Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2009-013074-41 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A controlled, randomized, open-label, multicenter study evaluating if early initiation of everolimus and early elimination of cyclosporine in de novo heart transplant recipients can improve long-term renal function and slow down the progression of chronic allograft vasculopathy
This was a prospective, multi-center, randomized, controlled, parallel group, open label study in de novo heart transplant recipients. Patients eligibility for randomization was assessed 5 days after heart transplant.. Patients fulfilling the inclusion and exclusion criteria were randomized to one of two treatment groups: either conventional treatment with Cyclosporine A (CsA), Mycophenolate mofetil (MMF), and corticosteroids (Group A), or low-dose CsA and everolimus, reduced dose MMF, and corticosteroids (Group B). After 7 to 11 weeks, CsA was discontinued in Group B, while the standard triple-drug immunosuppressive regimen was maintained in Group A.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Everolimus | Experimental | Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS. |
|
| Control | Experimental | Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclosporine | Drug | Cyclosporine (CsA) control group target blood level: 150-350 ng/mL (month 1-3); 100-250 ng/mL (month 4-6); 60-200 ng/mL (month 7-12); everolimus group target blood level: 75-175 ng/mL (month 1-3) |
| Measure | Description | Time Frame |
|---|---|---|
| Measured Glomerular Filtration Rate (mGFR), 12 Months After Heart Transplantation | Measured Glomerular Filtration Rate (mGFR) describes the flow rate of filtered fluid through the kidney. GFR is equal to the clearance rate when any solute is freely filtered and is neither reabsorbed nor secreted by the kidneys. The rate therefore measured is the quantity of the substance in the urine that originated from a calculable volume of blood. Participants' urine was used for this assessment at week 52 after heart transplant. | Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Progression of Chronic Allograft Vasculopathy (CAV) Based on Maximal Intimal Thickness (MIT) From Baseline to Week 52 | The progression of chronic allograft vasculopathy (CAV) was assessed by intravascular ultrasound (IVUS) examinations and measured Maximal Intimal Thickness (MIT)(in mm). A major coronary epicardial artery (preferentially the left-anterior descending coronary artery) was imaged, and the MIT parameters were recorded at baseline and at week 52. |
Not provided
De novo heart transplant recipients who had received induction therapy with antithomocyte globulin (ATG) were eligible for inclusion.
Recipients of multi-organ transplants or a previous transplant were excluded, as were those with a donor aged > 70 years, cold ischemia time >6 hours, patients with severe systemic infection, recipients of ABO incompatible transplants, patients with severe hypercholesterolemia (>350mg/dL) or hypertriglyceridemia (>750 mg/dL), patients with past (<5 years). In order to continue in the study after week 7-11 (period 1), patients had to complete first 7-11 weeks on randomized immunosuppression and none of the following criteria should be present: Ongoing rejection treatment or experience of one grade 3R rejection or two or more grade 2R rejections during first 7-11 weeks.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Århus N | DK-8200 | Denmark | |||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30354362 | Derived | Arora S, Andreassen AK, Karason K, Gustafsson F, Eiskjaer H, Botker HE, Radegran G, Gude E, Ioanes D, Solbu D, Dellgren G, Ueland T, Aukrust P, Gullestad L; SCHEDULE (Scandinavian Heart Transplant Everolimus De Novo Study With Early Calcineurin Inhibitors Avoidance) Investigators. Effect of Everolimus Initiation and Calcineurin Inhibitor Elimination on Cardiac Allograft Vasculopathy in De Novo Heart Transplant Recipients. Circ Heart Fail. 2018 Sep;11(9):e004050. doi: 10.1161/CIRCHEARTFAILURE.117.004050. | |
| 30312541 |
Not provided
Not provided
Group A (control) received treatment with Cyclosporine A (CsA), Mycophenolate mofetil (MMF), and corticosteroids.
Group B (everolimus), received: low-dose CsA and everolimus, reduced dose MMF, and corticosteroids.
After week 7-11, CsA was discontinued in Group B, while the standard triple-drug immunosuppressive regimen was maintained in Group A.
115 patients (56 in the everolimus group, 59 in the control group) were randomized and received study treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Everolimus | Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS. |
| FG001 | Control |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Mycophenolate mofetil | Drug | Mycophenolate mofetil (MMF) target dose for control group: 2000-3000 mg/day everolimus group target dose: 1500-2000 mg/day and 75-175 ng/mL after week 11 |
|
| Corticosteroids | Drug | Corticosteroids (CS) initiated at 0.2-0.5 mg/kg/day. Tapered to no less than 0.1 mg/kg at Month 3 for control and everolimus groups. |
|
| Everolimus | Drug | Everolimus 0.75 mg twice a day as starting dose up to a target blood level: 3-6 ng/mL (7-11 weeks) and 6-10 ng/mL for remaining of study |
|
| Anti Thymocyte Globulin | Drug | Induction therapy, Anti Thymocyte Globulin (ATG): 1-2 mg/kg/day during 3-5 days for control and everolimus groups after transplant surgery and prior to randomization. |
|
| Baseline and week 52 |
| Progression of Chronic Allograft Vasculopathy (CAV) Based on Incidence of Chronic Allograft Vasculopathy (CAV) From Baseline to Week 52 | the progression of chronic allograft vasculopathy (CAV) assessed by intravascular ultrasound (IVUS) examinations, measured the incidence of CAV (in percent of patients) at baseline and at week 52. Incidence of CAV represents percent of patients having a MIT (maximal intima thickness) > 0.5 mm. | Baseline and week 52 |
| Change in Calculated Glomerular Filtration Rate From Pre-transplantation to Week 52 | Change in calculated glomerular filtration rate from pre-transplantation to week 52 was calculated according to the Modification of Diet in Renal Disease (MDRD) method. Measurements were taken prior to transplant (day 1), between weeks 7 to 11 and end week 52. | Day 1, weeks 7 to 11(baseline) and of week 52 |
| Calculated Glomerular Filtration Rate From Pre-Transplantation to Week 52 | Calculated Glomerular Filtration Rate from pre-transplantation to week 52 was calculated according to the Modification of Diet in Renal Disease (MDRD) method. Measurements were taken prior to transplant (day 1), between weeks 7 to 11 and end of week 52. | Day 1, weeks 7 to 11 and of week 52 |
| Number of Rejections Leading to Hemodynamic Compromise | Number of all rejections were recorded through the duration of the study with the intent to identify rejections leading to hemodynamic compromise. | 52 weeks |
| Occurrence of Treatment Failures up to 12 Months After Transplant | Treatment failure was defined as the number of participants who died or lost their graft at any timepoint througout the duration of the study. | 52 weeks |
| Average Level of Protenuria at Week 52 | Proteinuria is measured as the ratio of albumin/creatinine mg/mmol. Measurements were taken from participants urine samples. | 52 weeks |
| Lipid Profile at 12 Months | Total Cholesterol, LDL-Chol, HDL-Chol and TG at week 52. Measurements were taken via participants blood samples. | 52 weeks |
| Change in Quality of Life Assessed by SF-36 (Minnesota Living With Heart Failure Questionnaire ([MLHF)]) From Pre-transplant to Week 52 of Treatment | Change in Quality of Life was assessed via the SF-36 (Minnesota Living with Heart Failure questionnaire ([MLHF)]) before transplant surgery and at week 52 of treatment. The SF-36 is a validated, self-administered questionnaire. The questionnaire, which includes 36 questions measures 8 dimensions of health: physical function, role-physical, bodily pain, general health, vitality, social function, role-emotional, and mental health. Scores can be summarized in 2 summary components assessing physical and mental health. Items in each dimension are coded, aggregated, summed, and transformed into a scale ranging from 0 (worse health) to 100 (best health). | Pre transplant and 52 weeks |
| Change in Quality of Life - Euro Quality of Life 5D (EQ-5D) | Change in Quality of Life was assessed via the EQ-5D questionnaire which consists of: EQ-5D-5L descriptive system and EQ Visual Analogue scale (EQ VAS). The EQ-5D-5L comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems). The patient indicates his/her health state by checking the most appropriate statement. This decision results in a 1-digit number expressing the level selected for that dimension. The digits for 5 dimensions are combined in a 5-digit number describing the respondent's health state. The possible score is 1 to 5 where a lower number indicates improvement. The EQ VAS records the patient's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'. The score is 0 to 100 where a higher score represents improvement. | Pre transplant and 52 weeks |
| Copenhagen |
| DK-2100 |
| Denmark |
| Novartis Investigative Site | Oslo | 0424 | Norway |
| Novartis Investigative Site | Gothenburg | 413 45 | Sweden |
| Novartis Investigative Site | Linköping | 581 85 | Sweden |
| Novartis Investigative Site | Lund | 221 85 | Sweden |
| Derived |
| Norum HM, Michelsen AE, Lekva T, Arora S, Otterdal K, Olsen MB, Kong XY, Gude E, Andreassen AK, Solbu D, Karason K, Dellgren G, Gullestad L, Aukrust P, Ueland T. Circulating delta-like Notch ligand 1 is correlated with cardiac allograft vasculopathy and suppressed in heart transplant recipients on everolimus-based immunosuppression. Am J Transplant. 2019 Apr;19(4):1050-1060. doi: 10.1111/ajt.15141. Epub 2018 Nov 5. |
| 30211826 | Derived | Andreassen AK, Broch K, Eiskjaer H, Karason K, Gude E, Molbak D, Stueflotten W, Gullestad L; SCHEDULE (SCandinavian HEart transplant everolimus De-novo stUdy with earLy calcineurin inhibitors avoidancE) Investigators. Blood Pressure in De Novo Heart Transplant Recipients Treated With Everolimus Compared With a Cyclosporine-based Regimen: Results From the Randomized SCHEDULE Trial. Transplantation. 2019 Apr;103(4):781-788. doi: 10.1097/TP.0000000000002445. |
| 28230646 | Derived | Nelson LM, Andreassen AK, Andersson B, Gude E, Eiskjaer H, Radegran G, Dellgren G, Gullestad L, Gustafsson F. Effect of Calcineurin Inhibitor-Free, Everolimus-Based Immunosuppressive Regimen on Albuminuria and Glomerular Filtration Rate After Heart Transplantation. Transplantation. 2017 Nov;101(11):2793-2800. doi: 10.1097/TP.0000000000001706. |
| 26820618 | Derived | Andreassen AK, Andersson B, Gustafsson F, Eiskjaer H, Radegran G, Gude E, Jansson K, Solbu D, Karason K, Arora S, Dellgren G, Gullestad L; SCHEDULE investigators. Everolimus Initiation With Early Calcineurin Inhibitor Withdrawal in De Novo Heart Transplant Recipients: Three-Year Results From the Randomized SCHEDULE Study. Am J Transplant. 2016 Apr;16(4):1238-47. doi: 10.1111/ajt.13588. Epub 2016 Jan 28. |
| 25041227 | Derived | Andreassen AK, Andersson B, Gustafsson F, Eiskjaer H, Radegran G, Gude E, Jansson K, Solbu D, Sigurdardottir V, Arora S, Dellgren G, Gullestad L; SCHEDULE Investigators. Everolimus initiation and early calcineurin inhibitor withdrawal in heart transplant recipients: a randomized trial. Am J Transplant. 2014 Aug;14(8):1828-38. doi: 10.1111/ajt.12809. |
Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Everolimus | Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS. |
| BG001 | Control | Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Measured Glomerular Filtration Rate (mGFR), 12 Months After Heart Transplantation | Measured Glomerular Filtration Rate (mGFR) describes the flow rate of filtered fluid through the kidney. GFR is equal to the clearance rate when any solute is freely filtered and is neither reabsorbed nor secreted by the kidneys. The rate therefore measured is the quantity of the substance in the urine that originated from a calculable volume of blood. Participants' urine was used for this assessment at week 52 after heart transplant. | The intent to treat population includes the full analysis set patients with available data and without any major protocol deviations or criteria causing exclusion and for which data was available for analysis. Patients were analyzed according to the treatment to which they were randomized. | Posted | Mean | Standard Deviation | mGFR ml/min | Week 52 |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Progression of Chronic Allograft Vasculopathy (CAV) Based on Maximal Intimal Thickness (MIT) From Baseline to Week 52 | The progression of chronic allograft vasculopathy (CAV) was assessed by intravascular ultrasound (IVUS) examinations and measured Maximal Intimal Thickness (MIT)(in mm). A major coronary epicardial artery (preferentially the left-anterior descending coronary artery) was imaged, and the MIT parameters were recorded at baseline and at week 52. | The intent to treat population includes the full analysis set patients with available data and without any major protocol deviations or criteria causing exclusion and for which data was available for analysis. Patients were analyzed according to the treatment to which they were randomized. | Posted | Mean | Standard Deviation | mm | Baseline and week 52 |
|
| |||||||||||||||||||||||||||||
| Secondary | Progression of Chronic Allograft Vasculopathy (CAV) Based on Incidence of Chronic Allograft Vasculopathy (CAV) From Baseline to Week 52 | the progression of chronic allograft vasculopathy (CAV) assessed by intravascular ultrasound (IVUS) examinations, measured the incidence of CAV (in percent of patients) at baseline and at week 52. Incidence of CAV represents percent of patients having a MIT (maximal intima thickness) > 0.5 mm. | The intent to treat population includes the full analysis set patients with available data and without any major protocol deviations or criteria causing exclusion and for which data was available for analysis. Patients were analyzed according to the treatment to which they were randomized. | Posted | Number | Percentage of patients | Baseline and week 52 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Change in Calculated Glomerular Filtration Rate From Pre-transplantation to Week 52 | Change in calculated glomerular filtration rate from pre-transplantation to week 52 was calculated according to the Modification of Diet in Renal Disease (MDRD) method. Measurements were taken prior to transplant (day 1), between weeks 7 to 11 and end week 52. | The intent to treat population includes the full analysis set patients with available data and without any major protocol deviations or criteria causing exclusion and for which data was available for analysis. Patients were analyzed according to the treatment to which they were randomized. | Posted | Mean | Standard Deviation | mGFR mL/min | Day 1, weeks 7 to 11(baseline) and of week 52 |
|
| |||||||||||||||||||||||||||||
| Secondary | Calculated Glomerular Filtration Rate From Pre-Transplantation to Week 52 | Calculated Glomerular Filtration Rate from pre-transplantation to week 52 was calculated according to the Modification of Diet in Renal Disease (MDRD) method. Measurements were taken prior to transplant (day 1), between weeks 7 to 11 and end of week 52. | The intent to treat population includes the full analysis set patients with available data and without any major protocol deviations or criteria causing exclusion and for which data was available for analysis. Patients were analyzed according to the treatment to which they were randomized. | Posted | Mean | Standard Deviation | mGFR mL/min | Day 1, weeks 7 to 11 and of week 52 |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Rejections Leading to Hemodynamic Compromise | Number of all rejections were recorded through the duration of the study with the intent to identify rejections leading to hemodynamic compromise. | The intent to treat population includes the full analysis set patients with available data and without any major protocol deviations or criteria causing exclusion and for which data was available for analysis. Patients were analyzed according to the treatment to which they were randomized. | Posted | Number | rejections | 52 weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | Occurrence of Treatment Failures up to 12 Months After Transplant | Treatment failure was defined as the number of participants who died or lost their graft at any timepoint througout the duration of the study. | The intent to treat population includes the full analysis set patients with available data and without any major protocol deviations or criteria causing exclusion and for which data was available for analysis. Patients were analyzed according to the treatment to which they were randomized. | Posted | Number | participants | 52 weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | Average Level of Protenuria at Week 52 | Proteinuria is measured as the ratio of albumin/creatinine mg/mmol. Measurements were taken from participants urine samples. | The safety sert include all randomized participants who received at least one dose of study medication and were able to provide urine samples at week 52. | Posted | Mean | Standard Deviation | mg/mmol | 52 weeks |
|
| |||||||||||||||||||||||||||||
| Secondary | Lipid Profile at 12 Months | Total Cholesterol, LDL-Chol, HDL-Chol and TG at week 52. Measurements were taken via participants blood samples. | The safety sert include all randomized participants who received at least one dose of study medication and had blood samples taken at week 52. | Posted | Mean | Standard Deviation | mmol/L | 52 weeks |
|
| |||||||||||||||||||||||||||||
| Secondary | Change in Quality of Life Assessed by SF-36 (Minnesota Living With Heart Failure Questionnaire ([MLHF)]) From Pre-transplant to Week 52 of Treatment | Change in Quality of Life was assessed via the SF-36 (Minnesota Living with Heart Failure questionnaire ([MLHF)]) before transplant surgery and at week 52 of treatment. The SF-36 is a validated, self-administered questionnaire. The questionnaire, which includes 36 questions measures 8 dimensions of health: physical function, role-physical, bodily pain, general health, vitality, social function, role-emotional, and mental health. Scores can be summarized in 2 summary components assessing physical and mental health. Items in each dimension are coded, aggregated, summed, and transformed into a scale ranging from 0 (worse health) to 100 (best health). | The intent to treat population includes the full analysis set patients with available data and without any major protocol deviations or criteria causing exclusion and for which data was available for analysis. Patients were analyzed according to the treatment to which they were randomized. | Posted | Mean | Standard Deviation | Units on a scale | Pre transplant and 52 weeks |
| ||||||||||||||||||||||||||||||
| Secondary | Change in Quality of Life - Euro Quality of Life 5D (EQ-5D) | Change in Quality of Life was assessed via the EQ-5D questionnaire which consists of: EQ-5D-5L descriptive system and EQ Visual Analogue scale (EQ VAS). The EQ-5D-5L comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems). The patient indicates his/her health state by checking the most appropriate statement. This decision results in a 1-digit number expressing the level selected for that dimension. The digits for 5 dimensions are combined in a 5-digit number describing the respondent's health state. The possible score is 1 to 5 where a lower number indicates improvement. The EQ VAS records the patient's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'. The score is 0 to 100 where a higher score represents improvement. | The intent to treat population includes the full analysis set patients with available data and without any major protocol deviations or criteria causing exclusion and for which data was available for analysis. Patients were analyzed according to the treatment to which they were randomized. | Posted | Mean | Standard Deviation | Units on a scale | Pre transplant and 52 weeks |
|
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 | Controls | Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study | 27 | 59 | 53 | 59 | ||
| EG001 | Everolimus | Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS. | 27 | 56 | 47 | 56 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | 15.1 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | 15.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | 15.1 | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | 15.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | 15.1 | Systematic Assessment |
| |
| Cardiac disorder | Cardiac disorders | 15.1 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | 15.1 | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | 15.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 15.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 15.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | 15.1 | Systematic Assessment |
| |
| Gastrointestinal pain | Gastrointestinal disorders | 15.1 | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | 15.1 | Systematic Assessment |
| |
| Megacolon | Gastrointestinal disorders | 15.1 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | 15.1 | Systematic Assessment |
| |
| Device malfunction | General disorders | 15.1 | Systematic Assessment |
| |
| Impaired healing | General disorders | 15.1 | Systematic Assessment |
| |
| Multi-organ failure | General disorders | 15.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | 15.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | 15.1 | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | 15.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | 15.1 | Systematic Assessment |
| |
| Gastroenteritis norovirus | Infections and infestations | 15.1 | Systematic Assessment |
| |
| Haemophilus infection | Infections and infestations | 15.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | 15.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | 15.1 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | 15.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 15.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | 15.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 15.1 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | 15.1 | Systematic Assessment |
| |
| Graft complication | Injury, poisoning and procedural complications | 15.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | 15.1 | Systematic Assessment |
| |
| Multiple fractures | Injury, poisoning and procedural complications | 15.1 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | 15.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | 15.1 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | 15.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | 15.1 | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | 15.1 | Systematic Assessment |
| |
| Skin cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 15.1 | Systematic Assessment |
| |
| Brain stem syndrome | Nervous system disorders | 15.1 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | 15.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | 15.1 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | 15.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 15.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | 15.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | 15.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | 15.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | 15.1 | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | 15.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | 15.1 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | 15.1 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | 15.1 | Systematic Assessment |
| |
| Chylothorax | Respiratory, thoracic and mediastinal disorders | 15.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 15.1 | Systematic Assessment |
| |
| Pleural haemorrhage | Respiratory, thoracic and mediastinal disorders | 15.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | 15.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | 15.1 | Systematic Assessment |
| |
| Pericardial drainage | Surgical and medical procedures | 15.1 | Systematic Assessment |
| |
| Suture removal | Surgical and medical procedures | 15.1 | Systematic Assessment |
| |
| Air embolism | Vascular disorders | 15.1 | Systematic Assessment |
| |
| Femoral artery occlusion | Vascular disorders | 15.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 15.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | 15.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | 15.1 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | 15.1 | Systematic Assessment |
| |
| Cardiac disorder | Cardiac disorders | 15.1 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | 15.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 15.1 | Systematic Assessment |
| |
| Oedema | General disorders | 15.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | 15.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | 15.1 | Systematic Assessment |
| |
| Candidiasis | Infections and infestations | 15.1 | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | 15.1 | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | 15.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | 15.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | 15.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 15.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 15.1 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | 15.1 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | 15.1 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | 15.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | 15.1 | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | 15.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 15.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 15.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | 15.1 | Systematic Assessment |
| |
| Nephropathy toxic | Renal and urinary disorders | 15.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | 15.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 15.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | 15.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | 15.1 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | 15.1 | Systematic Assessment |
| |
| Hirsutism | Skin and subcutaneous tissue disorders | 15.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 15.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | 15.1 | 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 pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study director | Novartis Pharmaceuticals | 862-778-8300 |
| ID | Term |
|---|---|
| D016572 | Cyclosporine |
| D009173 | Mycophenolic Acid |
| D000305 | Adrenal Cortex Hormones |
| D000068338 | Everolimus |
| D000961 | Antilymphocyte Serum |
| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D007106 | Immune Sera |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
| Male |
|
| Participants |
|
|
| Participants |
|
|
|
|
|
|
|
|
|
|
|
| OG001 |
| Control |
Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study. |
|
|