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The primary objective of the study is to examine the effect of denosumab on lumbar spine bone mineral density (BMD) after one year of treatment in newly transplanted renal allograft recipients. Secondary endpoints include BMD changes at the total hip and the femoral neck, changes in body height, changes in bone mineral metabolism parameters, incidence of fractures, and allograft function at one year. Safety measurements include the occurrence of rejection episodes, infectious complications, graft loss and mortality.
Renal allograft recipients are at high risk to suffer a substantial loss of bone mineral density (BMD) within the first year after kidney transplantation. This loss of BMD correlates with an increased risk for the development of osteoporosis or worsening of pre-existing osteopenia/osteoporosis, heightening the risk for the subsequent occurrence of fractures. Renal allograft recipients are often treated with calcium and vitamin D preparations to prevent BMD loss. The addition of bisphosphonates can further improve BMD. However, bisphosphonates are potentially nephrotoxic and promote adynamic bone disease, and are therefore not regularly prescribed.
Receptor Activator of Nuclear factor- Kappa-B Ligand (RANKL) is a key molecule mediating development, activity, and survival of osteoclasts. Osteoporosis results in part from increased osteoclastic bone resorption, and therefore the inhibition of RANKL activity has become an obvious therapeutic strategy to prevent bone mineral density (BMD) loss and the development of osteoporosis.
The novel anti-osteoporotic drug denosumab (trade name Prolia®) is a fully human monoclonal antibody against RANKL. By inhibiting the development and the activity as well as reducing the survival of osteoclasts it decreases bone resorption and increases bone density.
The hypothesis of the present study is that denosumab has a beneficial effect on the loss of BMD in the first year after renal transplantation. The preservation of BMD is a surrogate parameter, generally predicting subsequent improvements in the occurrence rate of fractures. The hypothesis will be tested by studying the effect of denosumab on BMD in newly transplanted renal allograft recipients.
The purpose of the present trial is to study the effect of denosumab on BMD in kidney allograft recipients. The study participants will be treated for 1 year, receiving a total of 2 injections of the standard 60 mg dose at baseline and at 6 months.
Ninety sequential renal allograft recipients will be randomized 1:1 to receive two subcutaneous 60 mg denosumab injections within 14 days and 6 months following renal transplantation, or no treatment. All patients will also receive oral standard treatment with 1000 mg calcium plus 800 IU vitamin D.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Denosumab | Experimental | 60 mg denosumab s.c. at baseline and after 6 months |
|
| Control | No Intervention | No treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Denosumab (Prolia) | Drug | 60 mg s.c. injection at baseline and after 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in BMD at the Total Lumbar Spine From Baseline to Month 12 | The total lumbar spine BMD was measured via Dual Energy X-ray Absorptiometry (DXA) and was expressed in g/cm2 hydroxylapatite | Baseline and month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in BMD at the Total Hip From Baseline to Month 12 | The total hip BMD was measured via Dual Energy X-ray Absorptiometry (DXA) and was expressed in g/cm2 hydroxylapatite | Baseline and month 12 |
| Percent Change in BMD at the Femoral Neck From Baseline to Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Levels of Calcium (mmol/L) at Baseline and Months 0.5, 1, 2, 3, 6, 12 | Blood levels of calcium (mmol/L) were measured at baseline and at months 0.5, 1, 2, 3, 6, and 12 | baseline, months 0.5, 1, 2, 3, 6, 12 |
| Blood Levels of Phosphate (mmol/L) at Baseline and Months 0.5, 1, 2, 3, 6, 12 |
The key inclusion criteria are:
Key exclusion criteria are:
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| Name | Affiliation | Role |
|---|---|---|
| Rudolf P Wuthrich, MD | Division of Nephrology, University Hospital, Zurich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Nephrology, University Hospital | Zurich | 8091 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26713403 | Result | Bonani M, Frey D, Brockmann J, Fehr T, Mueller TF, Saleh L, von Eckardstein A, Graf N, Wuthrich RP. Effect of Twice-Yearly Denosumab on Prevention of Bone Mineral Density Loss in De Novo Kidney Transplant Recipients: A Randomized Controlled Trial. Am J Transplant. 2016 Jun;16(6):1882-91. doi: 10.1111/ajt.13692. Epub 2016 Feb 29. | |
| 39382091 |
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Patients were recruited from June 20, 2011, to May 2, 2014. Patients were randomized after 15.7 ± 6.4 days after transplantation.
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| ID | Title | Description |
|---|---|---|
| FG000 | Denosumab | 60 mg denosumab s.c. at baseline and after 6 months Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months |
| FG001 | Control | No treatment |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Randomized patients with a functioning graft
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| ID | Title | Description |
|---|---|---|
| BG000 | Denosumab | 60 mg denosumab s.c. at baseline and after 6 months Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months |
| BG001 | Control | No treatment |
| 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 | Percent Change in BMD at the Total Lumbar Spine From Baseline to Month 12 | The total lumbar spine BMD was measured via Dual Energy X-ray Absorptiometry (DXA) and was expressed in g/cm2 hydroxylapatite | The intention-to-treat (ITT) population was used for the primary efficacy analysis, i.e. all subjects were included that have been randomized to the control group or to the denosumab group. Missing values were replaced with a last-value-carried-forward approach (LVCF). | Posted | Mean | Standard Deviation | percent change | Baseline and month 12 |
|
1 year
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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 | Denosumab | 60 mg denosumab s.c. at baseline and after 6 months Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | CTCAE (Unspecified) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infections | Infections and infestations | CTCAE (Unspecified) | Non-systematic Assessment | Cystitis (bladder infection) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Rudolf P. Wüthrich | University Hospital Zürich | +41 44 255 33 84 | rudolf.wuethrich@usz.ch |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D051436 | Renal Insufficiency, Chronic |
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069448 | Denosumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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The total femoral neck BMD was measured via Dual Energy X-ray Absorptiometry (DXA) and was expressed in g/cm2 hydroxylapatite |
| Baseline and month 12 |
| Percent Change in BMD at the Total Lumbar Spine From Baseline to Month 6 | The total lumbar spine BMD was measured via DXA and was expressed in g/cm2 hydroxylapatite. | Baseline and month 6 |
| Percent Change in BMD at the Total Hip From Baseline to Month 6 | The total hip BMD was measured via DXA and was expressed in g/cm2 hydroxylapatite | Baseline and month 6 |
| Percent Change in BMD at the Femoral Neck From Baseline to Month 6 | The femoral neck BMD was measured via DXA and was expressed in g/cm2 hydroxylapatite | Baseline and month 6 |
| Beta-CTX at Baseline and Months 3, 6 and 12 | Blood concentrations of beta-CTX (microgram/L) | baseline, month 3, month 6, and month 12 |
| P1NP at Baseline and Months 3, 6 and 12 | Blood concentrations of P1NP were measured in microgram/L | baseline, month 3, month 6, and month 12 |
Blood levels of phosphate (mmol/L) were measured at baseline and at months 0.5, 1, 2, 3, 6, 12 |
| baseline, months 0.5, 1, 2, 3, 6, 12 |
| Blood Levels of PTH (ng/L) at Baseline and Months 3, 6, and 12 | Blood levels of PTH (ng/L) were measured at baseline and at months 3, 6, and 12 | baseline and months 3, 6, and 12 |
| 25-OH-vitamin D3 | Blood levels of 25-OH-vitamin D3 were measured as microgramm/L | baseline, months 3, 6, and 12 |
| 1,25-(OH)2 Vitamin D3 | Blood levels of 1,25-(OH)2 vitamin D3 were measured as ng/L | baseline, months 3, 6, and 12 |
| Percent Change From Baseline in Total Volumetric Bone Mineral Densitiy (Tot.vBMD) at the Distal Tibia | Volumetric BMD (vBMD) was measured via HR-pQCT (Xtreme CT) at the distal tibia and was expressed as mg HA/cm3. | Baseline and month 12 |
| Percent Change From Baseline in Cortical Volumetric Bone Mineral Densitiy (Ct.vBMD) at the Distal Tibia | Volumetric BMD (vBMD) was measured via HR-pQCT (Xtreme CT) at the distal tibia and was expressed as mg HA/cm3. | Baseline and month 12 |
| Percent Change From Baseline in Trabecular Volumetric Bone Mineral Densitiy (Tb.vBMD) at the Distal Tibia | Volumetric BMD (vBMD) was measured via HR-pQCT (Xtreme CT) at the distal tibia and was expressed as mg HA/cm3. | Baseline and month 12 |
| Percent Change From Baseline in Cortical Thickness (Ct.Th) at the Distal Tibia | Cortical thickness was measured via HR-pQCT (Xtreme CT) at the distal tibia and was expressed as mm. | Baseline and month 12 |
| Percent Change From Baseline in Total Volumetric Bone Mineral Densitiy (Tot.vBMD) at the Distal Radius | Volumetric BMD (vBMD) was measured via HR-pQCT (Xtreme CT) at the distal radius and was expressed as mg HA/cm3. | Baseline and month 12 |
| Percent Change From Baseline in Cortical Volumetric Bone Mineral Densitiy (Ct.vBMD) at the Distal Radius | Volumetric BMD (vBMD) was measured via HR-pQCT (Xtreme CT) at the distal radius and was expressed as mg HA/cm3. | Baseline and month 12 |
| Percent Change From Baseline in Trabecular Volumetric Bone Mineral Densitiy (Tb.vBMD) at the Distal Radius | Volumetric BMD (vBMD) was measured via HR-pQCT (Xtreme CT) at the distal radius and was expressed as mg HA/cm3. | Baseline and month 12 |
| Percent Change From Baseline in Cortical Thickness (Ct.Th) at the Distal Radius | Cortical thickness was measured via HR-pQCT (Xtreme CT) at the distal radius and was expressed as mm. | Baseline and month 12 |
| Wajih Z, Karpe KM, Walters GD. Interventions for BK virus infection in kidney transplant recipients. Cochrane Database Syst Rev. 2024 Oct 9;10(10):CD013344. doi: 10.1002/14651858.CD013344.pub2. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Number of osteopenic patients | Number | participants |
|
| Number of osteoporotic patients | Number | participants |
|
No treatment |
|
|
|
| Secondary | Percent Change in BMD at the Total Hip From Baseline to Month 12 | The total hip BMD was measured via Dual Energy X-ray Absorptiometry (DXA) and was expressed in g/cm2 hydroxylapatite | The intention-to-treat (ITT) population was used for the analysis of this endpoint, i.e. all subjects were included in the analysis that have been randomized to the control group or to the denosumab group. Missing values were replaced with a last-value-carried-forward approach (LVCF). | Posted | Mean | Standard Deviation | percent change | Baseline and month 12 |
|
|
|
|
| Secondary | Percent Change in BMD at the Femoral Neck From Baseline to Month 12 | The total femoral neck BMD was measured via Dual Energy X-ray Absorptiometry (DXA) and was expressed in g/cm2 hydroxylapatite | The intention-to-treat (ITT) was used for the analysis of this endpoint, i.e. all subjects were included in the analysis that have been randomized to the control group or to the denosumab group. Missing values were replaced with a last-value-carried-forward approach (LVCF). | Posted | Mean | Standard Deviation | percent change | Baseline and month 12 |
|
|
|
|
| Secondary | Percent Change in BMD at the Total Lumbar Spine From Baseline to Month 6 | The total lumbar spine BMD was measured via DXA and was expressed in g/cm2 hydroxylapatite. | The intention-to-treat was used for the analysis of this endpoint, i.e. all subjects were included in the analysis that have been randomized to the control group or to the denosumab group. Missing values were replaced with a last-value-carried-forward approach (LVCF). | Posted | Mean | Standard Deviation | percent change | Baseline and month 6 |
|
|
|
|
| Secondary | Percent Change in BMD at the Total Hip From Baseline to Month 6 | The total hip BMD was measured via DXA and was expressed in g/cm2 hydroxylapatite | The intention-to-treat (ITT) population was used for the analysis of this endpoint, i.e. all subjects were included in the analysis that have been randomized to the control group or to the denosumab group. Missing values were replaced with a last-value-carried-forward approach (LVCF). | Posted | Mean | Standard Deviation | percent change | Baseline and month 6 |
|
|
|
|
| Secondary | Percent Change in BMD at the Femoral Neck From Baseline to Month 6 | The femoral neck BMD was measured via DXA and was expressed in g/cm2 hydroxylapatite | The intention-to-treat (ITT) population was used for the analysis of this endpoint, i.e. all subjects were included in the analysis that have been randomized to the control group or to the denosumab group. Missing values were replaced with a last-value-carried-forward approach (LVCF). | Posted | Mean | Standard Deviation | percent change | Baseline and month 6 |
|
|
|
|
| Secondary | Beta-CTX at Baseline and Months 3, 6 and 12 | Blood concentrations of beta-CTX (microgram/L) | For this endpoint, an available case analysis was performed, i.e., all randomised patients with valid data at all time points were included. | Posted | Least Squares Mean | 95% Confidence Interval | microgram/L | baseline, month 3, month 6, and month 12 |
|
|
|
|
| Secondary | P1NP at Baseline and Months 3, 6 and 12 | Blood concentrations of P1NP were measured in microgram/L | For this endpoints, an available case analysis was performed, i.e., all randomised patients with valid data at all time points were included. | Posted | Least Squares Mean | 95% Confidence Interval | microgram/L | baseline, month 3, month 6, and month 12 |
|
|
|
|
| Other Pre-specified | Blood Levels of Calcium (mmol/L) at Baseline and Months 0.5, 1, 2, 3, 6, 12 | Blood levels of calcium (mmol/L) were measured at baseline and at months 0.5, 1, 2, 3, 6, and 12 | For this endpoints, an available case analysis was performed, thus all randomised patients with valid data at all time points were included. | Posted | Least Squares Mean | 95% Confidence Interval | mmol/L | baseline, months 0.5, 1, 2, 3, 6, 12 |
|
|
|
|
| Other Pre-specified | Blood Levels of Phosphate (mmol/L) at Baseline and Months 0.5, 1, 2, 3, 6, 12 | Blood levels of phosphate (mmol/L) were measured at baseline and at months 0.5, 1, 2, 3, 6, 12 | For this endpoints, an available case analysis was performed, i.e., all randomised patients with valid data at all time points were included. | Posted | Least Squares Mean | 95% Confidence Interval | mmol/L | baseline, months 0.5, 1, 2, 3, 6, 12 |
|
|
|
|
| Other Pre-specified | Blood Levels of PTH (ng/L) at Baseline and Months 3, 6, and 12 | Blood levels of PTH (ng/L) were measured at baseline and at months 3, 6, and 12 | For this endpoint, an available case analysis was performed, i.e., all randomised patients with valid data at all time points were included. | Posted | Least Squares Mean | 95% Confidence Interval | ng/L | baseline and months 3, 6, and 12 |
|
|
|
|
| Other Pre-specified | 25-OH-vitamin D3 | Blood levels of 25-OH-vitamin D3 were measured as microgramm/L | For this endpoint, an available case analysis was performed, i.e., all randomised patients with valid data at all time points were included. | Posted | Least Squares Mean | 95% Confidence Interval | microgramm/L | baseline, months 3, 6, and 12 |
|
|
|
|
| Other Pre-specified | 1,25-(OH)2 Vitamin D3 | Blood levels of 1,25-(OH)2 vitamin D3 were measured as ng/L | For this endpoint, an available case analysis was performed, i.e., all randomised patients with valid data at all time points were included. | Posted | Least Squares Mean | 95% Confidence Interval | ng/L | baseline, months 3, 6, and 12 |
|
|
|
|
| Other Pre-specified | Percent Change From Baseline in Total Volumetric Bone Mineral Densitiy (Tot.vBMD) at the Distal Tibia | Volumetric BMD (vBMD) was measured via HR-pQCT (Xtreme CT) at the distal tibia and was expressed as mg HA/cm3. | Subgroup of patients (n=24) who participated in the HR-pQCT (Xtreme CT) subprotocol. | Posted | Median | 95% Confidence Interval | Percent change | Baseline and month 12 |
|
|
|
|
| Other Pre-specified | Percent Change From Baseline in Cortical Volumetric Bone Mineral Densitiy (Ct.vBMD) at the Distal Tibia | Volumetric BMD (vBMD) was measured via HR-pQCT (Xtreme CT) at the distal tibia and was expressed as mg HA/cm3. | Subgroup of patients (n=24) who participated in the HR-pQCT (Xtreme CT) subprotocol. | Posted | Median | 95% Confidence Interval | Percent change | Baseline and month 12 |
|
|
|
|
| Other Pre-specified | Percent Change From Baseline in Trabecular Volumetric Bone Mineral Densitiy (Tb.vBMD) at the Distal Tibia | Volumetric BMD (vBMD) was measured via HR-pQCT (Xtreme CT) at the distal tibia and was expressed as mg HA/cm3. | Subgroup of patients (n=24) who participated in the HR-pQCT (Xtreme CT) subprotocol. | Posted | Median | 95% Confidence Interval | Percent change | Baseline and month 12 |
|
|
|
|
| Other Pre-specified | Percent Change From Baseline in Cortical Thickness (Ct.Th) at the Distal Tibia | Cortical thickness was measured via HR-pQCT (Xtreme CT) at the distal tibia and was expressed as mm. | Subgroup of patients (n=24) who participated in the HR-pQCT (Xtreme CT) subprotocol. | Posted | Median | 95% Confidence Interval | Percent change | Baseline and month 12 |
|
|
|
|
| Other Pre-specified | Percent Change From Baseline in Total Volumetric Bone Mineral Densitiy (Tot.vBMD) at the Distal Radius | Volumetric BMD (vBMD) was measured via HR-pQCT (Xtreme CT) at the distal radius and was expressed as mg HA/cm3. | Subgroup of patients (n=24) who participated in the HR-pQCT (Xtreme CT) subprotocol. | Posted | Median | 95% Confidence Interval | Percent change | Baseline and month 12 |
|
|
|
|
| Other Pre-specified | Percent Change From Baseline in Cortical Volumetric Bone Mineral Densitiy (Ct.vBMD) at the Distal Radius | Volumetric BMD (vBMD) was measured via HR-pQCT (Xtreme CT) at the distal radius and was expressed as mg HA/cm3. | Subgroup of patients (n=24) who participated in the HR-pQCT (Xtreme CT) subprotocol. | Posted | Median | 95% Confidence Interval | Percent change | Baseline and month 12 |
|
|
|
|
| Other Pre-specified | Percent Change From Baseline in Trabecular Volumetric Bone Mineral Densitiy (Tb.vBMD) at the Distal Radius | Volumetric BMD (vBMD) was measured via HR-pQCT (Xtreme CT) at the distal radius and was expressed as mg HA/cm3. | Subgroup of patients (n=24) who participated in the HR-pQCT (Xtreme CT) subprotocol. | Posted | Median | 95% Confidence Interval | Percent change | Baseline and month 12 |
|
|
|
|
| Other Pre-specified | Percent Change From Baseline in Cortical Thickness (Ct.Th) at the Distal Radius | Cortical thickness was measured via HR-pQCT (Xtreme CT) at the distal radius and was expressed as mm. | Subgroup of patients (n=24) who participated in the HR-pQCT (Xtreme CT) subprotocol. | Posted | Median | 95% Confidence Interval | Percent change | Baseline and month 12 |
|
|
|
|
| 31 |
| 46 |
| 45 |
| 46 |
| EG001 | Control | No treatment | 29 | 44 | 44 | 44 |
| Transplant pyelonephritis | Infections and infestations | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| CMV viremia | Infections and infestations | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Flu-like disease | Infections and infestations | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Lymphocele | Blood and lymphatic system disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Acute rejection | Immune system disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Skin cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Thrombosis | Vascular disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Diabetes (post-transplant) | Endocrine disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Surgical intervention | Surgical and medical procedures | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Functional decline of transplant function | Renal and urinary disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Transplant ureter stenosis | Renal and urinary disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Peripheral arterial vascular disease | Vascular disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Respiratory infection | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Sinusitis | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Transplant artery stenosis | Renal and urinary disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Uterus myomatosus | Reproductive system and breast disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Retinitis | Infections and infestations | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Wound dehiscence | Surgical and medical procedures | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Bilateral nephrectomy of polycystic kidneys | Renal and urinary disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Fever | Infections and infestations | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Hematoma | Blood and lymphatic system disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Pulmonary embolism | Vascular disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Neck/back pain | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Generalized weakness | General disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Chest pain | Cardiac disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Ureteral leakage | Renal and urinary disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Abscess | Infections and infestations | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Aneurysm | Vascular disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Choledocholithiasis | Gastrointestinal disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Hyponatremia | Endocrine disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Infection without focus | Infections and infestations | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Ileus | Gastrointestinal disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Hematuria | Renal and urinary disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Hernia | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Transplant reflux testing | Surgical and medical procedures | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Selective ureteral sampling | Surgical and medical procedures | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Urethral stricture | Renal and urinary disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
|
| Diarrhea | Gastrointestinal disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Hypocalcemia | Endocrine disorders | CTCAE (Unspecified) | Non-systematic Assessment | Transient, asymptomatic hypocalcemia defined as total serum calcium <1.9 mmol/L |
|
| Thrombosis | Vascular disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Aphtous stomatitis | Infections and infestations | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Fever | General disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Hemorrhoids | Gastrointestinal disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Sore throat | Infections and infestations | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Exanthema | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Headache | General disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Muscle pain | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Neck/back pain | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Rhinorrhea | General disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Oral candidiasis | Infections and infestations | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Alopecia | General disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Fecal blood | Gastrointestinal disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Edema | General disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Folliculitis | Infections and infestations | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | CTCAE (Unspecified) | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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| month 12 |
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| month 6 |
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| month 12 |
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| month 6 |
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| month 12 |
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| month 6 |
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| month 12 |
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