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This multicenter, open-label extension study is designed to assess long-term efficacy and safety of 2.0 milligrams (mg)/kilogram(kg)/week of BMN 110 in patients diagnosed with Mucopolysaccharidosis IVA (MPS IVA). Patients with MPS IVA, who enrolled in a prior BioMarin sponsored clinical study of BMN 110 (NCT00884949; Study Identification Number MOR-002), were eligible to enroll in this study (except patients who enrolled in NCT01275066; Study Identification Number MOR-004).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMN 110 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMN 110 | Drug | Patients will receive an intravenous infusion of BMN110 at 2.0mg/kg/week, over a period of approximately 4 hours per infusion, for up to 240 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety Evaluation | The primary objective of the study is to evaluate the safety of weekly infusions of BMN 110; the safety variables included Adverse Events (AEs). The primary outcome measure data is presented in more detail under the Adverse Events section. | Entire Study Period, up to 240 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Endurance as Measured by the 6-minute Walk Test During the Pilot Trial (MOR-002) and Current Extension Trial (MOR-100). | Change from baseline in meters in 6-minute Walk Test. As a measure of endurance, a 6-minute walk test (6MWT) was performed according to the American Thoracic Society Guidelines. Patients were instructed to walk as far as possible in 6 minutes. | Baseline and every 12 weeks for up to 72 weeks during the MOR-002 pilot trial and every 24 weeks for up to 192 weeks during the MOR-100 extension trial |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Celeste Decker, MD | BioMarin Pharmaceutical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | United Kingdom | United Kingdom | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29526614 | Derived | Hendriksz C, Santra S, Jones SA, Geberhiwot T, Jesaitis L, Long B, Qi Y, Hawley SM, Decker C. Safety, immunogenicity, and clinical outcomes in patients with Morquio A syndrome participating in 2 sequential open-label studies of elosulfase alfa enzyme replacement therapy (MOR-002/MOR-100), representing 5 years of treatment. Mol Genet Metab. 2018 Apr;123(4):479-487. doi: 10.1016/j.ymgme.2018.02.011. Epub 2018 Feb 19. |
| Label | URL |
|---|---|
| BioMarin Pharmaceutical Inc. website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | BMN 110 | BMN 110: Patients will receive an intravenous infusion of BMN110 at 2.0mg/kg/week, over a period of approximately 4 hours per infusion, for up to 240 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Change in Baseline in Endurance as Measured by the 3 Minute Stair Climb During the Pilot Trial (MOR-002) and Current Extension Trial (MOR-100). | Change from baseline in the 3-minute Stair Climb Test (3MSCT). Patients walked up stairs that have a railing, which could be used for support, for 3 minutes, with the number of stairs climbed recorded. The test result was the number of steps climbed per minute. | Baseline and every 12 weeks for up to 72 weeks during the MOR-002 pilot trial and every 24 weeks for up to 192 weeks during the MOR-100 extension trial |
| Percent Change From Baseline in Urine Keratan Sulfate (uKS) Levels During the Pilot Trial (MOR-002) and Current Extension Trial (MOR-100). | Percent Change from baseline in Normalized Urine KS. The percent change was calculated (Week X value - baseline value)/baseline value *100% | Baseline and every 12 weeks for up to 72 weeks during the MOR-002 pilot trial and every 24 weeks for up to 168 weeks during the MOR-100 extension trial |
| Percent Change From Baseline in Respiratory Function Test MVV During the Pilot Trial (MOR-002) and Current Extension Trial (MOR-100). | Percent Change from baseline in Maximum Voluntary Ventilation. | Baseline and every 12 weeks for up to 72 weeks during the MOR-002 pilot trial and every 24 weeks for up to 192 weeks during the MOR-100 extension trial |
| Percent Change From Baseline in Respiratory Function Test FVC During the Pilot Trial (MOR-002) and Current Extension Trial (MOR-100). | Percent Change from baseline in Forced Vital Capacity. | Baseline and every 12 weeks for up to 72 weeks during the MOR-002 pilot trial and every 24 weeks for up to 192 weeks during the MOR-100 extension trial |
| Dumfries |
| United Kingdom |
| United Kingdom |
| London | United Kingdom | United Kingdom |
| Manchester | United Kingdom | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | BMN 110 | BMN 110: Patients will receive an intravenous infusion of BMN110 at 2.0mg/kg/week, over a period of approximately 4 hours per infusion, for up to 240 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Age, Customized | Number | participants |
| |||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Safety Evaluation | The primary objective of the study is to evaluate the safety of weekly infusions of BMN 110; the safety variables included Adverse Events (AEs). The primary outcome measure data is presented in more detail under the Adverse Events section. | The primary outcome measure data is presented in more detail under the Adverse Events section. | Posted | Number | participants | Entire Study Period, up to 240 weeks |
|
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Endurance as Measured by the 6-minute Walk Test During the Pilot Trial (MOR-002) and Current Extension Trial (MOR-100). | Change from baseline in meters in 6-minute Walk Test. As a measure of endurance, a 6-minute walk test (6MWT) was performed according to the American Thoracic Society Guidelines. Patients were instructed to walk as far as possible in 6 minutes. | Intent-to-Treat population (all subjects who enrolled in the study). Two patients were either physically (score was designated as 0 m) or developmentally (score was set to missing) unable to perform the 6MWT. The analysis was based on observed cases. | Posted | Mean | Standard Deviation | meters | Baseline and every 12 weeks for up to 72 weeks during the MOR-002 pilot trial and every 24 weeks for up to 192 weeks during the MOR-100 extension trial |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change in Baseline in Endurance as Measured by the 3 Minute Stair Climb During the Pilot Trial (MOR-002) and Current Extension Trial (MOR-100). | Change from baseline in the 3-minute Stair Climb Test (3MSCT). Patients walked up stairs that have a railing, which could be used for support, for 3 minutes, with the number of stairs climbed recorded. The test result was the number of steps climbed per minute. | Intent-to-Treat population (all subjects who enrolled in the study). One patient was developmentally unable to perform the 3MSCT and the test scores were set to missing. The analysis was based on observed cases. | Posted | Mean | Standard Deviation | steps/min | Baseline and every 12 weeks for up to 72 weeks during the MOR-002 pilot trial and every 24 weeks for up to 192 weeks during the MOR-100 extension trial |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Urine Keratan Sulfate (uKS) Levels During the Pilot Trial (MOR-002) and Current Extension Trial (MOR-100). | Percent Change from baseline in Normalized Urine KS. The percent change was calculated (Week X value - baseline value)/baseline value *100% | Intent-to-Treat population (all subjects who enrolled in the study). The analysis was based on observed cases. | Posted | Mean | Standard Deviation | percentage change | Baseline and every 12 weeks for up to 72 weeks during the MOR-002 pilot trial and every 24 weeks for up to 168 weeks during the MOR-100 extension trial |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Respiratory Function Test MVV During the Pilot Trial (MOR-002) and Current Extension Trial (MOR-100). | Percent Change from baseline in Maximum Voluntary Ventilation. | Intent-to-Treat population (all subjects who enrolled in the study). The analysis was based on observed cases. | Posted | Mean | Standard Deviation | percentage change | Baseline and every 12 weeks for up to 72 weeks during the MOR-002 pilot trial and every 24 weeks for up to 192 weeks during the MOR-100 extension trial |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Respiratory Function Test FVC During the Pilot Trial (MOR-002) and Current Extension Trial (MOR-100). | Percent Change from baseline in Forced Vital Capacity. | Intent-to-Treat population (all subjects who enrolled in the study). The analysis was based on observed cases. | Posted | Mean | Standard Deviation | percentage change | Baseline and every 12 weeks for up to 72 weeks during the MOR-002 pilot trial and every 24 weeks for up to 192 weeks during the MOR-100 extension trial |
|
|
Study Period, up to 240 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BMN 110 | BMN 110: Patients will receive an intravenous infusion of BMN110 at 2.0mg/kg/week, over a period of approximately 4 hours per infusion, for up to 240 weeks. | 19 | 20 | 20 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Supraventricular tachycardia | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Infusion site inflammation | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Infusion site reaction | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Type I hypersensitivity | Immune system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Catheter site infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Infusion site infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Pneumonia mycoplasmal | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Skull fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Knee deformity | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cervical cord compression | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Abscess drainage | Surgical and medical procedures | MedDRA 16.1 | Systematic Assessment |
| |
| Bone operation | Surgical and medical procedures | MedDRA 16.1 | Systematic Assessment |
| |
| Central venous catheterisation | Surgical and medical procedures | MedDRA 16.1 | Systematic Assessment |
| |
| Knee operation | Surgical and medical procedures | MedDRA 16.1 | Systematic Assessment |
| |
| Medical device implantation | Surgical and medical procedures | MedDRA 16.1 | Systematic Assessment |
| |
| Medical device removal | Surgical and medical procedures | MedDRA 16.1 | Systematic Assessment |
| |
| Orthopaedic procedure | Surgical and medical procedures | MedDRA 16.1 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Jugular vein distension | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Poor venous access | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Aortic valve incompetence | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Diastolic dysfunction | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Mitral valve disease | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pulmonary valve incompetence | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Tricuspid valve incompetence | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Congenital heart valve disorder | Congenital, familial and genetic disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cerumen impaction | Ear and labyrinth disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Deafness | Ear and labyrinth disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Deafness neurosensory | Ear and labyrinth disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Ear canal erythema | Ear and labyrinth disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Ear discomfort | Ear and labyrinth disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Ear disorder | Ear and labyrinth disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Ear pruritus | Ear and labyrinth disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hyperacusis | Ear and labyrinth disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Middle ear disorder | Ear and labyrinth disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Motion sickness | Ear and labyrinth disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Otorrhoea | Ear and labyrinth disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Tympanic membrane disorder | Ear and labyrinth disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Tympanic membrane hyperaemia | Ear and labyrinth disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Tympanic membrane perforation | Ear and labyrinth disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Autoimmune thyroiditis | Endocrine disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Eye discharge | Eye disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Eye pruritus | Eye disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Eye swelling | Eye disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Eyelid cyst | Eye disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dental plaque | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Faecal incontinence | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Gingival hyperpigmentation | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Glossodynia | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Lip disorder | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Lip pain | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Retching | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Tongue discolouration | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Tooth deposit | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Tooth disorder | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Application site reaction | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Application site vesicles | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Catheter site erythema | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Catheter site extravasation | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Catheter site inflammation | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Catheter site oedema | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Catheter site pain | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Catheter site rash | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Catheter site related reaction | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Catheter site scab | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Catheter site swelling | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Device connection issue | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Device dislocation | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Device expulsion | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Device leakage | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Device malfunction | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Device occlusion | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Extravasation | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Feeling hot | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Infusion site erythema | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Infusion site extravasation | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Infusion site pain | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Infusion site reaction | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Local swelling | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Medical device complication | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Medical device site reaction | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Vaccination site pain | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hepatomegaly | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Catheter site infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Eye infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Helminthic infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Lice infestation | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Molluscum contagiosum | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Nail infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Rash pustular | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Tinea pedis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Varicella | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Ear injury | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Eye contusion | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Face injury | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Lip injury | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Neck injury | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Occupational exposure to radiation | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Periorbital contusion | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Procedural headache | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Procedural vomiting | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Scar | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Scratch | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Skeletal injury | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Sunburn | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Wound complication | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Aspiration joint | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Blood immunoglobulin E increased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Blood immunoglobulin G decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Blood pressure systolic increased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Blood sodium increased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Body temperature increased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Breath sounds abnormal | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Cardiac murmur | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Computerised tomogram | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Electrocardiogram T wave amplitude decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Eosinophil count increased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Eosinophil percentage increased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Liver palpable subcostal | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Nuclear magnetic resonance imaging | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Nuclear magnetic resonance imaging spinal | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Oxygen saturation decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Protein total abnormal | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Protein urine | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Respiratory rate increased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Ultrasound scan abnormal | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Appetite disorder | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Atlantoaxial instability | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Axillary mass | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Joint instability | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Knee deformity | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Mobility decreased | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Ageusia | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Areflexia | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cervical cord compression | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Clonus | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Reflexes abnormal | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Enuresis | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Incontinence | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Polyuria | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Balanitis | Reproductive system and breast disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Genital ulceration | Reproductive system and breast disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Penile pain | Reproductive system and breast disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Perineal ulceration | Reproductive system and breast disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Scrotal erythema | Reproductive system and breast disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Vulvovaginal pruritus | Reproductive system and breast disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Nasal obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pharyngeal disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pharyngeal erythema | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pharyngeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Rales | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Eczema asteatotic | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Lichen planus | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Miliaria | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Onychomadesis | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Papule | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pigmentation disorder | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Skin depigmentation | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Skin mass | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Catheter removal | Surgical and medical procedures | MedDRA 16.1 | Systematic Assessment |
| |
| Cautery to nose | Surgical and medical procedures | MedDRA 16.1 | Systematic Assessment |
| |
| Central venous catheterisation | Surgical and medical procedures | MedDRA 16.1 | Systematic Assessment |
| |
| Ear tube insertion | Surgical and medical procedures | MedDRA 16.1 | Systematic Assessment |
| |
| Medical device removal | Surgical and medical procedures | MedDRA 16.1 | Systematic Assessment |
| |
| Thrombectomy | Surgical and medical procedures | MedDRA 16.1 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Poor venous access | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
PI cannot publish any data prior to multi-centre publication. If publication related to sub-sets of data it shall make reference to the relevant multi-centre publication. PI agrees to submit material to Sponsor for review at least 60 days prior to publication and incorporate all reasonable comments. During review, Sponsor may request that publication be delayed for up to 6 months from date of first submission to Sponsor in order for Sponsor to take steps to protect its proprietary information.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| BioMarin Medical Information Services | BioMarin Pharmaceutical Inc. | 800-983-4587 | medinfo@bmrn.com |
| ID | Term |
|---|---|
| D009085 | Mucopolysaccharidosis IV |
| D016464 | Lysosomal Storage Diseases |
| 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 |
| D017520 | Mucinoses |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C102295 | GALNS protein, human |
Not provided
Not provided
Not provided
| >=10 to <=18 years |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| Other |
|
|
|
|
|
|