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Primary : To evaluate the efficacy of sirolimus assessed by the incidence of biopsy-confirmed acute rejection episode at 6 months after transplantation in Korean renal transplantation recipients.
Secondary :
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sirolimus (Rapamune®) | Drug | (1mg tablets): Initial loading dose of 6mg/day, followed by maintenance dose of 2mg/day, which was adjusted to specified trough level. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Experiencing Biopsy Confirmed Acute Rejection Through Month 6 After Transplantation. | The diagnosis of acute rejection required a kidney biopsy. Biopsies were assessed using the Banff criteria, standardized diagnostic categories based on histological assessments (e.g., cell types and distributions). | 6 months after transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Glomerular Filtration Rate (GFR) (Nankivell Method) | GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. For this study, GFR was calculated using the Nankivell formula. A normal GFR is >90 mL/min, although children and older people usually have a lower GFR. Lower values indicate poorer kidney function. A GFR <15 is consistent with kidney failure. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Deagu | 700-712 | South Korea | ||||
Patients were screened up to 7 days.
Patients were recruited in Korea from March 2007 to November 2007.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Sirolimus (SRL) | Patients initially received SRL, Cyclosporine (CsA) and Corticosteroids. After 2-4 months following transplantation, CsA was progressively withdrawn. On Day 1 (within 48 hours after transplantation) SRL was initiated (6 mg loading dose). For Day 2 through CsA withdrawal (w/d), SRL dose was 2mg/day, with adjustment to maintain a target trough blood level of 5-15 ng/ml. During CsA w/d through month 6, SRL dose adjusted to a trough level of 15-30 ng/ml; and for months 7-12, a trough level of 12-24 ng/ml. CsA initiated before or within 48 hours after transplantation at a dose to attain a trough level of 200-400 ng/ml. From month 1 to time of CsA w/d, CsA dose was adjusted to maintain a trough level of 150-300 ng/ml. At 2 to 4 months after transplantation, CsA was withdrawn over 4-8 weeks. Corticosteroids were initiated within 24 hours before or after transplantation and tapered to ≥ 5 mg/day of prednisone by the end of week 13. W/d of corticosteroids was prohibited. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sirolimus (SRL) | Patients initially received SRL, Cyclosporine (CsA) and Corticosteroids. After 2-4 months following transplantation, CsA was progressively withdrawn. On Day 1 (within 48 hours after transplantation) SRL was initiated (6 mg loading dose). For Day 2 through CsA withdrawal (w/d), SRL dose was 2mg/day, with adjustment to maintain a target trough blood level of 5-15 ng/ml. During CsA w/d through month 6, SRL dose adjusted to a trough level of 15-30 ng/ml; and for months 7-12, a trough level of 12-24 ng/ml. CsA initiated before or within 48 hours after transplantation at a dose to attain a trough level of 200-400 ng/ml. From month 1 to time of CsA w/d, CsA dose was adjusted to maintain a trough level of 150-300 ng/ml. At 2 to 4 months after transplantation, CsA was withdrawn over 4-8 weeks. Corticosteroids were initiated within 24 hours before or after transplantation and tapered to ≥ 5 mg/day of prednisone by the end of week 13. W/d of corticosteroids was prohibited. |
| 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 | Number of Patients Experiencing Biopsy Confirmed Acute Rejection Through Month 6 After Transplantation. | The diagnosis of acute rejection required a kidney biopsy. Biopsies were assessed using the Banff criteria, standardized diagnostic categories based on histological assessments (e.g., cell types and distributions). | Patients who received at least one dosing of SRL after transplantation. | Posted | Nov 2009 | Number | patients | 6 months after transplantation |
|
Not provided
Not provided
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 | Sirolimus (SRL) | Patients initially received SRL, Cyclosporine (CsA) and Corticosteroids. After 2-4 months following transplantation, CsA was progressively withdrawn. On Day 1 (within 48 hours after transplantation) SRL was initiated (6 mg loading dose). For Day 2 through CsA withdrawal (w/d), SRL dose was 2mg/day, with adjustment to maintain a target trough blood level of 5-15 ng/ml. During CsA w/d through month 6, SRL dose adjusted to a trough level of 15-30 ng/ml; and for months 7-12, a trough level of 12-24 ng/ml. CsA initiated before or within 48 hours after transplantation at a dose to attain a trough level of 200-400 ng/ml. From month 1 to time of CsA w/d, CsA dose was adjusted to maintain a trough level of 150-300 ng/ml. At 2 to 4 months after transplantation, CsA was withdrawn over 4-8 weeks. Corticosteroids were initiated within 24 hours before or after transplantation and tapered to ≥ 5 mg/day of prednisone by the end of week 13. W/d of corticosteroids was prohibited. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Herpes zoster | Infections and infestations | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| U. S. Contact Center | Wyeth | clintrialresults@wyeth.com |
Not provided
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
Not provided
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| 6 and 12 months |
| Serum Creatinine | Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatine, commonly found in blood, urine, and muscle tissue. It is removed from the blood by the kidneys and excreted in urine. An increased level of creatinine in the blood indicates decreased kidney function. Normal adult blood levels of creatinine are 0.5 to 1.1 mg/dL for females and 0.6 to 1.2 mg/dL for males; however, the normal values are age-dependent as elderly patients typically have smaller muscle mass. | Baseline, 6 and 12 months |
| Patient and Graft Survival | Patient survival defined as patients living with or without a functioning graft. Graft survival defined as those patients who did not experience graft loss. Graft loss defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for >8 weeks), retransplant or death during the first 12 months after randomization. | 12 months |
| Number of Patients Experiencing Biopsy Confirmed Acute Rejection Through Month 12 After Transplantation | The diagnosis of acute rejection required a kidney biopsy. Biopsies were assessed using the Banff criteria, standardized diagnostic categories based on histological assessments (e.g., cell types and distributions). | 12 months after transplantation |
| Deagu |
| 700-721 |
| South Korea |
| Pusan | 614-735 | South Korea |
| Seoul | 110-744 | South Korea |
| Seoul | 120-752 | South Korea |
| Seoul | 135-710 | South Korea |
| Seoul | 137-701 | South Korea |
| Seoul | 138-736 | South Korea |
| Suwon | 443-721 | South Korea |
| Protocol Violation |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Glomerular Filtration Rate (GFR) (Nankivell Method) | GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. For this study, GFR was calculated using the Nankivell formula. A normal GFR is >90 mL/min, although children and older people usually have a lower GFR. Lower values indicate poorer kidney function. A GFR <15 is consistent with kidney failure. | Patients who received at least one dose of SRL after transplantation. Observed values | Posted | Nov 2009 | Mean | Standard Deviation | mL/min | 6 and 12 months |
|
|
|
| Secondary | Serum Creatinine | Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatine, commonly found in blood, urine, and muscle tissue. It is removed from the blood by the kidneys and excreted in urine. An increased level of creatinine in the blood indicates decreased kidney function. Normal adult blood levels of creatinine are 0.5 to 1.1 mg/dL for females and 0.6 to 1.2 mg/dL for males; however, the normal values are age-dependent as elderly patients typically have smaller muscle mass. | Patients who received at least one dose of SRL after transplantation. Observed values | Posted | Nov 2009 | Mean | Standard Deviation | mg/dl | Baseline, 6 and 12 months |
|
|
|
| Secondary | Patient and Graft Survival | Patient survival defined as patients living with or without a functioning graft. Graft survival defined as those patients who did not experience graft loss. Graft loss defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for >8 weeks), retransplant or death during the first 12 months after randomization. | Patients who received at least one dosing of SRL after transplantation. | Posted | Nov 2009 | Number | patients | 12 months |
|
|
|
| Secondary | Number of Patients Experiencing Biopsy Confirmed Acute Rejection Through Month 12 After Transplantation | The diagnosis of acute rejection required a kidney biopsy. Biopsies were assessed using the Banff criteria, standardized diagnostic categories based on histological assessments (e.g., cell types and distributions). | Patients who received at least one dosing of SRL after transplantation. | Posted | Nov 2009 | Number | patients | 12 months after transplantation |
|
|
|
| 39 |
| 79 |
| 79 |
| 79 |
| Pneumonia | Infections and infestations | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
|
| Varicella | Infections and infestations | Non-systematic Assessment |
|
| Parotitis | Infections and infestations | Non-systematic Assessment |
|
| Pulmonary tuberculosis | Infections and infestations | Non-systematic Assessment |
|
| Enterocolitis infectious | Infections and infestations | Non-systematic Assessment |
|
| Fungal infection | Infections and infestations | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | Non-systematic Assessment |
|
| Blood glucose increased | Investigations | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Abdominal hernia | Gastrointestinal disorders | Non-systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | Non-systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | Non-systematic Assessment |
|
| Faecaloma | Gastrointestinal disorders | Non-systematic Assessment |
|
| Lymphocele | Vascular disorders | Non-systematic Assessment |
|
| Pyrexia | General disorders | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | Non-systematic Assessment |
|
| Oedema | General disorders | Non-systematic Assessment |
|
| Asthenia | General disorders | Non-systematic Assessment |
|
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Asphyxia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | Non-systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | Non-systematic Assessment |
|
| Myocarditis | Cardiac disorders | Non-systematic Assessment |
|
| Haemolytic uraemic syndrome | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | Non-systematic Assessment |
|
| Renal mass | Renal and urinary disorders | Non-systematic Assessment |
|
| Seroma | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Osteonecrosis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Cervix carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Death | General disorders | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gingival hyperplasia | Gastrointestinal disorders | Non-systematic Assessment |
|
| Epigastric discomfort | Gastrointestinal disorders | Non-systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Oral disorder | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | Non-systematic Assessment |
|
| Oral discomfort | Gastrointestinal disorders | Non-systematic Assessment |
|
| Faecal incontinence | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | Non-systematic Assessment |
|
| Anorectal disorder | Gastrointestinal disorders | Non-systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | Non-systematic Assessment |
|
| Blood cholesterol increased | Investigations | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | Non-systematic Assessment |
|
| Urine output decreased | Investigations | Non-systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | Non-systematic Assessment |
|
| Hepatic enzyme increased | Investigations | Non-systematic Assessment |
|
| Blood triglycerides increased | Investigations | Non-systematic Assessment |
|
| Blood glucose increased | Investigations | Non-systematic Assessment |
|
| Weight increased | Investigations | Non-systematic Assessment |
|
| Blood pressure increased | Investigations | Non-systematic Assessment |
|
| Blood phosphorus decreased | Investigations | Non-systematic Assessment |
|
| Haemoglobin decreased | Investigations | Non-systematic Assessment |
|
| Blood albumin decreased | Investigations | Non-systematic Assessment |
|
| Blood potassium increased | Investigations | Non-systematic Assessment |
|
| Blood uric acid increased | Investigations | Non-systematic Assessment |
|
| Body temperature increased | Investigations | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | Non-systematic Assessment |
|
| Blood potassium decreased | Investigations | Non-systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | Non-systematic Assessment |
|
| Blood calcium decreased | Investigations | Non-systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | Non-systematic Assessment |
|
| Blood calcium increased | Investigations | Non-systematic Assessment |
|
| White blood cells urine positive | Investigations | Non-systematic Assessment |
|
| White blood cell count decreased | Investigations | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | Non-systematic Assessment |
|
| Herpes simplex | Infections and infestations | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | Non-systematic Assessment |
|
| Oral candidiasis | Infections and infestations | Non-systematic Assessment |
|
| Tinea versicolour | Infections and infestations | Non-systematic Assessment |
|
| Tinea pedis | Infections and infestations | Non-systematic Assessment |
|
| Varicella | Infections and infestations | Non-systematic Assessment |
|
| Vaginal infection | Infections and infestations | Non-systematic Assessment |
|
| Tinea cruris | Infections and infestations | Non-systematic Assessment |
|
| Folliculitis | Infections and infestations | Non-systematic Assessment |
|
| Bacteraemia | Infections and infestations | Non-systematic Assessment |
|
| BK virus infection | Infections and infestations | Non-systematic Assessment |
|
| Infection | Infections and infestations | Non-systematic Assessment |
|
| Skin infection | Infections and infestations | Non-systematic Assessment |
|
| Rash pustular | Infections and infestations | Non-systematic Assessment |
|
| Gingival infection | Infections and infestations | Non-systematic Assessment |
|
| Fungal infection | Infections and infestations | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | Non-systematic Assessment |
|
| Orchitis | Infections and infestations | Non-systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Electrolyte imbalance | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hyperamylasaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Pyrexia | General disorders | Non-systematic Assessment |
|
| Chest discomfort | General disorders | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | Non-systematic Assessment |
|
| Generalised oedema | General disorders | Non-systematic Assessment |
|
| Oedema | General disorders | Non-systematic Assessment |
|
| Pitting oedema | General disorders | Non-systematic Assessment |
|
| Face oedema | General disorders | Non-systematic Assessment |
|
| Chest pain | General disorders | Non-systematic Assessment |
|
| Catheter site pain | General disorders | Non-systematic Assessment |
|
| Mass | General disorders | Non-systematic Assessment |
|
| Influenza like illness | General disorders | Non-systematic Assessment |
|
| Swelling | General disorders | Non-systematic Assessment |
|
| Sense of oppression | General disorders | Non-systematic Assessment |
|
| Xerosis | General disorders | Non-systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Hirsutism | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Rash papular | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Periorbital oedema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Neurodermatitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Skin disorder | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Dermal cyst | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Rash macular | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Toxic skin eruption | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Swelling face | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Post procedural complication | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Postoperative wound complication | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Coccydynia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Convulsion | Nervous system disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | Non-systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | Non-systematic Assessment |
|
| Neuralgia | Nervous system disorders | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | Non-systematic Assessment |
|
| Dysarthria | Nervous system disorders | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | Non-systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | Non-systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | Non-systematic Assessment |
|
| Azotaemia | Renal and urinary disorders | Non-systematic Assessment |
|
| Albuminuria | Renal and urinary disorders | Non-systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | Non-systematic Assessment |
|
| Renal tubular necrosis | Renal and urinary disorders | Non-systematic Assessment |
|
| Amenorrhoea | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Ovarian cyst | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Genital haemorrhage | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Visual disturbance | Eye disorders | Non-systematic Assessment |
|
| Vision blurred | Eye disorders | Non-systematic Assessment |
|
| Xerophthalmia | Eye disorders | Non-systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | Non-systematic Assessment |
|
| Conjunctivitis | Eye disorders | Non-systematic Assessment |
|
| Dry eye | Eye disorders | Non-systematic Assessment |
|
| Eyelid oedema | Eye disorders | Non-systematic Assessment |
|
| Conjunctival oedema | Eye disorders | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | Non-systematic Assessment |
|
| Lymphocele | Vascular disorders | Non-systematic Assessment |
|
| Arrhythmia | Cardiac disorders | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | Non-systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | Non-systematic Assessment |
|
| Angina pectoris | Cardiac disorders | Non-systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | Non-systematic Assessment |
|
| Cushingoid | Endocrine disorders | Non-systematic Assessment |
|
| Hepatitis | Hepatobiliary disorders | Non-systematic Assessment |
|
| Hepatotoxicity | Hepatobiliary disorders | Non-systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | Non-systematic Assessment |
|
| Hypoacusis | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | Non-systematic Assessment |
|
The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication.
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Graft survival 12 months |
|