Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| H9B-MC-BCDR | Other Identifier | Eli Lilly and Company |
Not provided
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The purpose of this trial is to explore the effect of LY2127399 on those antibodies that are a barrier to kidney transplant. Transplantation is currently the definitive treatment for End-Stage Renal Disease (ESRD), providing prolonged survival and improved quality of life.
In this study, LY2127399 will be tested as a potential treatment to reduce the blood proteins in some participants with ESRD. These proteins are called alloantibodies and are made by the body to react with other proteins on cells of transplanted organs called human leukocyte antigen (HLA) proteins. When a participant has these antibodies, they are referred to as HLA-presensitized. Often the presence of these antibodies, categorized by a method called the panel reactive antibody (PRA), can make a person ineligible to receive a transplant or experience very long wait times on the kidney transplant waiting list. Therefore the need to reduce the antibodies is significant for the successful treatment of ESRD. This study will treat ESRD participants for 6 months with LY2127399 and measure PRA levels for a total of 18 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY2127399 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2127399 | Drug | 120 milligrams (mg) administered subcutaneously every 4 weeks for 20 weeks. A loading dose of 240 mg will be given as the first dose of the study medication |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in PRA | The PRA value is calculated and expressed as a percentage, which can range from 0 % to 100%. The value represents a summation of the total HLA antibody burden that the participant has and how frequently those HLA antigens appear in organ donor population. A calculated PRA of 20% means the participant has antibodies that represent an antigen frequency that exists in approximately 20% of the population. | Baseline, Weeks 8, 16, 24, 36, 52, 64 and 76 |
| Change From Baseline in Arcsine Transformed PRA Scores | The PRA value is calculated and expressed as a percentage, which can range from 0% to 100%. The value represents a summation of the total HLA antibody burden that the participant has and how frequently those HLA antigens appear in organ donor population. A calculated PRA of 20% means the participant has antibodies that represent an antigen frequency that exists in approximately 20% of the population. PRA scores were transformed using the arcsine function, which enables a skewed distribution of data typically expressed as proportions to achieve properties closer to a normal distribution. The range of possible arcsine transformed PRA scores is 0 (when PRA = 0) to approximately 1.57 (when PRA =100). Higher scores indicate the participant has antibodies against HLA antigens that appear frequently in the organ donor population. | Baseline, Weeks 8, 16, 24, 36, 52, 64 and 76 |
| Number of Participants With a Change From Baseline Positive to Post-Baseline Negative in the Summation of Top 10 Highest Antibody Levels (Class I and Class II Single Antigen Reactivity Reported Separately) During Treatment and Follow-Up | Baseline through Weeks 24, 52 and 76 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Serum Immunoglobulin Levels | Immunoglobulins (Ig), or antibodies, are large molecular weight proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Change from baseline in serum immunoglobulin A (IgA), immunoglobulin G (IgG), IgG1-4, and immunoglobulin M (IgM) levels are reported. A negative change indicates a decrease in Ig levels. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Indianapolis | Indiana | 46202 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26780484 | Derived | Mujtaba MA, Komocsar WJ, Nantz E, Samaniego MD, Henson SL, Hague JA, Lobashevsky AL, Higgins NG, Czader M, Book BK, Anderson MD, Pescovitz MD, Taber TE. Effect of Treatment With Tabalumab, a B Cell-Activating Factor Inhibitor, on Highly Sensitized Patients With End-Stage Renal Disease Awaiting Transplantation. Am J Transplant. 2016 Apr;16(4):1266-75. doi: 10.1111/ajt.13557. Epub 2016 Jan 18. |
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This study consisted of a 24-week treatment period (Weeks 0-24) and a follow-up period (up to Week 76). Participants who discontinued study drug administration were placed into the post-treatment follow-up period.
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| ID | Title | Description |
|---|---|---|
| FG000 | LY2127399 | LY2127399 was administered as a loading dose of 240-milligram (mg) subcutaneous (SC) injection at Week 0 followed by maintenance doses of 120-mg SC injections every 4 weeks at Weeks 4, 8, 12, 16 and 20. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period |
|
| |||||||||||||||||||||
| Post-Treatment Follow-Up Period |
|
All enrolled participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | LY2127399 | LY2127399 was administered as a loading dose of 240-mg SC injection at Week 0 followed by maintenance doses of 120-mg SC injections every 4 weeks at Weeks 4, 8, 12, 16 and 20. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in PRA | The PRA value is calculated and expressed as a percentage, which can range from 0 % to 100%. The value represents a summation of the total HLA antibody burden that the participant has and how frequently those HLA antigens appear in organ donor population. A calculated PRA of 20% means the participant has antibodies that represent an antigen frequency that exists in approximately 20% of the population. | All enrolled participants who received at least 1 dose of study drug, had a non-missing baseline PRA score and at least 1 non-missing post-baseline PRA score. | Posted | Mean | Standard Deviation | percentage of population | Baseline, Weeks 8, 16, 24, 36, 52, 64 and 76 |
|
Not provided
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LY2127399 | LY2127399 was administered as a loading dose of 240-mg SC injection at Week 0 followed by maintenance doses of 120-mg SC injections every 4 weeks at Weeks 4, 8, 12, 16 and 20. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
Not provided
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D014511 | Uremia |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C575974 | tabalumab |
Not provided
Not provided
Not provided
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| Baseline, Weeks 8, 16, 24, 36 and 52 |
| Percent Change From Baseline at Week 1 and Week 24 in Relative Percent of Lymphocytes for B Cell Populations in the Tonsil | B cell population counts are: Total B cells [cluster designation (CD)19+], mature naïve B cells [CD19+CD27-immunoglobulin D (IgD)+CD10-], switched memory B cells (CD19+CD27+IgD-), unswitched memory B cells (CD19+CD27+IgD+), germinal center B cells Bm2&apos (CD19+CD38+IgD+), germinal center B cells Bm3, Bm4 (CD19+CD38+IgD-), germinal center B cells (CD19+CD38+CD10+CD71+), transitional (Tr) B cells (CD19+CD38++/+++CD24+++/+CD10+) and Tr B cells (CD19+CD27-IgD+CD10+). | Baseline, Weeks 1 and 24 |
| Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood | B cell population counts are: Total B cells (CD19+), mature naïve B cells (CD19+CD27-IgD+CD10-), switched memory B cells (CD19+CD27+IgD-), unswitched memory B cells (CD19+CD27+IgD+), Tr B cells (CD19+CD38++/+++CD24+++/+CD10+) and Tr B cells (CD19+CD27-IgD+CD10+). | Baseline, Weeks1, 4, 8, 16, 24, 36, 52, 64 and 76 |
| Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood | B cell population counts are: Total B cells (CD19+), mature naïve B cells (CD19+CD27-IgD+CD10-), switched memory B cells (CD19+CD27+IgD-), unswitched memory B cells (CD19+CD27+IgD+), Tr B cells (CD19+CD38++/+++CD24+++/+CD10+) and Tr B cells (CD19+CD27-IgD+CD10+). | Baseline, Weeks1, 4, 8, 16, 24, 36 and 52 |
| Population Pharmacokinetics (PK): Constant Clearance | Population estimate of constant clearance as determined by population PK analysis. A 2-compartment model was used in PK modeling. Constant clearance is the PK parameter which describes the linear elimination of LY2127399 from serum. | Baseline through Week 24 |
| United States |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Panel Reactive Antibodies (PRA) | The PRA value is calculated and expressed as a percentage, which can range from 0 percent (%) to 100%. The value represents a summation of the total HLA antibody burden that the participant has and how frequently those HLA antigens appear in organ donor population. A calculated PRA of 20% means the participant has antibodies that represent an antigen frequency that exists in approximately 20% of the population. | Mean | Standard Deviation | percentage of population |
|
|
|
|
| Primary | Change From Baseline in Arcsine Transformed PRA Scores | The PRA value is calculated and expressed as a percentage, which can range from 0% to 100%. The value represents a summation of the total HLA antibody burden that the participant has and how frequently those HLA antigens appear in organ donor population. A calculated PRA of 20% means the participant has antibodies that represent an antigen frequency that exists in approximately 20% of the population. PRA scores were transformed using the arcsine function, which enables a skewed distribution of data typically expressed as proportions to achieve properties closer to a normal distribution. The range of possible arcsine transformed PRA scores is 0 (when PRA = 0) to approximately 1.57 (when PRA =100). Higher scores indicate the participant has antibodies against HLA antigens that appear frequently in the organ donor population. | All enrolled participants who received at least 1 dose of study drug, had a non-missing baseline PRA score and at least 1 non-missing post-baseline PRA score. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Weeks 8, 16, 24, 36, 52, 64 and 76 |
|
|
|
|
| Secondary | Change From Baseline in Serum Immunoglobulin Levels | Immunoglobulins (Ig), or antibodies, are large molecular weight proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Change from baseline in serum immunoglobulin A (IgA), immunoglobulin G (IgG), IgG1-4, and immunoglobulin M (IgM) levels are reported. A negative change indicates a decrease in Ig levels. | All enrolled participants who received at least 1 dose of study drug, had a non-missing baseline Ig value and at least 1 non-missing post-baseline Ig value. | Posted | Mean | Standard Deviation | grams/liter (g/L) | Baseline, Weeks 8, 16, 24, 36 and 52 |
|
|
|
| Secondary | Percent Change From Baseline at Week 1 and Week 24 in Relative Percent of Lymphocytes for B Cell Populations in the Tonsil | B cell population counts are: Total B cells [cluster designation (CD)19+], mature naïve B cells [CD19+CD27-immunoglobulin D (IgD)+CD10-], switched memory B cells (CD19+CD27+IgD-), unswitched memory B cells (CD19+CD27+IgD+), germinal center B cells Bm2&apos (CD19+CD38+IgD+), germinal center B cells Bm3, Bm4 (CD19+CD38+IgD-), germinal center B cells (CD19+CD38+CD10+CD71+), transitional (Tr) B cells (CD19+CD38++/+++CD24+++/+CD10+) and Tr B cells (CD19+CD27-IgD+CD10+). | All enrolled participants who received at least 1 dose of study drug, had a non-missing baseline tonsil B cell populations value and at least 1 non-missing post-baseline B cell populations value. | Posted | Mean | Standard Deviation | relative percent of Lymphocytes | Baseline, Weeks 1 and 24 |
|
|
|
| Secondary | Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood | B cell population counts are: Total B cells (CD19+), mature naïve B cells (CD19+CD27-IgD+CD10-), switched memory B cells (CD19+CD27+IgD-), unswitched memory B cells (CD19+CD27+IgD+), Tr B cells (CD19+CD38++/+++CD24+++/+CD10+) and Tr B cells (CD19+CD27-IgD+CD10+). | All enrolled participants who received at least 1 dose of study drug, had a non-missing baseline peripheral blood B cell populations value and at least 1 non-missing post-baseline B cell populations value. | Posted | Mean | Standard Deviation | relative percent of Lymphocytes | Baseline, Weeks1, 4, 8, 16, 24, 36, 52, 64 and 76 |
|
|
|
| Secondary | Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood | B cell population counts are: Total B cells (CD19+), mature naïve B cells (CD19+CD27-IgD+CD10-), switched memory B cells (CD19+CD27+IgD-), unswitched memory B cells (CD19+CD27+IgD+), Tr B cells (CD19+CD38++/+++CD24+++/+CD10+) and Tr B cells (CD19+CD27-IgD+CD10+). | All enrolled participants who received at least 1 dose of study drug, had a non-missing baseline peripheral blood B cell populations value and at least 1 non-missing post-baseline B cell populations value. | Posted | Mean | Standard Deviation | percent change in absolute counts | Baseline, Weeks1, 4, 8, 16, 24, 36 and 52 |
|
|
|
| Secondary | Population Pharmacokinetics (PK): Constant Clearance | Population estimate of constant clearance as determined by population PK analysis. A 2-compartment model was used in PK modeling. Constant clearance is the PK parameter which describes the linear elimination of LY2127399 from serum. | All randomized participants who received at least 1 dose of LY2127399 with evaluable LY2127399 PK data. | Posted | Mean | Standard Error | milliliters/hour (mL/h) | Baseline through Week 24 |
|
|
|
| Primary | Number of Participants With a Change From Baseline Positive to Post-Baseline Negative in the Summation of Top 10 Highest Antibody Levels (Class I and Class II Single Antigen Reactivity Reported Separately) During Treatment and Follow-Up | All enrolled participants who received at least 1 dose of study drug and had single antigen reactivity assessed at baseline, during treatment and during follow-up. | Posted | Count of Participants | Participants | No | Baseline through Weeks 24, 52 and 76 |
|
|
|
| 9 |
| 18 |
| 18 |
| 18 |
| Arrhythmia | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Cardiac tamponade | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hyperparathyroidism | Endocrine disorders | MedDRA 16.1 | Systematic Assessment |
|
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Lobar pneumonia | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Peritonitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Toxic encephalopathy | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| VIIth nerve paralysis | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Left ventricular hypertrophy | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hyperparathyroidism | Endocrine disorders | MedDRA 16.1 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 16.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Faecal incontinence | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Peptic ulcer | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Catheter site pain | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Feeling abnormal | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Injection site extravasation | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Medical device complication | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Thrombosis in device | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Bile duct stone | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Kidney transplant rejection | Immune system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Clostridium difficile infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Labyrinthitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Lobar pneumonia | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Arteriovenous fistula aneurysm | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Arteriovenous fistula site complication | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Post procedural discomfort | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Procedural hypotension | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Cardiac murmur | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Uraemic neuropathy | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
|
| Communication disorder | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
|
| Renal pain | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Uterine cyst | Reproductive system and breast disorders | MedDRA 16.1 | Systematic Assessment |
|
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
| Iliac vein occlusion | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
| Thrombophlebitis | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
Not provided
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
|
| Week 36 |
|
| Week 52 |
|
| Week 64 |
|
| Week 76 |
|
P-value is for Week 16. |
| 2-Sided |
| Superiority or Other |
| Mixed Effect Model Repeat Measurement | 0.073 | P-value is for Week 24. | 2-Sided | Superiority or Other |
| Mixed Effect Model Repeat Measurement | 0.004 | P-value is for Week 36. | 2-Sided | Superiority or Other |
| Mixed Effect Model Repeat Measurement | 0.699 | P-value is for Week 52. | 2-Sided | Superiority or Other |
| Mixed Effect Model Repeat Measurement | 0.095 | P-value is for Week 64. | 2-Sided | Superiority or Other |
| Mixed Effect Model Repeat Measurement | 0.082 | P-value is for Week 76. | 2-Sided | Superiority or Other |
| Title | Measurements |
|---|---|
|
| IgA at Week 36 |
|
| IgA at Week 52 |
|
| IgG at Week 8 |
|
| IgG at Week 16 |
|
| IgG at Week 24 |
|
| IgG at Week 36 |
|
| IgG at Week 52 |
|
| IgG1 at Week 8 |
|
| IgG1 at Week 16 |
|
| IgG1 at Week 24 |
|
| IgG1 at Week 36 |
|
| IgG1 at Week 52 |
|
| IgG2 at Week 8 |
|
| IgG2 at Week 16 |
|
| IgG2 at Week 24 |
|
| IgG2 at Week 36 |
|
| IgG2 at Week 52 |
|
| IgG3 at Week 8 |
|
| IgG3 at Week 16 |
|
| IgG3 at Week 24 |
|
| IgG3 at Week 36 |
|
| IgG3 at Week 52 |
|
| IgG4 at Week 8 |
|
| IgG4 at Week 16 |
|
| IgG4 at Week 24 |
|
| IgG4 at Week 36 |
|
| IgG4 at Week 52 |
|
| IgM at Week 8 |
|
| IgM at Week 16 |
|
| IgM at Week 24 |
|
| IgM at Week 36 |
|
| IgM at Week 52 |
|
| Title | Measurements |
|---|---|
|
| Mature naïve at Week 24 |
|
| Switched memory at Week 1 |
|
| Switched memory at Week 24 |
|
| Unswitched memory at Week 1 |
|
| Unswitched memory at Week 24 |
|
| Germinal center Bm2' at Week 1 |
|
| Germinal center Bm2' at Week 24 |
|
| Germinal center Bm3, Bm4 at Week 1 |
|
| Germinal center Bm3, Bm4 at Week 24 |
|
| Germinal center at Week 1 |
|
| Germinal center at Week 24 |
|
| Tr(CD19+CD38++/+++CD24+++/+CD10+) at Week 1 |
|
| Tr(CD19+CD38++/+++CD24+++/+CD10+) at Week 24 |
|
| Tr (CD19+CD27-IgD+CD10+) at Week 1 |
|
| Tr (CD19+CD27-IgD+CD10+) at Week24 |
|
| Title | Measurements |
|---|---|
|
| Total B cells at Week 16 |
|
| Total B cells at Week 24 |
|
| Total B cells at Week 36 |
|
| Total B cells at Week 52 |
|
| Total B cells at Week 64 |
|
| Total B cells at Week 76 |
|
| Mature naïve at Week 1 |
|
| Mature naïve at Week 4 |
|
| Mature naïve at Week 8 |
|
| Mature naïve at Week 16 |
|
| Mature naïve at Week 24 |
|
| Mature naïve at Week 36 |
|
| Mature naïve at Week 52 |
|
| Mature naïve at Week 64 |
|
| Mature naïve at Week 76 |
|
| Switched memory at Week 1 |
|
| Switched memory at Week 4 |
|
| Switched memory at Week 8 |
|
| Switched memory at Week 16 |
|
| Switched memory at Week 24 |
|
| Switched memory at Week 36 |
|
| Switched memory at Week 52 |
|
| Switched memory at Week 64 |
|
| Switched memory at Week 76 |
|
| Unswitched memory at Week 1 |
|
| Unswitched memory at Week 4 |
|
| Unswitched memory at Week 8 |
|
| Unswitched memory at Week 16 |
|
| Unswitched memory at Week 24 |
|
| Unswitched memory at Week 36 |
|
| Unswitched memory at Week 52 |
|
| Unswitched memory at Week 64 |
|
| Unswitched memory at Week 76 |
|
| Tr(CD19+CD38++/+++CD24+++/+CD10+) at Week 1 |
|
| Tr(CD19+CD38++/+++CD24+++/+CD10+) at Week 4 |
|
| Tr(CD19+CD38++/+++CD24+++/+CD10+) at Week 8 |
|
| Tr(CD19+CD38++/+++CD24+++/+CD10+) at Week 16 |
|
| Tr(CD19+CD38++/+++CD24+++/+CD10+) at Week 24 |
|
| Tr(CD19+CD38++/+++CD24+++/+CD10+) at Week 36 |
|
| Tr(CD19+CD38++/+++CD24+++/+CD10+) at Week 52 |
|
| Tr(CD19+CD38++/+++CD24+++/+CD10+) at Week 64 |
|
| Tr(CD19+CD38++/+++CD24+++/+CD10+) at Week 76 |
|
| Tr (CD19+CD27-IgD+CD10+) at Week1 |
|
| Tr (CD19+CD27-IgD+CD10+) at Week4 |
|
| Tr (CD19+CD27-IgD+CD10+) at Week8 |
|
| Tr (CD19+CD27-IgD+CD10+) at Week 16 |
|
| Tr (CD19+CD27-IgD+CD10+) at Week 24 |
|
| Tr (CD19+CD27-IgD+CD10+) at Week 36 |
|
| Tr (CD19+CD27-IgD+CD10+) at Week 52 |
|
| Tr (CD19+CD27-IgD+CD10+) at Week 64 |
|
| Tr (CD19+CD27-IgD+CD10+) at Week 76 |
|
| Title | Measurements |
|---|---|
|
| Total B cells at Week 16 |
|
| Total B cells at Week 24 |
|
| Total B cells at Week 36 |
|
| Total B cells at Week 52 |
|
| Mature naïve at Week 1 |
|
| Mature naïve at Week 4 |
|
| Mature naïve at Week 8 |
|
| Mature naïve at Week 16 |
|
| Mature naïve at Week 24 |
|
| Mature naïve at Week 36 |
|
| Mature naïve at Week 52 |
|
| Switched memory at Week 1 |
|
| Switched memory at Week 4 |
|
| Switched memory at Week 8 |
|
| Switched memory at Week 16 |
|
| Switched memory at Week 24 |
|
| Switched memory at Week 36 |
|
| Switched memory at Week 52 |
|
| Unswitched memory at Week 1 |
|
| Unswitched memory at Week 4 |
|
| Unswitched memory at Week 8 |
|
| Unswitched memory at Week 16 |
|
| Unswitched memory at Week 24 |
|
| Unswitched memory at Week 36 |
|
| Unswitched memory at Week 52 |
|
| Tr(CD19+CD38++/+++CD24+++/+CD10+) at Week 1 |
|
| Tr(CD19+CD38++/+++CD24+++/+CD10+) at Week 4 |
|
| Tr(CD19+CD38++/+++CD24+++/+CD10+) at Week 8 |
|
| Tr(CD19+CD38++/+++CD24+++/+CD10+) at Week 16 |
|
| Tr(CD19+CD38++/+++CD24+++/+CD10+) at Week 24 |
|
| Tr(CD19+CD38++/+++CD24+++/+CD10+) at Week 36 |
|
| Tr(CD19+CD38++/+++CD24+++/+CD10+) at Week 52 |
|
| Tr(CD19+CD27-IgD+CD10+) at Week 1 |
|
| Tr(CD19+CD27-IgD+CD10+) at Week 4 |
|
| Tr(CD19+CD27-IgD+CD10+) at Week 8 |
|
| Tr(CD19+CD27-IgD+CD10+) at Week 16 |
|
| Tr(CD19+CD27-IgD+CD10+) at Week 24 |
|
| Tr(CD19+CD27-IgD+CD10+) at Week 36 |
|
| Tr(CD19+CD27-IgD+CD10+) at Week 52 |
|
| Title | Measurements |
|---|---|
|
| Class II - Week 24 |
|
| Class II - Week 52 |
|
| Class II - Week 76 |
|