Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This observational study will investigate efficacy and safety of methoxy polyethyleneglycol-epoetin beta in participants with a kidney transplant. Data of each participant will be collected over 15 months of Mircera therapy.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kidney Transplant Participants | Participants with kidney transplant and a chronic kidney disease who were receiving methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methoxy-polyethyleneglycol epoetin beta | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a Hemoglobin Value of 11-12 Grams Per Deciliter (g/dL) From Visit 7 (Month 7) to Visit 9 (Month 9) | From Month 7 to Month 9 | |
| Percentage of Participants With a Hemoglobin Value of 11-13 g/dL From Visit 7 (Month 7) to Visit 9 (Month 9) | From Month 7 to Month 9 | |
| Percentage of Participants With a Hemoglobin Value of 11-13 g/dL From Visit 7 (Month 7) to Visit 12 (Month 12) | From Month 7 to Month 12 | |
| Percentage of Participants With a Hemoglobin Value of 11-13 g/dL From Visit 7 (Month 7) to Visit 15 (Month 15) | From Month 7 to Month 15 | |
| Percentage of Participants With a Hemoglobin Value of 10-13 g/dL From Visit 7 (Month 7) to Visit 12 (Month 12) | From Month 7 to Month 12 | |
| Percentage of Participants With a Hemoglobin Value of 10-13 g/dL From Visit 7 (Month 7) to Visit 15 (Month 15) | From Month 7 to Month 15 | |
| Average Duration in Months Mircera Was Administered at Current Dose After the Previous Dose Adjustment | Up to 50 months |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin Level Based on the Type of Kidney Transplantation Performed | Participants were classified based on the type of kidney transplantation they underwent before entering in to the study in to two groups; participants who received living donation and participants who received cadaveric donation. | Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Participants with kidney transplant prescribed methoxy polyethyleneglycol-epoetin beta
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Hann. Münden, Nephrologisches Zentrum Niedersachsen | Hannoversch Münden | 34346 | Germany |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Kidney Transplant Participants | Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety analysis set included participants who received at least 1 dose of study treatment. Age was reported for N=278 participants since data for 1 participant was missing.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Kidney Transplant Participants | Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months. |
| 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 | Percentage of Participants With a Hemoglobin Value of 11-12 Grams Per Deciliter (g/dL) From Visit 7 (Month 7) to Visit 9 (Month 9) | Efficacy analysis set (Included participants who reported no pregnancy during the study period and had dosing and hemoglobin data available during 1 of the 3 visits [Visits 7-9]). | Posted | Number | percentage of participants | From Month 7 to Month 9 |
|
|
Up to 50 months
Safety analysis set.
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 | Kidney Transplant Participants | Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (14.1) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bone marrow failure | Blood and lymphatic system disorders | MedDRA (14.1) | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-LaRoche | 800-821-8590 | genentech@druginfo.com |
Not provided
| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C508420 | continuous erythropoietin receptor activator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Hemoglobin Level Based on the Presence of Inflammatory Diseases | Participants were classified based on the presence of other inflammatory diseases at baseline in to two groups; participants with presence of inflammatory diseases and participants with absence of inflammatory diseases. | Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15) |
| Hemoglobin Level Based on the Etiology of Chronic Kidney Disease | Participants were classified based on the etiology of chronic kidney disease. The different etiological reasons included diabetic vasculopathy, hypertensive nephrosclerosis, glomerulonephritis, polycystic kidney, chronic pyelonephritis, other reasons and origin unknown. Hemoglobin levels in participants who had etiology of chronic kidney disease as 'glomerulonephritis' or 'other reasons' were presented as these were the majority of the etiological reasons for chronic kidney disease. | Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15) |
| Hemoglobin Level Based on the Acute Bleeding Episode(s) During the Study | Participants were classified in to two groups based on the presence of acute bleeding episodes during the study; presence or absence of bleeding episodes. | Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15) |
| Hemoglobin Level Based on the Glomerular Filtration Rate (GFR) | GFR is described as the flow rate of filtered fluid through the kidney and was determined using the Cockcroft-Gault formula to calculate the creatinine clearance. For males, creatinine clearance [milliliters per minute (mL/min)] = [(140 minus age) multiplied by (*) (body weight in kilogram [kg]) divided by [72 * serum creatinine milligrams per deciliter (mg/dL)]. For females, creatinine clearance (mL/min) = 0.85 * [(140 minus age) * (body weight in kg)] divided by [72 * serum creatinine (mg/dL)]. Participants were classified based on the GFR in to two groups; GFR less than (<) 30 mL/min and in the range of 30-60 mL/min and hemoglobin levels at different visits were presented.](streamdown:incomplete-link) | Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15) |
| Administration of other ESA |
|
| No further treatment necessary |
|
| Withdrawal by Subject |
|
| Death |
|
| Administrative reason |
|
| Adverse Event |
|
| Surgery |
|
| Other |
|
| Not recorded |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
| Primary | Percentage of Participants With a Hemoglobin Value of 11-13 g/dL From Visit 7 (Month 7) to Visit 9 (Month 9) | Efficacy analysis set. | Posted | Number | percentage of participants | From Month 7 to Month 9 |
|
|
|
| Primary | Percentage of Participants With a Hemoglobin Value of 11-13 g/dL From Visit 7 (Month 7) to Visit 12 (Month 12) | Efficacy analysis set. Participants who were evaluable at the specified time frame were included. | Posted | Number | percentage of participants | From Month 7 to Month 12 |
|
|
|
| Primary | Percentage of Participants With a Hemoglobin Value of 11-13 g/dL From Visit 7 (Month 7) to Visit 15 (Month 15) | Efficacy analysis set. Participants who were evaluable at the specified time frame were included. | Posted | Number | percentage of participants | From Month 7 to Month 15 |
|
|
|
| Primary | Percentage of Participants With a Hemoglobin Value of 10-13 g/dL From Visit 7 (Month 7) to Visit 12 (Month 12) | Efficacy analysis set. Participants who were evaluable at the specified time frame were included. | Posted | Number | percentage of participants | From Month 7 to Month 12 |
|
|
|
| Secondary | Hemoglobin Level Based on the Type of Kidney Transplantation Performed | Participants were classified based on the type of kidney transplantation they underwent before entering in to the study in to two groups; participants who received living donation and participants who received cadaveric donation. | Efficacy analysis set. n = number of participants who were evaluable at a particular visit. | Posted | Mean | Standard Deviation | g/dL | Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15) |
|
|
|
| Secondary | Hemoglobin Level Based on the Presence of Inflammatory Diseases | Participants were classified based on the presence of other inflammatory diseases at baseline in to two groups; participants with presence of inflammatory diseases and participants with absence of inflammatory diseases. | Efficacy analysis set. n = number of participants who were evaluable at a particular visit. | Posted | Mean | Standard Deviation | g/dL | Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15) |
|
|
|
| Secondary | Hemoglobin Level Based on the Etiology of Chronic Kidney Disease | Participants were classified based on the etiology of chronic kidney disease. The different etiological reasons included diabetic vasculopathy, hypertensive nephrosclerosis, glomerulonephritis, polycystic kidney, chronic pyelonephritis, other reasons and origin unknown. Hemoglobin levels in participants who had etiology of chronic kidney disease as 'glomerulonephritis' or 'other reasons' were presented as these were the majority of the etiological reasons for chronic kidney disease. | Efficacy analysis set. Participants who were evaluable for the specified group were included and n = number of participants who were evaluable at a particular visit. | Posted | Mean | Standard Deviation | g/dL | Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15) |
|
|
|
| Secondary | Hemoglobin Level Based on the Acute Bleeding Episode(s) During the Study | Participants were classified in to two groups based on the presence of acute bleeding episodes during the study; presence or absence of bleeding episodes. | Efficacy analysis set. Participants who were evaluable for the specified group were included and n = number of participants who were evaluable at a particular visit. | Posted | Mean | Standard Deviation | g/dL | Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15) |
|
|
|
| Secondary | Hemoglobin Level Based on the Glomerular Filtration Rate (GFR) | GFR is described as the flow rate of filtered fluid through the kidney and was determined using the Cockcroft-Gault formula to calculate the creatinine clearance. For males, creatinine clearance [milliliters per minute (mL/min)] = [(140 minus age) multiplied by (*) (body weight in kilogram [kg]) divided by [72 * serum creatinine milligrams per deciliter (mg/dL)]. For females, creatinine clearance (mL/min) = 0.85 * [(140 minus age) * (body weight in kg)] divided by [72 * serum creatinine (mg/dL)]. Participants were classified based on the GFR in to two groups; GFR less than (<) 30 mL/min and in the range of 30-60 mL/min and hemoglobin levels at different visits were presented.](streamdown:incomplete-link) | Efficacy analysis set. Participants who were evaluable for the specified group were included and n = number of participants who were evaluable at a particular visit. | Posted | Mean | Standard Deviation | g/dL | Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15) |
|
|
|
| Primary | Percentage of Participants With a Hemoglobin Value of 10-13 g/dL From Visit 7 (Month 7) to Visit 15 (Month 15) | Efficacy analysis set. Participants who were evaluable at the specified time frame were included. | Posted | Number | percentage of participants | From Month 7 to Month 15 |
|
|
|
| Primary | Average Duration in Months Mircera Was Administered at Current Dose After the Previous Dose Adjustment | Efficacy analysis set. Participants with non-missing values were included. | Posted | Mean | Standard Deviation | months | Up to 50 months |
|
|
|
| 32 |
| 279 |
| 42 |
| 279 |
| Angina pectoris | Cardiac disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Device failure | General disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Inflammation | General disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Multi-organ failure | General disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Sudden cardiac death | General disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Kidney transplant rejection | Immune system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Cytomegalovirus infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Gastroenteritis norovirus | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Human polyomavirus infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Intervertebral discitis | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Urinary tract infection enterococcal | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Varicella | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA (14.1) | Non-systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA (14.1) | Non-systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA (14.1) | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA (14.1) | Non-systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Non-systematic Assessment |
|
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Non-systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| VIth nerve disorder | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Dialysis | Surgical and medical procedures | MedDRA (14.1) | Non-systematic Assessment |
|
| Haemodialysis | Surgical and medical procedures | MedDRA (14.1) | Non-systematic Assessment |
|
| Parathyroidectomy | Surgical and medical procedures | MedDRA (14.1) | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Macrocytosis | Blood and lymphatic system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Tympanic membrane disorder | Ear and labyrinth disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Abdominal hernia | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Injection site pain | General disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Febrile infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Localised infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Molluscum contagiosum | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Epicondylitis | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Shunt occlusion | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA (14.1) | Non-systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA (14.1) | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA (14.1) | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Non-systematic Assessment |
|
| Neoplasm skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Phantom pain | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Psychomotor hyperactivity | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Nephrotic syndrome | Renal and urinary disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Hirsutism | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Night Sweats | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Walking disability | Social circumstances | MedDRA (14.1) | Non-systematic Assessment |
|
| Carpal tunnel decompression | Surgical and medical procedures | MedDRA (14.1) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (14.1) | Non-systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Visit 3 (Month 3) (n=27, 128) |
|
| Visit 4 (Month 4) (n=23, 128) |
|
| Visit 5 (Month 5) (n=25, 122) |
|
| Visit 6 (Month 6) (n=20, 113) |
|
| Visit 7 (Month 7) (n=21, 121) |
|
| Visit 8 (Month 8) (n=24, 113) |
|
| Visit 9 (Month 9) (n=17, 125) |
|
| Visit 10 (Month 10) (n=21, 107) |
|
| Visit 11 (Month 11) (n=18, 99) |
|
| Visit 12 (Month 12) (n=22, 110) |
|
| Visit 13 (Month 13) (n=23, 100) |
|
| Visit 14 (Month 14) (n=18, 101) |
|
| Visit 15 (Month 15) (n=21, 84) |
|
| Entire study (Month 1 to Month 15) (n=34, 159) |
|
| Visit 3 (Month 3) (n=45, 110) |
|
| Visit 4 (Month 4) (n=47, 104) |
|
| Visit 5 (Month 5) (n=43, 104) |
|
| Visit 6 (Month 6) (n=42, 91) |
|
| Visit 7 (Month 7) (n=40, 102) |
|
| Visit 8 (Month 8) (n=40, 97) |
|
| Visit 9 (Month 9) (n=42, 100) |
|
| Visit 10 (Month 10) (n=34, 94) |
|
| Visit 11 (Month 11) (n=34, 83) |
|
| Visit 12 (Month 12) (n=33, 99) |
|
| Visit 13 (Month 13) (n=36, 87) |
|
| Visit 14 (Month 14) (n=31, 88) |
|
| Visit 15 (Month 15) (n=27, 78) |
|
| Entire study (Month 1 to Month 15) (n=56, 137) |
|
| Visit 3 (Month 3) (n=49, 46) |
|
| Visit 4 (Month 4) (n=49, 41) |
|
| Visit 5 (Month 5) (n=46, 40) |
|
| Visit 6 (Month 6) (n=40, 36) |
|
| Visit 7 (Month 7) (n=46, 44) |
|
| Visit 8 (Month 8) (n=39, 35) |
|
| Visit 9 (Month 9) (n=45, 40) |
|
| Visit 10 (Month 10) (n=44, 31) |
|
| Visit 11 (Month 11) (n=33, 38) |
|
| Visit 12 (Month 12) (n=36, 41) |
|
| Visit 13 (Month 13) (n=41, 36) |
|
| Visit 14 (Month 14) (n=40, 33) |
|
| Visit 15 (Month 15) (n=35, 31) |
|
| Entire study (Month 1 to Month 15) (n=60, 55) |
|
| Title | Measurements |
|---|---|
|
| Visit 4 (Month 4) (n=150, 0) |
|
| Visit 5 (Month 5) (n=147, 0) |
|
| Visit 6 (Month 6) (n=132, 0) |
|
| Visit 7 (Month 7) (n=141, 0) |
|
| Visit 8 (Month 8) (n=137, 0) |
|
| Visit 9 (Month 9) (n=141, 0) |
|
| Visit 10 (Month 10) (n=128, 0) |
|
| Visit 11 (Month 11) (n=116, 0) |
|
| Visit 12 (Month 12) (n=132, 0) |
|
| Visit 13 (Month 13) (n=122, 0) |
|
| Visit 14 (Month 14) (n=118, 0) |
|
| Visit 15 (Month 15) (n=104, 0) |
|
| Entire study (Month 1 to Month 15) (n=192, 0) |
|
| Visit 3 (Month 3) (n=40, 48) |
|
| Visit 4 (Month 4) (n=37, 52) |
|
| Visit 5 (Month 5) (n=37, 47) |
|
| Visit 6 (Month 6) (n=34, 41) |
|
| Visit 7 (Month 7) (n=36, 46) |
|
| Visit 8 (Month 8) (n=28, 48) |
|
| Visit 9 (Month 9) (n=38, 46) |
|
| Visit 10 (Month 10) (n=30, 41) |
|
| Visit 11 (Month 11) (n=30, 38) |
|
| Visit 12 (Month 12) (n=27, 45) |
|
| Visit 13 (Month 13) (n=31, 39) |
|
| Visit 14 (Month 14) (n=27, 41) |
|
| Visit 15 (Month 15) (n=24, 35) |
|
| Entire study (Month 1 to Month 15) (n=46, 60) |
|