Extension Study to Evaluate Long Term Safety of Denosumab... | NCT00838201

Label	Type	Description	Intervention Names
Arm 1	Experimental		Drug: Denosumab

Name	Type	Description	Arm Group Labels	Other Names
Denosumab	Drug	60 mg SC of Denosumab will be administered on study day 1, month 6, month 12, and month 18	Arm 1

Measure	Description	Time Frame
Overall Survival Through Month 24		24 months

Name	Affiliation	Role
MD	Amgen	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Huntsville	Alabama	35801	United States
Research Site

Label	URL
AmgenTrials clinical trials website	View source

ID	Title	Description
FG000	Placebo/Denosumab 60 mg SC Q6M	Placebo in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study
FG001	Denosumab/Denosumab 60 mg SC Q6M	Denosumab 60 mg SC Q6M in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 15.0	Systematic Assessment	EG0002 affected185 at risk EG0012 affected199 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected185 at risk EG0010 affected199 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected185 at risk EG0010 affected199 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected185 at risk EG0010 affected199 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Angina pectoris	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0012 affected199 at risk
Angina unstable	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Bradycardia	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected185 at risk EG0010 affected199 at risk
Cardiac arrest	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Cardiac failure	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0005 affected185 at risk EG0010 affected199 at risk
Cardiac ventricular disorder	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected185 at risk EG0010 affected199 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Coronary artery disease	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Extrasystoles	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected185 at risk EG0010 affected199 at risk
Myocardial infarction	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0012 affected199 at risk
Sick sinus syndrome	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected185 at risk EG0011 affected199 at risk
Thyroglossal cyst	Congenital, familial and genetic disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected185 at risk EG0010 affected199 at risk
Cataract	Eye disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected185 at risk EG0011 affected199 at risk
Glaucoma	Eye disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected185 at risk EG0010 affected199 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Gastritis	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected185 at risk EG0010 affected199 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Large intestinal ulcer	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected185 at risk EG0010 affected199 at risk
Localised intraabdominal fluid collection	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Subileus	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected185 at risk EG0010 affected199 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Asthenia	General disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Death	General disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Implant site haematoma	General disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected185 at risk EG0010 affected199 at risk
Non-cardiac chest pain	General disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Oedema peripheral	General disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Pyrexia	General disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Bile duct obstruction	Hepatobiliary disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Jaundice	Hepatobiliary disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Arthritis bacterial	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 affected185 at risk EG0010 affected199 at risk
Bronchitis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Cellulitis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0002 affected185 at risk EG0011 affected199 at risk
Clostridial infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0002 affected185 at risk EG0011 affected199 at risk
Device related infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 affected185 at risk EG0010 affected199 at risk
Gastroenteritis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 affected185 at risk EG0010 affected199 at risk
Pneumonia	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0002 affected185 at risk EG0012 affected199 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 affected185 at risk EG0010 affected199 at risk
Pneumonia pneumococcal	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 affected185 at risk EG0010 affected199 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 affected185 at risk EG0010 affected199 at risk
Urinary tract infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0012 affected199 at risk
Urinary tract infection pseudomonal	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Urosepsis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 affected185 at risk EG0011 affected199 at risk
Wound infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 affected185 at risk EG0010 affected199 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0001 affected185 at risk EG0010 affected199 at risk
Ilium fracture	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Perirenal haematoma	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0001 affected185 at risk EG0010 affected199 at risk
Postoperative ileus	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Postoperative wound complication	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0001 affected185 at risk EG0010 affected199 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0001 affected185 at risk EG0010 affected199 at risk
Sternal fracture	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0001 affected185 at risk EG0010 affected199 at risk
Liver function test abnormal	Investigations	MedDRA 15.0	Systematic Assessment	EG0001 affected185 at risk EG0010 affected199 at risk
Oxygen saturation abnormal	Investigations	MedDRA 15.0	Systematic Assessment	EG0001 affected185 at risk EG0010 affected199 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 15.0	Systematic Assessment	EG0002 affected185 at risk EG0010 affected199 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 15.0	Systematic Assessment	EG0002 affected185 at risk EG0010 affected199 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected185 at risk EG0010 affected199 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected185 at risk EG0011 affected199 at risk
Osteonecrosis of jaw	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Vertebral foraminal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected185 at risk EG0010 affected199 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Systematic Assessment	EG0001 affected185 at risk EG0010 affected199 at risk
Adenocarcinoma pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Bile duct cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Bladder transitional cell carcinoma stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Brain neoplasm benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Colon cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Gastrointestinal stromal tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Intestinal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Laryngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Systematic Assessment	EG0001 affected185 at risk EG0010 affected199 at risk
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Systematic Assessment	EG0001 affected185 at risk EG0010 affected199 at risk
Metastases to lymph nodes	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Systematic Assessment	EG0001 affected185 at risk EG0010 affected199 at risk
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Systematic Assessment	EG0003 affected185 at risk EG0012 affected199 at risk
Prostate cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Prostate cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Systematic Assessment	EG0001 affected185 at risk EG0010 affected199 at risk
Basal ganglia infarction	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected185 at risk EG0010 affected199 at risk
Cerebral infarction	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected185 at risk EG0011 affected199 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected185 at risk EG0010 affected199 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0003 affected185 at risk EG0012 affected199 at risk
Convulsion	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected185 at risk EG0010 affected199 at risk
Dementia	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Petit mal epilepsy	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Presyncope	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Syncope	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected185 at risk EG0011 affected199 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0002 affected185 at risk EG0011 affected199 at risk
Confusional state	Psychiatric disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Delirium	Psychiatric disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Bladder obstruction	Renal and urinary disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Bladder outlet obstruction	Renal and urinary disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Haematuria	Renal and urinary disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected185 at risk EG0013 affected199 at risk
Renal failure	Renal and urinary disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected185 at risk EG0010 affected199 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected185 at risk EG0012 affected199 at risk
Ureteric obstruction	Renal and urinary disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Urinary retention	Renal and urinary disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected185 at risk EG0011 affected199 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected185 at risk EG0010 affected199 at risk
Prostatomegaly	Reproductive system and breast disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected185 at risk EG0010 affected199 at risk
Bronchial hyperreactivity	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected185 at risk EG0010 affected199 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected185 at risk EG0010 affected199 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected185 at risk EG0010 affected199 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0002 affected185 at risk EG0010 affected199 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected185 at risk EG0010 affected199 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected185 at risk EG0011 affected199 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0003 affected185 at risk EG0010 affected199 at risk
Nail discolouration	Skin and subcutaneous tissue disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected185 at risk EG0010 affected199 at risk
Aortic aneurysm	Vascular disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected185 at risk EG0010 affected199 at risk
Aortic dissection	Vascular disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Aortic stenosis	Vascular disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Arterial stenosis	Vascular disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected185 at risk EG0010 affected199 at risk
Hypotension	Vascular disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected185 at risk EG0011 affected199 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected185 at risk EG0011 affected199 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected185 at risk EG0010 affected199 at risk

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo/ Denosumab 60 mg Q6M	Placebo in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study			45	185	47	185
EG001	Denosumab/ Denosumab 60 mg Q6M	Denosumab 60 mg SC Q6M in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study			51	199	46	199

ID	Term
D009369	Neoplasms
D002277	Carcinoma
D011471	Prostatic Neoplasms

ID	Term
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D011469	Prostatic Diseases
D052801	Male Urogenital Diseases

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins

ID	Title	Description
BG000	Placebo/Denosumab 60 mg SC Q6M	Placebo in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study
BG001	Denosumab/Denosumab 60 mg SC Q6M	Denosumab 60 mg SC Q6M in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study
BG002	Total	Total of all reporting groups

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Constipation	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG00016 affected185 at risk EG00113 affected199 at risk
Nausea	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0008 affected185 at risk EG00111 affected199 at risk
Urinary tract infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0006 affected185 at risk EG00112 affected199 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG00012 affected185 at risk EG00110 affected199 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0008 affected185 at risk EG00111 affected199 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG00011 affected185 at risk EG0019 affected199 at risk