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| ID | Type | Description | Link |
|---|---|---|---|
| B1741025 |
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The purpose of this observational study is to examine the clinical outcomes of the use of sirolimus as base therapy in kidney allograft recipients from Expanded Criteria Donors (ECD) under conditions of routine clinical practice. The primary objective is to identify the current criteria/reasons to use sirolimus as base therapy in this selected population and define and understand the emerging patterns of immunosuppressive treatment with sirolimus.
pilot study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sirolimus | Drug | Non interventional. Sirolimus administered by Principal Investigator per standard practice and labeling. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Main Reason for the Use of Sirolimus (Rapamune) Therapy | The study employ a questionnaire which included different clinical criteria to determine the main medical reason for the introduction of sirolimus (Rapamune) therapy after renal transplant. The physician responsible selected the one that was considered the main reason for introduction of sirolimus (Rapamune) as base immunosuppressive therapy. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Probability of Graft Survival | Graft survival was considered in participants who did not experience graft failure. Graft failure was determined by return to dialysis for a period of at least 12 weeks with no return of function, or graft loss whichever occurred sooner. | Month 12 |
| Probability of no Acute Rejection |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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Kidney allograft recipients
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Caba | Buenos Aires | 1425 | Argentina | ||
| Pfizer Investigational Site |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sirolimus | Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sirolimus | Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Main Reason for the Use of Sirolimus (Rapamune) Therapy | The study employ a questionnaire which included different clinical criteria to determine the main medical reason for the introduction of sirolimus (Rapamune) therapy after renal transplant. The physician responsible selected the one that was considered the main reason for introduction of sirolimus (Rapamune) as base immunosuppressive therapy. | Intention-to-Treat (ITT) population included all participants who were treated with Rapamune for at least 4 or 5 weeks. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline |
|
Not provided
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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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 | Sirolimus | Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Escherichia urinary tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Escherichia urinary tract infection | Infections and infestations | MedDRA v15.00 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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Diagnosis of acute rejection was made via kidney biopsy. Categorization of biopsies with suspected acute rejection was based on histological findings using updated 1997 Banff criteria: Grade 1A: significant interstitial infiltration (greater than [>] 25 percent [%] of parenchyma affected) and foci of moderate tubulitis (5-10 cells/tubular cross section), Grade 1B: significant interstitial infiltration (>25% of parenchyma affected) and severe tubulitis (>10 mononuclear cells/tubular cross section), Grade 2A: mild-moderate intimal arteritis, Grade 2B: severe intimal arteritis comprising >25% of the luminal area and Grade 3: transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells. Probability of no acute rejection throughout the sirolimus (Rapamune) therapy was estimated using Kaplan-Meier method. |
| Month 12 |
| Probability of Participant Survival | Participant's survival defined as participant living with or without a functioning graft. Probability of participant survival throughout the sirolimus (Rapamune) therapy was estimated using Kaplan-Meier method. | Month 12 |
| Average Dose of Immunosuppressive Drugs Administered | Immunosuppressive drugs administered included cyclosporin A (CsA) administration based on monitoring of plasma trough levels (C0), CsA administration based on monitoring of plasma levels 2-hours after CsA dose (C2), tacrolimus, and sirolimus (Rapamune). | Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53 |
| Average Blood Level of Immunosuppressive Drugs Administered | Immunosuppressive drugs administered included cyclosporin A (CsA) administration based on monitoring of plasma trough levels (C0), CsA administration based on monitoring of plasma levels 2-hours after CsA dose (C2), tacrolimus, and sirolimus (Rapamune). | Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53 |
| Average Creatinine Clearance | Creatinine clearance (CCr) is a measure of glomerular filtration rate (GMFR), an index of kidney function. CCr is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 milliliter per minute (mL/min) and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function. | Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53 |
| Average Proteinuria | Proteinuria defined as the presence of an excess of serum proteins in the urine. Normal value of proteinuria is below 0.15 grams per 24 hours (g/24 hr). | Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53 |
| Percentage of Participants Who Prematurely Discontinued the Sirolimus (Rapamune) Therapy | Baseline up to Month 12 |
| Percentage of Participants Who Prematurely Discontinued the Sirolimus (Rapamune) Therapy Due to Inefficacy | Baseline up to Month 12 |
| Percentage of Participants Who Prematurely Discontinued the Sirolimus (Rapamune) Therapy Due to Adverse Events | An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Participants who discontinued sirolimus (Rapamune) therapy prematurely due to AE were obliged to discontinue sirolimus (Rapamune) therapy permanently, are reported. | Baseline up to Month 12 |
| Body Mass Index | BMI was calculated as weight divided by height squared and measured as kilogram per square meter (kg/m^2). | Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53 |
| Number of Participants With Body Temperature | Body temperature was measured in degree Celsius. Each participants were classified into three different categories based on their body temperature: body temperature less than 35 degree Celsius = hypothermia, body temperature between 35 to 37.5 degree Celsius = feverless, and body temperature greater than 37.5 degree Celsius = fever. | Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53 |
| Blood Pressure | Systolic and diastolic blood pressure (BP) was measured after the participant had rested in the supine position for at least 5 minutes with the participant's arm supported at the level of the heart, and recorded to the nearest millimeters of mercury (mmHg). | Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53 |
| Pulse Rate | Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53 |
| Body Weight | Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53 |
| Percentage of Participants With Physical Abnormalities | Physical abnormalities included all the abnormalities related to general disorders and administration site conditions, gastrointestinal disorders, skin and subcutaneous tissue disorders, vascular disorders, investigations, infections and infestations, eye disorders, respiratory, thoracic and mediastinal disorders, nervous system disorders, musculoskeletal and connective tissue disorders, injury, poisoning and procedural complications, surgical and medical procedures, psychiatric disorders, neoplasms benign, malignant and unspecified (incl cysts and polyps), ear and labyrinth disorders, and congenital, familial and genetic disorders. | Baseline up to Month 12 |
| Percentage of Participants With Adverse Events | An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. | Baseline up to Month 12 |
| Percentage of Participants With Serious Adverse Events | An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Baseline up to Month 12 |
| Percentage of Participants With Clinically-Significant Electrocardiogram Abnormalities | Standard 12-lead ECG was performed. ECG intervals included PR interval (time between the onset of atrial depolarization and the onset of ventricular depolarization), QRS interval (represented ventricular depolarization), QT interval (time corresponding to the beginning of depolarization to repolarization of the ventricles) corrected using Fridericia's formula (QTcF = QT divided by cube root of RR interval) and heart rate (time interval between consecutive heart beats [RR interval]). | Baseline up to Month 12 |
| Percentage of Participants With Clinically-Significant Radiological Abnormalities | Radiological examination was performed to evaluate presence or signs of infections or pneumonitis. | Baseline up to Month 12 |
| Caba |
| Buenos Aires |
| C1093AAS |
| Argentina |
| Pfizer Investigational Site | Caba | Buenos Aires | C1181ACH | Argentina |
| Pfizer Investigational Site | Caba | Buenos Aires | Argentina |
| Pfizer Investigational Site | Barrio General Paz | Córdoba Province | 5016 | Argentina |
| Pfizer Investigational Site | Santa Fe | Santa Fe Province | 3000 | Argentina |
| Pfizer Investigational Site | San Miguel de Tucumán | Tucumán Province | 4000 | Argentina |
| Pfizer Investigational Site | Córdoba | 5016 | Argentina |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Probability of Graft Survival | Graft survival was considered in participants who did not experience graft failure. Graft failure was determined by return to dialysis for a period of at least 12 weeks with no return of function, or graft loss whichever occurred sooner. | ITT population included all participants who were treated with Rapamune for at least 4 or 5 weeks. | Posted | Number | 95% Confidence Interval | probability of graft survival | Month 12 |
|
|
|
| Secondary | Probability of no Acute Rejection | Diagnosis of acute rejection was made via kidney biopsy. Categorization of biopsies with suspected acute rejection was based on histological findings using updated 1997 Banff criteria: Grade 1A: significant interstitial infiltration (greater than [>] 25 percent [%] of parenchyma affected) and foci of moderate tubulitis (5-10 cells/tubular cross section), Grade 1B: significant interstitial infiltration (>25% of parenchyma affected) and severe tubulitis (>10 mononuclear cells/tubular cross section), Grade 2A: mild-moderate intimal arteritis, Grade 2B: severe intimal arteritis comprising >25% of the luminal area and Grade 3: transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells. Probability of no acute rejection throughout the sirolimus (Rapamune) therapy was estimated using Kaplan-Meier method. | ITT population included all participants who were treated with Rapamune for at least 4 or 5 weeks. | Posted | Number | 95% Confidence Interval | probability of no acute rejection | Month 12 |
|
|
|
| Secondary | Probability of Participant Survival | Participant's survival defined as participant living with or without a functioning graft. Probability of participant survival throughout the sirolimus (Rapamune) therapy was estimated using Kaplan-Meier method. | ITT population included all participants who were treated with Rapamune for at least 4 or 5 weeks. | Posted | Number | 95% Confidence Interval | probability of participant survival | Month 12 |
|
|
|
| Secondary | Average Dose of Immunosuppressive Drugs Administered | Immunosuppressive drugs administered included cyclosporin A (CsA) administration based on monitoring of plasma trough levels (C0), CsA administration based on monitoring of plasma levels 2-hours after CsA dose (C2), tacrolimus, and sirolimus (Rapamune). | ITT population. N(number of participants analyzed)=participants evaluable for this measure. n=participants evaluable at given time point for specified immunosuppressive. Results not reported for CsA C0 at Week 1/2, 12/13, 24/25; CsA C2 at Week 1/2, 4/5, 12/13, 24/25, 52/53; sirolimus at baseline as no participants evaluable at those time points. | Posted | Mean | Standard Deviation | milligram per day | Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53 |
|
|
|
| Secondary | Average Blood Level of Immunosuppressive Drugs Administered | Immunosuppressive drugs administered included cyclosporin A (CsA) administration based on monitoring of plasma trough levels (C0), CsA administration based on monitoring of plasma levels 2-hours after CsA dose (C2), tacrolimus, and sirolimus (Rapamune). | ITT population. N(number of participants analyzed)=participants evaluable for this measure. n=participants evaluable at given time point for specified immunosuppressive. Results not reported for CsA C0 at Week 1/2, 12/13, 24/25; CsA C2 at Week 1/2, 4/5, 12/13, 24/25, 52/53; sirolimus at baseline as no participants evaluable at those time points. | Posted | Mean | Standard Deviation | nanogram per milliliter (ng/mL) | Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53 |
|
|
|
| Secondary | Average Creatinine Clearance | Creatinine clearance (CCr) is a measure of glomerular filtration rate (GMFR), an index of kidney function. CCr is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 milliliter per minute (mL/min) and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function. | ITT population included all participants who were treated with Rapamune for at least 4 or 5 weeks. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points. | Posted | Mean | Standard Deviation | milliliter per minute (mL/min) | Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53 |
|
|
|
| Secondary | Average Proteinuria | Proteinuria defined as the presence of an excess of serum proteins in the urine. Normal value of proteinuria is below 0.15 grams per 24 hours (g/24 hr). | ITT population included all participants who were treated with Rapamune for at least 4 or 5 weeks. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points. | Posted | Mean | Standard Deviation | g/24 hr | Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53 |
|
|
|
| Secondary | Percentage of Participants Who Prematurely Discontinued the Sirolimus (Rapamune) Therapy | ITT population included all participants who were treated with Rapamune for at least 4 or 5 weeks. | Posted | Number | percentage of participants | Baseline up to Month 12 |
|
|
|
| Secondary | Percentage of Participants Who Prematurely Discontinued the Sirolimus (Rapamune) Therapy Due to Inefficacy | ITT population included all participants who were treated with Rapamune for at least 4 or 5 weeks. | Posted | Number | percentage of participants | Baseline up to Month 12 |
|
|
|
| Secondary | Percentage of Participants Who Prematurely Discontinued the Sirolimus (Rapamune) Therapy Due to Adverse Events | An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Participants who discontinued sirolimus (Rapamune) therapy prematurely due to AE were obliged to discontinue sirolimus (Rapamune) therapy permanently, are reported. | ITT population included all participants who were treated with Rapamune for at least 4 or 5 weeks. | Posted | Number | percentage of participants | Baseline up to Month 12 |
|
|
|
| Secondary | Body Mass Index | BMI was calculated as weight divided by height squared and measured as kilogram per square meter (kg/m^2). | Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points. | Posted | Mean | Standard Deviation | kg/m^2 | Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53 |
|
|
|
| Secondary | Number of Participants With Body Temperature | Body temperature was measured in degree Celsius. Each participants were classified into three different categories based on their body temperature: body temperature less than 35 degree Celsius = hypothermia, body temperature between 35 to 37.5 degree Celsius = feverless, and body temperature greater than 37.5 degree Celsius = fever. | Safety population. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points. Results for hypothermia not reported as none of the participants was found hypothermic. | Posted | Number | participants | Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53 |
|
|
|
| Secondary | Blood Pressure | Systolic and diastolic blood pressure (BP) was measured after the participant had rested in the supine position for at least 5 minutes with the participant's arm supported at the level of the heart, and recorded to the nearest millimeters of mercury (mmHg). | Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points. | Posted | Mean | Standard Deviation | mmHg | Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53 |
|
|
|
| Secondary | Pulse Rate | Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points. | Posted | Mean | Standard Deviation | beats per minute | Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53 |
|
|
|
| Secondary | Body Weight | Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points. | Posted | Mean | Standard Deviation | kilogram | Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53 |
|
|
|
| Secondary | Percentage of Participants With Physical Abnormalities | Physical abnormalities included all the abnormalities related to general disorders and administration site conditions, gastrointestinal disorders, skin and subcutaneous tissue disorders, vascular disorders, investigations, infections and infestations, eye disorders, respiratory, thoracic and mediastinal disorders, nervous system disorders, musculoskeletal and connective tissue disorders, injury, poisoning and procedural complications, surgical and medical procedures, psychiatric disorders, neoplasms benign, malignant and unspecified (incl cysts and polyps), ear and labyrinth disorders, and congenital, familial and genetic disorders. | Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated. | Posted | Number | percentage of participants | Baseline up to Month 12 |
|
|
|
| Secondary | Percentage of Participants With Adverse Events | An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. | Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated. | Posted | Number | percentage of participants | Baseline up to Month 12 |
|
|
|
| Secondary | Percentage of Participants With Serious Adverse Events | An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated. | Posted | Number | percentage of participants | Baseline up to Month 12 |
|
|
|
| Secondary | Percentage of Participants With Clinically-Significant Electrocardiogram Abnormalities | Standard 12-lead ECG was performed. ECG intervals included PR interval (time between the onset of atrial depolarization and the onset of ventricular depolarization), QRS interval (represented ventricular depolarization), QT interval (time corresponding to the beginning of depolarization to repolarization of the ventricles) corrected using Fridericia's formula (QTcF = QT divided by cube root of RR interval) and heart rate (time interval between consecutive heart beats [RR interval]). | Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated. | Posted | Number | percentage of participants | Baseline up to Month 12 |
|
|
|
| Secondary | Percentage of Participants With Clinically-Significant Radiological Abnormalities | Radiological examination was performed to evaluate presence or signs of infections or pneumonitis. | Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated. | Posted | Number | percentage of participants | Baseline up to Month 12 |
|
|
|
| 21 |
| 52 |
| 42 |
| 52 |
| Urinary tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Clostridium difficile colitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Klebsiella infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Pneumonia escherichia | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Zygomycosis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
|
| Generalised oedema | General disorders | MedDRA | Non-systematic Assessment |
|
| Oedema | General disorders | MedDRA | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA | Non-systematic Assessment |
|
| Spinal pain | General disorders | MedDRA | Non-systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Neurological decompensation | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Renal lymphocele | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Transplant rejection | Immune system disorders | MedDRA | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA | Non-systematic Assessment |
|
| Leg amputation | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Blood creatine increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
|
| Candidiasis | Infections and infestations | MedDRA v15.00 | Non-systematic Assessment |
|
| Onychomycosis | Infections and infestations | MedDRA v15.00 | Non-systematic Assessment |
|
| Tinea versicolour | Infections and infestations | MedDRA v15.00 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA v15.00 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA v15.00 | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA v15.00 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA v15.00 | Non-systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA v15.00 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA v15.00 | Non-systematic Assessment |
|
| Acute sinusitis | Infections and infestations | MedDRA v15.00 | Non-systematic Assessment |
|
| Furuncle | Infections and infestations | MedDRA v15.00 | Non-systematic Assessment |
|
| Gastroenteritis rotavirus | Infections and infestations | MedDRA v15.00 | Non-systematic Assessment |
|
| Genital herpes | Infections and infestations | MedDRA v15.00 | Non-systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA v15.00 | Non-systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA v15.00 | Non-systematic Assessment |
|
| Otitis media acute | Infections and infestations | MedDRA v15.00 | Non-systematic Assessment |
|
| Peritonsillitis | Infections and infestations | MedDRA v15.00 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA v15.00 | Non-systematic Assessment |
|
| Pseudomonas infection | Infections and infestations | MedDRA v15.00 | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA v15.00 | Non-systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA v15.00 | Non-systematic Assessment |
|
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA v15.00 | Non-systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA v15.00 | Non-systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA v15.00 | Non-systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA v15.00 | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v15.00 | Non-systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA v15.00 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA v15.00 | Non-systematic Assessment |
|
| Lymphocele | Vascular disorders | MedDRA v15.00 | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA v15.00 | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA v15.00 | Non-systematic Assessment |
|
| Varicose ulceration | Vascular disorders | MedDRA v15.00 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA v15.00 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA v15.00 | Non-systematic Assessment |
|
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA v15.00 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA v15.00 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA v15.00 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA v15.00 | Non-systematic Assessment |
|
| Faecaloma | Gastrointestinal disorders | MedDRA v15.00 | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA v15.00 | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA v15.00 | Non-systematic Assessment |
|
| Gingivitis | Gastrointestinal disorders | MedDRA v15.00 | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA v15.00 | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA v15.00 | Non-systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA v15.00 | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA v15.00 | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA v15.00 | Non-systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA v15.00 | Non-systematic Assessment |
|
| Weight increased | Investigations | MedDRA v15.00 | Non-systematic Assessment |
|
| Blood creatine increased | Investigations | MedDRA v15.00 | Non-systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA v15.00 | Non-systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA v15.00 | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA v15.00 | Non-systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA v15.00 | Non-systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA v15.00 | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA v15.00 | Non-systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA v15.00 | Non-systematic Assessment |
|
| Aphasia | Nervous system disorders | MedDRA v15.00 | Non-systematic Assessment |
|
| Cognitive disorder | Nervous system disorders | MedDRA v15.00 | Non-systematic Assessment |
|
| Dysarthria | Nervous system disorders | MedDRA v15.00 | Non-systematic Assessment |
|
| Polyneuropathy | Nervous system disorders | MedDRA v15.00 | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA v15.00 | Non-systematic Assessment |
|
| Trigeminal neuralgia | Nervous system disorders | MedDRA v15.00 | Non-systematic Assessment |
|
| Visual field defect NOS | Nervous system disorders | MedDRA v15.00 | Non-systematic Assessment |
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA v15.00 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v15.00 | Non-systematic Assessment |
|
| Muscle haemorrhage | Musculoskeletal and connective tissue disorders | MedDRA v15.00 | Non-systematic Assessment |
|
| Visual acuity reduced | Eye disorders | MedDRA v15.00 | Non-systematic Assessment |
|
| Conjunctival irritation | Eye disorders | MedDRA v15.00 | Non-systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA v15.00 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v15.00 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v15.00 | Non-systematic Assessment |
|
| Colon adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v15.00 | Non-systematic Assessment |
|
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v15.00 | Non-systematic Assessment |
|
| Vulvovaginal human papilloma virus infection | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v15.00 | Non-systematic Assessment |
|
| Animal bite | Injury, poisoning and procedural complications | MedDRA v15.00 | Non-systematic Assessment |
|
| Hand fracture | Injury, poisoning and procedural complications | MedDRA v15.00 | Non-systematic Assessment |
|
| Mouth injury | Injury, poisoning and procedural complications | MedDRA v15.00 | Non-systematic Assessment |
|
| Breast calcifications | Reproductive system and breast disorders | MedDRA v15.00 | Non-systematic Assessment |
|
| Haematospermia | Reproductive system and breast disorders | MedDRA v15.00 | Non-systematic Assessment |
|
| Panic attack | Psychiatric disorders | MedDRA v15.00 | Non-systematic Assessment |
|
| Transplant rejection | Immune system disorders | MedDRA v15.00 | Non-systematic Assessment |
|
| Hepatic steatosis | Hepatobiliary disorders | MedDRA v15.00 | Non-systematic Assessment |
|
| Deafness | Ear and labyrinth disorders | MedDRA v15.00 | Non-systematic Assessment |
|
| Epidermal naevus | Congenital, familial and genetic disorders | MedDRA v15.00 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Measurements |
|---|---|
|
| Week 1 or 2: Tacrolimus (n=12) |
|
| Week 1 or 2: Sirolimus (n=44) |
|
| Week 4 or 5: CsA (C0) (n=1) |
|
| Week 4 or 5: Tacrolimus (n=6) |
|
| Week 4 or 5: Sirolimus (n=42) |
|
| Week 12 or 13: Tacrolimus (n=4) |
|
| Week 12 or 13: Sirolimus (n=47) |
|
| Week 24 or 25: Tacrolimus (n=2) |
|
| Week 24 or 25: Sirolimus (n=46) |
|
| Week 52 or 53: CsA (C0) (n=1) |
|
| Week 52 or 53: Tacrolimus (n=1) |
|
| Week 52 or 53: Sirolimus (n=36) |
|
| Title | Measurements |
|---|---|
|
| Week 1 or 2: Tacrolimus (n=12) |
|
| Week 1 or 2: Sirolimus (n=44) |
|
| Week 4 or 5: CsA (C0) (n=1) |
|
| Week 4 or 5: Tacrolimus (n=6) |
|
| Week 4 or 5: Sirolimus (n=42) |
|
| Week 12 or 13: Tacrolimus (n=4) |
|
| Week 12 or 13: Sirolimus (n=47) |
|
| Week 24 or 25: Tacrolimus (n=2) |
|
| Week 24 or 25: Sirolimus (n=46) |
|
| Week 52 or 53: CsA (C0) (n=1) |
|
| Week 52 or 53: Tacrolimus (n=1) |
|
| Week 52 or 53: Sirolimus (n=36) |
|
| Title | Measurements |
|---|---|
|
| Week 12 or 13 (n=48) |
|
| Week 24 or 25 (n=46) |
|
| Week 52 or 53 (n=38) |
|
| Title | Measurements |
|---|---|
|
| Week 12 or 13 (n=25) |
|
| Week 24 or 25 (n=23) |
|
| Week 52 or 53 (n=18) |
|
| Title | Measurements |
|---|---|
|
| Week 12 or 13 (n=17) |
|
| Week 24 or 25 (n=17) |
|
| Week 52 or 53 (n=13) |
|
| Title | Measurements |
|---|---|
|
| Week 12 or 13: Feverless (n=17) |
|
| Week 12 or 13: Fever (n=17) |
|
| Week 24 or 25: Feverless (n=17) |
|
| Week 52 or 53: Feverless (n=14) |
|
| Title | Measurements |
|---|---|
|
| Week 1 or 2: Diastolic BP (n=48) |
|
| Week 4 or 5: Systolic BP (n=45) |
|
| Week 4 or 5: Diastolic BP (n=45) |
|
| Week 12 or 13: Systolic BP (n=47) |
|
| Week 12 or 13: Diastolic BP (n=47) |
|
| Week 24 or 25: Systolic BP (n=40) |
|
| Week 24 or 25: Diastolic BP (n=40) |
|
| Week 52 or 53: Systolic BP (n=37) |
|
| Week 52 or 53: Diastolic BP (n=37) |
|
| Title | Measurements |
|---|---|
|
| Week 12 or 13 (n=22) |
|
| Week 24 or 25 (n=22) |
|
| Week 52 or 53 (n=22) |
|
| Title | Measurements |
|---|---|
|
| Week 12 or 13 (n=43) |
|
| Week 24 or 25 (n=37) |
|
| Week 52 or 53 (n=34) |
|