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The purpose of this study is to evaluate if the delayed administration of everolimus could reduce the everolimus associated "anti-proliferative complications" (e.g. wound healing disorder) while maintaining efficacy, when compared to the immediate administration of everolimus in de novo renal transplant patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Everolimus | Active Comparator | Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL. |
|
| Delayed Everolimus | Experimental | Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Everolimus (RAD001) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Considered in Failure for the Primary Failure Endpoint at 3 Months | "In Failure", is at least one of these events occurred within the first 3 months: delayed graft function(DGF), (need for dialysis within the first 7 days,minus day one,post-transplantation); Biopsy proven acute rejection (BPAR), Graft loss, (allograft was presumed lost on the day the patient started and not removable from dialysis). Death; Loss to follow-up; Wound healing disorder(Any wound related to the kidney transplantation being opened beyond 3 weeks, or infected, or drained fluid or herniated was considered not healed). | Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Considered in Failure for the Primary Failure Endpoint at 6 Months Post-transplantation. | The primary efficacy variable was the "primary failure endpoint" at 6 months defined as the occurrence of one or more of the following events within the first 6 months:
|
Not provided
Inclusion Criteria:
Recipients of cadaveric kidney transplants
Patients at risk of DGF defined as one or more of the following:
Exclusion Criteria:
Other protocol-defined exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis | Basel | Switzerland |
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| ID | Title | Description |
|---|---|---|
| FG000 | Immediate Everolimus | Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL. |
| FG001 | Delayed Everolimus | Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Immediate Everolimus | Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL. |
| BG001 | Delayed Everolimus |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | baseline measure based on randomized population. |
| 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 Considered in Failure for the Primary Failure Endpoint at 3 Months | "In Failure", is at least one of these events occurred within the first 3 months: delayed graft function(DGF), (need for dialysis within the first 7 days,minus day one,post-transplantation); Biopsy proven acute rejection (BPAR), Graft loss, (allograft was presumed lost on the day the patient started and not removable from dialysis). Death; Loss to follow-up; Wound healing disorder(Any wound related to the kidney transplantation being opened beyond 3 weeks, or infected, or drained fluid or herniated was considered not healed). | Intention to treat (ITT) population. | Posted | Number | Participants | Month 3 |
|
Month 12
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Immediate Everolimus | Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
Not provided
| ID | Term |
|---|---|
| D000068338 | Everolimus |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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Not provided
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| at 6 Month post-transplantation |
| Number of Participants Considered in Failure for the Primary Failure Endpoint at 12 Months Post-transplantation. | The primary efficacy variable was the "primary failure endpoint" at 12 months defined as the occurrence of one or more of the following events within the first 12 months:
| at 12 Month post-transplantation |
| Number of Participants Who Underwent Any Dialysis Within the 12-month Treatment Period | The number of patients who underwent any dialysis within the 12-month treatment period. | Month 12 |
| Duration of Dialysis | The mean duration in days of any dialysis session that occurred within the 12 month treatment period. | 12 months |
| Number of Participants With Any Wound Healing Disorder During the 12-month Treatment Period | A wound was considered healed if all the suture material and staples were removed and the wound was intact by 3 weeks. Any wound opened beyond this point, infected, drained fluid or herniated was considered not healed. | Month 12 |
| Lost to Follow-up |
|
Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Baseline measure based on randomized population. | Count of Participants | Participants |
|
| OG001 | Delayed Everolimus | Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated. |
|
|
| Secondary | Number of Participants Considered in Failure for the Primary Failure Endpoint at 6 Months Post-transplantation. | The primary efficacy variable was the "primary failure endpoint" at 6 months defined as the occurrence of one or more of the following events within the first 6 months:
| Intention to treat (ITT) population. | Posted | Number | Participants | at 6 Month post-transplantation |
|
|
|
| Secondary | Number of Participants Considered in Failure for the Primary Failure Endpoint at 12 Months Post-transplantation. | The primary efficacy variable was the "primary failure endpoint" at 12 months defined as the occurrence of one or more of the following events within the first 12 months:
| Intention to treat (ITT) population. | Posted | Number | Participants | at 12 Month post-transplantation |
|
|
|
| Secondary | Number of Participants Who Underwent Any Dialysis Within the 12-month Treatment Period | The number of patients who underwent any dialysis within the 12-month treatment period. | Intention to treat (ITT) population. | Posted | Number | Participants | Month 12 |
|
|
|
| Secondary | Duration of Dialysis | The mean duration in days of any dialysis session that occurred within the 12 month treatment period. | The number of patients analyzed includes those with any dialysis in the 12 month period | Posted | Mean | Standard Deviation | Days | 12 months |
|
|
|
| Secondary | Number of Participants With Any Wound Healing Disorder During the 12-month Treatment Period | A wound was considered healed if all the suture material and staples were removed and the wound was intact by 3 weeks. Any wound opened beyond this point, infected, drained fluid or herniated was considered not healed. | Intention to treat (ITT) population. | Posted | Number | Participants | Month 12 |
|
|
|
| 45 |
| 65 |
| 64 |
| 65 |
| EG001 | Delayed Everolimus | Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated. | 57 | 74 | 70 | 74 |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Acute coronary syndrome | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Tachyarrhythmia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Amaurosis | Eye disorders | MedDRA | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA | Systematic Assessment |
|
| Retinal artery thrombosis | Eye disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Hernial eventration | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Oesophageal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Oesophageal ulcer | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Tongue oedema | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA | Systematic Assessment |
|
| Chills | General disorders | MedDRA | Systematic Assessment |
|
| Hyperthermia | General disorders | MedDRA | Systematic Assessment |
|
| Implant site haematoma | General disorders | MedDRA | Systematic Assessment |
|
| Oedema | General disorders | MedDRA | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
|
| Sudden death | General disorders | MedDRA | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| Cholestasis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| Cytolytic hepatitis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| Transplant rejection | Immune system disorders | MedDRA | Systematic Assessment |
|
| Abscess | Infections and infestations | MedDRA | Systematic Assessment |
|
| Arthritis bacterial | Infections and infestations | MedDRA | Systematic Assessment |
|
| Aspergillosis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Catheter sepsis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Cerebral aspergillosis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Cytomegalovirus infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Encephalitic infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Endocarditis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Genital infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA | Systematic Assessment |
|
| Infected lymphocele | Infections and infestations | MedDRA | Systematic Assessment |
|
| Kidney infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Lymph node tuberculosis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Oesophageal candidiasis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Osteomyelitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Peritoneal infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pneumonia legionella | Infections and infestations | MedDRA | Systematic Assessment |
|
| Prostate infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pseudomembranous colitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | MedDRA | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Arteriovenous fistula thrombosis | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Complications of transplanted kidney | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Drug toxicity | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Graft loss | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Graft thrombosis | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Multiple drug overdose | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Post procedural haematuria | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Blood creatine increased | Investigations | MedDRA | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA | Systematic Assessment |
|
| Red blood cell count decreased | Investigations | MedDRA | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Fluid overload | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Fluid retention | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hypercreatininaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Chondrocalcinosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Kaposi's sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Prostatic adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Cerebral ischaemia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Encephalopathy | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Anuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Bladder disorder | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Extravasation of urine | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Nephropathy toxic | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Nephrotic syndrome | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Obstructive uropathy | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Pyelocaliectasis | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Renal aneurysm | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Renal artery stenosis | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Renal tubular disorder | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Renal tubular necrosis | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Ureteric stenosis | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Aortic stenosis | Vascular disorders | MedDRA | Systematic Assessment |
|
| Arterial haemorrhage | Vascular disorders | MedDRA | Systematic Assessment |
|
| Arterial thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Lymphocele | Vascular disorders | MedDRA | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA | Systematic Assessment |
|
| Superior vena caval stenosis | Vascular disorders | MedDRA | Systematic Assessment |
|
| Thrombophlebitis | Vascular disorders | MedDRA | Systematic Assessment |
|
| Vena cava thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
|
| Venous thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Cytomegalovirus infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Complications of transplanted kidney | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Acidosis | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Bladder spasm | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Lymphocele | Vascular disorders | MedDRA | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| Efficacy failure (Total) |
|
| --BPAR |
|
| --Graft Loss |
|
| --Death |
|
| --Lost to follow-up (composite efficacy endpoint) |
|
| Wound healing disorder |
|
| Loss to follow-up for the primary failure endpoint |
|
| Efficacy failure (Total) |
|
| --BPAR |
|
| --Graft Loss |
|
| --Death |
|
| --Lost to follow-up (composite efficacy endpoint) |
|
| Wound healing disorder |
|
| Loss to follow-up for the primary failure endpoint |
|
| Wound healing disorder unrelated to transplant |
|