Study Evaluating Changes In Bone Mineral Density (BMD), A... | NCT00752557

ID	Type	Description	Link
B1921002	Other Identifier	Alias Study Number
2007-007456-34	EudraCT Number

Label	Type	Description	Intervention Names
1	Experimental	rhBMP-2/CPM , 1.0 mg/mL	Drug: rhBMP-2/CPM injection and bisphosphonates, calcium, and vitamin D (oral bisphosphonate therapy)
2	Experimental	rhBMP-2/CPM , 2.0 mg/mL	Drug: rhBMP-2/CPM injection and bisphosphonates, calcium, and vitamin D (oral bisphosphonate therapy)
3	Active Comparator	Oral bisphosphonate therapy (standard of care)	Drug: bisphosphonates, calcium, and vitamin D

Name	Type	Description	Arm Group Labels	Other Names
rhBMP-2/CPM injection and bisphosphonates, calcium, and vitamin D (oral bisphosphonate therapy)	Drug	Single, unilateral intraosseous injection of 6mL of rhBMP-2/CPM , 1.0 mg/mL.

Measure	Description	Time Frame
Change From Baseline in Bone Mineral Density (BMD) Measured by Dual-Energy X-ray Absorptiometry (DXA)	Evaluating local changes (expected increases) in BMD after administration of rhBMP-2/CPM, compared to those observed with systemic osteoporosis therapy alone. Alternatively, if changes in the total area surrounding the proximal femur are observed, bone mineral content (BMC) may instead be applied for the primary measure. BMD is defined as a derived measure of bone density, generated by dividing the bone mineral content value obtained from a bone densitometry technique (for example, DXA) by the total area of the region scanned.	Baseline, 12 months post dose
Time Course Distribution of Volumetric BMD for the Hip Under Study (HUS) for Total Hip	Time course distribution of volumetric Bone mineral density (BMD) for hip is assessed by volumetric Quantitative Computed Tomography (vQCT) technique which is a 4-detector spiral (helical) computed tomography (CT) scanner with designated calibration phantom, obtain a CT scan of the proximal femora (bilateral simultaneous acquisition with volumetric rendering) to identify the specified region of interests (ROIs) for volumetric parameter to be quantified, reconstruct images of both hips and send reconstructed data (in electronic format). The vQCT regions of interest are cortical, the subcortical and trabecular. Cortical and the subcortical BMD are distinguished from trabecular effects. Peeled trabecular BMD reflects the subtraction of the extended CPM. Integral BMD reflects the cortical, subcortical, and peeled trabecular regions (minus the extended Calcium phosphate matrix [CPM]).	At Month 12
Timecourse Distribution of Volumetric Bone Mineral Density (BMD) for the Hip Under Study (HUS). Volume of Interest: Femoral Neck	Evaluating local changes (expected increases) in BMD after administration of rhBMP-2/CPM, compared to those observed with systemic osteoporosis therapy alone. Alternatively, if changes in the total area surrounding the proximal femur are observed, bone mineral content (BMC) may instead be applied for the primary measure.	At Month 12

Measure	Description	Time Frame
Summary of Volumetric Density of Cortical and Trabecular Bone Calculated by Quantitative Computed Tomography (vQTC)	Here, measurement of density of cortical and trabecular bone in various regions of interest (ROIs) in the femoral neck, proximal shaft, and individual trochanters and was calculated by Quantitative Computed Tomography (vQTC) in ROIs.	24 months

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Arizona Research Center, Inc.		Phoenix	Arizona	85023	United States
John C. Lincoln Hospital - Deer Valley

Label	URL
To obtain contact information for a study center near you, click here.	View source

ID	Title	Description
FG000	Standard of Care Control	Participants had received systemic osteoporosis therapy with an oral bisphosphonate plus supplemental calcium, and vitamin D as prescribed by the study physician.
FG001	rhBMP-2/CPM 1.0 mg/mL

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 Bone Mineral Density (BMD) Measured by Dual-Energy X-ray Absorptiometry (DXA)

Evaluating local changes (expected increases) in BMD after administration of rhBMP-2/CPM, compared to those observed with systemic osteoporosis therapy alone. Alternatively, if changes in the total area surrounding the proximal femur are observed, bone mineral content (BMC) may instead be applied for the primary measure. BMD is defined as a derived measure of bone density, generated by dividing the bone mineral content value obtained from a bone densitometry technique (for example, DXA) by the total area of the region scanned.

As-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants were grouped as per the treatment they received (not to the treatment they were randomly assigned). Here, overall number of participants analyzed = participants evaluable for this outcome measure.

Posted

Mean

Standard Deviation

gram per centimeter squared (g/cm^2)

Baseline, 12 months post dose

ID	Title	Description
OG000	Standard of Care Control	Participants had received systemic osteoporosis therapy with an oral bisphosphonate plus supplemental calcium, and vitamin D as prescribed by the study physician.
OG001	rhBMP-2/CPM 1.0 mg/mL	Participants had received 1 mg/mL rhBMP 2/CPM administered via intraosseous injection administered percutaneously to the proximal femur. Participants in treatment groups additionally received SOC treatment for OP.
OG002	rhBMP-2/CPm 2.0 mg/mL	Participants had received 2 mg/mL rhBMP 2/CPM administered via intraosseous injection administered percutaneously to the proximal femur. Participants in treatment groups additionally received SOC treatment for OP.

Units	Counts
Participants	OG00014 OG00112 OG00214

Title

Denominators

Categories

Total hip

Title	Measurements
	OG000-0.0026± 0.018 OG0010.1299± 0.045 OG0020.1196± 0.063

Intertrochanter

Primary

Time Course Distribution of Volumetric BMD for the Hip Under Study (HUS) for Total Hip

Time course distribution of volumetric Bone mineral density (BMD) for hip is assessed by volumetric Quantitative Computed Tomography (vQCT) technique which is a 4-detector spiral (helical) computed tomography (CT) scanner with designated calibration phantom, obtain a CT scan of the proximal femora (bilateral simultaneous acquisition with volumetric rendering) to identify the specified region of interests (ROIs) for volumetric parameter to be quantified, reconstruct images of both hips and send reconstructed data (in electronic format). The vQCT regions of interest are cortical, the subcortical and trabecular. Cortical and the subcortical BMD are distinguished from trabecular effects. Peeled trabecular BMD reflects the subtraction of the extended CPM. Integral BMD reflects the cortical, subcortical, and peeled trabecular regions (minus the extended Calcium phosphate matrix [CPM]).

Posted

Mean

Standard Deviation

milligram per centimeter cubed (mg/cm^3)

At Month 12

ID	Title	Description
OG000	Standard of Care Control	Participants had received systemic osteoporosis therapy with an oral bisphosphonate plus supplemental calcium, and vitamin D as prescribed by the study physician.

Secondary

Summary of Volumetric Density of Cortical and Trabecular Bone Calculated by Quantitative Computed Tomography (vQTC)

Here, measurement of density of cortical and trabecular bone in various regions of interest (ROIs) in the femoral neck, proximal shaft, and individual trochanters and was calculated by Quantitative Computed Tomography (vQTC) in ROIs.

Posted

Mean

Standard Deviation

mg/cm^3

24 months

ID	Title	Description
OG000	Standard of Care Control	Participants had received systemic osteoporosis therapy with an oral bisphosphonate plus supplemental calcium, and vitamin D as prescribed by the study physician.
OG001	rhBMP-2/CPM 1.0 mg/mL	Participants had received 1 mg/mL rhBMP 2/CPM administered via intraosseous injection administered percutaneously to the proximal femur. Participants in treatment groups additionally received SOC treatment for OP.
OG002	rhBMP-2/CPm 2.0 mg/mL

Secondary

Number Participant Responses to Injectability Questionnaire Injected Population

Investigator documents preparation of the study medication evaluates injectability and product placement relative to desired location (for participants in active treatment groups). Surgeon performing the injection had to complete the questionnaire that evaluates ease of preparing the study medication, ability to administer study medication, and ability for the study medication to remain in the location it was administered.

Only those participants who were injected with rhBMP-2/CPM were included in the injected population. Any participant who received SOC alone was excluded from this population.

Posted

Number

Participants

Participants were monitored after treatment administration (dosing period)

ID	Title	Description
OG000	rhBMP-2/CPM 1.0 mg/mL	Participants had received 1 mg/mL rhBMP 2/CPM administered via intraosseous injection administered percutaneously to the proximal femur. Participants in treatment groups additionally received SOC treatment for OP.
OG001	rhBMP-2/CPm 2.0 mg/mL	Participants had received 2 mg/mL rhBMP 2/CPM administered via intraosseous injection administered percutaneously to the proximal femur. Participants in treatment groups additionally received SOC treatment for OP.

Secondary

Number of Participants With Any Significant Changes in Serum Biomarkers of Bone Turnover From Baseline

Participants with significant change in serum biomarkers of bone formation and resorption from baseline are reported. Significant changes were judged by investigator.

As-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).

Posted

Number

participants

Baseline up to 12 months

ID	Title	Description
OG000	Standard of Care Control	Participants had received systemic osteoporosis therapy with an oral bisphosphonate plus supplemental calcium, and vitamin D as prescribed by the study physician.
OG001	rhBMP-2/CPM 1.0 mg/mL	Participants had received 1 mg/mL rhBMP 2/CPM administered via intraosseous injection administered percutaneously to the proximal femur. Participants in treatment groups additionally received SOC treatment for OP.
OG002	rhBMP-2/CPm 2.0 mg/mL	Participants had received 2 mg/mL rhBMP 2/CPM administered via intraosseous injection administered percutaneously to the proximal femur. Participants in treatment groups additionally received SOC treatment for OP.

Primary

Timecourse Distribution of Volumetric Bone Mineral Density (BMD) for the Hip Under Study (HUS). Volume of Interest: Femoral Neck

Posted

Mean

Standard Deviation

mg/cm^3

At Month 12

ID	Title	Description
OG000	Standard of Care Control	Participants had received systemic osteoporosis therapy with an oral bisphosphonate plus supplemental calcium, and vitamin D as prescribed by the study physician.
OG001	rhBMP-2/CPM 1.0 mg/mL	Participants had received 1 mg/mL rhBMP 2/CPM administered via intraosseous injection administered percutaneously to the proximal femur. Participants in treatment groups additionally received SOC treatment for OP.
OG002

Secondary

Percentage Change From Baseline in Areal Bone Mineral Density (BMD) for Contralateral Total Hip

Evaluating local changes (expected increases) in BMD after administration of rhBMP-2/CPM, compared to those observed with systemic osteoporosis therapy alone. The percentage change from baseline in BMD for total hip (assessed by DXA) is presented for the contralateral (untreated) hip below.

Posted

Mean

Standard Deviation

Percent change

36 months

ID	Title	Description
OG000	Standard of Care Control	Participants had received systemic osteoporosis therapy with an oral bisphosphonate plus supplemental calcium, and vitamin D as prescribed by the study physician.
OG001	rhBMP-2/CPM 1.0 mg/mL	Participants had received 1 mg/mL rhBMP 2/CPM administered via intraosseous injection administered percutaneously to the proximal femur. Participants in treatment groups additionally received SOC treatment for OP.
OG002	rhBMP-2/CPm 2.0 mg/mL

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected15 at risk EG0021 affected14 at risk
Bone marrow oedema	Blood and lymphatic system disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Lymph node calcification	Blood and lymphatic system disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Atrioventricular block first degree	Cardiac disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Chronotropic incompetence	Cardiac disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Supraventricular extrasystoles	Cardiac disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Ear pain	Ear and labyrinth disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Vertigo	Ear and labyrinth disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0021 affected14 at risk
Hypothyroidism	Endocrine disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0021 affected14 at risk
Blepharitis	Eye disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0021 affected14 at risk
Choroidal haemorrhage	Eye disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected15 at risk EG0020 affected14 at risk
Dark circles under eyes	Eye disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0021 affected14 at risk
Eye pain	Eye disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0021 affected14 at risk
Eyelid ptosis	Eye disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Cataract	Eye disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0021 affected14 at risk
Macular generation	Eye disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0021 affected14 at risk
Ocular hyperaemia	Eye disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected15 at risk EG0020 affected14 at risk
retinal haemorrhage	Eye disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected15 at risk EG0021 affected14 at risk
Visual acuity reduced	Eye disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Cheilitis	Gastrointestinal disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Constipation	Gastrointestinal disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0001 affected17 at risk EG0013 affected15 at risk EG0020 affected14 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0012 affected15 at risk EG0020 affected14 at risk
Dry mouth	Gastrointestinal disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected15 at risk EG0020 affected14 at risk
Dysphagia	Gastrointestinal disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0012 affected15 at risk EG0020 affected14 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0021 affected14 at risk
Gastritis	Gastrointestinal disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0021 affected14 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0021 affected14 at risk
Nausea	Gastrointestinal disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0001 affected17 at risk EG0016 affected15 at risk EG0025 affected14 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Oral discomfort	Gastrointestinal disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Pancreatic cyst	Gastrointestinal disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Vomiting	Gastrointestinal disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0013 affected15 at risk EG0023 affected14 at risk
Breakthrough pain	General disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0021 affected14 at risk
Chills	General disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0021 affected14 at risk
Facial pain	General disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0021 affected14 at risk
Fatigue	General disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0021 affected14 at risk
Gait deviation	General disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected15 at risk EG0020 affected14 at risk
Gait disturbance	General disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0001 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Injection site bruising	General disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0021 affected14 at risk
Injection site discharge	General disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Injection site erythema	General disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0012 affected15 at risk EG0020 affected14 at risk
Injection site mass	General disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Injection site pain	General disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0025 affected14 at risk
Injection site swelling	General disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0012 affected15 at risk EG0020 affected14 at risk
Malaise	General disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Non-cardiac chest pain	General disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0021 affected14 at risk
Oedema	General disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Oedema peripheral	General disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Pain	General disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0002 affected17 at risk EG0012 affected15 at risk EG0021 affected14 at risk
Peripheral swelling	General disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0001 affected17 at risk EG0011 affected15 at risk EG0021 affected14 at risk
Pyrexia	General disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0022 affected14 at risk
Soft tissue inflammation	General disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Seasonal allergy	Immune system disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0021 affected14 at risk
Arthritis infective	Infections and infestations	MedDRA (v17.1)	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected15 at risk EG0020 affected14 at risk
Bronchitis	Infections and infestations	MedDRA (v17.1)	Non-systematic Assessment	EG0001 affected17 at risk EG0012 affected15 at risk EG0022 affected14 at risk
Coccidioidomycosis	Infections and infestations	MedDRA (v17.1)	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected15 at risk EG0020 affected14 at risk
Cystitis	Infections and infestations	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0021 affected14 at risk
Diarrhoea infectious	Infections and infestations	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Gastroenteritis viral	Infections and infestations	MedDRA (v17.1)	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected15 at risk EG0020 affected14 at risk
Influenza	Infections and infestations	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0021 affected14 at risk
Labyrinthitis	Infections and infestations	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Lung infection	Infections and infestations	MedDRA (v17.1)	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected15 at risk EG0020 affected14 at risk
Nasopharyngitis	Infections and infestations	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0022 affected14 at risk
Onychomycosis	Infections and infestations	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0021 affected14 at risk
Oral herpes	Infections and infestations	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0022 affected14 at risk
Osteomyelitis	Infections and infestations	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Pharyngitis streptococcal	Infections and infestations	MedDRA (v17.1)	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected15 at risk EG0020 affected14 at risk
Pneumonia	Infections and infestations	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0021 affected14 at risk
Rhinitis	Infections and infestations	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Sinusitis	Infections and infestations	MedDRA (v17.1)	Non-systematic Assessment	EG0001 affected17 at risk EG0012 affected15 at risk EG0021 affected14 at risk
Tooth infection	Infections and infestations	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0022 affected14 at risk
Urinary tract infection	Infections and infestations	MedDRA (v17.1)	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected15 at risk EG0020 affected14 at risk
Vulvovaginal mycotic infection	Infections and infestations	MedDRA (v17.1)	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected15 at risk EG0020 affected14 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0021 affected14 at risk
Epicondylitis	Injury, poisoning and procedural complications	MedDRA (v17.1)	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected15 at risk EG0020 affected14 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (v17.1)	Non-systematic Assessment	EG0004 affected17 at risk EG0015 affected15 at risk EG0023 affected14 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0021 affected14 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA (v17.1)	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected15 at risk EG0020 affected14 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0021 affected14 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0021 affected14 at risk
Injection related reaction	Injury, poisoning and procedural complications	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA (v17.1)	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected15 at risk EG0020 affected14 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA (v17.1)	Non-systematic Assessment	EG0001 affected17 at risk EG0011 affected15 at risk EG0021 affected14 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA (v17.1)	Non-systematic Assessment	EG0002 affected17 at risk EG0010 affected15 at risk EG0020 affected14 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0021 affected14 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA (v17.1)	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected15 at risk EG0020 affected14 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Patella fracture	Injury, poisoning and procedural complications	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Procedural hypotension	Injury, poisoning and procedural complications	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0021 affected14 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0012 affected15 at risk EG0025 affected14 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA (v17.1)	Non-systematic Assessment	EG0001 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Skeletal injury	Injury, poisoning and procedural complications	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0021 affected14 at risk
Skin abrasion	Injury, poisoning and procedural complications	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0021 affected14 at risk
Superficial injury of eye	Injury, poisoning and procedural complications	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Wound	Injury, poisoning and procedural complications	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0021 affected14 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0022 affected14 at risk
Alanine aminotransferase increased	Investigations	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0021 affected14 at risk
Aspartate aminotransferase increased	Investigations	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0021 affected14 at risk
Chest X-ray abnormal	Investigations	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Scan bone marrow abnormal	Investigations	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Urine output increased	Investigations	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0021 affected14 at risk
Weight decreased	Investigations	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0021 affected14 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected15 at risk EG0020 affected14 at risk
Iodine deficiency	Metabolism and nutrition disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0021 affected14 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0005 affected17 at risk EG00112 affected15 at risk EG0029 affected14 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected15 at risk EG0020 affected14 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0002 affected17 at risk EG0014 affected15 at risk EG0023 affected14 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0001 affected17 at risk EG0012 affected15 at risk EG0021 affected14 at risk
Exostosis	Musculoskeletal and connective tissue disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0021 affected14 at risk
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0021 affected14 at risk
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0012 affected15 at risk EG0020 affected14 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0001 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Joint effusion	Musculoskeletal and connective tissue disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Joint range of motion decreased	Musculoskeletal and connective tissue disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0002 affected17 at risk EG0013 affected15 at risk EG0024 affected14 at risk
Limb discomfort	Musculoskeletal and connective tissue disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Mobility decreased	Musculoskeletal and connective tissue disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0001 affected17 at risk EG0012 affected15 at risk EG0021 affected14 at risk
Muscle swelling	Musculoskeletal and connective tissue disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0021 affected14 at risk
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0002 affected17 at risk EG0013 affected15 at risk EG0022 affected14 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0002 affected17 at risk EG0011 affected15 at risk EG0022 affected14 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0001 affected17 at risk EG0012 affected15 at risk EG0020 affected14 at risk
Osteitis	Musculoskeletal and connective tissue disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected15 at risk EG0020 affected14 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0001 affected17 at risk EG0012 affected15 at risk EG0022 affected14 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0003 affected17 at risk EG0012 affected15 at risk EG0024 affected14 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0021 affected14 at risk
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Plantar fasciitis	Musculoskeletal and connective tissue disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0001 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Scoliosis	Musculoskeletal and connective tissue disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Synovitis	Musculoskeletal and connective tissue disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Temporomandibular joint syndrome	Musculoskeletal and connective tissue disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0021 affected14 at risk
Vertebral osteophyte	Musculoskeletal and connective tissue disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Weight bearing difficulty	Musculoskeletal and connective tissue disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0012 affected15 at risk EG0021 affected14 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Benign neoplasm of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Choroid melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0021 affected14 at risk
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Dysplastic naevus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Seborrhoeic keratosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Skin papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0021 affected14 at risk
Tumour ulceration	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0021 affected14 at risk
Balance disorder	Nervous system disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0001 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Dizziness	Nervous system disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected15 at risk EG0022 affected14 at risk
Dizziness postural	Nervous system disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Headache	Nervous system disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0001 affected17 at risk EG0011 affected15 at risk EG0022 affected14 at risk
Hypoaesthesia	Nervous system disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0021 affected14 at risk
Lethargy	Nervous system disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected15 at risk EG0020 affected14 at risk
Loss of consciousness	Nervous system disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Meralgia paraesthetica	Nervous system disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0021 affected14 at risk
Neuralgia	Nervous system disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected15 at risk EG0020 affected14 at risk
Peroneal nerve palsy	Nervous system disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0021 affected14 at risk
Sciatica	Nervous system disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0021 affected14 at risk
Sinus headache	Nervous system disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
VIIth nerve paralysis	Nervous system disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0021 affected14 at risk
Depression	Psychiatric disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0021 affected14 at risk
Anxiety	Psychiatric disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0021 affected14 at risk
Insomnia	Psychiatric disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0022 affected14 at risk
Dysuria	Renal and urinary disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Haematuria	Renal and urinary disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0021 affected14 at risk
Incontinence	Renal and urinary disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Renal failure	Renal and urinary disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Vulvovaginal discomfort	Reproductive system and breast disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Vulvovaginal pruritus	Reproductive system and breast disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0012 affected15 at risk EG0021 affected14 at risk
Choking sensation	Respiratory, thoracic and mediastinal disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected15 at risk EG0020 affected14 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0003 affected17 at risk EG0011 affected15 at risk EG0023 affected14 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0002 affected17 at risk EG0012 affected15 at risk EG0021 affected14 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected15 at risk EG0021 affected14 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0021 affected14 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0021 affected14 at risk
Dandruff	Skin and subcutaneous tissue disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0012 affected15 at risk EG0021 affected14 at risk
Ingrowing nail	Skin and subcutaneous tissue disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected15 at risk EG0020 affected14 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected15 at risk EG0021 affected14 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0021 affected14 at risk
Aortic calcification	Vascular disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Hypertension	Vascular disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0021 affected14 at risk
Hypotension	Vascular disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0012 affected15 at risk EG0020 affected14 at risk
Vascular calcification	Vascular disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk

ID	Term
D001851	Bone Diseases, Metabolic
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D004164	Diphosphonates
D002118	Calcium
D014807	Vitamin D

ID	Term
D063065	Organophosphonates
D009943	Organophosphorus Compounds
D009930	Organic Chemicals
D008673	Metals, Alkaline Earth
D004602	Elements
D007287	Inorganic Chemicals
D008670	Metals
D001779	Blood Coagulation Factors
D001685	Biological Factors
D012632	Secosteroids
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds

ID	Title	Description
BG000	Standard of Care Control	Participants had received systemic osteoporosis therapy with an oral bisphosphonate plus supplemental calcium, and vitamin D as prescribed by the study physician.
BG001	rhBMP-2/CPM 1.0 mg/mL	Participants had received 1 mg/mL rhBMP 2/CPM administered via intraosseous injection administered percutaneously to the proximal femur. Participants in treatment groups additionally received SOC treatment for OP.
BG002	rhBMP-2/CPm 2.0 mg/mL	Participants had received 2 mg/mL rhBMP 2/CPM administered via intraosseous injection administered percutaneously to the proximal femur. Participants in treatment groups additionally received SOC treatment for OP.
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Standard of Care Control	Participants had received systemic osteoporosis therapy with an oral bisphosphonate plus supplemental calcium, and vitamin D as prescribed by the study physician.	3	17	13	17
EG001	rhBMP-2/CPM 1.0 mg/mL	Participants had received 1 mg/mL rhBMP 2/CPM administered via intraosseous injection administered percutaneously to the proximal femur. Participants in treatment groups additionally received SOC treatment for OP.	7	15	15	15
EG002	rhBMP-2/CPm 2.0 mg/mL	Participants had received 2 mg/mL rhBMP 2/CPM administered via intraosseous injection administered percutaneously to the proximal femur. Participants in treatment groups additionally received SOC treatment for OP.	7	14	12	14

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina Pectoris	Cardiac disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Myocardial Infarction	Cardiac disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0021 affected14 at risk
Bronchopneumonia	Infections and infestations	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA (v17.1)	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected15 at risk EG0020 affected14 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Cystitis	Infections and infestations	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0021 affected14 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0021 affected14 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Nuclear magnetic resonance imaging abnormal	Investigations	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0021 affected14 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Bone infarction	Musculoskeletal and connective tissue disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0021 affected14 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected15 at risk EG0020 affected14 at risk
Joint range of motion decreased	Musculoskeletal and connective tissue disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0021 affected14 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0022 affected14 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0021 affected14 at risk
Thyroid neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Intracranial aneurysm	Nervous system disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected15 at risk EG0020 affected14 at risk
Syncope	Nervous system disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected15 at risk EG0020 affected14 at risk
Haematuria	Renal and urinary disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected15 at risk EG0021 affected14 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA (v17.1)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected15 at risk EG0020 affected14 at risk