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| ID | Type | Description | Link |
|---|---|---|---|
| B1741220 |
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To compare the safety and efficacy of cyclosporine (CsA) + mycophenolate mofetil (MMF) + corticosteroids © to CsA + Rapamune + Cs with CsA elimination in the Rapamune arm with the introduction of MMF in de novo renal allograft recipients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (CsA+Rapamune+CS) | Active Comparator |
| |
| Arm B (CsA+MMF+CS) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CsA+Rapamune+CS | Drug | Part 1: Rapamune will be given as a loading dose of 6 mg once followed by maintenance dose of 2 mg to achieve a target trough level of 8-15 ng/ml. Part 2: Rapamune dose will be adjusted to achieve a target trough level of 10-15ng/ml through 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Efficacy Failure | Efficacy failure was defined as first occurrence of either biopsy confirmed acute rejection, graft loss or death within 12 months of post-transplantation. Percentage of participants with efficacy failure was reported. | Baseline up to Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Creatinine Level | Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatine, commonly found in blood, urine and muscle tissue. It is removed from the blood by the kidneys and excreted in urine. An increased level of creatinine in the blood indicates decreased kidney function. Normal adult blood levels of creatinine are 0.5 to 1.1 milligram per deciliter (mg/dL) for females and 0.6 to 1.2 mg/dL for males; however, the normal values are age-dependent as elderly patients typically have smaller muscle mass. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Labbafinejad Hospital | Tehran | Iran | ||||
| Modarres Hospital |
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 | CsA+Rapamune+CS | Month 0-3: rapamune 6 milligram (mg) tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 nanogram per milliliter (ng/mL) in combination with cyclosporine (CsA) tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, mycophenolate mofetil (MMF) tablet orally at a dose of 1-1.5 grams per day (g/day) and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received corticosteroids (CS) tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months. |
| FG001 | CsA+MMF+CS | Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CsA+Rapamune+CS | Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months. |
| 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 | Incidence of Efficacy Failure | Efficacy failure was defined as first occurrence of either biopsy confirmed acute rejection, graft loss or death within 12 months of post-transplantation. Percentage of participants with efficacy failure was reported. | Per-protocol 1 (PP1) population included all participants who had completed study, also included those who dropped out of study due to occurrence of death, graft loss, or biopsy-confirmed acute rejection and had no major protocol deviations. | Posted | Number | percentage of participants | Baseline up to Month 12 |
|
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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 | CsA+Rapamune+CS | Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aplasia pure red cell | Blood and lymphatic system disorders | MedDRA v13.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v15.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| CsA+MMF+CS | Drug | The control arm is the standard local practice (official protocol) in Iran: Cyclosporine + MMF + Corticosteroid. The time period is from pre-study screening / baseline evaluation up to 12 months for patients who are maintained on CsA + MMF + CS. |
|
| Month 3, 6, 12 |
| Creatinine Clearance | Creatinine clearance (CCr) is a measure 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 millimeters 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. | Month 3, 6, 12 |
| Glomerular Filtration Rate (GFR) by Nankivell Method | GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR was calculated using the Nankivell formula. GFR by Nankivell equation= (6.7 per serum creatinine) plus (0.25*body weight) minus (0.5*serum urea) minus (100 per height square) plus (35 for male or 25 for female). A normal GFR is greater than (>)90 mL/min per 1.73 m^2 [mL/min/1.73 m^2], although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR less than (<)15 mL/min/1.73 m^2 indicated kidney failure. | Month 3, 6, 12 |
| Incidence of Biopsy-Confirmed Acute Rejection | Diagnosis of acute rejection was made via kidney biopsy using Banff criteria. Percentage of participants with biopsy-confirmed acute rejection was reported. | Baseline up to Month 6 |
| Histologic Grade of First 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: cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (5-10 cells/tubular cross section), Grade 1B: with severe tubulitis (>10 cells/tubular cross section), Grade 2A: mild-moderate intimal arteritis, Grade 2B: severe intimal arteritis and Grade 3: transmural arterits and/or fibrinoid necrosis. Data is reported as percentage of participants. | Baseline up to Month 12 |
| Percentage of Participants Who Survived | Survival defined as participants living with or without a functioning graft. | Month 12 |
| Percentage of Participants With Graft Survival | Graft survival defined as those participants who did not experience graft loss. Graft loss defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for >8 weeks), retransplant or death during the first 12 months after randomization. | Month 12 |
| Incidence of Presumptive or Documented Infection | Presumptive or documented infection during the 12 months after transplantation; was confirmed by culture, biopsy, or serology and reported. Percentage of participants with presumptive or documented infection was reported. | Baseline up to Month 12 |
| Incidence of Histologically Confirmed Lymphoproliferative Disease | Lymphoproliferative disorder represents an abnormal proliferation of B cells in response to either primary or reactivated infection with Epstein-Barr virus. Percentage of participants with histologically confirmed lymphoproliferative disease was reported. | Baseline up to Month 12 |
| Percentage of Participants With Efficacy Failure or Premature Elimination | Efficacy failure was defined as the first occurrence of acute rejection, graft loss, or death. Premature elimination was defined as elimination from the study for any other reason. | Month 12 |
| Incidence of Anemia | Diagnostic criterion for anemia was based on the laboratory results; in men: hemoglobin (Hb) <14 gram per deciliter (g/dL), hematocrit (Hct) <42%, or red blood cells (RBCs) <4.5 million/liter (million/L); for women: Hb <12 g/dL, Hct <37%, or RBC < 4 million/L. Percentage of participants with anaemia was reported. | Baseline up to Month 12 |
| Number of Participants Who Discontinued | Number of participants who discontinued the study treatment due to any reason is reported. | Month 12 |
| Tehran |
| Iran |
| Shariati Hospital | Tehran | Iran |
| Taleqani Hospital | Tehran | Iran |
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Graft Loss |
|
| Study Events |
|
| Other |
|
| BG001 | CsA+MMF+CS | Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | CsA+MMF+CS | Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months. |
|
|
|
| Secondary | Serum Creatinine Level | Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatine, commonly found in blood, urine and muscle tissue. It is removed from the blood by the kidneys and excreted in urine. An increased level of creatinine in the blood indicates decreased kidney function. Normal adult blood levels of creatinine are 0.5 to 1.1 milligram per deciliter (mg/dL) for females and 0.6 to 1.2 mg/dL for males; however, the normal values are age-dependent as elderly patients typically have smaller muscle mass. | PP1 population. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' is number of participants evaluable at specific time points for each arm group. | Posted | Mean | Standard Deviation | mg/dL | Month 3, 6, 12 |
|
|
|
|
| Secondary | Creatinine Clearance | Creatinine clearance (CCr) is a measure 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 millimeters 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. | PP1 population. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' is number of participants evaluable at specific time points for each arm group. | Posted | Mean | Standard Deviation | mL/min | Month 3, 6, 12 |
|
|
|
|
| Secondary | Glomerular Filtration Rate (GFR) by Nankivell Method | GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR was calculated using the Nankivell formula. GFR by Nankivell equation= (6.7 per serum creatinine) plus (0.25*body weight) minus (0.5*serum urea) minus (100 per height square) plus (35 for male or 25 for female). A normal GFR is greater than (>)90 mL/min per 1.73 m^2 [mL/min/1.73 m^2], although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR less than (<)15 mL/min/1.73 m^2 indicated kidney failure. | PP1 population. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' is number of participants evaluable at specific time points for each arm group. | Posted | Mean | Standard Deviation | mL/min/1.73 m^2 | Month 3, 6, 12 |
|
|
|
|
| Secondary | Incidence of Biopsy-Confirmed Acute Rejection | Diagnosis of acute rejection was made via kidney biopsy using Banff criteria. Percentage of participants with biopsy-confirmed acute rejection was reported. | PP2 population included all participants who had completed study, also included those who dropped out of the study due to biopsy confirmed acute rejection at Month 6. | Posted | Number | percentage of participants | Baseline up to Month 6 |
|
|
|
|
| Secondary | Histologic Grade of First 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: cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (5-10 cells/tubular cross section), Grade 1B: with severe tubulitis (>10 cells/tubular cross section), Grade 2A: mild-moderate intimal arteritis, Grade 2B: severe intimal arteritis and Grade 3: transmural arterits and/or fibrinoid necrosis. Data is reported as percentage of participants. | PP2 population included all participants who had completed study, also included those who dropped out of the study due to biopsy confirmed acute rejection at Month 6. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Number | percentage of participants | Baseline up to Month 12 |
|
|
|
| Secondary | Percentage of Participants Who Survived | Survival defined as participants living with or without a functioning graft. | PP3 population included all participants who had completed study, also included those who dropped out of the study due to the occurrence of death. | Posted | Number | percentage of participants | Month 12 |
|
|
|
|
| Secondary | Percentage of Participants With Graft Survival | Graft survival defined as those participants who did not experience graft loss. Graft loss defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for >8 weeks), retransplant or death during the first 12 months after randomization. | PP4 population included all participants who had completed study, also included those who dropped out of the study due to the occurrence of graft loss. | Posted | Number | percentage of participants | Month 12 |
|
|
|
|
| Secondary | Incidence of Presumptive or Documented Infection | Presumptive or documented infection during the 12 months after transplantation; was confirmed by culture, biopsy, or serology and reported. Percentage of participants with presumptive or documented infection was reported. | Analysis population included all participants enrolled in the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Number | percentage of participants | Baseline up to Month 12 |
|
|
|
|
| Secondary | Incidence of Histologically Confirmed Lymphoproliferative Disease | Lymphoproliferative disorder represents an abnormal proliferation of B cells in response to either primary or reactivated infection with Epstein-Barr virus. Percentage of participants with histologically confirmed lymphoproliferative disease was reported. | Analysis population included all participants enrolled in the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Number | percentage of participants | Baseline up to Month 12 |
|
|
|
|
| Secondary | Percentage of Participants With Efficacy Failure or Premature Elimination | Efficacy failure was defined as the first occurrence of acute rejection, graft loss, or death. Premature elimination was defined as elimination from the study for any other reason. | Analysis population included all participants enrolled in the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Number | percentage of participants | Month 12 |
|
|
|
|
| Secondary | Incidence of Anemia | Diagnostic criterion for anemia was based on the laboratory results; in men: hemoglobin (Hb) <14 gram per deciliter (g/dL), hematocrit (Hct) <42%, or red blood cells (RBCs) <4.5 million/liter (million/L); for women: Hb <12 g/dL, Hct <37%, or RBC < 4 million/L. Percentage of participants with anaemia was reported. | Analysis population included all participants enrolled in the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Number | percentage of participants | Baseline up to Month 12 |
|
|
|
|
| Secondary | Number of Participants Who Discontinued | Number of participants who discontinued the study treatment due to any reason is reported. | Analysis population included all participants enrolled in the study. | Posted | Number | participants | Month 12 |
|
|
|
|
| 56 |
| 125 |
| 67 |
| 125 |
| EG001 | CsA+MMF+CS | Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months. | 44 | 120 | 44 | 120 |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Haemolytic uraemic syndrome | Blood and lymphatic system disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Acute abdomen | Gastrointestinal disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Gastroenteritis | Gastrointestinal disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Volvolus | Gastrointestinal disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Impaired healing | General disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Peripheral oedema | General disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Sudden death | General disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Transplant rejection | Immune system disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Candidiasis | Infections and infestations | MedDRA v13.0 | Non-systematic Assessment |
|
| Cytomegalovirus infection | Infections and infestations | MedDRA v13.0 | Non-systematic Assessment |
|
| Diabetic foot infection | Infections and infestations | MedDRA v13.0 | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA v13.0 | Non-systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA v13.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA v13.0 | Non-systematic Assessment |
|
| Penile infection | Infections and infestations | MedDRA v13.0 | Non-systematic Assessment |
|
| Perlvic abscess | Infections and infestations | MedDRA v13.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA v13.0 | Non-systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA v13.0 | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA v13.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA v13.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA v13.0 | Non-systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA v13.0 | Non-systematic Assessment |
|
| Drug toxicity | Injury, poisoning and procedural complications | MedDRA v13.0 | Non-systematic Assessment |
|
| Kidney rupture | Injury, poisoning and procedural complications | MedDRA v13.0 | Non-systematic Assessment |
|
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA v13.0 | Non-systematic Assessment |
|
| Postoperative wound complications | Injury, poisoning and procedural complications | MedDRA v13.0 | Non-systematic Assessment |
|
| Seroma | Injury, poisoning and procedural complications | MedDRA v13.0 | Non-systematic Assessment |
|
| Therapeutic agent toxicity | Injury, poisoning and procedural complications | MedDRA v13.0 | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA v13.0 | Non-systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA v13.0 | Non-systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA v13.0 | Non-systematic Assessment |
|
| Cytomegalovirus test positiv | Investigations | MedDRA v13.0 | Non-systematic Assessment |
|
| Lipids increased | Investigations | MedDRA v13.0 | Non-systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Diabetic neuropathy | Nervous system disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Nervous system disorder | Nervous system disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Hyperoxaluria | Renal and urinary disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Obstructive uropathy | Renal and urinary disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Renal artery thrombosis | Renal and urinary disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Renal tubular necrosis | Renal and urinary disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Ureteral necrosis | Renal and urinary disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Ureteric obstruction | Renal and urinary disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Ureteric stenosis | Renal and urinary disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Arterial thrombosis | Vascular disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Hypertensive crisis | Vascular disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Lymphocele | Vascular disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Oral disorder | Gastrointestinal disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Impaired healing | General disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Oedema | General disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Peripheral oedema | General disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Transplant rejection | Immune system disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Candidiasis | Infections and infestations | MedDRA v15.1 | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA v15.1 | Non-systematic Assessment |
|
| Cytomegalovirus infection | Infections and infestations | MedDRA v15.1 | Non-systematic Assessment |
|
| Fungal infection | Infections and infestations | MedDRA v15.1 | Non-systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA v15.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA v15.1 | Non-systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA v15.1 | Non-systematic Assessment |
|
| Oral infection | Infections and infestations | MedDRA v15.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA v15.1 | Non-systematic Assessment |
|
| Postoperative wound complication | Injury, poisoning and procedural complications | MedDRA v15.1 | Non-systematic Assessment |
|
| Seroma | Injury, poisoning and procedural complications | MedDRA v15.1 | Non-systematic Assessment |
|
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA v15.1 | Non-systematic Assessment |
|
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA v15.1 | Non-systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA v15.1 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA v15.1 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA v15.1 | Non-systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA v15.1 | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA v15.1 | Non-systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA v15.1 | Non-systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA v15.1 | Non-systematic Assessment |
|
| Cytomegalovirus test positive | Investigations | MedDRA v15.1 | Non-systematic Assessment |
|
| Drug level increased | Investigations | MedDRA v15.1 | Non-systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA v15.1 | Non-systematic Assessment |
|
| Immunosuppressant drug level increased | Investigations | MedDRA v15.1 | Non-systematic Assessment |
|
| Lipids increased | Investigations | MedDRA v15.1 | Non-systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA v15.1 | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA v15.1 | Non-systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA v15.1 | Non-systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Nocturia | Renal and urinary disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Renal tubular necrosis | Renal and urinary disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Renal vein thrombosis | Renal and urinary disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Diabetic foot | Skin and subcutaneous tissue disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Lymphocele | Vascular disorders | MedDRA v15.1 | 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.
| Month 12 (n=98, 91) |
|
Month 6: One-way ANOVA was used to test the difference.
| ANOVA |
| 0.381 |
Statistical testing was based on 5% significance level. |
| 2-Sided |
| Superiority or Other |
| Month 12: One-way ANOVA was used to test the difference. | ANOVA | 0.096 | Statistical testing was based on 5% significance level. | 2-Sided | Superiority or Other |
| Month 12 (n=98, 91) |
|
| ANOVA |
| 0.660 |
Statistical testing was based on 5% significance level. |
| 2-Sided |
| Superiority or Other |
| Month 12: One-way ANOVA was used to test the difference. | ANOVA | 0.518 | Statistical testing was based on 5% significance level. | 2-Sided | Superiority or Other |
| Month 12 (n=98, 91) |
|
| ANOVA |
| 0.738 |
Statistical testing was based on 5% significance level. |
| 2-Sided |
| Superiority or Other |
| Month 12: One-way ANOVA was used to test the difference. | ANOVA | 0.977 | Statistical testing was based on 5% significance level. | 2-Sided | Superiority or Other |