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Evaluate the efficacy and safety of denosumab in the treatment of involutional (postmenopausal and senile) osteoporotic subjects with prevalent fragility vertebral fracture(s)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Denosumab (subcutaneously - every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months). |
|
| 2 | Placebo Comparator | Placebo (subcutaneously every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months). |
|
| 3 | Active Comparator | Alendronate sodium hydrate oral tablets weekly + daily calcium and vitamin D supplements for 24 months (open label reference arm). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Denosumab | Drug | Subcutaneous injection every 6 months for 24 months, followed by a 12-month period of denosumab (subcutaneously - every six months). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of New or Worsening Vertebral Fractures in Osteoporotic Subjects Treated With Denosumab Compared to Placebo | Baseline to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Non-vertebral Fractures | The results are expressed as percentage by Kaplan-Meier estimate the percentage of participants with non-vertebral fractures | Baseline to 24 Months |
| Percentage of Participants With Hip Fractures in Osteoporotic Participants Treated With Denosumab Compared to Treatment With Placebo. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daiichi Sankyo | R&D Division, Daiichi Sankyo Co., Ltd. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fukuoka | Japan | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24646104 | Result | Nakamura T, Matsumoto T, Sugimoto T, Hosoi T, Miki T, Gorai I, Yoshikawa H, Tanaka Y, Tanaka S, Sone T, Nakano T, Ito M, Matsui S, Yoneda T, Takami H, Watanabe K, Osakabe T, Shiraki M, Fukunaga M. Clinical Trials Express: fracture risk reduction with denosumab in Japanese postmenopausal women and men with osteoporosis: denosumab fracture intervention randomized placebo controlled trial (DIRECT). J Clin Endocrinol Metab. 2014 Jul;99(7):2599-607. doi: 10.1210/jc.2013-4175. Epub 2014 Mar 19. | |
| 25403903 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Denosumab | Denosumab (subcutaneously - every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months). |
| FG001 | Placebo | Placebo (subcutaneously every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months). |
| FG002 | Alendronate | Alendronate sodium hydrate oral tablets weekly + daily calcium and vitamin D supplements for 24 months (open label reference arm). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The demography information shows the number of participants included in the full analysis set (FAS) for efficacy analyses, which includes all randomized subjects except for those who did not have osteoporosis, did not receive the investigational product, or had no available efficacy data after the first dose of the investigational product.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Denosumab | Denosumab (subcutaneously - every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months). |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Incidence of New or Worsening Vertebral Fractures in Osteoporotic Subjects Treated With Denosumab Compared to Placebo | Posted | Mean | 95% Confidence Interval | Vertebral fractures | Baseline to 24 months |
|
Baseline to 24 months
The number of participants for which serious adverse reactions are reported are the ones included in the safety data analysis set. This data set includes all participants who received at least one dose of investigational product.
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 | Denosumab | Denosumab (subcutaneously - every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| H. Takami | Daiichi Sankyo Co., Ltd. | +81 3 5740 3445 | takami.hideo.hs@daiichisankyo.co.jp |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069448 | Denosumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Placebo | Drug | Subcutaneous injection every 6 months for 24 months, followed by a 12-month period of denosumab (subcutaneously - every six months). |
|
| Alendronate sodium hydrate | Drug | Oral tablet once a week for 24 months |
|
The results are expressed as a percentage by Kaplan-Meier estimate. |
| Baseline to 24 Months |
| Osaka |
| Japan |
| Sapporo | Japan |
| Tokyo | Japan |
| Result |
| Sugimoto T, Matsumoto T, Hosoi T, Miki T, Gorai I, Yoshikawa H, Tanaka Y, Tanaka S, Fukunaga M, Sone T, Nakano T, Ito M, Matsui S, Yoneda T, Takami H, Watanabe K, Osakabe T, Okubo N, Shiraki M, Nakamura T. Three-year denosumab treatment in postmenopausal Japanese women and men with osteoporosis: results from a 1-year open-label extension of the Denosumab Fracture Intervention Randomized Placebo Controlled Trial (DIRECT). Osteoporos Int. 2015 Feb;26(2):765-74. doi: 10.1007/s00198-014-2964-2. Epub 2014 Nov 18. |
| 32839843 | Derived | Okubo N, Matsui S, Matsumoto T, Sugimoto T, Hosoi T, Osakabe T, Watanabe K, Takami H, Shiraki M, Nakamura T. Relationship Between Bone Mineral Density and Risk of Vertebral Fractures with Denosumab Treatment in Japanese Postmenopausal Women and Men with Osteoporosis. Calcif Tissue Int. 2020 Dec;107(6):559-566. doi: 10.1007/s00223-020-00750-y. Epub 2020 Aug 25. |
Placebo (subcutaneously every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
| BG002 | Alendronate | Alendronate sodium hydrate oral tablets weekly + daily calcium and vitamin D supplements for 24 months (open label reference arm). |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| the number of participants with vertebral fractures | the number of participants with vertebral fractures | Number | Participants |
|
| Alendronate |
Alendronate sodium hydrate oral tablets weekly + daily calcium and vitamin D supplements for 24 months (open label reference arm). |
|
|
|
| Secondary | The Percentage of Non-vertebral Fractures | The results are expressed as percentage by Kaplan-Meier estimate the percentage of participants with non-vertebral fractures | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline to 24 Months |
|
|
|
|
| Secondary | Percentage of Participants With Hip Fractures in Osteoporotic Participants Treated With Denosumab Compared to Treatment With Placebo. | The results are expressed as a percentage by Kaplan-Meier estimate. | Posted | Number | percentage of participants | Baseline to 24 Months |
|
|
|
|
| 65 |
| 475 |
| 475 |
| 475 |
| EG001 | Placebo | Placebo (subcutaneously every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months). | 68 | 481 | 481 | 481 |
| EG002 | Alendronate | Alendronate sodium hydrate oral tablets weekly + daily calcium and vitamin D supplements for 24 months (open label reference arm). | 30 | 242 | 242 | 242 |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Muscle atrophy | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Fractured coccyx | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Heat illness | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Patella fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Cerebral haemorrhage traumatic | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Fractured ischium | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Fractured sacrum | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Pubis fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Scapula fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cerebellar haemorrhage | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Altered state of consciousness | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Autonomic nervous system imbalance | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Intracranial aneurysm | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Colonic polyp | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Abdominal hernia | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Femoral hernia, obstructive | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Gastrointestinal mucosal exfoliation | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Large intestine perforation | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Rectal prolapse | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Gastric polyps | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Proctalgia | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Oesophageal ulcer | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Metastases to lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Bile duct cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Colon adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Metastases to lymph nodes | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Large intestine carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Paget's disease of the breast | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Haemangioblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Enteritis infectious | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Respiratory moniliasis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Arthritis bacterial | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Atrioventricular block complete | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cardiac failure acute | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Mitral valve incompetence | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hepatic cyst | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Foreign body aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Paranasal cyst | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 14.0 | Systematic Assessment |
|
| Maculopathy | Eye disorders | MedDRA 14.0 | Systematic Assessment |
|
| Macular degeneration | Eye disorders | MedDRA 14.0 | Systematic Assessment |
|
| Aortic aneurysm | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Varicose vein | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Circulatory collapse | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 14.0 | Systematic Assessment |
|
| Sudden hearing loss | Ear and labyrinth disorders | MedDRA 14.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Device dislocation | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Device breakage | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dysthymic disorder | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
|
| Neurosis | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cataract operation | Surgical and medical procedures | MedDRA 14.0 | Systematic Assessment |
|
| Varicose vein operation | Surgical and medical procedures | MedDRA 14.0 | Systematic Assessment |
|
| Calculus urinary | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Mixed incontinence | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Uterine prolapse | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cystocele | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pelvic prolapse | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
|
| Vaginal relaxation | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Thyroid mass | Endocrine disorders | MedDRA 14.0 | Systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Periodontitis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
|
Principal Investigator shall not publish the results of the Study at any time without the prior written approval of Sponsor.
| D009750 |
| Nutritional and Metabolic Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |