## Protocol Section
### Identification Module
**NCT ID:** NCT01536379

**Brief Title:** A Study of Belimumab in the Prevention of Kidney Transplant Rejection

**Official Title:** BEL114424: A Phase 2 Pilot, Multicentered, Randomised, Double Blind, Placebo-Controlled Study to Evaluate the Potential for Efficacy and the Safety of Belimumab Plus Standard of Care Versus Placebo Plus Standard of Care in the Prevention of Allograft Rejection in Adult Subjects After Renal Transplantation

#### Organization Study ID Info
**ID:** 114424
#### Organization
**Class:** INDUSTRY
**Full Name:** GlaxoSmithKline
### Status Module
#### Completion Date
**Date:** 2016-02

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-04-25

**Type:** ACTUAL

**Last Update Submit Date:** 2017-03-14

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2016-02

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2017-04-25

**Type:** ACTUAL

**Results First Submit Date:** 2016-10-05

**Results First Submit QC Date:** 2017-03-14

#### Start Date
**Date:** 2013-09

**Status Verified Date:** 2017-03

#### Study First Post Date
**Date:** 2012-02-22
**Type:** ESTIMATED
**Study First Submit Date:** 2012-02-16
**Study First Submit QC Date:** 2012-02-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** GlaxoSmithKline

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Kidney transplantation is the best treatment for many patients with kidney failure. Sometimes a transplanted kidney is rejected by the patient's immune system. Many types of immune system cells, including B cells, are active in rejection. B cells produce antibodies against anything the body sees as non-self, like germs or a transplanted kidney. Most medicines that help prevent transplant rejection affect cells other than B cells. Belimumab is a medication used to treat a disease called lupus. Belimumab slows development of antibody-producing B cells. This study will test whether belimumab works on parts of the immune system that cause rejection. Twenty to thirty adults getting a kidney transplant will be in this study. Like flipping a coin, a computer will randomly assign half to be given belimumab and half to be given placebo (a fake medicine). Patients and doctors will not know which medicine was assigned until the study is over. A total of 7 doses of study medicine will be given through a vein. One dose will be given during transplant surgery, and the other 6 will be given 2, 4, 8, 12, 16 and 20 weeks after transplant surgery. Usual transplant medicines will also be given. After all of the doses have been given, patients will be watched and tested at 24, 36, and 52 weeks after the transplant surgery. Blood samples will be tested to see what study medicines do to the immune system in transplant patients. If patients get a kidney biopsy, the samples will be tested to see if belimumab had any effect. Patients will be asked many questions to see if they are having any side effects. The study will be done at Addenbrooke's Hospital in Cambridge and Guys \&St Thomas Hospital in London, United Kingdom. A pharmaceutical company, GlaxoSmithKline, is funding the study.

### Conditions Module

**Conditions:**

- Transplantation, Organ

**Keywords:**

- Infection

- Quality of Life

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 30

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Subjects will receive belimumab 10 mg/ Kilogram (kg) infusion on Days 0, 14, 28 and every 4 weeks thereafter for a total of 7 infusions. The last dose of investigational product will be administered at the Week 20 visit; In addition to investigational product, all subjects will receive standard of care.

**Intervention Names:**

- Drug: Belimumab

**Label:** Belimumab 10 mg

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Subjects will receive placebo infusion on Days 0, 14, 28 and every 4 weeks thereafter for a total of 7 infusions. The last dose of investigational product will be administered at the Week 20 visit; In addition to investigational product, all subjects will receive standard of care

**Intervention Names:**

- Drug: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Belimumab 10 mg

**Description:** Belimumab (10 mg/kg) will be given as an intravenous solution over a 1 hour time period administered every 4 weeks for 24 weeks (with an additional dose at Week 2)

**Name:** Belimumab

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo

**Description:** Placebo will be given as an intravenous solution over a 1 hour time period administered every 4 weeks for 24 weeks (with an additional dose at Week 2)

**Name:** Placebo

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Naive B cell is cell that is not exposed to antigen. Naïve B cell count is CD20+CD27 concentration of cells (conc-cell)/cubic millimeter (cumm). Change from Baseline in naïve B cells was calculated as the value at Week 24 minus the value at Baseline. MITT Population consisted of all participants randomized to treatment, who have had taken at least one dose of study. Participants analyzed included those who had data at Week 24 for naïve B cells count (MITT Population). Baseline value used in the analysis was of Day 0 (Day of transplant). Adjusted mean differences (treatment-placebo) and 95% confidence intervals for differences were obtained from mixed-models repeated-measures (MMRM) model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments.

**Measure:** Change From Baseline in naïve B Cells From Baseline to Week 24

**Time Frame:** Baseline and Week 24

**Description:** Number of participants with AEs, SAEs and AESI are summarized. The On-treatment (OT) phase started on the day and time of receiving the start of the first infusion and ended on the last dose date plus 28 days. The Post-treatment (PT) phase started 29 days after day of last dose up to 1 year. An AE is any untoward medical occurrence, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that at any dose results in, death, is life threatening, Requires hospitalization or prolongation of existing hospitalization, Results in disability/incapacity, Is a congenital anomaly/birth defect or event that but may jeopardize the subject or may require medical or surgical intervention to prevent one of the other outcomes listed. AESI included malignant neoplasms, infusion/anaphylaxis/hypersensitivity reactions, all infections, depression/suicide/self-injury, deaths.

**Measure:** Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)

**Time Frame:** Up to 1 year

**Description:** All infections included: 1. Opportunistic infections per-clinical assessment, 2. Herpes Zoster, a. Recurrent, b. Disseminated, 3. Sepsis. Opportunistic infections were identified using list of preferred terms as per Medical Dictionary for Regulatory Activities (MedDRA) version 18.1. Any events falling under these preferred terms were adjudicated to determine if criteria was met for an opportunistic infection.

**Measure:** Number of Incidence of All Infections and Serious Infections

**Time Frame:** Up to 1 year

**Description:** Change from Baseline in SBP and DBP were assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value at Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

**Measure:** Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 24 and Week 52

**Time Frame:** Baseline, Week 24 and Week 52

**Description:** Change from Baseline in heart rate was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value at Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

**Measure:** Change From Baseline in Heart Rate From Baseline at Week 24 and Week 52

**Time Frame:** Baseline, Week 24 and Week 52

**Description:** Change from Baseline in body temperature was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value at Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

**Measure:** Change From Baseline in Body Temperature From Baseline at Week 24 and Week 52

**Time Frame:** Baseline, Week 24 and Week 52

**Description:** Number of participants outside the normal range (NR) for SBP and DBP was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Number of participants outside the normal range are summarized by less than (\<) normal range and greater than (\>) normal range categories at Week 24 and Week 52. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

**Measure:** Number of Participants Outside the Normal Range (NR) for SBP and DBP at Week 24 and Week 52

**Time Frame:** Week 24 and Week 52

**Description:** Number of participants outside the normal range (NR) for heart rate was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Number of participants outside the normal range are summarized by less than (\<) normal range and greater than (\>) normal range categories at Week 24 and Week 52. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

**Measure:** Number of Participants Outside the Normal Range (NR) for Heart Rate at Week 24 and Week 52

**Time Frame:** Week 24 and Week 52

**Description:** Number of participants outside the normal range (NR) for body temperature was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Number of participants outside the normal range are summarized by less than (\<) normal range and greater than (\>) normal range categories at Week 24 and Week 52. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

**Measure:** Number of Participants Outside the Normal Range (NR) for Body Temperature at Week 24 and Week 52

**Time Frame:** Week 24 and Week 52

**Description:** Hematology parameters included: basophils (B), eosinophils (E), lymphocytes (L), monocytes (M), total neutrophils (N), platelet count (PC) and white blood cells (WBC). Change from Baseline in haematology parameter was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

**Measure:** Change From Baseline in the Indicated Hematology Parameters at Week 24 and Week 52

**Time Frame:** Baseline, Week 24 and Week 52

**Description:** Change from Baseline in hemoglobin was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

**Measure:** Change From Baseline in the Haematology Parameter- Hemoglobin at Week 24 and Week 52

**Time Frame:** Baseline, Week 24 and Week 52

**Description:** Endpoint was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

**Measure:** Change From Baseline in the Hematology Parameter- Hematocrit at Week 24 and Week 52

**Time Frame:** Baseline, Week 24 and Week 52

**Description:** Change from Baseline in MCH was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

**Measure:** Change From Baseline in Haematology Parameter- Mean Corposcular Hemoglobin (MCH) at Week 24 and Week 52

**Time Frame:** Baseline, Week 24 and Week 52

**Description:** Change from Baseline in MCV was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

**Measure:** Change From Baseline in Haematology Parameter- Mean Corposcular Volume (MCV) at Week 24 and Week 52

**Time Frame:** Baseline, Week 24 and Week 52

**Description:** Change from Baseline in RBC was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

**Measure:** Change From Baseline in Haematology Parameter- Red Blood Cell (RBC) at Week 24 and Week 52

**Time Frame:** Baseline, Week 24 and Week 52

**Description:** Change from Baseline in albumin was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

**Measure:** Change From Baseline in Clinical Chemistry Parameter- Albumin at Week 24 and Week 52

**Time Frame:** Baseline, Week 24 and Week 52

**Description:** Clinical chemistry parameter included alkaline phosphatase (ALP), alanine amino Transferase (ALT) and aspartate amino transferase (AST). Endpoint was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

**Measure:** Change From Baseline in Clinical Chemistry Parameter- ALP, ALT, AST at Week 24 and Week 52

**Time Frame:** Baseline, Week 24 and Week 52

**Description:** Clinical chemistry parameters included direct bilirubin (DB), total bilirubin (TB) and creatinine (C). Endpoint was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

**Measure:** Change From Baseline in Clinical Chemistry Parameter- Direct Bilirubin, Total Bilirubin and Creatinine at Week 24 and Week 52

**Time Frame:** Baseline, Week 24 and Week 52

**Description:** Clinical chemistry parameters included calcium (Ca), carbon dioxide content/bicarbonate (CO2/Bicar), glucose (Gl), potassium (K), sodium (Na), phosphorus inorganic (PhI), urea/blood urine nitrogen (U/BUN). Endpoint was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

**Measure:** Change From Baseline in Clinical Chemistry Parameter- Ca, CO2/Bicar, Gl, K, Na, PhI, U/BUN at Week 24 and Week 52

**Time Frame:** Baseline, Week 24 and Week 52

**Description:** Change from Baseline in GFR was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

**Measure:** Change From Baseline in Clinical Chemistry Parameter- Glomerular Filtration Rate (GFR) at Week 24 and Week 52

**Time Frame:** Baseline, Week 24 and Week 52

**Description:** Change from Baseline in immunoglobulins IgA, IgG and IgM was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

**Measure:** Change From Baseline in Immunoglobulin A (IgA), Immunoglobulin G (IgG) and Immunoglobulin M (IgM) at Week 24 and Week 52

**Time Frame:** Baseline, Week 24 and Week 52

#### Secondary Outcomes

**Description:** Memory B cells are B cell sub-type that are formed within germinal centres following primary infection and are important in generating an accelerated and more robust antibody-mediated immune response in the case of re-infection. Memory B cell count included CD20+CD27+ cells/mm\^3. Baseline value used in the analysis was of Day 0 (Day of transplant). Endpoint was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Percent change from Baseline in Memory B cell count was calculated as the value at Week 24 and Week 52 minus the value at Baseline multiplied by 100. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Median Difference and 95% confidence interval of difference obtained using the Hodges-Lehmann method.

**Measure:** Median Percent Change From Baseline in Memory B Cell Count at Week 24 and Week 52

**Time Frame:** Baseline, Week 24 and Week 52

**Description:** Activated memory B cell-CD95% count is CD19+CD27+CD95 conc-cells/mL. Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

**Measure:** Activated Memory B Cells Count at Week 24 and Week 52

**Time Frame:** Week 24 and Week 52

**Description:** Activated memory B cell-CD95% percentage is CD19+CD27+CD95+ (%CD19/CD27). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

**Measure:** Activated Memory B Cells Percentage at Week 24 and Week 52

**Time Frame:** Week 24 and Week 52

**Description:** Transitional B cell count (Newell) is CD19+CD24b+CD38b+IgD+ (Conc-cells/mL). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

**Measure:** Transitional B Cells Count at Week 24 and Week 52

**Time Frame:** Week 24 and Week 52

**Description:** Transitional B cell percentage (Newell) is CD19+CD24b+CD38b+IgD+ (%CD19+). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

**Measure:** Transitional B Cells Percentage at Week 24 and Week 52

**Time Frame:** Week 24 and Week 52

**Description:** A T cell is a type of lymphocyte that plays a central role in cell-mediated immunity. Activated T cell count Codarri is CD4+ CD25hi CD45RA- IL 7Rhi (Conc-cells/mL). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

**Measure:** Activated T Cell Count at Week 24 and Week 52

**Time Frame:** Week 24 and Week 52

**Description:** Activated T cell percentage (Codarri)= CD4+ CD25hi CD45RA- IL 7Rhi (% of CD4+). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

**Measure:** Activated T Cell Percentage at Week 24 and Week 52

**Time Frame:** Week 24 and Week 52

**Description:** Regulatory T cell count is CD4+ CD25hi IL-7Rlo (Conc-cells/mL). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

**Measure:** Regulatory T Cell Count at Week 24 and Week 52

**Time Frame:** Week 24 and Week 52

**Description:** Regulatory T cell (%CD4) = CD4+ CD25hi IL-7Rlo (% of CD4+). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

**Measure:** Regulatory T Cell (%CD4) at Week 24 and Week 52

**Time Frame:** Week 24 and Week 52

**Description:** Activated: regulatory T cell ratio is Activated T cell CD4+CD25hi CD45RA IL 7Rhi (absolute number)/ Regulatory T cell CD4+CD25hi CD45RA IL 7Rlo (absolute number). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

**Measure:** Mean Activated: Regulatory T Cell Ratio at Week 24 and Week 52

**Time Frame:** Week 24 and Week 52

**Description:** The endpoint diagnosis was made by a proven biopsy result. Number of rejections only counted once per participant. The proportion of participants with episodes of acute rejection was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

**Measure:** Proportion of Participants With Episodes of Acute Rejection at Week 24 and Week 52

**Time Frame:** Week 24 and Week 52

**Description:** Adjusted mean difference for serum creatinine values (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction, at Week 24 and Week 52. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

**Measure:** Mean Serum Creatinine at Week 24 and Week 52

**Time Frame:** Week 24 and Week 52

**Description:** The estimated glomerular filtration rate (eGFR) were calculated by the abbreviated Modification of Diet in Renal Disease (MDRD) equation. Adjusted mean difference(treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction at Week 24 and Week 52. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the indicated time points were analyzed (represented by n= X, X in the category titles).

**Measure:** Mean eGFR at Week 24 and Week 52

**Time Frame:** Week 24 and Week 52

**Description:** Adjusted mean difference (treatment-placebo) for Prednisolone use and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction at Week 24. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments Only those participants available at indicated timepoints were analyzed (represented by n=X, X in the category titles).

**Measure:** Mean Prednisolone Use at Week 24

**Time Frame:** Week 24

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Eligible for kidney transplantation: Considered eligible for transplantation after undergoing multidisciplinary evaluation at the institution at which the transplantation will be performed
* Donor characteristics: Receiving a deceased donor kidney or a living donor kidney allograft
* Age \& Gender: Male or female between 18 and 75 years of age, inclusive, at the time of signing the informed consent
* Female Subjects: Not pregnant or nursing and at least one of the following conditions apply: a. Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy or postmenopausal defined as 12 months of spontaneous amenorrhea. In the absence of confirmatory laboratory assessments \[(a blood sample with simultaneous follicle stimulating hormone (FSH) \> 40 million international units per milliliter (MIU/mL) and estradiol \< 40 picogram per milliliter (pg/mL) (\<147 picomole per liter \[pmol/L\])\] in questionable cases, female subjects will be required to use one of the contraception methods as described by the investigator or designee, until confirmatory results become available; b. Questionable post-menopausal status and agrees to use one of the contraception methods as described by the investigator or designee, from Day 0 until 16 weeks after the last dose of investigational product or until postmenopausal status is confirmed with a blood sample with simultaneous follicle stimulating hormone (FSH) \> 40 MIU/mL and estradiol status who are using hormone replacement therapy (HRT) will be required to use one of the contraception methods as described by the investigator or designee, until post-menopausal status is confirmed. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method; c. Child-bearing potential and agrees to use one of the contraception methods as described by the investigator or designee, from Day 0 until 16 weeks after the last dose of investigational product.
* Liver function (most recent values available before transplantation): alanine aminotransferase (ALT) \< 2x upper limit of normal (ULN); bilirubin \<= 1.5xULN (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%).
* Immunosuppressants: at the time of transplantation, planned to receive a combination of immunosuppressants including basiliximab, mycophenolate mofetil, tacrolimus, prednisolone

Exclusion Criteria:

* Donor characteristics: receiving a kidney allograft from a donor with any of the following characteristics: a) cold ischemic time exceeding 36 hours; b) age \< 5 years old; c) for donors after brain death (DBD), age \>70 years old; d) for donors after cardiac death (DCD) age \>70 years old; e) ABO blood type incompatible against the recipient; f) 0 0 0 HLA-A -B -DR mismatch against the recipient by National Health Service Blood and Transplant (NHSBT criteria; g) T- and/or B-cell positive crossmatch by complement dependent cytotoxicity or flow cytometry against the recipient. Note :- (In some situations it may be that a pre-existing T- and/or B-cell positive crossmatch by complement dependent cytotoxicity or flow cytometry against the recipient will only be fully revealed immediately after the transplant; in such situations they will be recorded as having met exclusion criteria and withdraw from further involvement in the study; h) serology positive for hepatitis B (except hepatitis B surface antibody and prior vaccination), hepatitis C or human immunodeficiency virus (HIV)
* Transplant other than kidney: has previously received a hematopoietic stem cell/marrow transplant or an organ transplant other than a kidney (with the exception of corneal transplantation)
* Planned immunosuppressant regimen: are being considered for steroid-free or alemtuzumab induction
* Prior therapy at any time: has ever received any of the following: a) B-cell targeted therapy (e.g., rituximab, other anti-CD20 agents, anti-CD22 \[epratuzumab\], anti-CD52 \[alemtuzumab\], BLyS-receptor fusion protein \[BR3\], TACI fragment, crystallizable (Fc), or belimumab)
* 364 Day prior therapy: has received any of the following within 364 days before Day 0: a) Cyclophosphamide; b) Abatacept; c) A biologic investigational agent other than B-cell targeted therapy \[e.g., abetimus sodium, anti CD40L antibody (e.g., BG9588/ IDEC 131; investigational agent applies to any drug not approved for sale in the country in which it is being used\]
* 90 Day prior therapy: has received any of the following within 90 days before Day 0: a) Anti- Tumor necrosis factor (TNF) or anti-Interleukin (IL)-6 therapy (e.g., adalimumab, etanercept, infliximab, tocilizumab); b) Interleukin-1 receptor antagonists (e.g., anakinra); c) Intravenous immunoglobulin (IVIG); d) Plasmapheresis, leukapheresis
* 60 Day prior therapy: has received any of the following within 60 days before Day 0: a) A non-biologic investigational agent (investigational agent applies to any drug not approved for sale in the country in which it is being used); b) Any new immunosuppressive/immunomodulatory agent; tacrolimus, Mycophenolate mofetil (MMF), and corticosteroids are permitted. Inhaled steroids and new topical immunosuppressive agents (e.g., eye drops, topical creams) are also allowed.
* 30 Day prior therapy: has received any of the following within 30 days before Day 0: a) A live vaccine; b) An increase in dose of an immunosuppressive/immunomodulatory agent (decreases in dose or discontinuations are permitted). Increases in doses of tacrolimus, MMF, and corticosteroids are permitted.
* Malignancy: has a history of malignancy in the past 5 years except for adequately treated cancers of the skin (basal or squamous cell) or carcinoma in situ of the uterine cervix.
* Acute or chronic infection: has required management of acute or chronic infections (excludes prophylaxis of infections), as follows: a) Currently receiving any suppressive therapy for a chronic infection (such as tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteria), which, in the opinion of the investigator, could put the subject at undue risk; b) Hospitalized for treatment of infection within 30 days before Day 0, which, in the opinion of the investigator, could put the subject at undue risk ; c) Treated for an infection with parenteral (intravenous or intramuscular)\] antibiotics (antibacterials, antivirals, anti-fungals, or anti-parasitic agents) within 30 days before Day 0, which, in the opinion of the investigator, could put the subject at undue risk
* Other disease/conditions: has any of the following: a) clinical evidence of significant unstable or uncontrolled acute or chronic diseases (i.e., cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, neurological, malignancy or infectious diseases) which, in the opinion of the investigator, could confound the results of the study or put the subject at undue risk; b) a surgical procedure planned in the 6 months after Day 0, other than kidney transplantation or related procedure; c) a known history of any other medical disease (e.g., cardiopulmonary), laboratory abnormality, or condition (e.g., poor venous access) that, in the opinion of the investigator, makes the subject unsuitable for the study
* Hepatitis: known to have serologic evidence of hepatitis B infection based on the results of testing for hepatitis B surface antigen (HBsAg), or antibodies against hepatitis B core antigen (HBc) and/or hepatitis B surface antigen (HBs) as follows: a) Patients positive for HBsAg are excluded; ) Patients negative for HBsAg and anti-HBc antibody but positive for anti-HBs antibody and with no history of hepatitis B vaccination are excluded; c) Patients negative for HBsAg but positive for both anti-HBc and anti-HBs antibodies are excluded; d) Patients negative for HBsAg and anti-HBs antibody but positive for anti-HBc antibody are excluded; e) Or has known serologic evidence of hepatitis C infection based on the results of testing for hepatitis C antibody and hepatitis C recombinant immunoblot assay (RIBA) as follows: Patients with a positive test for Hepatitis C antibody confirmed on the same sample with a Hepatitis C RIBA immunoblot assay. Patients who are positive for Hepatitis C antibody, and who are negative when the Hepatitis C RIBA immunoblot assay is performed on the same sample, will be eligible to participate. Patients who are positive for Hepatitis C antibody and who have a positive or indeterminate result when the Hepatitis C RIBA immunoblot assay is performed on the same sample, will not be eligible to participate.
* HIV: known to have a historically positive HIV test or tests positive at screening for HIV.
* Immunodeficiency: recipient with a history of immunodeficiency (defined as Immunoglobulin A isotype (IgA) level \<10 milligrams per deciliter (mg/dL) or have Immunoglobulin G isotype (IgG) level \<400 mg/dL).
* Laboratory abnormalities: has an abnormal laboratory assessment, which is judged clinically significant by the investigator.
* Lymphopenia: has a lymphocyte count \<500/ millimeter (mm)\^3.
* Drug Sensitivity: has a history of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy including a previous anaphylactic reaction to parenteral administration contrast agents, human or murine proteins or monoclonal antibodies that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.
* Substance abuse: has evidence of current drug or alcohol abuse or dependence.
* Blood donation: where participation in the study would result in donation of blood or blood products in excess of 700 mL within a 56-day period
* Venous access: has venous access limitations likely to preclude monthly infusions
* Compliance: is unlikely to comply with scheduled study visits based on investigator judgment or has a history of substance abuse, psychiatric disorder or condition that may compromise communication with the investigator

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Cambridge

**Country:** United Kingdom

**Facility:** GSK Investigational Site

**Zip:** CB2 0QQ

**Location 2:**

**City:** London

**Country:** United Kingdom

**Facility:** GSK Investigational Site

**Zip:** SE1 9RT

#### Overall Officials

**Official 1:**

**Affiliation:** GlaxoSmithKline

**Name:** GSK Clinical Trials

**Role:** STUDY_DIRECTOR

### References Module

#### References

**Citation:** Banham GD, Flint SM, Torpey N, Lyons PA, Shanahan DN, Gibson A, Watson CJE, O'Sullivan AM, Chadwick JA, Foster KE, Jones RB, Devey LR, Richards A, Erwig LP, Savage CO, Smith KGC, Henderson RB, Clatworthy MR. Belimumab in kidney transplantation: an experimental medicine, randomised, placebo-controlled phase 2 trial. Lancet. 2018 Jun 30;391(10140):2619-2630. doi: 10.1016/S0140-6736(18)30984-X. Epub 2018 Jun 14.

**PMID:** 29910042

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T6034

- Name: Quality of Life

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Ancestors

- ID: D000007166

- Term: Immunosuppressive Agents

- ID: D000007155

- Term: Immunologic Factors

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

- ID: M287398

- Name: Belimumab

- Relevance: HIGH

- As Found: Inject

- ID: M10212

- Name: Immunosuppressive Agents

- Relevance: LOW

- As Found: Unknown

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000511911

- Term: Belimumab

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** On-treatment SAEs and non-serious AEs are reported for MITT Population.

#### Event Groups

**Group ID:** EG000

**Title:** Placebo

**Description:** Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.

**ID:** EG000

**Other Num Affected:** 9

**Other Num at Risk:** 13

**Serious Number Affected:** 7

**Serious Number At Risk:** 13

**Title:** Placebo

**Group ID:** EG001

**Title:** Belimumab 10mg/kg

**Description:** Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.

**ID:** EG001

**Other Num Affected:** 9

**Other Num at Risk:** 12

**Serious Number Affected:** 5

**Serious Number At Risk:** 12

**Title:** Belimumab 10mg/kg

**Frequency Threshold:** 5

#### Other Events

**Term:** Diarrhoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA version 18.1

**Term:** Leukopenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA version 18.1

**Term:** Urinary tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version 18.1

**Term:** Anaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA version 18.1

**Term:** Dyspepsia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA version 18.1

**Term:** Alanine aminotransferase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA version 18.1

**Term:** Lower respiratory tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version 18.1

**Term:** Nasopharyngitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version 18.1

**Term:** Polyomavirus test positive

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA version 18.1

**Term:** Diabetes mellitus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA version 18.1

**Term:** Dizziness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA version 18.1

**Term:** Oesophagitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA version 18.1

**Term:** Tonsillitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version 18.1

**Term:** Vomiting

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA version 18.1

**Term:** Wound infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version 18.1

**Term:** Anaemia vitamin B12 deficiency

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA version 18.1

**Term:** Cold sweat

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA version 18.1

**Term:** Cough

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA version 18.1

**Term:** Cytomegalovirus test positive

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA version 18.1

**Term:** Duodenal ulcer

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA version 18.1

**Term:** Duodenitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA version 18.1

**Term:** Epstein-Barr virus test positive

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA version 18.1

**Term:** Headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA version 18.1

**Term:** Hip fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA version 18.1

**Term:** Hyperhidrosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA version 18.1

**Term:** Hypertension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA version 18.1

**Term:** Infusion related reaction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA version 18.1

**Term:** Iron deficiency anaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA version 18.1

**Term:** Migraine

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA version 18.1

**Term:** Mouth ulceration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA version 18.1

**Term:** Myalgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA version 18.1

**Term:** Onychomycosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version 18.1

**Term:** Oral candidiasis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version 18.1

**Term:** Palpitations

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA version 18.1

**Term:** Paraesthesia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA version 18.1

**Term:** Pneumonia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version 18.1

**Term:** Polycythaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA version 18.1

**Term:** Polyomavirus-associated nephropathy

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version 18.1

**Term:** Renal artery stenosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA version 18.1

**Term:** Renal cyst infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version 18.1

**Term:** Respiratory disorder

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA version 18.1

**Term:** Tachycardia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA version 18.1

**Term:** Thrombocytopenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA version 18.1

**Term:** Tremor

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA version 18.1

**Term:** Ulcerative gastritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA version 18.1

**Term:** Upper respiratory tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version 18.1

**Term:** Urinary tract infection enterococcal

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version 18.1

**Term:** Vasculitic rash

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA version 18.1

**Term:** Vertigo

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Ear and labyrinth disorders

**Source Vocabulary:** MedDRA version 18.1

**Term:** Vulvovaginal candidiasis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version 18.1

#### Serious Events

**Term:** Acute myocardial infarction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA version 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 13

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 12

**Term:** Alanine aminotransferase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA version 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 13

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 12

**Term:** Anaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA version 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 13

**Num Events:** 3

**Group ID:** EG001

**Num At Risk:** 12

**Term:** Blood creatinine increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA version 18.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 13

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 12

**Num Events:** 1

**Term:** Cardiac failure acute

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA version 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 13

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 12

**Term:** Cellulitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 13

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 12

**Term:** Clostridium difficile colitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version 18.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 13

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 12

**Num Events:** 1

**Term:** Colitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA version 18.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 13

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 12

**Num Events:** 1

**Term:** Dehydration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA version 18.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 13

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 12

**Num Events:** 1

**Term:** Delirium

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA version 18.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 13

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 12

**Num Events:** 1

**Term:** Diarrhoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA version 18.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 13

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 12

**Num Events:** 1

**Term:** Escherichia urinary tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 13

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 12

**Term:** Focal segmental glomerulosclerosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA version 18.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 13

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 12

**Num Events:** 1

**Term:** Glomerulonephritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA version 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 13

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 12

**Term:** Hip fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA version 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 13

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 12

**Term:** Lymphocele

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA version 18.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 13

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 12

**Num Events:** 1

**Term:** Pneumonia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version 18.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 13

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 12

**Num Events:** 1

**Term:** Pulmonary oedema

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA version 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 13

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 12

**Term:** Renal cyst infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 13

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 12

**Term:** Tonsillitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 13

**Num Events:** 2

**Group ID:** EG001

**Num At Risk:** 12

**Term:** Transplant rejection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Immune system disorders

**Source Vocabulary:** MedDRA version 18.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 13

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 12

**Num Events:** 1

**Term:** Urinary tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 13

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 12

**Term:** Urosepsis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version 18.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 13

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 12

**Num Events:** 1

**Term:** Wound infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version 18.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 13

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 12

**Num Events:** 1

**Time Frame:** Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 52 weeks).

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 13

**Group ID:** BG001

**Value:** 12

**Group ID:** BG002

**Value:** 25

**Units:** Participants

### Group

**ID:** BG000

**Title:** Placebo

**Description:** Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.

### Group

**ID:** BG001

**Title:** Belimumab 10mg/kg

**Description:** Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 14.02

**Value:** 51.0

#### Measurement

**Group ID:** BG001

**Spread:** 11.02

**Value:** 54.3

#### Measurement

**Group ID:** BG002

**Spread:** 12.52

**Value:** 52.6

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 4

#### Measurement

**Group ID:** BG001

**Value:** 7

#### Measurement

**Group ID:** BG002

**Value:** 11

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 9

#### Measurement

**Group ID:** BG001

**Value:** 5

#### Measurement

**Group ID:** BG002

**Value:** 14

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 12

#### Measurement

**Group ID:** BG001

**Value:** 11

#### Measurement

**Group ID:** BG002

**Value:** 23

**Class Title:** White/Caucasian

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 2

**Class Title:** Asian

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** Years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** NUMBER
**Title:** Race/Ethnicity, Customized
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
**Other Details:** GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Point of Contact
**Organization:** GlaxoSmithKline
**Phone:** 866-435-7343
**Title:** GSK Response Center
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** -109.5
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 40.7
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 37.24
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -34.4
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
### Outcome Measure 7
### Outcome Measure 8
### Outcome Measure 9
### Outcome Measure 10
### Outcome Measure 11
### Outcome Measure 12
### Outcome Measure 13
### Outcome Measure 14
### Outcome Measure 15
### Outcome Measure 16
### Outcome Measure 17
### Outcome Measure 18
### Outcome Measure 19
### Outcome Measure 20
### Outcome Measure 21
### Outcome Measure 22
#### Analysis
**CI Lower Limit:** 90.00
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 550.00
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Week 24 comparison
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Median Difference (Final Values)
**Parameter Value:** 204.35
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** -169.84
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 25.00
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Week 52 comparison
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Median Difference (Final Values)
**Parameter Value:** -33.06
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
### Outcome Measure 23
#### Analysis
**CI Lower Limit:** -50457.0
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 52921.8
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 25735.56
**Estimate Comment:** Week 24 comparison
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 1232.40
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** -61868.9
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 35612.2
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 24165.18
**Estimate Comment:** Week 52 comparison
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -13128.35
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
### Outcome Measure 24
#### Analysis
**CI Lower Limit:** -31.3
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 3.7
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 8.78
**Estimate Comment:** Week 24 comparison
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -13.8
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** -8.6
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 22.2
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 7.68
**Estimate Comment:** Week 52 comparison
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 6.8
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
### Outcome Measure 25
#### Analysis
**CI Lower Limit:** -12105
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 6524
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 4651.1
**Estimate Comment:** Week 24 comparison
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -2791
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** -9487
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 8572
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 4501.8
**Estimate Comment:** Week 52 comparison
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -458
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
### Outcome Measure 26
#### Analysis
**CI Lower Limit:** -3.59
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.01
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 1.156
**Estimate Comment:** Week 24 comparison
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -1.29
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** -1.24
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 2.82
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 1.017
**Estimate Comment:** Week 52 comparison
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 0.79
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
### Outcome Measure 27
#### Analysis
**CI Lower Limit:** -100559.1
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 39905.3
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 34677.86
**Estimate Comment:** Week 24 comparison
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -30326.9
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** -113218.9
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 19308.3
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 32594.81
**Estimate Comment:** Week 52 comparison
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -46955.3
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
### Outcome Measure 28
#### Analysis
**CI Lower Limit:** -10.1
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 4.2
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 3.54
**Estimate Comment:** Week 24 comparison
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -3.0
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** -7.2
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 6.3
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 3.35
**Estimate Comment:** Week 52 comparison
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -0.4
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
### Outcome Measure 29
#### Analysis
**CI Lower Limit:** -24661.1
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 25957.7
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 12618.44
**Estimate Comment:** Week 24 comparison
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 648.3
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** -29994.8
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 18757.0
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 12153.03
**Estimate Comment:** Week 52 comparison
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -5618.9
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
### Outcome Measure 30
#### Analysis
**CI Lower Limit:** -3.2
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 3.5
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 1.67
**Estimate Comment:** Week 24 comparison
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 0.1
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** -3.5
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 2.3
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 1.45
**Estimate Comment:** Week 52 comparison
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -0.6
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
### Outcome Measure 31
#### Analysis
**CI Lower Limit:** -4.07
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.98
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 1.255
**Estimate Comment:** Week 24 comparison
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -1.54
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** -3.68
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.67
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 1.329
**Estimate Comment:** Week 52 comparison
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -1.01
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
### Outcome Measure 32
#### Analysis
**CI Lower Limit:** -0.638
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.505
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Week 24 comparison
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Difference in Proportion
**Parameter Value:** -0.067
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** -0.838
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.305
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Week 52 comparison
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Difference in Proportion
**Parameter Value:** -0.267
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
### Outcome Measure 33
#### Analysis
**CI Lower Limit:** -105.9
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 100.3
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 52.06
**Estimate Comment:** Week 24 comparison
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -2.8
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** -107.1
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 81.4
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 47.52
**Estimate Comment:** Week 52 comparison
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -12.9
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
### Outcome Measure 34
#### Analysis
**CI Lower Limit:** -31.56
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 5.71
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 9.440
**Estimate Comment:** Week 24 comparison
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -12.92
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** -19.11
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 13.72
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 8.315
**Estimate Comment:** Week 52 comparison
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -2.70
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
### Outcome Measure 35
#### Analysis
**CI Lower Limit:** -4.84
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 3.96
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 2.225
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -0.44
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 25.55
- **Upper Limit:** 
- **Value:** 4.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 27.50
- **Upper Limit:** 
- **Value:** -30.4
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 10
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 11
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 10
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 14.3275
- **Upper Limit:** 
- **Value:** -4.444
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 13.8289
- **Upper Limit:** 
- **Value:** 7.286
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 13.9668
- **Upper Limit:** 
- **Value:** -6.545
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 8.5479
- **Upper Limit:** 
- **Value:** 4.200
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 26.0960
- **Upper Limit:** 
- **Value:** 2.000
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 35.9444
- **Upper Limit:** 
- **Value:** 10.000
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 27.2046
- **Upper Limit:** 
- **Value:** -2.909
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 27.9008
- **Upper Limit:** 
- **Value:** 3.300
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 16.8983
- **Upper Limit:** 
- **Value:** 5.125
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 13.6345
- **Upper Limit:** 
- **Value:** 1.500
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 11.5065
- **Upper Limit:** 
- **Value:** 2.000
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 15.4200
- **Upper Limit:** 
- **Value:** -2.444
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.7025
- **Upper Limit:** 
- **Value:** 0.025
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.5007
- **Upper Limit:** 
- **Value:** -0.233
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.4803
- **Upper Limit:** 
- **Value:** -0.045
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.5417
- **Upper Limit:** 
- **Value:** 0.030
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
#### Outcome Measure 10
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.0215
- **Upper Limit:** 
- **Value:** -0.001
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.0207
- **Upper Limit:** 
- **Value:** -0.015
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.1024
- **Upper Limit:** 
- **Value:** 0.033
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.0357
- **Upper Limit:** 
- **Value:** -0.005
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.0250
- **Upper Limit:** 
- **Value:** -0.531
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.1274
- **Upper Limit:** 
- **Value:** -0.140
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.8048
- **Upper Limit:** 
- **Value:** -0.392
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.1489
- **Upper Limit:** 
- **Value:** -0.127
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.6457
- **Upper Limit:** 
- **Value:** -0.218
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.3467
- **Upper Limit:** 
- **Value:** -0.347
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.5841
- **Upper Limit:** 
- **Value:** 0.085
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.3357
- **Upper Limit:** 
- **Value:** -0.245
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.2231
- **Upper Limit:** 
- **Value:** -0.097
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.3509
- **Upper Limit:** 
- **Value:** -0.365
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.1799
- **Upper Limit:** 
- **Value:** 0.001
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.3892
- **Upper Limit:** 
- **Value:** -0.111
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.6602
- **Upper Limit:** 
- **Value:** 0.946
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.4752
- **Upper Limit:** 
- **Value:** -0.083
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.5533
- **Upper Limit:** 
- **Value:** 1.657
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 3.3406
- **Upper Limit:** 
- **Value:** -0.606
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 59.64
- **Upper Limit:** 
- **Value:** 15.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 40.35
- **Upper Limit:** 
- **Value:** 7.3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 55.81
- **Upper Limit:** 
- **Value:** 18.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 54.14
- **Upper Limit:** 
- **Value:** -10.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.483
- **Upper Limit:** 
- **Value:** 0.10
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.868
- **Upper Limit:** 
- **Value:** -0.95
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.572
- **Upper Limit:** 
- **Value:** 1.47
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 3.557
- **Upper Limit:** 
- **Value:** -1.11
**Title:** 
#### Outcome Measure 11
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 24.84
- **Upper Limit:** 
- **Value:** 5.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 28.90
- **Upper Limit:** 
- **Value:** 13.2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 22.69
- **Upper Limit:** 
- **Value:** 12.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 23.48
- **Upper Limit:** 
- **Value:** 6.3
**Title:** 
#### Outcome Measure 12
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.06625
- **Upper Limit:** 
- **Value:** 0.0216
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.09540
- **Upper Limit:** 
- **Value:** 0.0477
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.06813
- **Upper Limit:** 
- **Value:** 0.0434
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.07045
- **Upper Limit:** 
- **Value:** 0.0238
**Title:** 
#### Outcome Measure 13
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.173
- **Upper Limit:** 
- **Value:** -0.79
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.683
- **Upper Limit:** 
- **Value:** -1.37
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.516
- **Upper Limit:** 
- **Value:** -1.59
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.743
- **Upper Limit:** 
- **Value:** -1.93
**Title:** 
#### Outcome Measure 14
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 6.430
- **Upper Limit:** 
- **Value:** -1.73
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 8.198
- **Upper Limit:** 
- **Value:** -2.55
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 4.340
- **Upper Limit:** 
- **Value:** -3.58
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 7.041
- **Upper Limit:** 
- **Value:** -4.61
**Title:** 
#### Outcome Measure 15
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.6716
- **Upper Limit:** 
- **Value:** 0.298
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.8097
- **Upper Limit:** 
- **Value:** 0.645
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.7064
- **Upper Limit:** 
- **Value:** 0.635
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.5884
- **Upper Limit:** 
- **Value:** 0.468
**Title:** 
#### Outcome Measure 16
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.62
- **Upper Limit:** 
- **Value:** 4.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 4.91
- **Upper Limit:** 
- **Value:** 2.9
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.00
- **Upper Limit:** 
- **Value:** 2.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 4.98
- **Upper Limit:** 
- **Value:** 1.8
**Title:** 
#### Outcome Measure 17
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 26.14
- **Upper Limit:** 
- **Value:** -16.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 60.03
- **Upper Limit:** 
- **Value:** -5.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 35.25
- **Upper Limit:** 
- **Value:** -17.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 80.63
- **Upper Limit:** 
- **Value:** 19.9
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 15.86
- **Upper Limit:** 
- **Value:** 1.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 7.56
- **Upper Limit:** 
- **Value:** 5.1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 11.16
- **Upper Limit:** 
- **Value:** -2.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 5.80
- **Upper Limit:** 
- **Value:** 2.1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 7.91
- **Upper Limit:** 
- **Value:** 3.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 4.04
- **Upper Limit:** 
- **Value:** 7.3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 5.68
- **Upper Limit:** 
- **Value:** 3.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 3.86
- **Upper Limit:** 
- **Value:** 9.3
**Title:** 
#### Outcome Measure 18
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.51
- **Upper Limit:** 
- **Value:** 0.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 3.06
- **Upper Limit:** 
- **Value:** -0.7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.54
- **Upper Limit:** 
- **Value:** 0.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.30
- **Upper Limit:** 
- **Value:** 0.2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 6.50
- **Upper Limit:** 
- **Value:** 3.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 5.22
- **Upper Limit:** 
- **Value:** 2.7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 5.26
- **Upper Limit:** 
- **Value:** 2.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 3.38
- **Upper Limit:** 
- **Value:** 2.9
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 317.54
- **Upper Limit:** 
- **Value:** -471.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 183.53
- **Upper Limit:** 
- **Value:** -571.3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 310.54
- **Upper Limit:** 
- **Value:** -468.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 271.89
- **Upper Limit:** 
- **Value:** -609.8
**Title:** 
#### Outcome Measure 19
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.1344
- **Upper Limit:** 
- **Value:** 0.116
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.1942
- **Upper Limit:** 
- **Value:** 0.167
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.1013
- **Upper Limit:** 
- **Value:** 0.116
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.1386
- **Upper Limit:** 
- **Value:** 0.128
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 5.951
- **Upper Limit:** 
- **Value:** -3.73
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 3.449
- **Upper Limit:** 
- **Value:** 1.70
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 5.142
- **Upper Limit:** 
- **Value:** -2.68
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 3.588
- **Upper Limit:** 
- **Value:** 0.77
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.093
- **Upper Limit:** 
- **Value:** 0.20
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.003
- **Upper Limit:** 
- **Value:** -0.04
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.483
- **Upper Limit:** 
- **Value:** -0.32
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 4.107
- **Upper Limit:** 
- **Value:** 1.79
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.723
- **Upper Limit:** 
- **Value:** 0.06
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.923
- **Upper Limit:** 
- **Value:** -0.63
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.535
- **Upper Limit:** 
- **Value:** -0.02
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.877
- **Upper Limit:** 
- **Value:** -0.44
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 4.03
- **Upper Limit:** 
- **Value:** -0.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 5.01
- **Upper Limit:** 
- **Value:** 5.9
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.71
- **Upper Limit:** 
- **Value:** -0.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 4.71
- **Upper Limit:** 
- **Value:** 2.2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.3843
- **Upper Limit:** 
- **Value:** -0.225
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.5862
- **Upper Limit:** 
- **Value:** -0.913
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.4234
- **Upper Limit:** 
- **Value:** -0.227
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.5453
- **Upper Limit:** 
- **Value:** -0.726
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 12.164
- **Upper Limit:** 
- **Value:** -5.91
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 9.128
- **Upper Limit:** 
- **Value:** -9.47
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 14.967
- **Upper Limit:** 
- **Value:** -8.13
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 7.323
- **Upper Limit:** 
- **Value:** -9.01
**Title:** 
#### Outcome Measure 20
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 23.604
- **Upper Limit:** 
- **Value:** 42.80
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 10.731
- **Upper Limit:** 
- **Value:** 44.36
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 29.140
- **Upper Limit:** 
- **Value:** 42.33
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 15.176
- **Upper Limit:** 
- **Value:** 53.75
**Title:** 
#### Outcome Measure 21
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.2828
- **Upper Limit:** 
- **Value:** -0.500
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.6429
- **Upper Limit:** 
- **Value:** -0.433
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.0000
- **Upper Limit:** 
- **Value:** -0.300
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.5292
- **Upper Limit:** 
- **Value:** -0.500
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.184
- **Upper Limit:** 
- **Value:** -1.02
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.731
- **Upper Limit:** 
- **Value:** -2.40
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.595
- **Upper Limit:** 
- **Value:** 0.78
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.702
- **Upper Limit:** 
- **Value:** -2.13
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.0000
- **Upper Limit:** 
- **Value:** -0.100
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.3512
- **Upper Limit:** 
- **Value:** -0.133
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.0000
- **Upper Limit:** 
- **Value:** 0.0000
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.4933
- **Upper Limit:** 
- **Value:** -0.333
**Title:** 
#### Outcome Measure 22
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -88
- **Spread:** 
- **Upper Limit:** 320
- **Value:** -12.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 40
- **Spread:** 
- **Upper Limit:** 800
- **Value:** 177.8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -67
- **Spread:** 
- **Upper Limit:** 340
- **Value:** 2.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -80
- **Spread:** 
- **Upper Limit:** 44
- **Value:** -33.3
**Title:** 
#### Outcome Measure 23
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 16664.42
- **Upper Limit:** 
- **Value:** 37157.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 18682.83
- **Upper Limit:** 
- **Value:** 38389.6
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 15744.17
- **Upper Limit:** 
- **Value:** 24220.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 17711.36
- **Upper Limit:** 
- **Value:** 11092.5
**Title:** 
#### Outcome Measure 24
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 5.94
- **Upper Limit:** 
- **Value:** 32.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 6.06
- **Upper Limit:** 
- **Value:** 19.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 5.07
- **Upper Limit:** 
- **Value:** 32.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 5.48
- **Upper Limit:** 
- **Value:** 38.8
**Title:** 
#### Outcome Measure 25
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2910.9
- **Upper Limit:** 
- **Value:** 5470
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 3518.4
- **Upper Limit:** 
- **Value:** 2679
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2836.7
- **Upper Limit:** 
- **Value:** 7110
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 3291.5
- **Upper Limit:** 
- **Value:** 6652
**Title:** 
#### Outcome Measure 26
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.776
- **Upper Limit:** 
- **Value:** 2.43
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.869
- **Upper Limit:** 
- **Value:** 1.14
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.713
- **Upper Limit:** 
- **Value:** 2.61
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.731
- **Upper Limit:** 
- **Value:** 3.41
**Title:** 
#### Outcome Measure 27
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 22998.02
- **Upper Limit:** 
- **Value:** 109279.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 26155.19
- **Upper Limit:** 
- **Value:** 78952.7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 21898.24
- **Upper Limit:** 
- **Value:** 122304.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 24313.62
- **Upper Limit:** 
- **Value:** 75349.4
**Title:** 
#### Outcome Measure 28
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.29
- **Upper Limit:** 
- **Value:** 17.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.58
- **Upper Limit:** 
- **Value:** 14.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.15
- **Upper Limit:** 
- **Value:** 15.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.33
- **Upper Limit:** 
- **Value:** 14.7
**Title:** 
#### Outcome Measure 29
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 8427.77
- **Upper Limit:** 
- **Value:** 23586.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 9238.41
- **Upper Limit:** 
- **Value:** 24234.5
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 7676.99
- **Upper Limit:** 
- **Value:** 33038.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 9093.84
- **Upper Limit:** 
- **Value:** 27419.8
**Title:** 
#### Outcome Measure 30
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.12
- **Upper Limit:** 
- **Value:** 4.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.25
- **Upper Limit:** 
- **Value:** 4.6
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.01
- **Upper Limit:** 
- **Value:** 5.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.04
- **Upper Limit:** 
- **Value:** 4.4
**Title:** 
#### Outcome Measure 31
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.832
- **Upper Limit:** 
- **Value:** 4.88
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.915
- **Upper Limit:** 
- **Value:** 3.33
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.779
- **Upper Limit:** 
- **Value:** 4.62
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.942
- **Upper Limit:** 
- **Value:** 3.61
**Title:** 
#### Outcome Measure 32
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0.33
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0.33
**Title:** 
#### Outcome Measure 33
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 35.24
- **Upper Limit:** 
- **Value:** 115.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 38.20
- **Upper Limit:** 
- **Value:** 112.3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 33.50
- **Upper Limit:** 
- **Value:** 135.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 33.37
- **Upper Limit:** 
- **Value:** 122.6
**Title:** 
#### Outcome Measure 34
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 6.119
- **Upper Limit:** 
- **Value:** 62.25
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 6.897
- **Upper Limit:** 
- **Value:** 49.33
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 5.732
- **Upper Limit:** 
- **Value:** 58.99
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 5.765
- **Upper Limit:** 
- **Value:** 56.29
**Title:** 
#### Outcome Measure 35
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.438
- **Upper Limit:** 
- **Value:** 5.71
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.713
- **Upper Limit:** 
- **Value:** 5.27
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Naive B cell is cell that is not exposed to antigen. Naïve B cell count is CD20+CD27 concentration of cells (conc-cell)/cubic millimeter (cumm). Change from Baseline in naïve B cells was calculated as the value at Week 24 minus the value at Baseline. MITT Population consisted of all participants randomized to treatment, who have had taken at least one dose of study. Participants analyzed included those who had data at Week 24 for naïve B cells count (MITT Population). Baseline value used in the analysis was of Day 0 (Day of transplant). Adjusted mean differences (treatment-placebo) and 95% confidence intervals for differences were obtained from mixed-models repeated-measures (MMRM) model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Modified Intent to treat (MITT) Population
**Reporting Status:** POSTED
**Time Frame:** Baseline and Week 24
**Title:** Change From Baseline in naïve B Cells From Baseline to Week 24
**Type:** PRIMARY
**Unit of Measure:** cells/mm^3
##### Group
**Description:** Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG001
**Title:** Belimumab 10mg/kg
#### Outcome Measure 2
**Description:** Number of participants with AEs, SAEs and AESI are summarized. The On-treatment (OT) phase started on the day and time of receiving the start of the first infusion and ended on the last dose date plus 28 days. The Post-treatment (PT) phase started 29 days after day of last dose up to 1 year. An AE is any untoward medical occurrence, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that at any dose results in, death, is life threatening, Requires hospitalization or prolongation of existing hospitalization, Results in disability/incapacity, Is a congenital anomaly/birth defect or event that but may jeopardize the subject or may require medical or surgical intervention to prevent one of the other outcomes listed. AESI included malignant neoplasms, infusion/anaphylaxis/hypersensitivity reactions, all infections, depression/suicide/self-injury, deaths.
**Parameter Type:** NUMBER
**Population Description:** mITT Population
**Reporting Status:** POSTED
**Time Frame:** Up to 1 year
**Title:** Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG001
**Title:** Belimumab 10mg/kg
#### Outcome Measure 3
**Description:** All infections included: 1. Opportunistic infections per-clinical assessment, 2. Herpes Zoster, a. Recurrent, b. Disseminated, 3. Sepsis. Opportunistic infections were identified using list of preferred terms as per Medical Dictionary for Regulatory Activities (MedDRA) version 18.1. Any events falling under these preferred terms were adjudicated to determine if criteria was met for an opportunistic infection.
**Parameter Type:** NUMBER
**Population Description:** mITT Population
**Reporting Status:** POSTED
**Time Frame:** Up to 1 year
**Title:** Number of Incidence of All Infections and Serious Infections
**Type:** PRIMARY
**Unit of Measure:** Infections
##### Group
**Description:** Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG001
**Title:** Belimumab 10mg/kg
#### Outcome Measure 4
**Description:** Change from Baseline in SBP and DBP were assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value at Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** mITT Population
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 24 and Week 52
**Title:** Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 24 and Week 52
**Type:** PRIMARY
**Unit of Measure:** millimeter of mercury (mmHg)
##### Group
**Description:** Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG001
**Title:** Belimumab 10mg/kg
#### Outcome Measure 5
**Description:** Change from Baseline in heart rate was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value at Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** mITT Population
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 24 and Week 52
**Title:** Change From Baseline in Heart Rate From Baseline at Week 24 and Week 52
**Type:** PRIMARY
**Unit of Measure:** Beats per minute (BPM)
##### Group
**Description:** Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG001
**Title:** Belimumab 10mg/kg
#### Outcome Measure 6
**Description:** Change from Baseline in body temperature was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value at Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** mITT Population
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 24 and Week 52
**Title:** Change From Baseline in Body Temperature From Baseline at Week 24 and Week 52
**Type:** PRIMARY
**Unit of Measure:** Degree Centigrade
##### Group
**Description:** Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG001
**Title:** Belimumab 10mg/kg
#### Outcome Measure 7
**Description:** Number of participants outside the normal range (NR) for SBP and DBP was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Number of participants outside the normal range are summarized by less than (\<) normal range and greater than (\>) normal range categories at Week 24 and Week 52. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
**Parameter Type:** NUMBER
**Population Description:** mITT Population
**Reporting Status:** POSTED
**Time Frame:** Week 24 and Week 52
**Title:** Number of Participants Outside the Normal Range (NR) for SBP and DBP at Week 24 and Week 52
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG001
**Title:** Belimumab 10mg/kg
#### Outcome Measure 8
**Description:** Number of participants outside the normal range (NR) for heart rate was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Number of participants outside the normal range are summarized by less than (\<) normal range and greater than (\>) normal range categories at Week 24 and Week 52. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
**Parameter Type:** NUMBER
**Population Description:** mITT Population
**Reporting Status:** POSTED
**Time Frame:** Week 24 and Week 52
**Title:** Number of Participants Outside the Normal Range (NR) for Heart Rate at Week 24 and Week 52
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG001
**Title:** Belimumab 10mg/kg
#### Outcome Measure 9
**Description:** Number of participants outside the normal range (NR) for body temperature was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Number of participants outside the normal range are summarized by less than (\<) normal range and greater than (\>) normal range categories at Week 24 and Week 52. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
**Parameter Type:** NUMBER
**Population Description:** mITT Population
**Reporting Status:** POSTED
**Time Frame:** Week 24 and Week 52
**Title:** Number of Participants Outside the Normal Range (NR) for Body Temperature at Week 24 and Week 52
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG001
**Title:** Belimumab 10mg/kg
#### Outcome Measure 10
**Description:** Hematology parameters included: basophils (B), eosinophils (E), lymphocytes (L), monocytes (M), total neutrophils (N), platelet count (PC) and white blood cells (WBC). Change from Baseline in haematology parameter was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** mITT Population
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 24 and Week 52
**Title:** Change From Baseline in the Indicated Hematology Parameters at Week 24 and Week 52
**Type:** PRIMARY
**Unit of Measure:** Gills/Liter (GI/L)
##### Group
**Description:** Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG001
**Title:** Belimumab 10mg/kg
#### Outcome Measure 11
**Description:** Change from Baseline in hemoglobin was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** mITT Population
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 24 and Week 52
**Title:** Change From Baseline in the Haematology Parameter- Hemoglobin at Week 24 and Week 52
**Type:** PRIMARY
**Unit of Measure:** Grams per Liter (G/L)
##### Group
**Description:** Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG001
**Title:** Belimumab 10mg/kg
#### Outcome Measure 12
**Description:** Endpoint was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** mITT Population
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 24 and Week 52
**Title:** Change From Baseline in the Hematology Parameter- Hematocrit at Week 24 and Week 52
**Type:** PRIMARY
**Unit of Measure:** Percentage of blood
##### Group
**Description:** Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG001
**Title:** Belimumab 10mg/kg
#### Outcome Measure 13
**Description:** Change from Baseline in MCH was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** mITT Population
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 24 and Week 52
**Title:** Change From Baseline in Haematology Parameter- Mean Corposcular Hemoglobin (MCH) at Week 24 and Week 52
**Type:** PRIMARY
**Unit of Measure:** Picogram (pg)
##### Group
**Description:** Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG001
**Title:** Belimumab 10mg/kg
#### Outcome Measure 14
**Description:** Change from Baseline in MCV was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** mITT Population
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 24 and Week 52
**Title:** Change From Baseline in Haematology Parameter- Mean Corposcular Volume (MCV) at Week 24 and Week 52
**Type:** PRIMARY
**Unit of Measure:** Femtoliter (FL)
##### Group
**Description:** Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG001
**Title:** Belimumab 10mg/kg
#### Outcome Measure 15
**Description:** Change from Baseline in RBC was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** mITT Population
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 24 and Week 52
**Title:** Change From Baseline in Haematology Parameter- Red Blood Cell (RBC) at Week 24 and Week 52
**Type:** PRIMARY
**Unit of Measure:** Tera (TI)/L
##### Group
**Description:** Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG001
**Title:** Belimumab 10mg/kg
#### Outcome Measure 16
**Description:** Change from Baseline in albumin was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** mITT Population
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 24 and Week 52
**Title:** Change From Baseline in Clinical Chemistry Parameter- Albumin at Week 24 and Week 52
**Type:** PRIMARY
**Unit of Measure:** G/L
##### Group
**Description:** Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG001
**Title:** Belimumab 10mg/kg
#### Outcome Measure 17
**Description:** Clinical chemistry parameter included alkaline phosphatase (ALP), alanine amino Transferase (ALT) and aspartate amino transferase (AST). Endpoint was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** mITT Population
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 24 and Week 52
**Title:** Change From Baseline in Clinical Chemistry Parameter- ALP, ALT, AST at Week 24 and Week 52
**Type:** PRIMARY
**Unit of Measure:** International Unit (IU)/L
##### Group
**Description:** Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG001
**Title:** Belimumab 10mg/kg
#### Outcome Measure 18
**Description:** Clinical chemistry parameters included direct bilirubin (DB), total bilirubin (TB) and creatinine (C). Endpoint was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** mITT Population
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 24 and Week 52
**Title:** Change From Baseline in Clinical Chemistry Parameter- Direct Bilirubin, Total Bilirubin and Creatinine at Week 24 and Week 52
**Type:** PRIMARY
**Unit of Measure:** Micromole per Liter (umol/L)
##### Group
**Description:** Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG001
**Title:** Belimumab 10mg/kg
#### Outcome Measure 19
**Description:** Clinical chemistry parameters included calcium (Ca), carbon dioxide content/bicarbonate (CO2/Bicar), glucose (Gl), potassium (K), sodium (Na), phosphorus inorganic (PhI), urea/blood urine nitrogen (U/BUN). Endpoint was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** mITT Population
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 24 and Week 52
**Title:** Change From Baseline in Clinical Chemistry Parameter- Ca, CO2/Bicar, Gl, K, Na, PhI, U/BUN at Week 24 and Week 52
**Type:** PRIMARY
**Unit of Measure:** Millimole (MMOL)/L
##### Group
**Description:** Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG001
**Title:** Belimumab 10mg/kg
#### Outcome Measure 20
**Description:** Change from Baseline in GFR was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** mITT Population
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 24 and Week 52
**Title:** Change From Baseline in Clinical Chemistry Parameter- Glomerular Filtration Rate (GFR) at Week 24 and Week 52
**Type:** PRIMARY
**Unit of Measure:** milliliter (mL)/Minute (min)
##### Group
**Description:** Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG001
**Title:** Belimumab 10mg/kg
#### Outcome Measure 21
**Description:** Change from Baseline in immunoglobulins IgA, IgG and IgM was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** mITT Population
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 24 and Week 52
**Title:** Change From Baseline in Immunoglobulin A (IgA), Immunoglobulin G (IgG) and Immunoglobulin M (IgM) at Week 24 and Week 52
**Type:** PRIMARY
**Unit of Measure:** G/L
##### Group
**Description:** Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG001
**Title:** Belimumab 10mg/kg
#### Outcome Measure 22
**Description:** Memory B cells are B cell sub-type that are formed within germinal centres following primary infection and are important in generating an accelerated and more robust antibody-mediated immune response in the case of re-infection. Memory B cell count included CD20+CD27+ cells/mm\^3. Baseline value used in the analysis was of Day 0 (Day of transplant). Endpoint was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Percent change from Baseline in Memory B cell count was calculated as the value at Week 24 and Week 52 minus the value at Baseline multiplied by 100. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Median Difference and 95% confidence interval of difference obtained using the Hodges-Lehmann method.
**Dispersion Type:** Full Range
**Parameter Type:** MEDIAN
**Population Description:** mITT Population
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 24 and Week 52
**Title:** Median Percent Change From Baseline in Memory B Cell Count at Week 24 and Week 52
**Type:** SECONDARY
**Unit of Measure:** Percent change
##### Group
**Description:** Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG001
**Title:** Belimumab 10mg/kg
#### Outcome Measure 23
**Description:** Activated memory B cell-CD95% count is CD19+CD27+CD95 conc-cells/mL. Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** mITT Population
**Reporting Status:** POSTED
**Time Frame:** Week 24 and Week 52
**Title:** Activated Memory B Cells Count at Week 24 and Week 52
**Type:** SECONDARY
**Unit of Measure:** cells/mL
##### Group
**Description:** Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG001
**Title:** Belimumab 10mg/kg
#### Outcome Measure 24
**Description:** Activated memory B cell-CD95% percentage is CD19+CD27+CD95+ (%CD19/CD27). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** mITT Population
**Reporting Status:** POSTED
**Time Frame:** Week 24 and Week 52
**Title:** Activated Memory B Cells Percentage at Week 24 and Week 52
**Type:** SECONDARY
**Unit of Measure:** Percentage of activated memory B cells
##### Group
**Description:** Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG001
**Title:** Belimumab 10mg/kg
#### Outcome Measure 25
**Description:** Transitional B cell count (Newell) is CD19+CD24b+CD38b+IgD+ (Conc-cells/mL). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** mITT Population
**Reporting Status:** POSTED
**Time Frame:** Week 24 and Week 52
**Title:** Transitional B Cells Count at Week 24 and Week 52
**Type:** SECONDARY
**Unit of Measure:** cells/mL
##### Group
**Description:** Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG001
**Title:** Belimumab 10mg/kg
#### Outcome Measure 26
**Description:** Transitional B cell percentage (Newell) is CD19+CD24b+CD38b+IgD+ (%CD19+). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** mITT Population
**Reporting Status:** POSTED
**Time Frame:** Week 24 and Week 52
**Title:** Transitional B Cells Percentage at Week 24 and Week 52
**Type:** SECONDARY
**Unit of Measure:** Percentage of transitional B cells
##### Group
**Description:** Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG001
**Title:** Belimumab 10mg/kg
#### Outcome Measure 27
**Description:** A T cell is a type of lymphocyte that plays a central role in cell-mediated immunity. Activated T cell count Codarri is CD4+ CD25hi CD45RA- IL 7Rhi (Conc-cells/mL). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** mITT Population
**Reporting Status:** POSTED
**Time Frame:** Week 24 and Week 52
**Title:** Activated T Cell Count at Week 24 and Week 52
**Type:** SECONDARY
**Unit of Measure:** cells/mL
##### Group
**Description:** Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG001
**Title:** Belimumab 10mg/kg
#### Outcome Measure 28
**Description:** Activated T cell percentage (Codarri)= CD4+ CD25hi CD45RA- IL 7Rhi (% of CD4+). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** mITT Population
**Reporting Status:** POSTED
**Time Frame:** Week 24 and Week 52
**Title:** Activated T Cell Percentage at Week 24 and Week 52
**Type:** SECONDARY
**Unit of Measure:** Percentage of activated T cell
##### Group
**Description:** Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG001
**Title:** Belimumab 10mg/kg
#### Outcome Measure 29
**Description:** Regulatory T cell count is CD4+ CD25hi IL-7Rlo (Conc-cells/mL). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** mITT Population
**Reporting Status:** POSTED
**Time Frame:** Week 24 and Week 52
**Title:** Regulatory T Cell Count at Week 24 and Week 52
**Type:** SECONDARY
**Unit of Measure:** cells/mL
##### Group
**Description:** Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG001
**Title:** Belimumab 10mg/kg
#### Outcome Measure 30
**Description:** Regulatory T cell (%CD4) = CD4+ CD25hi IL-7Rlo (% of CD4+). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** mITT Population
**Reporting Status:** POSTED
**Time Frame:** Week 24 and Week 52
**Title:** Regulatory T Cell (%CD4) at Week 24 and Week 52
**Type:** SECONDARY
**Unit of Measure:** Percentage of Regulatory T cell
##### Group
**Description:** Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG001
**Title:** Belimumab 10mg/kg
#### Outcome Measure 31
**Description:** Activated: regulatory T cell ratio is Activated T cell CD4+CD25hi CD45RA IL 7Rhi (absolute number)/ Regulatory T cell CD4+CD25hi CD45RA IL 7Rlo (absolute number). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** mITT Population
**Reporting Status:** POSTED
**Time Frame:** Week 24 and Week 52
**Title:** Mean Activated: Regulatory T Cell Ratio at Week 24 and Week 52
**Type:** SECONDARY
**Unit of Measure:** Ratio
##### Group
**Description:** Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG001
**Title:** Belimumab 10mg/kg
#### Outcome Measure 32
**Description:** The endpoint diagnosis was made by a proven biopsy result. Number of rejections only counted once per participant. The proportion of participants with episodes of acute rejection was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
**Parameter Type:** NUMBER
**Population Description:** mITT Population. Participants analyzed had at least one biopsy.
**Reporting Status:** POSTED
**Time Frame:** Week 24 and Week 52
**Title:** Proportion of Participants With Episodes of Acute Rejection at Week 24 and Week 52
**Type:** SECONDARY
**Unit of Measure:** Proportion of participants
##### Group
**Description:** Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG001
**Title:** Belimumab 10mg/kg
#### Outcome Measure 33
**Description:** Adjusted mean difference for serum creatinine values (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction, at Week 24 and Week 52. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** mITT Population
**Reporting Status:** POSTED
**Time Frame:** Week 24 and Week 52
**Title:** Mean Serum Creatinine at Week 24 and Week 52
**Type:** SECONDARY
**Unit of Measure:** micromole/L
##### Group
**Description:** Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG001
**Title:** Belimumab 10mg/kg
#### Outcome Measure 34
**Description:** The estimated glomerular filtration rate (eGFR) were calculated by the abbreviated Modification of Diet in Renal Disease (MDRD) equation. Adjusted mean difference(treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction at Week 24 and Week 52. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the indicated time points were analyzed (represented by n= X, X in the category titles).
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** mITT Population
**Reporting Status:** POSTED
**Time Frame:** Week 24 and Week 52
**Title:** Mean eGFR at Week 24 and Week 52
**Type:** SECONDARY
**Unit of Measure:** mL/minute/1.73 square meter (m^2)
##### Group
**Description:** Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG001
**Title:** Belimumab 10mg/kg
#### Outcome Measure 35
**Description:** Adjusted mean difference (treatment-placebo) for Prednisolone use and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction at Week 24. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments Only those participants available at indicated timepoints were analyzed (represented by n=X, X in the category titles).
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** mITT Population
**Reporting Status:** POSTED
**Time Frame:** Week 24
**Title:** Mean Prednisolone Use at Week 24
**Type:** SECONDARY
**Unit of Measure:** mg/day
##### Group
**Description:** Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** OG001
**Title:** Belimumab 10mg/kg
### Participant Flow Module
#### Group
**Description:** Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** FG000
**Title:** Placebo
#### Group
**Description:** Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
**ID:** FG001
**Title:** Belimumab 10mg/kg
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 13
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 12
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 11
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 9
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 2
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 3
**Pre-Assignment Details:** Participants were randomized to 1 of the 2 treatments groups in a 1:1 ratio and received standard of care in addition to investigational products (IPs). Participants received IP infusion on Day 0, Day 14, Day 28 and every 4 weeks thereafter for a total of 7 infusions.
**Recruitment Details:** A total of 30 renal transplant recipients were enrolled, of which 28 were randomized and 25 were transplanted.
**Has Results:** True