.1	Systematic Assessment	EG0002 affected23 at risk EG0011 affected22 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Fluid retention	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG00014 affected23 at risk EG00113 affected22 at risk
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected23 at risk EG0012 affected22 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG00012 affected23 at risk EG00111 affected22 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0011 affected22 at risk
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Extraskeletal ossification	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0011 affected22 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0011 affected22 at risk
Growth retardation	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Inguinal mass	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Joint crepitation	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0004 affected23 at risk EG0012 affected22 at risk
Joint effusion	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Joint instability	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Joint lock	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Joint range of motion decreased	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected23 at risk EG0014 affected22 at risk
Joint stiffness	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0012 affected22 at risk
Joint warmth	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Limb discomfort	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Lordosis	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Lower limb deformity	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Muscle atrophy	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0011 affected22 at risk
Muscle contracture	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0004 affected23 at risk EG0012 affected22 at risk
Muscle tightness	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Muscle twitching	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0012 affected22 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected23 at risk EG0012 affected22 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected23 at risk EG0011 affected22 at risk
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG00011 affected23 at risk EG0017 affected22 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected23 at risk EG0015 affected22 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0007 affected23 at risk EG0014 affected22 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0005 affected23 at risk EG0019 affected22 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG00018 affected23 at risk EG00114 affected22 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Sensation of heaviness	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Soft tissue disorder	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Tendon pain	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0011 affected22 at risk
Trigger finger	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Unequal limb length	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Cholesteatoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Melanocytic naevus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0011 affected22 at risk
Aphonia	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected23 at risk EG0013 affected22 at risk
Cervical cord compression	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Cervical root pain	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Clonus	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0012 affected22 at risk
Clumsiness	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Convulsion	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0012 affected22 at risk
Coordination abnormal	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Dizziness	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0009 affected23 at risk EG0015 affected22 at risk
Dizziness postural	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Dyskinesia	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Grand mal convulsion	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Head discomfort	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Headache	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG00019 affected23 at risk EG00119 affected22 at risk
Hoffmann's sign	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0012 affected22 at risk
Hyperreflexia	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0004 affected23 at risk EG0016 affected22 at risk
Hypertonia	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected23 at risk EG0011 affected22 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected23 at risk EG0014 affected22 at risk
Hyporeflexia	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0012 affected22 at risk
Intracranial pressure increased	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Irregular sleep phase	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Lethargy	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected23 at risk EG0012 affected22 at risk
Loss of consciousness	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Loss of proprioception	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Migraine	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected23 at risk EG0013 affected22 at risk
Myoclonus	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Nervous system disorder	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Neuralgia	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0011 affected22 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Nystagmus	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Paraesthesia	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected23 at risk EG0014 affected22 at risk
Poor quality sleep	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Post-traumatic headache	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Psychomotor hyperactivity	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Reflexes abnormal	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Sensory disturbance	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected23 at risk EG0011 affected22 at risk
Sensory loss	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Sinus headache	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Somnolence	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected23 at risk EG0012 affected22 at risk
Speech disorder	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Syncope	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0012 affected22 at risk
Tremor	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Agitation	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Anxiety	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected23 at risk EG0011 affected22 at risk
Apathy	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Bipolar disorder	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Daydreaming	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Depression	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0014 affected22 at risk
Disorientation	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Flat affect	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Insomnia	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0015 affected22 at risk
Major depression	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Mental status changes	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Restlessness	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Sleep disorder	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0012 affected22 at risk
Bilirubinuria	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Dysuria	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0012 affected22 at risk
Enuresis	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Ketonuria	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Micturition urgency	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Polyuria	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0012 affected22 at risk
Urinary retention	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Urinary tract pain	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Amenorrhoea	Reproductive system and breast disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA 11.1	Systematic Assessment	EG0005 affected23 at risk EG0013 affected22 at risk
Genital discharge	Reproductive system and breast disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0011 affected22 at risk
Menstrual discomfort	Reproductive system and breast disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected23 at risk EG0010 affected22 at risk
Menstruation irregular	Reproductive system and breast disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0011 affected22 at risk
Apnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0013 affected22 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Bronchial secretion retention	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG00018 affected23 at risk EG00116 affected22 at risk
Dry throat	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0012 affected22 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0005 affected23 at risk EG0013 affected22 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0011 affected22 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected23 at risk EG0012 affected22 at risk
Increased bronchial secretion	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Increased upper airway secretion	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0011 affected22 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0009 affected23 at risk EG0018 affected22 at risk
Nasal discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0011 affected22 at risk
Nasal inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG00016 affected23 at risk EG00115 affected22 at risk
Pharyngeal erythema	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Pharyngeal lesion	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0012 affected22 at risk
Rales	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected23 at risk EG0014 affected22 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG00011 affected23 at risk EG0019 affected22 at risk
Rhonchi	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0012 affected22 at risk
Sinus disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0011 affected22 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected23 at risk EG0015 affected22 at risk
Sneezing	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0006 affected23 at risk EG0015 affected22 at risk
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Upper airway resistance syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Upper respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected23 at risk EG0012 affected22 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected23 at risk EG0011 affected22 at risk
Acrodermatitis	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Blister	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Butterfly rash	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Cold sweat	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected23 at risk EG0010 affected22 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0006 affected23 at risk EG0013 affected22 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0011 affected22 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected23 at risk EG0013 affected22 at risk
Excessive granulation tissue	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Ingrowing nail	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected23 at risk EG0011 affected22 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Pain of skin	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Photosensitivity reaction	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Pigmentation disorder	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected23 at risk EG0013 affected22 at risk
Pruritus generalised	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG00012 affected23 at risk EG0018 affected22 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0011 affected22 at risk
Rash generalised	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Rash macular	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0011 affected22 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Rash papular	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0012 affected22 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected23 at risk EG0011 affected22 at risk
Scab	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Scar	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Skin discolouration	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Skin erosion	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Skin exfoliation	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Skin induration	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Skin inflammation	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0004 affected23 at risk EG0013 affected22 at risk
Skin reaction	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Swelling face	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0011 affected22 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected23 at risk EG0012 affected22 at risk
Tooth extraction	Surgical and medical procedures	MedDRA 11.1	Systematic Assessment	EG0002 affected23 at risk EG0012 affected22 at risk
Tooth repair	Surgical and medical procedures	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Flushing	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected23 at risk EG0015 affected22 at risk
Hypertension	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected23 at risk EG0011 affected22 at risk
Hypotension	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected22 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Pallor	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected22 at risk
Poor venous access	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0004 affected23 at risk EG0012 affected22 at risk
Vein disorder	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected23 at risk EG0011 affected22 at risk

ID	Term
D009083	Mucopolysaccharidoses
D002239	Carbohydrate Metabolism, Inborn Errors
D008661	Metabolism, Inborn Errors
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D016464	Lysosomal Storage Diseases
D017520	Mucinoses
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D006026	Glycoside Hydrolases
D006867	Hydrolases
D004798	Enzymes
D045762	Enzymes and Coenzymes

ID	Title	Description
BG000	Placebo/Aldurazyme	Patients received placebo for 26 weeks in the Double-Blind Study then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 182 weeks of Aldurazyme treatment.
BG001	Aldurazyme/Aldurazyme	Patients received 26 weeks of Aldurazyme treatment in the Double-Blind Study and then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 208 weeks of Aldurazyme treatment.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo/\|Aldurazyme*Check Title*	Placebo/\|Aldurazyme*Check Description*			11	23	23	23
EG001	Aldurazyme/\|Aldurazyme*Check Title*	Aldurazyme/\|Aldurazyme*Check Description*			14	22	22	22