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The purpose of this study is to describe the safety and tolerability of denosumab administration as measured by adverse events, immunogenicity, and safety laboratory parameters in subjects who previously received either zoledronic acid (Zometa®) or denosumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| amg 162 | Drug | 120 mg SC injection of denosumab Q4W until the subject has access to commercially available product or for up to 2 years, which ever comes first. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Survived | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Jindřichův Hradec | 377 01 | Czechia | |||
| Research Site |
Not provided
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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Subjects recuited in this open-label extension study were those who were enrolled in the 2 parent (phase 3, randomized, double-blind, active-controlled) studies 20050103 (NCT00321620) or 20050136 (NCT00321464) at sites in the Czech Republic and United Kingdom.
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| ID | Title | Description |
|---|---|---|
| FG000 | Zoledronic Acid 4 mg Q4W / Denosumab 120 mg Q4W | This cohort received Zoledronic Acid 4 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study. |
| FG001 | Denosumab 120 mg Q4W / Denosumab 120 mg Q4W |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| KroměřÞ |
| 767 55 |
| Czechia |
| Research Site | Olomouc | 775 20 | Czechia |
| Research Site | Prague | 110 00 | Czechia |
| Research Site | Prague | 140 00 | Czechia |
| Research Site | Prague | 140 44 | Czechia |
| Research Site | Prague | 150 06 | Czechia |
| Research Site | Prague | 160 00 | Czechia |
| Research Site | ZlÃn | 762 75 | Czechia |
| Research Site | Chichester | PO19 4SE | United Kingdom |
| Research Site | Leeds | LS9 7TF | United Kingdom |
| Research Site | London | SE1 9RT | United Kingdom |
| Research Site | London | W2 1NY | United Kingdom |
| Research Site | Manchester | M20 4BX | United Kingdom |
| Research Site | Northwood | HA6 2RN | United Kingdom |
| Research Site | Peterborough | PE3 9GZ | United Kingdom |
| Research Site | York | YO31 8HE | United Kingdom |
This cohort received Denosumab 120 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Zoledronic Acid 4 mg Q4W / Denosumab 120 mg Q4W | This cohort received Zoledronic Acid 4 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study. |
| BG001 | Denosumab 120 mg Q4W / Denosumab 120 mg Q4W | This cohort received Denosumab 120 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Survived | Full Analysis Set | Posted | Number | Participants | 2 years |
|
|
|
2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Zoledronic Acid 4 mg Q4W / Denosumab 120 mg Q4W | This cohort received Zoledronic Acid 4 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study. | 8 | 17 | 13 | 17 | ||
| EG001 | Denosumab 120 mg Q4W / Denosumab 120 mg Q4W | This cohort received Denosumab 120 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study. | 10 | 18 | 13 | 18 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Metastases to meninges | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
| |
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
| |
| Prostate cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Grand mal convulsion | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Partial seizures | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Hip arthroplasty | Surgical and medical procedures | MedDRA 14.1 | Systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Ear haemorrhage | Ear and labyrinth disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Cushingoid | Endocrine disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Eye swelling | Eye disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Abdominal rigidity | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Duodenitis | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Gastric disorder | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Gingival pain | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Gingivitis | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Oral disorder | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Sensitivity of teeth | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Tooth loss | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Facial pain | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Feeling hot | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Local swelling | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Localised oedema | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Mucosal necrosis | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Submandibular mass | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Swelling | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Liver disorder | Hepatobiliary disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Immunodeficiency | Immune system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Borrelia infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Oral fungal infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| Fractured coccyx | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| Eastern Cooperative Oncology Group performance status worsened | Investigations | MedDRA 14.1 | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Bone disorder | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Osteitis | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Periostitis | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Sensation of heaviness | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
| |
| Tumour flare | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Coordination abnormal | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Post herpetic neuralgia | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Bladder obstruction | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Penile oedema | Reproductive system and breast disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Hydrothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Nail dystrophy | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Photosensitivity allergic reaction | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Denture wearer | Social circumstances | MedDRA 14.1 | Systematic Assessment |
| |
| Tooth extraction | Surgical and medical procedures | MedDRA 14.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results aftercompletion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D001943 | Breast Neoplasms |
| D009369 | Neoplasms |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069448 | Denosumab |
| 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 |
Not provided
Not provided
| Male |
|
| Black or African American |
|