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The purpose of this study is to assess the pharmacokinetics and safety of belatacept in de novo renal transplant subjects treated with belatacept-based immunosuppressant medication
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | 10mg/kg 6 doses (Day 1, 5, week 2, 4, 8 and 12) for 12 weeks |
|
| B | Active Comparator | 5mg/kg 33 doses (every 4 weeks) for 144 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Belatacept | Drug | IV infusion |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Belatacept Serum Concentrations Between Weeks 12 and 16 by Nominal Collection Time, Following 10mg/kg IV Belatacept - Pharmacokinetic Population | Pharmacokinetic (PK) sampling started from pre-dose (0 hour) on Day 84 and ended at 672 hour (h) on Day 112 (between Weeks 12 to 16). The samples were analyzed for belatacept by enzyme-linked immunosorbent assay (ELISA) using a validated method and measured as nanograms/milliliter (ng/mL). Less than the lower limit of quantification (LLQ), 3.000 ng/mL concentration value was treated as missing. | Day 84 to Day 112 |
| Maximum Observed Serum Concentration (Cmax) Between Weeks 12 and 16 Following 10mg/kg IV Belatacept and Trough Serum Concentration Prior to Dosing (Cmin) - Pharmacokinetic Population | Cmax, Cmin are measured in micrograms per milliliter (µg/mL). At Day 84, blood samples obtained from pre-dose (0 hour) and ended at 672 hour (h) on Day 112. Serum samples were analyzed for belatacept by enzyme-linked immunosorbent assay (ELISA) using a validated method. Individual participant PK parameters were derived from serum concentration versus time data using a non-compartmental method, using a validated PK analysis program (KineticaTM 4.4.1 within the eToolbox [version 2.6.1]). Actual sampling times were used for PK calculations. The Cmax, and the Cmin were recorded directly from experimental observations. Using no weighting factor, the terminal log-linear phase of the concentration-time curve was identified by least-square linear regression of at least 3 data points that yielded a maximum G-criteria, which is also referred to as adjusted R-squared. Values below lower limits of quantification (LLQ), 0.003 µg/mL, were set to 0.0015 for computation of summary statistics. | Day 84 to Day 112 |
| Time of Maximum Observed Serum Concentration (Tmax) Between Weeks 12 and 16 Following 10mg/kg IV Belatacept - Pharmacokinetic Population | Tmax measured in hours (h). At Day 84, blood samples obtained from pre-dose (0 hour) and ended at 672 (h) on Day 112 . The samples were analyzed for belatacept by enzyme-linked immunosorbent assay (ELISA) using a validated method. Individual participant PK parameters were derived from serum concentration versus time data using a non-compartmental method, using a validated PK analysis program (KineticaTM 4.4.1 within the eToolbox [version 2.6.1]). Actual sampling times were used for PK calculations. |
| Measure | Description | Time Frame |
|---|---|---|
| Summary of Trough Serum Concentration of Belatacept Prior to Dosing up to 3 Years Post Transplantation - Pharmacokinetic Population | Blood samples were obtained pre and post dose at designated time points up to Day 112 and thereafter, pre-dose samples were obtained at Days 168 and 364, and then once yearly up to end of Year 3. The samples were analyzed for belatacept by enzyme-linked immunosorbent assay (ELISA) using a validated method. Individual participant PK parameters were derived from serum concentration versus time data using a non-compartmental method, using a validated PK analysis program (KineticaTM 4.4.1 within the eToolbox [version 2.6.1]). Actual sampling times were used for PK calculations. The trough serum concentration (Cmin), was recorded directly from experimental observations. Using no weighting factor, the terminal log-linear phase of the concentration-time curve was identified by least-square linear regression of at least 3 data points that yielded a maximum G-criteria, which is also referred to as adjusted R-squared. Cmin was measured as micrograms per milliliter (µg/mL). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Western New England Renal & Transplant | Springfield | Massachusetts | 01107 | United States | ||
| Henry Ford Hospital |
14 participants enrolled; 12 received study drug; 2 not treated due to: kidney damage (1) and prolonged cold ischemia (1). Study continued for up to 3 years until drug approval in participant's country. Participants continued in a 1 year extension after conclusion of the 3rd year.
First participant, first visit: 3 March 2008. Last subject, last visit 6 September 2012. Participants had received a renal transplant from a living or deceased donor with an anticipated cold ischemia time of less than (<) 24 hours (h)
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| ID | Title | Description |
|---|---|---|
| FG000 | Belatacept 10mg/kg; 5mg/kg Maintenance | Participants received intravenous (IV) belatacept (10 milligram per kilogram body weight (mg/kg) on Days 1 and 5, and then every 2 weeks through Month 1 (Weeks 2 and 4), and then every 4 weeks through Month 4 (Weeks 8 and 12). After 4 months, participants received a maintenance dose of 5 mg/kg belatacept administered every 4 weeks until completion of the trial (3 years and then a 1 year extension was available for those who completed the 3rd year). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Day 1 up to 3 Years of Planned Study |
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| ||||||||||||||||||||||||
| 1 Year Long Term Extension (LTE) |
|
Participants treated with study drug after renal transplant.
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| ID | Title | Description |
|---|---|---|
| BG000 | IV Belatacept 10mg/kg With 5mg/kg Maintenance | Participants received intravenous (IV) belatacept (10 milligram per kilogram body weight (mg/kg) on Days 1 and 5, and then every 2 weeks through Month 1 (Weeks 2 and 4), and then every 4 weeks through Month 4 (Weeks 8 and 12). After 4 months, participants received a maintenance dose of 5 mg/kg belatacept administered every 4 weeks until completion of the trial. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Belatacept Serum Concentrations Between Weeks 12 and 16 by Nominal Collection Time, Following 10mg/kg IV Belatacept - Pharmacokinetic Population | Pharmacokinetic (PK) sampling started from pre-dose (0 hour) on Day 84 and ended at 672 hour (h) on Day 112 (between Weeks 12 to 16). The samples were analyzed for belatacept by enzyme-linked immunosorbent assay (ELISA) using a validated method and measured as nanograms/milliliter (ng/mL). Less than the lower limit of quantification (LLQ), 3.000 ng/mL concentration value was treated as missing. | Number (N) of participants analyzed for each collection time was 10, except for time 0.50 h, which was missing 1 participant. Therefore Number (N) for Time 0.50 h = 9. | Posted | Mean | Standard Deviation | ng/mL | Day 84 to Day 112 |
|
Day 1 (day of transplant) up to 3 years post transplant for the study and 1 additional year for the 1 year extension for those participants who entered the extension.
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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 | Bela 10-5mg/kg |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myelopathy | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aneurysm | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Clinical.Trials@bms.com |
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| ID | Term |
|---|---|
| D000069594 | Abatacept |
| ID | Term |
|---|---|
| D018796 | Immunoconjugates |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D012712 | Serum Globulins |
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| Day 84 to Day 112 |
| Area Under the Concentration Time Curve Within a Dosing Interval (AUC) (TAU) Between Weeks 12 and 16 Following 10 mg/kg IV Belatacept - Pharmacokinetic Population | At Day 84, blood samples obtained from pre-dose (0 hour) and ended at 672 hour (h) on Day 112. The samples were analyzed for belatacept by enzyme-linked immunosorbent assay (ELISA) using a validated method. Individual participant PK parameters were derived from serum concentration versus time data using a non-compartmental method, using a validated PK analysis program (KineticaTM 4.4.1 within the eToolbox [version 2.6.1]). The area under the concentration-time curve in one dose interval [AUC(TAU), where TAU = 4 weeks] were calculated using the mixed log-linear trapezoidal algorithm in Kinetica. Actual sampling times were used for PK calculations. AUC (TAU) was measured as micrograms multiplied by time(h) per milliliter (µg*h/mL). | Day 82 to Day 112 |
| Total Body Clearance (CLT) Between Weeks 12 and 16 Following 10mg/kg IV Belatacept - Pharmacokinetic Population | At Day 84, blood samples obtained from pre-dose (0 hour) and ended at 672 hour (h) on Day 112. The samples were analyzed for belatacept by enzyme-linked immunosorbent assay (ELISA) using a validated method. Individual participant PK parameters were derived from serum concentration versus time data using a non-compartmental method, using a validated PK analysis program (KineticaTM 4.4.1 within the eToolbox [version 2.6.1]). Actual sampling times were used for PK calculations. CLT was calculated by dividing the dose by AUC(TAU) and was adjusted to body weight. CLT was measured as milliliter per time per kg body weight (mL/h/kg). | Day 84 to Day 112 |
| Steady-state Volume Distribution (Vss) Following 10mg/kg IV Belatacept Between Weeks 12 and 16 - Pharmacokinetic Population | At Day 84, blood samples obtained from pre-dose (0 hour) and ended at 672 hour (h) on Day 112. The samples were analyzed for belatacept by enzyme-linked immunosorbent assay (ELISA) using a validated method. Individual participant PK parameters were derived from serum concentration versus time data using a non-compartmental method, using a validated PK analysis program (KineticaTM 4.4.1 within the eToolbox [version 2.6.1]). Actual sampling times were used for PK calculations. Vss was calculated by dividing the dose by AUC and multiply the mean residence time (MRT). Vss was adjusted to body weight and measured as liter per kilogram body weight (l/kg). | Day 84 to Day 112 |
| Serum Half Life (T-HALF) Between Weeks 12 and 16 Following 10mg/kg IV Belatacept - Pharmacokinetic Population | At Day 84, blood samples obtained from pre-dose (0 hour) and ended at 672 hour (h) on Day 112. The samples were analyzed for belatacept by enzyme-linked immunosorbent assay (ELISA) using a validated method. Individual participant PK parameters were derived from serum concentration versus time data using a non-compartmental method, using a validated PK analysis program (KineticaTM 4.4.1 within the eToolbox [version 2.6.1]). Actual sampling times were used for PK calculations. T-HALF was calculated as ln2/Lz, where Lz is the absolute value of the slope of the terminal log-linear phase. T-HALF is measured in hours (h). | Day 84 to Day 112 |
| Day 1 to Day 1092 |
| Acute Rejection, Graft Loss, and Death up to 3 Years Post Transplantation in Planned Study and 1 Year Long Term Extension - All Treated Participants | Acute rejection of transplant defined as a clinicopathological event requiring clinical evidence and biopsy confirmation by central pathologist. Graft loss was defined as either functional loss or physical loss. Day 1 is day of transplantation. | Day 1 up to 4 years post transplantation |
| Mean Change From Baseline to Days 5, 28, 112, 168, and 364 in Tryptophan - All Treated Participants | Indoleamine 2,3 dioxygenase (IDO) is a tryptophan catabolizing enzyme that can be induced in antigen-presenting cells by the engagement of B7 by cytotoxic lymphocyte antigen 4 (CTLA-4). Tryptophan depletion in cellular microenvironments has an inhibitory effect on T cells and may be part of a broader immuno-regulatory effect of IDO induction. The IDO activity was determined by measuring the quantity of tryptophan and its metabolite, kynurenine, in serum samples using a validated high performance liquid chromatography (HPLC) method. Baseline is defined as pre-dose. Tryptophan was measured in micromoles (µM) | Baseline to Day 364 |
| Mean Change From Baseline to Days 5, 28, 112, 168, and 364 in Kynurenine - All Treated Participants | Indoleamine 2,3 dioxygenase (IDO) is a tryptophan catabolizing enzyme that can be induced in antigen-presenting cells by the engagement of B7 by CTLA-4. Tryptophan depletion in cellular microenvironments has an inhibitory effect on T cells and may be part of a broader immuno-regulatory effect of IDO induction. The IDO activity was determined by measuring the quantity of tryptophan and its metabolite, kynurenine, in serum samples using a validated high performance liquid chromatography (HPLC) method. Baseline is defined as pre-dose. Kynurenine was measured in micromoles (µM). | Day 1 to Day 364 |
| Detriot |
| Michigan |
| 48202 |
| United States |
| Local Institution | Capital Federal | Buenos Aires | 1425 | Argentina |
| Local Institution | Aguascalientes | Aguascalientes | 20219 | Mexico |
| Local Institution | Cuernavaca | Morelos | 62448 | Mexico |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Standard Deviation | kilograms |
|
|
|
| Primary | Maximum Observed Serum Concentration (Cmax) Between Weeks 12 and 16 Following 10mg/kg IV Belatacept and Trough Serum Concentration Prior to Dosing (Cmin) - Pharmacokinetic Population | Cmax, Cmin are measured in micrograms per milliliter (µg/mL). At Day 84, blood samples obtained from pre-dose (0 hour) and ended at 672 hour (h) on Day 112. Serum samples were analyzed for belatacept by enzyme-linked immunosorbent assay (ELISA) using a validated method. Individual participant PK parameters were derived from serum concentration versus time data using a non-compartmental method, using a validated PK analysis program (KineticaTM 4.4.1 within the eToolbox [version 2.6.1]). Actual sampling times were used for PK calculations. The Cmax, and the Cmin were recorded directly from experimental observations. Using no weighting factor, the terminal log-linear phase of the concentration-time curve was identified by least-square linear regression of at least 3 data points that yielded a maximum G-criteria, which is also referred to as adjusted R-squared. Values below lower limits of quantification (LLQ), 0.003 µg/mL, were set to 0.0015 for computation of summary statistics. | One participant excluded from analysis of Cmax and Tmax due to a very high concentration value (it was considered an outlier) therefore, for Cmax, Number of participants analyzed (N)=9. | Posted | Geometric Mean | Geometric Coefficient of Variation | µg/mL | Day 84 to Day 112 |
|
|
|
| Primary | Time of Maximum Observed Serum Concentration (Tmax) Between Weeks 12 and 16 Following 10mg/kg IV Belatacept - Pharmacokinetic Population | Tmax measured in hours (h). At Day 84, blood samples obtained from pre-dose (0 hour) and ended at 672 (h) on Day 112 . The samples were analyzed for belatacept by enzyme-linked immunosorbent assay (ELISA) using a validated method. Individual participant PK parameters were derived from serum concentration versus time data using a non-compartmental method, using a validated PK analysis program (KineticaTM 4.4.1 within the eToolbox [version 2.6.1]). Actual sampling times were used for PK calculations. | 1 participant excluded from analysis of Cmax and Tmax due to a very high concentration value (it was considered an outlier) therefore, for Tmax, Number of participants analyzed (N)=9. | Posted | Median | Full Range | hours | Day 84 to Day 112 |
|
|
|
| Primary | Area Under the Concentration Time Curve Within a Dosing Interval (AUC) (TAU) Between Weeks 12 and 16 Following 10 mg/kg IV Belatacept - Pharmacokinetic Population | At Day 84, blood samples obtained from pre-dose (0 hour) and ended at 672 hour (h) on Day 112. The samples were analyzed for belatacept by enzyme-linked immunosorbent assay (ELISA) using a validated method. Individual participant PK parameters were derived from serum concentration versus time data using a non-compartmental method, using a validated PK analysis program (KineticaTM 4.4.1 within the eToolbox [version 2.6.1]). The area under the concentration-time curve in one dose interval [AUC(TAU), where TAU = 4 weeks] were calculated using the mixed log-linear trapezoidal algorithm in Kinetica. Actual sampling times were used for PK calculations. AUC (TAU) was measured as micrograms multiplied by time(h) per milliliter (µg*h/mL). | Posted | Geometric Mean | Geometric Coefficient of Variation | µg*h/mL | Day 82 to Day 112 |
|
|
|
| Secondary | Summary of Trough Serum Concentration of Belatacept Prior to Dosing up to 3 Years Post Transplantation - Pharmacokinetic Population | Blood samples were obtained pre and post dose at designated time points up to Day 112 and thereafter, pre-dose samples were obtained at Days 168 and 364, and then once yearly up to end of Year 3. The samples were analyzed for belatacept by enzyme-linked immunosorbent assay (ELISA) using a validated method. Individual participant PK parameters were derived from serum concentration versus time data using a non-compartmental method, using a validated PK analysis program (KineticaTM 4.4.1 within the eToolbox [version 2.6.1]). Actual sampling times were used for PK calculations. The trough serum concentration (Cmin), was recorded directly from experimental observations. Using no weighting factor, the terminal log-linear phase of the concentration-time curve was identified by least-square linear regression of at least 3 data points that yielded a maximum G-criteria, which is also referred to as adjusted R-squared. Cmin was measured as micrograms per milliliter (µg/mL). | Number of participants (N) analyzed = 11 for Days 5, 14,and 28; and 12 for Day 56. Days 84, 112, 168, 364 N=10. | Posted | Geometric Mean | Geometric Coefficient of Variation | µg/mL | Day 1 to Day 1092 |
|
|
|
| Primary | Total Body Clearance (CLT) Between Weeks 12 and 16 Following 10mg/kg IV Belatacept - Pharmacokinetic Population | At Day 84, blood samples obtained from pre-dose (0 hour) and ended at 672 hour (h) on Day 112. The samples were analyzed for belatacept by enzyme-linked immunosorbent assay (ELISA) using a validated method. Individual participant PK parameters were derived from serum concentration versus time data using a non-compartmental method, using a validated PK analysis program (KineticaTM 4.4.1 within the eToolbox [version 2.6.1]). Actual sampling times were used for PK calculations. CLT was calculated by dividing the dose by AUC(TAU) and was adjusted to body weight. CLT was measured as milliliter per time per kg body weight (mL/h/kg). | Participants who were treated and had PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | mL/h/kg | Day 84 to Day 112 |
|
|
|
| Primary | Steady-state Volume Distribution (Vss) Following 10mg/kg IV Belatacept Between Weeks 12 and 16 - Pharmacokinetic Population | At Day 84, blood samples obtained from pre-dose (0 hour) and ended at 672 hour (h) on Day 112. The samples were analyzed for belatacept by enzyme-linked immunosorbent assay (ELISA) using a validated method. Individual participant PK parameters were derived from serum concentration versus time data using a non-compartmental method, using a validated PK analysis program (KineticaTM 4.4.1 within the eToolbox [version 2.6.1]). Actual sampling times were used for PK calculations. Vss was calculated by dividing the dose by AUC and multiply the mean residence time (MRT). Vss was adjusted to body weight and measured as liter per kilogram body weight (l/kg). | Posted | Mean | Standard Deviation | l/kg | Day 84 to Day 112 |
|
|
|
| Primary | Serum Half Life (T-HALF) Between Weeks 12 and 16 Following 10mg/kg IV Belatacept - Pharmacokinetic Population | At Day 84, blood samples obtained from pre-dose (0 hour) and ended at 672 hour (h) on Day 112. The samples were analyzed for belatacept by enzyme-linked immunosorbent assay (ELISA) using a validated method. Individual participant PK parameters were derived from serum concentration versus time data using a non-compartmental method, using a validated PK analysis program (KineticaTM 4.4.1 within the eToolbox [version 2.6.1]). Actual sampling times were used for PK calculations. T-HALF was calculated as ln2/Lz, where Lz is the absolute value of the slope of the terminal log-linear phase. T-HALF is measured in hours (h). | Posted | Mean | Standard Deviation | hours | Day 84 to Day 112 |
|
|
|
| Secondary | Acute Rejection, Graft Loss, and Death up to 3 Years Post Transplantation in Planned Study and 1 Year Long Term Extension - All Treated Participants | Acute rejection of transplant defined as a clinicopathological event requiring clinical evidence and biopsy confirmation by central pathologist. Graft loss was defined as either functional loss or physical loss. Day 1 is day of transplantation. | All treated participants were analyzed during the planned 3 year study N=12. Only 9 participants entered the LTE so N=9 for LTE. | Posted | Number | participants | Day 1 up to 4 years post transplantation |
|
|
|
| Secondary | Mean Change From Baseline to Days 5, 28, 112, 168, and 364 in Tryptophan - All Treated Participants | Indoleamine 2,3 dioxygenase (IDO) is a tryptophan catabolizing enzyme that can be induced in antigen-presenting cells by the engagement of B7 by cytotoxic lymphocyte antigen 4 (CTLA-4). Tryptophan depletion in cellular microenvironments has an inhibitory effect on T cells and may be part of a broader immuno-regulatory effect of IDO induction. The IDO activity was determined by measuring the quantity of tryptophan and its metabolite, kynurenine, in serum samples using a validated high performance liquid chromatography (HPLC) method. Baseline is defined as pre-dose. Tryptophan was measured in micromoles (µM) | Number analyzed for Baseline, Days 5, 28, 112, 168, 364 = 12, 11, 11, 10, 10, and 10, respectively. | Posted | Mean | Standard Deviation | µM | Baseline to Day 364 |
|
|
|
| Secondary | Mean Change From Baseline to Days 5, 28, 112, 168, and 364 in Kynurenine - All Treated Participants | Indoleamine 2,3 dioxygenase (IDO) is a tryptophan catabolizing enzyme that can be induced in antigen-presenting cells by the engagement of B7 by CTLA-4. Tryptophan depletion in cellular microenvironments has an inhibitory effect on T cells and may be part of a broader immuno-regulatory effect of IDO induction. The IDO activity was determined by measuring the quantity of tryptophan and its metabolite, kynurenine, in serum samples using a validated high performance liquid chromatography (HPLC) method. Baseline is defined as pre-dose. Kynurenine was measured in micromoles (µM). | Number analyzed for Baseline, Days 5, 28, 112, 168, 364 = 12, 11, 11, 10, 10, and 10, respectively. | Posted | Mean | Standard Deviation | µM | Day 1 to Day 364 |
|
|
|
| 6 |
| 12 |
| 12 |
| 12 |
| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Intracranial aneurysm | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Ureteral necrosis | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Blood creatine increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Meningitis viral | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Congenital cystic kidney disease | Congenital, familial and genetic disorders | MedDRA 15.1 | Systematic Assessment |
|
| Gastritis haemorrhagic | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Retroperitoneal haematoma | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA 15.1 | Systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 15.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Myelopathy | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Onychomycosis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pharyngotonsillitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Skin injury | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Eye haemorrhage | Eye disorders | MedDRA 15.1 | Systematic Assessment |
|
| Food poisoning | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Tinea versicolour | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 15.1 | Systematic Assessment |
|
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Arterial spasm | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Candidiasis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Chalazion | Eye disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Glucose tolerance impaired | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Molluscum contagiosum | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Scoliosis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Traumatic renal injury | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| BK virus infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Fluid overload | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Gastrointestinal sounds abnormal | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Graft dysfunction | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypocholesterolaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Incision site pain | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Infected cyst | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Overweight | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Perinephric effusion | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Renal vein thrombosis | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Wound evisceration | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Body tinea | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cervicobrachial syndrome | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cyst | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Genital discharge | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
|
| Genital lesion | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Leukocyturia | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Polycythaemia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Renal haemorrhage | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Amnesia | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Body temperature increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Retinal haemorrhage | Eye disorders | MedDRA 15.1 | Systematic Assessment |
|
| Urethral stenosis | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Exostosis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Incision site cellulitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Odynophagia | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Papule | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Furuncle | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Hiatus hernia | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Ischaemic ulcer | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Nocturia | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Seborrhoeic keratosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Tinea cruris | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Troponin increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Urine output increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Vaginal infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005916 | Globulins |
| Title | Measurements |
|---|---|
|
| Day 56 Post Transplantation (N=12) |
|
| Day 84 Post Transplantation |
|
| Day 112 Post Transplantation |
|
| Day 168 Post Transplantation |
|
| Day 364 Post Transplantation |
|
| Day 728 Post Transplantation |
|
| Day 1092 Post Transplantation |
|
| Title | Measurements |
|---|---|
|
|
| Day 168 Post Transplantation |
|
| Day 364 Post Transplantation |
|
| Title | Measurements |
|---|---|
|
| Day 168 Post Transplantation |
|
| Day 364 Post Transplantation |
|