Long-Term Efficacy and Safety Extension Study of BMN 110... | NCT01415427

Label	Type	Description	Intervention Names
BMN 110 Weekly	Experimental	BMN 110 Weekly: In Part 1, patients will receive an intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours once a week.	Drug: BMN 110 - Weekly
BMN 110 Every Other Week	Experimental	BMN 110 Every Other Week: In Part 1, patients will receive an intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours every other week and will receive infusions of placebo on alternating weeks.	Drug: BMN 110 - Every Other Week

Name	Type	Description	Arm Group Labels	Other Names
BMN 110 - Weekly	Drug	In Part 1, patients will receive intravenous (IV) infusions of study drug at a dose of 2.0 mg/kg/qw administered over a period of approximately 4 hours once a week. In Part 2, patients will continue to receive 2.0 mg/kg of BMN 110 every week, with no placebo.

Measure	Description	Time Frame
Change From Baseline in 6-minute Walk (6MW) Test - ITT	Efficacy was assessed by changes from baseline in 6-minute walk test	Baseline to week 168
Change From Baseline in 6-minute Walk (6MW) Test - MPP	Efficacy was assessed by changes from baseline in 6-minute walk test	Baseline to week 168

Measure	Description	Time Frame
Change From Baseline in 3-minute Stair Climb Test - ITT	Efficacy was assessed by changes from baseline in 3-minute stair climb test.	Baseline to week 168
Change From Baseline in 3-minute Stair Climb Test - MPP

Name	Affiliation	Role
Debra Lounsbury	BioMarin Pharmaceutical	Study Director

PubMed Identifier	Type	Citation	Retractions
29248359	Derived	Hendriksz CJ, Parini R, AlSayed MD, Raiman J, Giugliani R, Mitchell JJ, Burton BK, Guelbert N, Stewart FJ, Hughes DA, Matousek R, Hawley SM, Decker C, Harmatz PR. Impact of long-term elosulfase alfa on activities of daily living in patients with Morquio A syndrome in an open-label, multi-center, phase 3 extension study. Mol Genet Metab. 2018 Feb;123(2):127-134. doi: 10.1016/j.ymgme.2017.11.015. Epub 2017 Dec 5.
28535791

ID	Title	Description
FG000	PBO-QOW	Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
FG001	PBO-QW

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 in 6-minute Walk (6MW) Test - ITT

Efficacy was assessed by changes from baseline in 6-minute walk test

ITT-intent-to-treat population, defined as all patients enrolled in the study who received patient IDs regardless of whether they received study drug or not.

Posted

Mean

Standard Deviation

meters

Baseline to week 168

ID	Title	Description
OG000	PBO-QOW	Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
OG001	PBO-QW	Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 +Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
OG002	QOW-QOW	Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
OG003	QW-QW	Weekly infusions of 2.0 mg/kg/week BMN 110 for a total of 24 consecutive weeks in MOR004 + Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
OG004	Total	All treatment groups

Units	Counts
Participants	OG00029 OG00129 OG00259 OG003

Title	Denominators	Categories
Baseline	ParticipantsOG00029 ParticipantsOG00129 ParticipantsOG00259 ParticipantsOG003

Primary

Change From Baseline in 6-minute Walk (6MW) Test - MPP

Efficacy was assessed by changes from baseline in 6-minute walk test

MPP- modified per-protocol population, define as the ITT(intent to treat) after removing patients who had orthosurgery in first 120 weeks or <96 doses in first 120 weeks.

Posted

Mean

Standard Deviation

meters

Baseline to week 168

ID	Title	Description
OG000	PBO-QOW	Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
OG001	PBO-QW	Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 +Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
OG002	QOW-QOW	Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
OG003	QW-QW

Secondary

Change From Baseline in 3-minute Stair Climb Test - ITT

Efficacy was assessed by changes from baseline in 3-minute stair climb test.

ITT-intent-to-treat population, defined as all patients enrolled in the study who received patient IDs regardless of whether they received study drug or not

Posted

Mean

Standard Deviation

stairs/min

Baseline to week 168

ID	Title	Description
OG000	PBO-QOW	Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
OG001	PBO-QW	Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 +Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
OG002	QOW-QOW	Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
OG003	QW-QW

Secondary

Change From Baseline in 3-minute Stair Climb Test - MPP

Efficacy was assessed by changes from baseline in 3-minute stair climb test.

MPP- modified per-protocol population, define as the ITT(intent to treat) after removing patients who had orthosurgery in first 120 weeks or <96 doses in first 120 weeks

Posted

Mean

Standard Deviation

stairs/min

Baseline to week 168

ID	Title	Description
OG000	PBO-QOW	Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
OG001	PBO-QW	Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 +Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
OG002	QOW-QOW	Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
OG003	QW-QW

Secondary

Change From Baseline in Urine Keratan Sulfate - ITT

Efficacy was assessed by changes from baseline in urine keratan sulfate (normalized to urine creatinine.)

ITT-intent-to-treat population, defined as all patients enrolled in the study who received patient IDs regardless of whether they received study drug or not

Posted

Mean

Standard Deviation

ug/mg

Baseline to week 168

ID	Title	Description
OG000	PBO-QOW	Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
OG001	PBO-QW	Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 +Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
OG002	QOW-QOW	Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
OG003	QW-QW

Secondary

Change From Baseline in Urine Keratan Sulfate - MPP

Efficacy was assessed by changes from baseline in urine keratan sulfate (normalized to urine creatinine.)

MPP- modified per-protocol population, define as the ITT(intent to treat) after removing patients who had orthosurgery in first 120 weeks or <96 doses in first 120 weeks

Posted

Mean

Standard Deviation

ug/mg

Baseline to week 168

ID	Title	Description
OG000	PBO-QOW	Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
OG001	PBO-QW	Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 +Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
OG002	QOW-QOW	Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
OG003	QW-QW

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cardio-respiratory arrest	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0021 events1 affected59 at risk EG0030 events0 affected56 at risk EG0041 events1 affected173 at risk
Congenital osteodystrophy	Congenital, familial and genetic disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected59 at risk EG003
Developmental hip dysplasia	Congenital, familial and genetic disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected29 at risk EG0021 events1 affected59 at risk EG003
Deafness	Ear and labyrinth disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected59 at risk EG003
Middle ear effusion	Ear and labyrinth disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected29 at risk EG0021 events1 affected59 at risk EG003
Strabismus	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected29 at risk EG0020 events0 affected59 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected59 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected29 at risk EG0020 events0 affected59 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0021 events1 affected59 at risk EG003
Oesophageal spasm	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected29 at risk EG0020 events0 affected59 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0021 events1 affected59 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0021 events1 affected59 at risk EG003
Device dislocation	General disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected29 at risk EG0021 events1 affected59 at risk EG003
Device occlusion	General disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0021 events1 affected59 at risk EG003
Pyrexia	General disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0021 events1 affected59 at risk EG003
Anaphylactic reaction	Immune system disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected29 at risk EG0021 events1 affected59 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected59 at risk EG003
Appendicitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected59 at risk EG003
Dengue fever	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0021 events1 affected59 at risk EG003
Diverticulitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0021 events1 affected59 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected29 at risk EG0022 events2 affected59 at risk EG003
Infected cyst	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected59 at risk EG003
Influenza	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected59 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected59 at risk EG003
Mononucleosis syndrome	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected59 at risk EG003
Otitis media	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0023 events1 affected59 at risk EG003
Otitis media chronic	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected59 at risk EG003
Pilonidal cyst	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected59 at risk EG003
Pneumonia	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected59 at risk EG003
Tooth abscess	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0021 events1 affected59 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected59 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected29 at risk EG0020 events0 affected59 at risk EG003
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0021 events1 affected59 at risk EG003
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected29 at risk EG0020 events0 affected59 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected59 at risk EG003
Pseudomeningocele	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected59 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0021 events1 affected59 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0022 events2 affected59 at risk EG003
Joint instability	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected29 at risk EG0010 events0 affected29 at risk EG0021 events1 affected59 at risk EG003
Knee deformity	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0008 events6 affected29 at risk EG0019 events8 affected29 at risk EG0027 events7 affected59 at risk EG003
Limb deformity	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected59 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected29 at risk EG0020 events0 affected59 at risk EG003
Osteochondrosis	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0021 events1 affected59 at risk EG003
Cervical cord compression	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0011 events1 affected29 at risk EG0020 events0 affected59 at risk EG003
Cervical myelopathy	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected59 at risk EG003
Convulsion	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected29 at risk EG0020 events0 affected59 at risk EG003
Myelopathy	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0021 events1 affected59 at risk EG003
Paraplegia	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected59 at risk EG003
Quadriplegia	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected29 at risk EG0020 events0 affected59 at risk EG003
Spinal cord compression	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected59 at risk EG003
Spinal cord ischaemia	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0021 events1 affected59 at risk EG003
Blighted ovum	Pregnancy, puerperium and perinatal conditions	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected59 at risk EG003
Ectopic pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected59 at risk EG003
Somatoform disorder	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0022 events1 affected59 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected59 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0021 events1 affected59 at risk EG003
Bronchopneumopathy	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0021 events1 affected59 at risk EG003
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected59 at risk EG003
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0021 events1 affected59 at risk EG003
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected29 at risk EG0021 events1 affected59 at risk EG003
Status asthmaticus	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected59 at risk EG003
Tonsillar hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected59 at risk EG003
Tracheal disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected29 at risk EG0020 events0 affected59 at risk EG003
Tracheal stenosis	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0021 events1 affected59 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0021 events1 affected59 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected59 at risk EG003
Child abuse	Social circumstances	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0021 events1 affected59 at risk EG003
Central venous catheterisation	Surgical and medical procedures	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected29 at risk EG0023 events3 affected59 at risk EG003
Epiphyseal stapling	Surgical and medical procedures	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected29 at risk EG0020 events0 affected59 at risk EG003
Knee operation	Surgical and medical procedures	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected59 at risk EG003
Medical device implantation	Surgical and medical procedures	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0021 events1 affected59 at risk EG003
Medical device removal	Surgical and medical procedures	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected59 at risk EG003
Spinal decompression	Surgical and medical procedures	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0021 events1 affected59 at risk EG003
Poor venous access	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0012 events2 affected29 at risk EG0025 events5 affected59 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG0004 events3 affected29 at risk EG0010 events0 affected29 at risk EG0021 events1 affected59 at risk EG0030 events0 affected56 at risk EG0045 events4 affected173 at risk
Aortic valve disease	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0011 events1 affected29 at risk EG0025 events5 affected59 at risk EG003
Aortic valve incompetence	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0013 events3 affected29 at risk EG0028 events8 affected59 at risk EG003
Left ventricular hypertrophy	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0021 events1 affected59 at risk EG003
Mitral valve disease	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0011 events1 affected29 at risk EG0026 events6 affected59 at risk EG003
Mitral valve incompetence	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0004 events4 affected29 at risk EG0016 events6 affected29 at risk EG00212 events12 affected59 at risk EG003
Palpitations	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0014 events2 affected29 at risk EG0021 events1 affected59 at risk EG003
Pulmonary valve incompetence	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected29 at risk EG0013 events3 affected29 at risk EG0022 events2 affected59 at risk EG003
Sinus arrhythmia	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0023 events3 affected59 at risk EG003
Sinus tachycardia	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0014 events3 affected29 at risk EG0021 events1 affected59 at risk EG003
Tachycardia	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG00014 events8 affected29 at risk EG00115 events4 affected29 at risk EG00231 events8 affected59 at risk EG003
Tricuspid valve incompetence	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0006 events6 affected29 at risk EG0011 events1 affected29 at risk EG00212 events11 affected59 at risk EG003
Ear discomfort	Ear and labyrinth disorders	MedDRA 16.1	Systematic Assessment	EG0003 events2 affected29 at risk EG0010 events0 affected29 at risk EG0021 events1 affected59 at risk EG003
Ear pain	Ear and labyrinth disorders	MedDRA 16.1	Systematic Assessment	EG00016 events10 affected29 at risk EG0018 events7 affected29 at risk EG00242 events19 affected59 at risk EG003
Hypoacusis	Ear and labyrinth disorders	MedDRA 16.1	Systematic Assessment	EG0003 events2 affected29 at risk EG0010 events0 affected29 at risk EG0023 events3 affected59 at risk EG003
Middle ear effusion	Ear and labyrinth disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected29 at risk EG0010 events0 affected29 at risk EG0021 events1 affected59 at risk EG003
Motion sickness	Ear and labyrinth disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0011 events1 affected29 at risk EG0020 events0 affected59 at risk EG003
Tinnitus	Ear and labyrinth disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected59 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 16.1	Systematic Assessment	EG0004 events1 affected29 at risk EG0012 events2 affected29 at risk EG0027 events3 affected59 at risk EG003
Astigmatism	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0013 events3 affected29 at risk EG0020 events0 affected59 at risk EG003
Conjunctivitis	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected29 at risk EG0012 events2 affected29 at risk EG0029 events6 affected59 at risk EG003
Corneal opacity	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0003 events3 affected29 at risk EG0015 events5 affected29 at risk EG0025 events5 affected59 at risk EG003
Glaucoma	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0012 events2 affected29 at risk EG0020 events0 affected59 at risk EG003
Myopia	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0012 events2 affected29 at risk EG0021 events1 affected59 at risk EG003
Ocular hyperaemia	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0012 events2 affected29 at risk EG0024 events3 affected59 at risk EG003
Visual impairment	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected59 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0006 events3 affected29 at risk EG0011 events1 affected29 at risk EG0028 events5 affected59 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG00019 events3 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected59 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG00019 events12 affected29 at risk EG0018 events6 affected29 at risk EG00259 events22 affected59 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected29 at risk EG0023 events3 affected59 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG00015 events8 affected29 at risk EG00111 events9 affected29 at risk EG00216 events9 affected59 at risk EG003
Anal pruritus	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected29 at risk EG0010 events0 affected29 at risk EG0021 events1 affected59 at risk EG003
Breath odour	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0013 events3 affected29 at risk EG0020 events0 affected59 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0005 events4 affected29 at risk EG0014 events4 affected29 at risk EG0027 events7 affected59 at risk EG003
Dental caries	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0013 events3 affected29 at risk EG0024 events4 affected59 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG00026 events11 affected29 at risk EG00127 events11 affected29 at risk EG00271 events25 affected59 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG00026 events3 affected29 at risk EG0015 events5 affected29 at risk EG0025 events3 affected59 at risk EG003
Enterocolitis	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0023 events3 affected59 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0006 events2 affected29 at risk EG0011 events1 affected29 at risk EG0022 events2 affected59 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0011 events1 affected29 at risk EG0023 events2 affected59 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected29 at risk EG0010 events0 affected29 at risk EG0021 events1 affected59 at risk EG003
Mouth ulceration	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0003 events2 affected29 at risk EG0010 events0 affected29 at risk EG0023 events2 affected59 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG00034 events15 affected29 at risk EG00118 events10 affected29 at risk EG00265 events26 affected59 at risk EG003
Proctalgia	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected59 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected29 at risk EG0023 events3 affected59 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0004 events3 affected29 at risk EG0015 events3 affected29 at risk EG00214 events8 affected59 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG000105 events20 affected29 at risk EG00162 events17 affected29 at risk EG002134 events39 affected59 at risk EG003
Asthenia	General disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0012 events2 affected29 at risk EG0022 events1 affected59 at risk EG003
Catheter site pain	General disorders	MedDRA 16.1	Systematic Assessment	EG0006 events2 affected29 at risk EG0010 events0 affected29 at risk EG0026 events6 affected59 at risk EG003
Chest discomfort	General disorders	MedDRA 16.1	Systematic Assessment	EG0004 events3 affected29 at risk EG0013 events2 affected29 at risk EG0022 events2 affected59 at risk EG003
Chest pain	General disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0012 events2 affected29 at risk EG0025 events3 affected59 at risk EG003
Chills	General disorders	MedDRA 16.1	Systematic Assessment	EG0004 events4 affected29 at risk EG0011 events1 affected29 at risk EG00210 events8 affected59 at risk EG003
Device dislocation	General disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected29 at risk EG0010 events0 affected29 at risk EG0024 events3 affected59 at risk EG003
Device occlusion	General disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0013 events1 affected29 at risk EG0022 events2 affected59 at risk EG003
Effusion	General disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0012 events2 affected29 at risk EG0021 events1 affected59 at risk EG003
Extravasation	General disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0013 events3 affected29 at risk EG0026 events3 affected59 at risk EG003
Fatigue	General disorders	MedDRA 16.1	Systematic Assessment	EG00017 events10 affected29 at risk EG00145 events13 affected29 at risk EG00232 events16 affected59 at risk EG003
Feeling hot	General disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected29 at risk EG0024 events4 affected59 at risk EG003
Gait disturbance	General disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected29 at risk EG0024 events3 affected59 at risk EG003
Hyperthermia	General disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0012 events2 affected29 at risk EG0020 events0 affected59 at risk EG003
Influenza like illness	General disorders	MedDRA 16.1	Systematic Assessment	EG0003 events3 affected29 at risk EG0011 events1 affected29 at risk EG0021 events1 affected59 at risk EG003
Infusion site extravasation	General disorders	MedDRA 16.1	Systematic Assessment	EG0004 events3 affected29 at risk EG0012 events1 affected29 at risk EG00212 events9 affected59 at risk EG003
Infusion site pain	General disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected29 at risk EG0011 events1 affected29 at risk EG0028 events6 affected59 at risk EG003
Infusion site rash	General disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected29 at risk EG0010 events0 affected29 at risk EG0022 events2 affected59 at risk EG003
Infusion site swelling	General disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected29 at risk EG0023 events3 affected59 at risk EG003
Irritability	General disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected59 at risk EG003
Local swelling	General disorders	MedDRA 16.1	Systematic Assessment	EG0007 events3 affected29 at risk EG0010 events0 affected29 at risk EG0025 events5 affected59 at risk EG003
Malaise	General disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected29 at risk EG0015 events3 affected29 at risk EG0027 events6 affected59 at risk EG003
Medical device complication	General disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected29 at risk EG0013 events1 affected29 at risk EG0026 events5 affected59 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0011 events1 affected29 at risk EG0024 events4 affected59 at risk EG003
Oedema	General disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0012 events2 affected29 at risk EG0020 events0 affected59 at risk EG003
Oedema peripheral	General disorders	MedDRA 16.1	Systematic Assessment	EG0004 events1 affected29 at risk EG0010 events0 affected29 at risk EG0024 events4 affected59 at risk EG003
Pain	General disorders	MedDRA 16.1	Systematic Assessment	EG0006 events5 affected29 at risk EG0013 events1 affected29 at risk EG0028 events6 affected59 at risk EG003
Puncture site pain	General disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected29 at risk EG0024 events4 affected59 at risk EG003
Pyrexia	General disorders	MedDRA 16.1	Systematic Assessment	EG00091 events22 affected29 at risk EG00162 events19 affected29 at risk EG002113 events38 affected59 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected29 at risk EG0028 events5 affected59 at risk EG003
Seasonal allergy	Immune system disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected29 at risk EG0014 events2 affected29 at risk EG0026 events4 affected59 at risk EG003
Bronchitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0007 events5 affected29 at risk EG0014 events3 affected29 at risk EG0028 events7 affected59 at risk EG003
Cellulitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected59 at risk EG003
Ear infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0009 events7 affected29 at risk EG0013 events3 affected29 at risk EG00213 events5 affected59 at risk EG003
Fungal infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected29 at risk EG0010 events0 affected29 at risk EG0022 events2 affected59 at risk EG003
Furuncle	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0004 events2 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected59 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0009 events5 affected29 at risk EG00113 events9 affected29 at risk EG00236 events24 affected59 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected29 at risk EG0011 events1 affected29 at risk EG0022 events2 affected59 at risk EG003
Gingivitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0013 events2 affected29 at risk EG0023 events3 affected59 at risk EG003
Hordeolum	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0002 events1 affected29 at risk EG0011 events1 affected29 at risk EG00214 events6 affected59 at risk EG003
Influenza	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0007 events3 affected29 at risk EG0016 events5 affected29 at risk EG00224 events11 affected59 at risk EG003
Laryngitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0024 events3 affected59 at risk EG003
Lice infestation	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0022 events1 affected59 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0002 events1 affected29 at risk EG0011 events1 affected29 at risk EG0022 events2 affected59 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG00034 events13 affected29 at risk EG00128 events13 affected29 at risk EG00262 events29 affected59 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected29 at risk EG0027 events4 affected59 at risk EG003
Oral herpes	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0002 events1 affected29 at risk EG0011 events1 affected29 at risk EG0027 events4 affected59 at risk EG003
Otitis externa	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0004 events3 affected29 at risk EG0011 events1 affected29 at risk EG00215 events8 affected59 at risk EG003
Otitis media	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG00010 events8 affected29 at risk EG0015 events5 affected29 at risk EG00229 events11 affected59 at risk EG003
Otitis media acute	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0002 events1 affected29 at risk EG0012 events2 affected29 at risk EG00211 events5 affected59 at risk EG003
Pharyngitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG00012 events9 affected29 at risk EG0017 events6 affected29 at risk EG00210 events8 affected59 at risk EG003
Rash pustular	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected59 at risk EG003
Respiratory tract infection viral	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0012 events2 affected29 at risk EG0026 events3 affected59 at risk EG003
Rhinitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG00021 events9 affected29 at risk EG00117 events6 affected29 at risk EG00230 events11 affected59 at risk EG003
Sinusitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0007 events5 affected29 at risk EG0011 events1 affected29 at risk EG0024 events4 affected59 at risk EG003
Tinea pedis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected29 at risk EG0011 events1 affected29 at risk EG0020 events0 affected59 at risk EG003
Tonsillitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0003 events2 affected29 at risk EG0012 events2 affected29 at risk EG0028 events5 affected59 at risk EG003
Tooth infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0012 events2 affected29 at risk EG0021 events1 affected59 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG00053 events13 affected29 at risk EG00125 events8 affected29 at risk EG00282 events24 affected59 at risk EG003
Varicella	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected29 at risk EG0023 events3 affected59 at risk EG003
Viral infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0003 events1 affected29 at risk EG0015 events3 affected29 at risk EG00212 events9 affected59 at risk EG003
Viral pharyngitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected59 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG00012 events6 affected29 at risk EG0010 events0 affected29 at risk EG0029 events5 affected59 at risk EG003
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected29 at risk EG0022 events2 affected59 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0003 events3 affected29 at risk EG0010 events0 affected29 at risk EG0023 events2 affected59 at risk EG003
Excoriation	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0025 events4 affected59 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0005 events4 affected29 at risk EG0014 events3 affected29 at risk EG00220 events12 affected59 at risk EG003
Head injury	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected29 at risk EG0028 events4 affected59 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0005 events3 affected29 at risk EG0010 events0 affected29 at risk EG0024 events2 affected59 at risk EG003
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0025 events4 affected59 at risk EG003
Joint injury	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0024 events4 affected59 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected29 at risk EG0011 events1 affected29 at risk EG0021 events1 affected59 at risk EG003
Limb injury	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected29 at risk EG0010 events0 affected29 at risk EG0023 events3 affected59 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0009 events3 affected29 at risk EG0012 events2 affected29 at risk EG0027 events6 affected59 at risk EG003
Tooth fracture	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected29 at risk EG0010 events0 affected29 at risk EG0021 events1 affected59 at risk EG003
Blood cholesterol increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected59 at risk EG003
Blood pressure diastolic increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0014 events2 affected29 at risk EG0029 events3 affected59 at risk EG003
Blood pressure increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0006 events2 affected29 at risk EG0010 events0 affected29 at risk EG0023 events3 affected59 at risk EG003
Blood pressure systolic increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0017 events2 affected29 at risk EG00228 events3 affected59 at risk EG003
Blood urine present	Investigations	MedDRA 16.1	Systematic Assessment	EG0005 events2 affected29 at risk EG0010 events0 affected29 at risk EG0021 events1 affected59 at risk EG003
Heart rate decreased	Investigations	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected59 at risk EG003
Heart rate increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0003 events2 affected29 at risk EG0011 events1 affected29 at risk EG0024 events4 affected59 at risk EG003
Oxygen saturation decreased	Investigations	MedDRA 16.1	Systematic Assessment	EG00017 events6 affected29 at risk EG00115 events3 affected29 at risk EG00216 events9 affected59 at risk EG003
Respiratory rate increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0005 events4 affected29 at risk EG0011 events1 affected29 at risk EG0022 events2 affected59 at risk EG003
Vital capacity decreased	Investigations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected29 at risk EG0023 events3 affected59 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0013 events2 affected29 at risk EG0021 events1 affected59 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG00090 events20 affected29 at risk EG00157 events16 affected29 at risk EG00293 events40 affected59 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG00017 events10 affected29 at risk EG0016 events4 affected29 at risk EG00245 events19 affected59 at risk EG003
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected29 at risk EG0010 events0 affected29 at risk EG0022 events2 affected59 at risk EG003
Knee deformity	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected29 at risk EG0016 events5 affected29 at risk EG0021 events1 affected59 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected29 at risk EG0014 events3 affected29 at risk EG0021 events1 affected59 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0003 events1 affected29 at risk EG0012 events1 affected29 at risk EG0025 events5 affected59 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG00014 events7 affected29 at risk EG0019 events4 affected29 at risk EG00214 events10 affected59 at risk EG003
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected29 at risk EG0012 events1 affected29 at risk EG0024 events3 affected59 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG00011 events7 affected29 at risk EG0011 events1 affected29 at risk EG0023 events3 affected59 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0009 events9 affected29 at risk EG0013 events3 affected29 at risk EG00214 events9 affected59 at risk EG003
Osteopenia	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected29 at risk EG0011 events1 affected29 at risk EG0024 events4 affected59 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG00054 events16 affected29 at risk EG00125 events12 affected29 at risk EG00280 events27 affected59 at risk EG003
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0003 events3 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected59 at risk EG003
Skin papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected29 at risk EG0023 events3 affected59 at risk EG003
Cervical cord compression	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected59 at risk EG003
Dizziness	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0006 events5 affected29 at risk EG0016 events6 affected29 at risk EG00220 events8 affected59 at risk EG003
Headache	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG000102 events23 affected29 at risk EG00167 events16 affected29 at risk EG002232 events39 affected59 at risk EG003
Hyperreflexia	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0003 events2 affected29 at risk EG0014 events3 affected29 at risk EG0022 events1 affected59 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0011 events1 affected29 at risk EG0025 events4 affected59 at risk EG003
Lethargy	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0011 events1 affected29 at risk EG0023 events3 affected59 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0011 events1 affected29 at risk EG0022 events2 affected59 at risk EG003
Somnolence	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG00028 events2 affected29 at risk EG0013 events3 affected29 at risk EG0021 events1 affected59 at risk EG003
Syncope	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0019 events2 affected29 at risk EG0020 events0 affected59 at risk EG003
Agitation	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected29 at risk EG0022 events2 affected59 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG0004 events3 affected29 at risk EG0014 events3 affected29 at risk EG0027 events5 affected59 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected29 at risk EG0011 events1 affected29 at risk EG0023 events2 affected59 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected29 at risk EG0010 events0 affected29 at risk EG0023 events3 affected59 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0022 events1 affected59 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0024 events4 affected59 at risk EG003
Proteinuria	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected29 at risk EG0010 events0 affected29 at risk EG0024 events3 affected59 at risk EG003
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA 16.1	Systematic Assessment	EG00011 events3 affected29 at risk EG0014 events1 affected29 at risk EG00224 events5 affected59 at risk EG003
Allergic cough	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0002 events1 affected29 at risk EG0010 events0 affected29 at risk EG0023 events3 affected59 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected29 at risk EG0013 events2 affected29 at risk EG00212 events5 affected59 at risk EG003
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected29 at risk EG0026 events5 affected59 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG00062 events21 affected29 at risk EG00149 events14 affected29 at risk EG00285 events37 affected59 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0008 events6 affected29 at risk EG0017 events5 affected29 at risk EG00233 events12 affected59 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0009 events3 affected29 at risk EG0018 events4 affected29 at risk EG0026 events5 affected59 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG00021 events10 affected29 at risk EG0016 events4 affected29 at risk EG00224 events15 affected59 at risk EG003
Nasal obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG00010 events3 affected29 at risk EG0013 events3 affected29 at risk EG0027 events6 affected59 at risk EG003
Neonatal hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0022 events2 affected59 at risk EG003
Obstructive airways disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected29 at risk EG0021 events1 affected59 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG00024 events13 affected29 at risk EG00116 events11 affected29 at risk EG00248 events23 affected59 at risk EG003
Pharyngeal disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected59 at risk EG003
Pharyngeal erythema	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected59 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0013 events3 affected29 at risk EG0022 events2 affected59 at risk EG003
Respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0025 events3 affected59 at risk EG003
Restrictive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected29 at risk EG0010 events0 affected29 at risk EG0021 events1 affected59 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0003 events3 affected29 at risk EG0017 events5 affected29 at risk EG00214 events9 affected59 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0006 events5 affected29 at risk EG00110 events5 affected29 at risk EG00216 events7 affected59 at risk EG003
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected29 at risk EG0011 events1 affected29 at risk EG0020 events0 affected59 at risk EG003
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0012 events2 affected29 at risk EG0024 events4 affected59 at risk EG003
Sneezing	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected29 at risk EG0011 events1 affected29 at risk EG0021 events1 affected59 at risk EG003
Tachypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0003 events3 affected29 at risk EG0011 events1 affected29 at risk EG0026 events3 affected59 at risk EG003
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0003 events3 affected29 at risk EG0011 events1 affected29 at risk EG0020 events0 affected59 at risk EG003
Tonsillar hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0003 events2 affected29 at risk EG0012 events2 affected29 at risk EG0023 events2 affected59 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG00010 events5 affected29 at risk EG0016 events5 affected29 at risk EG0028 events6 affected59 at risk EG003
Acne	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected29 at risk EG0013 events3 affected29 at risk EG0022 events2 affected59 at risk EG003
Blister	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0026 events3 affected59 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected29 at risk EG0021 events1 affected59 at risk EG003
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected29 at risk EG0010 events0 affected29 at risk EG0025 events5 affected59 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0003 events3 affected29 at risk EG0010 events0 affected29 at risk EG0021 events1 affected59 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected29 at risk EG0017 events4 affected29 at risk EG00210 events8 affected59 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG00012 events6 affected29 at risk EG0014 events3 affected29 at risk EG0027 events7 affected59 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0016 events4 affected29 at risk EG0021 events1 affected59 at risk EG003
Petechiae	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0024 events4 affected59 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG00018 events7 affected29 at risk EG0016 events3 affected29 at risk EG00228 events8 affected59 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG00013 events8 affected29 at risk EG00130 events8 affected29 at risk EG00261 events15 affected59 at risk EG003
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0003 events2 affected29 at risk EG0010 events0 affected29 at risk EG0023 events1 affected59 at risk EG003
Rash macular	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0005 events1 affected29 at risk EG0011 events1 affected29 at risk EG0021 events1 affected59 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG00259 events3 affected59 at risk EG003
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0023 events3 affected59 at risk EG003
Skin disorder	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected59 at risk EG003
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected29 at risk EG0011 events1 affected29 at risk EG0023 events3 affected59 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG00038 events6 affected29 at risk EG00137 events1 affected29 at risk EG00253 events11 affected59 at risk EG003
Central venous catheterisation	Surgical and medical procedures	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0011 events1 affected29 at risk EG0023 events3 affected59 at risk EG003
Tooth extraction	Surgical and medical procedures	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0012 events2 affected29 at risk EG0026 events4 affected59 at risk EG003
Flushing	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0003 events1 affected29 at risk EG0012 events2 affected29 at risk EG0022 events2 affected59 at risk EG003
Hot flush	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0016 events2 affected29 at risk EG0025 events3 affected59 at risk EG003
Hypertension	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected29 at risk EG00113 events4 affected29 at risk EG00228 events6 affected59 at risk EG003
Hypotension	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected29 at risk EG0011 events1 affected29 at risk EG0026 events3 affected59 at risk EG003
Pallor	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0003 events2 affected29 at risk EG0012 events2 affected29 at risk EG0024 events2 affected59 at risk EG003
Poor venous access	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG00021 events6 affected29 at risk EG00110 events5 affected29 at risk EG0027 events6 affected59 at risk EG003

Facility	Status	City	State	ZIP	Country	Contacts
		Phoenix	Arizona		United States

ID	Title	Description
BG000	PBO-QOW	Placebo in MOR004 + BMN110 2.0 mg/kg/qow in MOR005
BG001	PBO-QW	Placebo in MOR004 + BMN110 2.0 mg/kg/qw in MOR005
BG002	QOW-QOW	BMN110 2.0 mg/kg/qow in MOR004 + BMN110 2.0 mg/kg/qow in MOR005
BG003	QW-QW	BMN110 2.0 mg/kg/qw in MOR004 + BMN110 2.0 mg/kg/qw in MOR005
BG004	Total	Total of all reporting groups

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

ID	Term
D002810	Chondroitinases and Chondroitin Lyases
C491158	Galns protein, mouse
C102295	GALNS protein, human
D056947	Enzyme Replacement Therapy

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	PBO-QOW	PBO-QOW	0	29	17	29	29	29
EG001	PBO-QW	PBO-QW	0	29	15	29	29	29
EG002	QOW-QOW	QOW-QOW	1	59	26	59	59	59
EG003	QW-QW	QW-QW	0	56	31	56	56	56
EG004	Total	Total	1	173	89	173	173	173

ID	Term
D013429	Sulfatases
D004950	Esterases
D006867	Hydrolases
D004798	Enzymes
D045762	Enzymes and Coenzymes
D011133	Polysaccharide-Lyases
D019757	Carbon-Oxygen Lyases
D008190	Lyases
D057487	Enzyme Therapy
D004358	Drug Therapy
D013812	Therapeutics