| Primary | The Change in the Markers of Growth, Apoptosis, Inflammation and Oxidation Measured in Endomyocardial Biopsies | The markers assessed were p-ERK ½ (phosphorylated extracellular signal-regulated kinase), p-JNK (phosphorylated jun N-terminal kinase) and p-p38 MAPK (phosphorylated mitogen-activated protein kinase). The data for each biopsy marker were expressed as a ratio of its densitometry / densitometry of glyceraldehyde-3-phosphate dehydrogenase (GAPDH). Change is defined as Week 52 assessment- Week 2 assessment. | The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. | Posted | | Mean | Standard Deviation | Densitometry / Densitometry of GAPDH | | 2 Weeks and 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus - Adult | Adults: 0.05 - 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant | | OG001 | Cyclosporine - Adult | Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant |
| | | Title | Denominators | Categories |
|---|
| p-ERK ½ - Week 2 | - ParticipantsOG00036
- ParticipantsOG00137
| |
| |
| Primary | The Change in the Markers of Growth, Apoptosis, Inflammation and Oxidation Measured in Endomyocardial Biopsies (Pediatric Population) | The markers assessed were p-ERK ½, p-JNK and p-p38 MAPK. The data for each biopsy marker were expressed as a ratio of its densitometry / densitometry of glyceraldehyde-3-phosphate dehydrogenase (GAPDH). Change is defined as Week 52 assessment- Week 2 assessment. | The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. | Posted | | Mean | Standard Deviation | Densitometry / Densitometry of GAPDH | | 2 Weeks and 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus - Pediatric | Pediatrics: 0.05 - 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant | | OG001 | Cyclosporine - Pediatric | Pediatrics: 6 - 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant |
| |
| Secondary | Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: MCP-1 | Change is defined as Week 52 assessment - Pre-Transplant assessment. MCP-1= monocyte chemoattractant protein-1 | The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. | Posted | | Mean | Standard Deviation | pg/mL | | Pre-Transplant and 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus - Adult | Adults: 0.05 - 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant | | OG001 | Cyclosporine - Adult | Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant |
| |
| Secondary | Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: s-ICAM | Change is defined as Week 52 assessment - Pre-Transplant assessment. s-ICAM= soluble-intracellular adhesion molecule | The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. | Posted | | Mean | Standard Deviation | ng/mL | | Pre-Transplant and 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus - Adult | Adults: 0.05 - 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant | | OG001 | Cyclosporine - Adult | Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant |
| |
| Secondary | Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: E-selectin | Change is defined as Week 52 assessment - Pre-Transplant assessment. | The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. | Posted | | Mean | Standard Deviation | ng/mL | | Pre-Transplant and 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus - Adult | Adults: 0.05 - 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant | | OG001 | Cyclosporine - Adult | Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant |
| |
| Secondary | Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Homocysteine | Change is defined as Week 52 assessment - Pre-Transplant assessment. | The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. | Posted | | Mean | Standard Deviation | μmol/L | | Pre-Transplant and 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus - Adult | Adults: 0.05 - 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant | | OG001 | Cyclosporine - Adult | Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant |
| |
| Secondary | Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: hsCRP | Change is defined as Week 52 assessment - Pre-Transplant assessment. hsCRP= high-sensitivity C Reactive Protein | The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. | Posted | | Mean | Standard Deviation | mg/L | | Pre-Transplant and 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus - Adult | Adults: 0.05 - 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant | | OG001 | Cyclosporine - Adult | Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant |
| |
| Secondary | Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: F2 Isoprostanes | Change is defined as Week 52 assessment - Pre-Transplant assessment. | The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. | Posted | | Mean | Standard Deviation | pg/mL | | Pre-Transplant and 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus - Adult | Adults: 0.05 - 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant | | OG001 | Cyclosporine - Adult | Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant |
| |
| Secondary | Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: T-bars | Change is defined as Week 52 assessment - Pre-Transplant assessment. T-bars = thiobarbituric acid reactive substances | The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. | Posted | | Mean | Standard Deviation | nmol/mL | | Pre-Transplant and 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus - Adult | Adults: 0.05 - 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant | | OG001 | Cyclosporine - Adult | Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant |
| |
| Secondary | Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Nitrotyrosine | Change is defined as Week 52 assessment - Pre-Transplant assessment. | The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. | Posted | | Mean | Standard Deviation | nM | | Pre-Transplant and 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus - Adult | Adults: 0.05 - 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant | | OG001 | Cyclosporine - Adult | Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant |
| |
| Secondary | Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: GSH/GSSG | Change is defined as Week 52 assessment - Pre-Transplant assessment. GSH/GSSG= ratio of reduced to oxidised glutathione | The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. | Posted | | Mean | Standard Deviation | Ratio | | Pre-Transplant and 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus - Adult | Adults: 0.05 - 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant | | OG001 | Cyclosporine - Adult | Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant |
| |
| Secondary | Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: BNP | Change is defined as Week 52 assessment - Pre-Transplant assessment. BNP= Brain Natriuretic Peptide | The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. | Posted | | Mean | Standard Deviation | ng/L | | Pre-Transplant and 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus - Adult | Adults: 0.05 - 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant | | OG001 | Cyclosporine - Adult | Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant |
| |
| Secondary | Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Troponin T | Change is defined as Week 52 assessment - Pre-Transplant assessment. | The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. | Posted | | Mean | Standard Deviation | ug/L | | Pre-Transplant and 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus - Adult | Adults: 0.05 - 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant | | OG001 | Cyclosporine - Adult | Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant |
| |
| Secondary | Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Osteopontin | Change is defined as Week 52 assessment - Pre-Transplant assessment. | The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. | Posted | | Mean | Standard Deviation | ng/mL | | Pre-Transplant and 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus - Adult | Adults: 0.05 - 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant | | OG001 | Cyclosporine - Adult | Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant |
| |
| Secondary | Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Fibrinogen | Change is defined as Week 52 assessment - Pre-Transplant assessment. | The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. | Posted | | Mean | Standard Deviation | g/L | | Pre-Transplant and 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus - Adult | Adults: 0.05 - 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant | | OG001 | Cyclosporine - Adult | Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant |
| |
| Secondary | Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: IL-6 | Change is defined as Week 52 assessment - Pre-Transplant assessment. IL= Interleukin | The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. | Posted | | Mean | Standard Deviation | pg/mL | | Pre-Transplant and 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus - Adult | Adults: 0.05 - 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant | | OG001 | Cyclosporine - Adult | Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant |
| |
| Secondary | Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: IL-18 | Change is defined as Week 52 assessment - Pre-Transplant assessment. | The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. | Posted | | Mean | Standard Deviation | pg/mL | | Pre-Transplant and 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus - Adult | Adults: 0.05 - 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant | | OG001 | Cyclosporine - Adult | Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant |
| |
| Secondary | Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Cystatin-C | Change is defined as Week 52 assessment - Pre-Transplant assessment. | The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. | Posted | | Mean | Standard Deviation | mg/L | | Pre-Transplant and 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus - Adult | Adults: 0.05 - 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant | | OG001 | Cyclosporine - Adult | Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant |
| |
| Secondary | Number of Acute Rejection Episodes by International Society of Heart and Lung Transplantation (ISHLT) Criteria | Acute rejection was defined as a rejection with ISHLT Grade ≥3A or by the presence of hemodynamic compromise. ISHLT Grades ≥3A include: Multifocal Moderate Rejection; Diffuse, Borderline Severe Acute Rejection; and Severe Acute Rejection. Patients may report more than one acute rejection. | The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. | Posted | | Number | | Rejection Episodes | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus - Adult | Adults: 0.05 - 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant | | OG001 | Cyclosporine - Adult | Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant |
| |
| Secondary | Time to First Acute Rejection Episode Following de Novo Cardiac Transplant | Acute Rejection was defined as a rejection with ISHLT Grade ≥3A or by the presence of hemodynamic compromise. ISHLT Grades ≥3A include: Multifocal Moderate Rejection; Diffuse, Borderline Severe Acute Rejection; and Severe Acute Rejection. Time to first acute rejection is defined as: date of onset - date of transplant. | The population analyzed represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. Only participants who experienced acute rejection were included in the analysis. | Posted | | Mean | Standard Deviation | Days | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus - Adult | Adults: 0.05 - 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant | | OG001 | Cyclosporine - Adult | Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant |
| |
| Secondary | Number of Patients Requiring Antilymphocyte Antibodies or Steroids for Treatment of Severe Acute Rejection | Severe Acute Rejection is defined as rejection with ISHLT Grade 4. | The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. | Posted | | Number | | Patients | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus - Adult | Adults: 0.05 - 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant | | OG001 | Cyclosporine - Adult | Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant |
| |
| Secondary | Number of Cardiac Rejection Episodes Requiring Treatment | The number of rejection episodes requiring treatment (medications started/ stopped, non-medication treatment, or both) regardless of biopsy grade or presence of hemodynamic compromise. | The number of participants analyzed per arm represents Treatment Exposure Population - defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. | Posted | | Number | | Rejection Episodes | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus - Adult | Adults: 0.05 - 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant | | OG001 | Cyclosporine - Adult | Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant |
| |
| Secondary | Mean Cases of Acute Rejection (MCAR) Per Patient | MCAR represents the average number of acute rejections among all patients in each treatment group. Results were based on rejection episodes with endomyocardial biopsies. Acute rejection was defined as a rejection with ISHLT Grade ≥3A or by the presence of hemodynamic compromise. ISHLT Grades ≥3A include: Multifocal Moderate Rejection; Diffuse, Borderline Severe Acute Rejection; and Severe Acute Rejection. | The number of participants analyzed per arm represents Treatment Exposure Population - defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. | Posted | | Mean | Standard Deviation | MCAR per patient | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus - Adult | Adults: 0.05 - 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant | | OG001 | Cyclosporine - Adult | Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant |
| |
| Secondary | Number of Patients With Successful Steroid Taper or Withdrawal at Weeks 26 and 52 | A successful steroid taper or withdrawal was defined as steroids (prednisone) being discontinued or tapered to the suggested dose level after week 26. | The number of participants analyzed per arm represents Treatment Exposure Population - defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. | Posted | | Number | | Patients | | 26 Weeks and 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus - Adult | Adults: 0.05 - 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant | | OG001 | Cyclosporine - Adult | Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant |
| |
| Secondary | Number of Patients With Treatment Failure and Crossover for Treatment Failure | Treatment failure was defined as death, re-transplantation, withdrawal due to an Adverse Event, or a switch of main immunosuppressant medication, whichever came first. Crossover was defined as a switch from originally administered primary immunosuppressant (tacrolimus or cyclosporine) to the alternate primary immunosuppressant. | The number of participants analyzed per arm represents Treatment Exposure Population - defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. | Posted | | Number | | Patients | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus - Adult | Adults: 0.05 - 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant | | OG001 | Cyclosporine - Adult | Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant |
| |
| Secondary | Changes in Circulating Markers of Inflammation and Oxidation: F2 Isoprostanes (Pediatric Population) | Change is defined as Week 52 assessment - Pre-Transplant assessment | The number of participants analyzed per arm represents Treatment Exposure Population - defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. | Posted | | Mean | Standard Deviation | pg/mL | | Pre-Transplant and 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus - Pediatric | Pediatrics: 0.05 - 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant | | OG001 | Cyclosporine - Pediatric | Pediatrics: 6 - 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant |
| |
| Secondary | Changes in Circulating Markers of Inflammation and Oxidation: Nitrotyrosine (Pediatric Population) | Change is defined as Week 52 assessment - Pre-Transplant assessment | The number of participants analyzed per arm represents Treatment Exposure Population - defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. | Posted | | Mean | Standard Deviation | nM | | Pre-Transplant and 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus - Pediatric | Pediatrics: 0.05 - 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant | | OG001 | Cyclosporine - Pediatric | Pediatrics: 6 - 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant |
| |
| Secondary | Changes in Circulating Markers of Inflammation and Oxidation: hsCRP (Pediatric Population) | Change is defined as Week 52 assessment - Pre-Transplant assessment | The number of participants analyzed per arm represents Treatment Exposure Population - defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. | Posted | | Mean | Standard Deviation | mg/L | | Pre-Transplant and 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus - Pediatric | Pediatrics: 0.05 - 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant | | OG001 | Cyclosporine - Pediatric | Pediatrics: 6 - 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant |
| |
| Secondary | Changes in Circulating Markers of Inflammation and Oxidation: Cystatin-C (Pediatric Population) | Change is defined as Week 52 assessment - Pre-Transplant assessment | The number of participants analyzed per arm represents Treatment Exposure Population - defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. | Posted | | Mean | Standard Deviation | mg/L | | Pre-Transplant and 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus - Pediatric | Pediatrics: 0.05 - 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant | | OG001 | Cyclosporine - Pediatric | Pediatrics: 6 - 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant |
| |
| Secondary | Number of Acute Rejection Episodes by International Society of Heart and Lung Transplantation (ISHLT) Criteria (Pediatric Population) | Acute rejection was defined as a rejection with ISHLT Grade ≥3A or by the presence of hemodynamic compromise. ISHLT Grades ≥3A include: Multifocal Moderate Rejection; Diffuse, Borderline Severe Acute Rejection; and Severe Acute Rejection. Patients may report more than one rejection episode. | The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. | Posted | | Number | | Rejection Episodes | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus - Pediatric | Pediatrics: 0.05 - 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant | | OG001 | Cyclosporine - Pediatric | Pediatrics: 6 - 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant |
| |
| Secondary | Time to First Acute Rejection Episode Following de Novo Cardiac Transplant (Pediatric Population) | Acute Rejection was defined as a rejection with ISHLT Grade ≥3A or by the presence of hemodynamic compromise. ISHLT Grades ≥3A include: Multifocal Moderate Rejection; Diffuse, Borderline Severe Acute Rejection; and Severe Acute Rejection. Time to first acute rejection is defined as: date of onset - date of transplant. | The population analyzed represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. Only participants who experienced acute rejection were included in the analysis. | Posted | | Mean | Standard Deviation | Days | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus - Pediatric | Pediatrics: 0.05 - 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant | | OG001 | Cyclosporine - Pediatric | Pediatrics: 6 - 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant |
| |
| Secondary | Number of Patients Requiring Antilymphocyte Antibodies or Steroids for Treatment of Severe Acute Rejection (Pediatric Population) | Severe Acute Rejection was defined as rejection with ISHLT Grade 4. | The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. | Posted | | Number | | Patients | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus - Pediatric | Pediatrics: 0.05 - 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant | | OG001 | Cyclosporine - Pediatric | Pediatrics: 6 - 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant |
| |
| Secondary | Number of Cardiac Rejection Episodes Requiring Treatment (Pediatric Population) | A summary of rejection episodes requiring treatment regardless of biopsy grade or presence of hemodynamic compromise. | The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. | Posted | | Number | | Rejection Episodes | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus - Pediatric | Pediatrics: 0.05 - 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant | | OG001 | Cyclosporine - Pediatric | Pediatrics: 6 - 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant |
| |
| Secondary | Mean Cases of Acute Rejection (MCAR) Per Patient (Pediatric Population) | MCAR represents the average number of acute rejections among all patients in each treatment group. Results were based on rejection episodes with endomyocardial biopsies. Acute rejection was defined as a rejection with ISHLT Grade ≥3A or by the presence of hemodynamic compromise. ISHLT Grades ≥3A include: Multifocal Moderate Rejection; Diffuse, Borderline Severe Acute Rejection; and Severe Acute Rejection. | The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. | Posted | | Mean | Standard Deviation | MCAR per patient | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus - Pediatric | Pediatrics: 0.05 - 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant | | OG001 | Cyclosporine - Pediatric | Pediatrics: 6 - 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant |
| |
| Secondary | Number of Patients With Successful Steroid Taper or Withdrawal at Weeks 26 and 52 (Pediatric Population) | A successful steroid taper or withdrawal was defined as steroids (prednisone) being discontinued or tapered to the suggested dose level after week 26. | The number of participants analyzed per arm represents Treatment Exposure Population - defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. | Posted | | Number | | Patients | | 26 Weeks and 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus - Pediatric | Pediatrics: 0.05 - 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant | | OG001 | Cyclosporine - Pediatric | Pediatrics: 6 - 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant |
| |
| Secondary | Number of Patients With Treatment Failure and Crossover for Treatment Failure (Pediatric Population) | Treatment failure was defined as death, re-transplantation, withdrawal due to an Adverse Event, or a switch of main immunosuppressant medication, whichever came first. Crossover was defined as a switch from originally administered primary immunosuppressant (tacrolimus or cyclosporine) to the alternate primary immunosuppressant. | The number of participants analyzed per arm represents Treatment Exposure Population - defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. | Posted | | Number | | Patients | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus - Pediatric | Pediatrics: 0.05 - 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant | | OG001 | Cyclosporine - Pediatric | Pediatrics: 6 - 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant |
| |