Persistence With Prolia® (Denosumab) in Postmenopausal Wo... | NCT02732210

Measure	Description	Time Frame
Percentage of Participants With Persistence With Prolia® at 12 Ponths	A participant was considered persistent with Prolia® at 12 months if they received at least 2 Prolia® injections no more than 6 months plus 8 weeks (239 days) apart.	12 months
Percentage of Participants With Persistence With Prolia® at 24 Months	A participant was considered persistent with Prolia® at 24 months if they received at least 4 Prolia® injections and the length of time between any 2 consecutive Prolia® injections does not exceed 6 months plus 8 weeks (239 days).	24 months

Measure	Description	Time Frame
Time to Non-persistence	For non-persistent participants, time to non-persistence was calculated as the time between the date of the first injection and the date of last injection received during the period where the participant was still classified as persistent plus 6 months (183 days).	24 months
Number of Prolia® Injections Received

Name	Affiliation	Role
MD	Amgen	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Birmingham	Alabama	35205	United States
Research Site

PubMed Identifier	Type	Citation	Retractions
25236877	Background	Silverman SL, Siris E, Kendler DL, Belazi D, Brown JP, Gold DT, Lewiecki EM, Papaioannou A, Simonelli C, Ferreira I, Balasubramanian A, Dakin P, Ho P, Siddhanti S, Stolshek B, Recknor C. Persistence at 12 months with denosumab in postmenopausal women with osteoporosis: interim results from a prospective observational study. Osteoporos Int. 2015 Jan;26(1):361-72. doi: 10.1007/s00198-014-2871-6. Epub 2014 Sep 19.
30088189

Label	URL
AmgenTrials clinical trials website	View source

ID	Title	Description
FG000	Canada	Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in Canada.
FG001	United States

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

Percentage of Participants With Persistence With Prolia® at 12 Ponths

A participant was considered persistent with Prolia® at 12 months if they received at least 2 Prolia® injections no more than 6 months plus 8 weeks (239 days) apart.

Full Analysis Set (all enrolled participants)

Posted

Number

95% Confidence Interval

percentage of participants

12 months

ID	Title	Description
OG000	Canada	Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in Canada.
OG001	United States	Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in the United States.

Units	Counts
Participants	OG000303 OG001632

Title

Denominators

Categories

Title	Measurements
	OG00087.8(83.6 to 91.3) OG00181.0(77.7 to 84.0)

Primary

Percentage of Participants With Persistence With Prolia® at 24 Months

A participant was considered persistent with Prolia® at 24 months if they received at least 4 Prolia® injections and the length of time between any 2 consecutive Prolia® injections does not exceed 6 months plus 8 weeks (239 days).

Full analysis set

Posted

Number

95% Confidence Interval

percentage of participants

24 months

ID	Title	Description
OG000	Canada	Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in Canada.
OG001	United States	Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in the United States.

Units	Counts
Participants	OG000

Secondary

Time to Non-persistence

For non-persistent participants, time to non-persistence was calculated as the time between the date of the first injection and the date of last injection received during the period where the participant was still classified as persistent plus 6 months (183 days).

Full analysis set with non-persistence at 24 months

Posted

Median

Inter-Quartile Range

months

24 months

ID	Title	Description
OG000	Canada	Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in Canada.
OG001	United States	Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in the United States.

Units	Counts
Participants	OG000

Secondary

Number of Prolia® Injections Received

The number of injections that a participant received over 24 months (including the baseline injection) regardless of when the injection was received.

Full analysis set

Posted

Median

Inter-Quartile Range

prolia injections

24 months

ID	Title	Description
OG000	Canada	Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in Canada.
OG001	United States	Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in the United States.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Satisfying Medication-taking Behavior at 12 Months

Percentage of participants satisfying medication-taking behavior defined as, following the first Prolia® injection, the participant received a second Prolia® injection and the length of time between the first and the second Prolia® injection did not exceed 6 months with a grace period of ± 4 weeks.

Full analysis set

Posted

Number

95% Confidence Interval

percentage of participants

12 months

ID	Title	Description
OG000	Canada	Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in Canada.
OG001	United States	Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in the United States.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Satisfying Medication-taking Behavior at 24 Months

Percentage of participants satisfying medication-taking behavior defined as the participant received all 4 Prolia® injections and the length of time between any 2 consecutive Prolia® injections did not exceed 6 months with a grace period of ± 4 weeks.

Full analysis set

Posted

Number

95% Confidence Interval

percentage of participants

24 months

ID	Title	Description
OG000	Canada	Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in Canada.
OG001	United States	Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in the United States.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected303 at risk EG0012 affected632 at risk
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected303 at risk EG0010 affected632 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0015 affected632 at risk
Angina pectoris	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0013 affected632 at risk
Atrial flutter	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected303 at risk EG0010 affected632 at risk
Cardiac arrest	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected303 at risk EG0012 affected632 at risk
Cardiac failure	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0014 affected632 at risk
Cardiac tamponade	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Coronary artery disease	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Coronary artery embolism	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Myocardial infarction	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected303 at risk EG0010 affected632 at risk
Sick sinus syndrome	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected303 at risk EG0010 affected632 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Adrenocortical insufficiency acute	Endocrine disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0012 affected632 at risk
Constipation	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Crohn's disease	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected303 at risk EG0010 affected632 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Gastritis	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected303 at risk EG0010 affected632 at risk
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Rectal prolapse	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0013 affected632 at risk
Vomiting	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Chest pain	General disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0012 affected632 at risk
Death	General disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0013 affected632 at risk
Multi-organ failure	General disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Pyrexia	General disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Aeromona infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Bronchitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0012 affected632 at risk
Cellulitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0015 affected632 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0013 affected632 at risk
Device related sepsis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected303 at risk EG0010 affected632 at risk
Diverticulitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Empyema	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Gangrene	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Gastroenteritis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Herpes zoster	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Lobar pneumonia	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Mycobacterium avium complex infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Necrotising fasciitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Osteomyelitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Pneumonia	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected303 at risk EG0019 affected632 at risk
Pneumonia influenzal	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Sepsis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Urinary tract infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0014 affected632 at risk
Wound infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0013 affected632 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Fractured sacrum	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected303 at risk EG0011 affected632 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0014 affected632 at risk
Patella fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Perirenal haematoma	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Pubis fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0012 affected632 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0013 affected632 at risk
Wound	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Helicobacter test positive	Investigations	MedDRA 17.0	Systematic Assessment	EG0001 affected303 at risk EG0010 affected632 at risk
International normalised ratio increased	Investigations	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0013 affected632 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected303 at risk EG0011 affected632 at risk
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected303 at risk EG0010 affected632 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected303 at risk EG0010 affected632 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected303 at risk EG0010 affected632 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected303 at risk EG0010 affected632 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected303 at risk EG0010 affected632 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected303 at risk EG0010 affected632 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected303 at risk EG0010 affected632 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Systemic lupus erythematosus	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Adenocarcinoma pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0001 affected303 at risk EG0010 affected632 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0002 affected303 at risk EG0013 affected632 at risk
Breast cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Breast cancer stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Endometrial cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Intraductal proliferative breast lesion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0001 affected303 at risk EG0010 affected632 at risk
Liposarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0001 affected303 at risk EG0010 affected632 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Ovarian cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Ovarian cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0001 affected303 at risk EG0010 affected632 at risk
Small cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0001 affected303 at risk EG0010 affected632 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected303 at risk EG0010 affected632 at risk
Cerebral infarction	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected303 at risk EG0012 affected632 at risk
Convulsion	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected303 at risk EG0011 affected632 at risk
Dementia	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Embolic stroke	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Essential tremor	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected303 at risk EG0010 affected632 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Headache	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0012 affected632 at risk
Hemiplegia	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected303 at risk EG0010 affected632 at risk
Intracranial venous sinus thrombosis	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Migraine	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Neuritis	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Paraesthesia	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Sciatica	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected303 at risk EG0010 affected632 at risk
Syncope	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected303 at risk EG0011 affected632 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected303 at risk EG0013 affected632 at risk
Communication disorder	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Mental status changes	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Bladder prolapse	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Cystitis haemorrhagic	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Haematuria	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected303 at risk EG0012 affected632 at risk
Renal injury	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0003 affected303 at risk EG0011 affected632 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected303 at risk EG0010 affected632 at risk
Obstructive airways disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Pulmonary cavitation	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected303 at risk EG0011 affected632 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected303 at risk EG0010 affected632 at risk
Hip arthroplasty	Surgical and medical procedures	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Knee arthroplasty	Surgical and medical procedures	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0012 affected632 at risk
Shoulder operation	Surgical and medical procedures	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Spinal operation	Surgical and medical procedures	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Toe amputation	Surgical and medical procedures	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Aortic dissection	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Arteriosclerosis	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected303 at risk EG0010 affected632 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected303 at risk EG0011 affected632 at risk
Hypertension	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0013 affected632 at risk
Hypertensive emergency	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Jugular vein thrombosis	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected303 at risk EG0010 affected632 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected303 at risk EG0012 affected632 at risk
Venous thrombosis limb	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected303 at risk EG0011 affected632 at risk

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

ID	Title	Description
BG000	Canada	Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in Canada.
BG001	United States	Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in the United States.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Canada	Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in Canada.			27	303	0	303
EG001	United States	Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in the United States.			95	632	0	632