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This study will be conducted to evaluate the safety, efficacy and pharmacokinetics of belimumab administered in combination with background standard therapy in pediatric participants with active SLE.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pediatric participants receiving belimumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Belimumab | Drug | Belimumab will be administered. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events of Special Interest (AESIs) Through Week 52 | An adverse event (AE) is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AESIs included malignancies, post-infusion systemic or hypersensitivity reactions, infections (including serious infections of special interest), and depression, suicide, or self-injury. Infections of special interest included opportunistic infections (OI), herpes zoster (HZ), tuberculosis (TB), and sepsis. Number of participants with AESIs as identified by custom Medical Dictionary for Regulatory Activities (MedDRA) query has been reported. | Up to Week 52 |
| Number of Participants With Greater Than Equal to (>=) 4 Points Reduction From Baseline to Week 52 in Safety of Estrogen in Lupus National Assessment - Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) Score | The SELENA-SLEDAI score is a cumulative and weighted index for assessing SLE disease activity in participants with SLE. It consists of 24 disease descriptors related to signs and symptoms, laboratory tests, and physician's assessment across 9 organ systems. Each descriptor is assigned a weighted score (8 descriptors with a weight of 8 each, 6 descriptors with a weight of 4 each, 7 descriptors with a weight of 2 each, and 3 descriptors with a weight of 1 each) which is added up if the descriptor is observed during a visit or within the preceding 10 days. The total score ranges from 0 (no disease activity) to 105 (all 24 descriptors present simultaneously). A higher score indicates a more significant degree of disease activity. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Number of participants with a decrease of 4 points or more in the score at Week 52 compared to their Baseline score is presented. | Baseline (Day 0) and Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With AEs and Serious Adverse Events (SAEs) Through Week 52 | An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a birth defect or congenital anomaly, or other situations as per the medical or scientific judgment of the investigator. Number of participants with AEs and SAEs has been reported. |
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Inclusion criteria:
Exclusion Criteria:
Have an estimated glomerular filtration rate (eGFR) as calculated by Schwartz Formula of less than 30 mL/minutes.
Have acute severe nephritis defined as a significant worsening of renal disease (for example [e.g.], the presence of urinary sediments and other lab abnormalities) that, in the opinion of the study investigator, may lead to the participant requiring induction therapy with intravenous (IV) cyclophosphamide, Mycophenolate mofetil (MMF) or high dose corticosteroids during the first 6 months of the study.
Have a history of a major organ transplant (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplant.
Have clinical evidence of significant, unstable or uncontrolled, acute or chronic diseases not due to SLE (cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy or infectious diseases) which, in the opinion of the investigator, could confound the results of the study or put the participant at undue risk.
Have a planned surgical procedure or a 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 participant unsuitable for the study.
Have a history of malignant neoplasm within the last 5 years.
Have a history of a primary immunodeficiency.
Have an Immunoglobulin A (IgA) deficiency (IgA level less than [<]10 mg/deciliters [milligrams/dL]).
Have acute or chronic infections requiring management.
Have recent infections that, in the opinions of the investigator, makes the participant unsuitable for the study or could put the participant at undue risk.
Have current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within 364 days prior to Day 0.
Have a Grade 3 or greater laboratory abnormality based on the protocol toxicity scale except for the following that are allowed:
Have a history of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins or monoclonal antibodies.
Have evidence of serious suicide risk including any history of suicidal behavior in the last 6 months or who in the investigator's judgment, poses a significant suicide risk.
Have received treatment with belimumab at any time.
Have received any of the following within 364 days of Day 0:
Have required 3 or more courses of systemic corticosteroids for concomitant conditions (e.g., asthma, atopic dermatitis) within 90 days of Day 0.
Have received any of the following within 90 days of Day 0:
Have received any of the following within 30 days of Day 0:
Have received a live or live-attenuated vaccine within 30 days of Day 0.
Have active central nervous system (CNS) lupus (including seizures, psychosis, organic brain syndrome, cerebrovascular accident [CVA], cerebritis or CNS vasculitis) requiring therapeutic intervention within 60 days of Day 0.
Have required renal replacement therapy (e.g., hemodialysis, peritoneal dialysis) within 90 days of Day 0 or be currently on renal replacement therapy.
Participation in an interventional clinical study either concurrently or within 6 months of screening. Participation in an observational study may be permitted.
Have a historically positive test or test positive at screening for Human immunodeficiency virus (HIV) antibody.
Evidence of active or latent tuberculosis (TB) as documented by medical history and examination, chest X-rays (posteroanterior) and a positive (not indeterminate) QuantiFERON-TB Gold Plus test.
Hepatitis B: Serologic evidence of Hepatitis B (HB) infection defined as Hepatitis B surface antigen positive (HBsAg+) or Hepatitis B core antibody positive (HBcAb+).
Hepatitis C: Positive test for Hepatitis C antibody at screening.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Beijing | 100045 | China | |||
| GSK Investigational Site |
IPD for this study will be made available via the Clinical Study Data Request site.
IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
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| ID | Title | Description |
|---|---|---|
| FG000 | Belimumab | Participants with active systemic lupus erythematosus (SLE) received belimumab at 10 milligrams per kilogram (mg/kg) body weight by intravenous (IV) infusion over a minimum of 1 hour on Days 0, 14, 28, and then every 28 days through Week 48 in combination with standard therapy. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 22, 2024 | May 22, 2025 |
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| Standard therapy |
| Drug |
Standard therapy will be continued. |
|
| Up to Week 52 |
| Percentage of Participants With >=4 Points Reduction From Baseline in SELENA-SLEDAI Score by Each Visit | The SELENA-SLEDAI score is a cumulative and weighted index for assessing SLE disease activity in participants with SLE. It consists of 24 disease descriptors related to signs and symptoms, laboratory tests, and physician's assessment across 9 organ systems. Each descriptor is assigned a weighted score (8 descriptors with a weight of 8 each, 6 descriptors with a weight of 4 each, 7 descriptors with a weight of 2 each, and 3 descriptors with a weight of 1 each) which is added up if the descriptor is observed during a visit or within the preceding 10 days. The total score ranges from 0 (no disease activity) to 105 (all 24 descriptors present simultaneously). A higher score indicates a more significant degree of disease activity. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Percentage of participants with a decrease of 4 points or more in the score at each visit compared to their Baseline score is presented. | Baseline (Day 0) and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 |
| Change From Baseline to Week 52 in Physician Global Assessment (PGA) | The PGA is used to assess the participant's current disease activity by investigator. It is collected on a 10 centimeter (cm) visual analogue scale. The score ranges from 0 (no activity) to 3 (severe activity). Lower score means no disease activity, higher score means severe disease activity. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. | Baseline (Day 0) and Week 52 |
| Change From Baseline to Week 52 in Parent Global Assessment (ParentGA) | The ParentGA is used to assess the participant's overall well-being at the moment rated on a 21-numbered circle visual analog scale by the parent. The score ranges from 0 (very well) to 10 (very poorly). Higher score indicates worse effect of the illness on the child. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. | Baseline (Day 0) and Week 52 |
| Change From Baseline in Average Daily Prednisone Equivalent Dose at Week 52 | The average daily prednisone equivalent dose accounted for all steroids taken IV, intramuscularly (IM), subcutaneously (SC), intradermally, and orally for both SLE and non-SLE reasons. All steroid dosages were converted to a prednisone equivalent in mg at each visit. The daily prednisone equivalent dose for a steroid was calculated as follows: collected dose of the steroid in mg multiplied by (*) conversion factor * frequency factor. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. At Baseline, the average daily prednisone equivalent dose was the sum of all prednisone doses over 7 consecutive days up to but not including Day 0, divided by 7. The average daily prednisone dose at Week 52 visit was the sum of all prednisone doses over 7 consecutive days up to and including the Week 52 visit, divided by 7. Average daily prednisone equivalent dose was expressed in milligrams per day. | Baseline (Day 0) and Week 52 |
| Time to First Flare Over 52 Weeks | The SLE flare index (SFI) is used to categorize SLE flares as mild/moderate or severe. A mild/moderate SFI flare involves: a SELENA-SLEDAI score increase of 3 to 12 points (higher score means greater disease activity); SLE symptom development; prednisone dose increase (but not above 0.5 milligrams per kilogram per day [mg/kg/day]); non-steroidal anti-inflammatory drugs (NSAIDs)/hydroxychloroquine addition; or PGA score increase by 1 or more, but not to more than 2.5 (higher score means greater disease activity). A severe SFI flare involves: SELENA-SLEDAI score increase over 12 points; onset or worsening of severe SLE symptoms; prednisone dose increase above 0.5 mg/kg/day; introduction of potent immunosuppressants; hospitalization; or PGA score reaching 2.5 or higher. Time to first SLE flare (mild/moderate or severe) was the number of days from treatment start date until the participant met an event. Time to first flare was defined as event date minus treatment start date plus 1. | Up to Week 52 |
| Time to First Severe Flare Over 52 Weeks | The SFI is used to categorize SLE flares as mild/moderate or severe. A severe SFI flare involves SELENA-SLEDAI score increase over 12 points (higher score means greater disease activity), onset or worsening of severe SLE symptoms, prednisone dose increase above 0.5 mg/kg/day, introduction of potent immunosuppressants, hospitalization, or PGA score reaching 2.5 or higher (higher score means higher disease activity). Time to first severe SLE flare was the number of days from treatment start date until the participant met an event. Time to first severe flare was defined as event date minus treatment start date plus 1. | Up to Week 52 |
| Median Belimumab Concentration Levels at Day 0, 7, and 14 Days Post First Dose, and Pre-infusion and Post-infusion at Day 84 | Blood samples were collected at indicated time points for measurement of plasma concentrations of belimumab. | Days 0, 7, and 14 days post first dose, and pre-infusion and post-infusion at Day 84 |
| Apparent Total Clearance of Belimumab | Blood samples were collected at indicated time points for PK analysis of belimumab. | Days 0, 7, and 14 days post first dose, and pre-infusion and post-infusion at Day 84 |
| Volume of Distribution of Belimumab | Blood samples were collected at indicated time points for PK analysis of belimumab. | Days 0, 7, and 14 days post first dose, and pre-infusion and post-infusion at Day 84 |
| Terminal Half-life (t1/2) of Belimumab | Blood samples were collected at indicated time points for PK analysis of belimumab. | Days 0, 7, and 14 days post first dose, and pre-infusion and post-infusion at Day 84 |
| Maximum Plasma Concentration (Cmax) of Belimumab at Steady State | Blood samples were collected at indicated time points for PK analysis of belimumab. | Days 0, 7, and 14 days post first dose, and pre-infusion and post-infusion at Day 84 |
| Minimum Plasma Concentration Reached Prior to Administration of Next Dose (Cmin) of Belimumab at Steady State | Blood samples were collected at indicated time points for PK analysis of belimumab. | Days 0, 7, and 14 days post first dose, and pre-infusion and post-infusion at Day 84 |
| Average Plasma Concentration (Cavg) of Belimumab at Steady State | Blood samples were collected at indicated time points for PK analysis of belimumab. | Days 0, 7, and 14 days post first dose, and pre-infusion and post-infusion at Day 84 |
| Area Under the Concentration Curve (AUC) of Belimumab at Steady State | Blood samples were collected at indicated time points for PK analysis of belimumab. | Days 0, 7, and 14 days post first dose, and pre-infusion and post-infusion at Day 84 |
| Changchun |
| 130021 |
| China |
| GSK Investigational Site | Changsha | 410007 | China |
| GSK Investigational Site | Chongqing | 400014 | China |
| GSK Investigational Site | Hangzhou | 310052 | China |
| GSK Investigational Site | Nanjing | 210011 | China |
| GSK Investigational Site | Shanghai | 361006 | China |
| GSK Investigational Site | Suzhou | 215007 | China |
| GSK Investigational Site | Xi'an | 710054 | China |
| Pharmacokinetic (PK) Population | PK population consisted of all the participants who received at least one dose of study treatment and for whom at least one post belimumab treatment PK sample was obtained and analyzed. |
|
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Belimumab | Participants with active SLE received belimumab at 10 mg/kg body weight by IV infusion over a minimum of 1 hour on Days 0, 14, 28, and then every 28 days through Week 48 in combination with standard therapy. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | YEARS |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events of Special Interest (AESIs) Through Week 52 | An adverse event (AE) is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AESIs included malignancies, post-infusion systemic or hypersensitivity reactions, infections (including serious infections of special interest), and depression, suicide, or self-injury. Infections of special interest included opportunistic infections (OI), herpes zoster (HZ), tuberculosis (TB), and sepsis. Number of participants with AESIs as identified by custom Medical Dictionary for Regulatory Activities (MedDRA) query has been reported. | Intent-to-Treat (ITT) population consisted of all participants who received at least one dose of study treatment. | Posted | Count of Participants | Participants | Up to Week 52 |
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| Primary | Number of Participants With Greater Than Equal to (>=) 4 Points Reduction From Baseline to Week 52 in Safety of Estrogen in Lupus National Assessment - Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) Score | The SELENA-SLEDAI score is a cumulative and weighted index for assessing SLE disease activity in participants with SLE. It consists of 24 disease descriptors related to signs and symptoms, laboratory tests, and physician's assessment across 9 organ systems. Each descriptor is assigned a weighted score (8 descriptors with a weight of 8 each, 6 descriptors with a weight of 4 each, 7 descriptors with a weight of 2 each, and 3 descriptors with a weight of 1 each) which is added up if the descriptor is observed during a visit or within the preceding 10 days. The total score ranges from 0 (no disease activity) to 105 (all 24 descriptors present simultaneously). A higher score indicates a more significant degree of disease activity. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Number of participants with a decrease of 4 points or more in the score at Week 52 compared to their Baseline score is presented. | ITT population consisted of all participants who received at least one dose of study treatment. One participant with Baseline SELENA-SLEDAI score less than 4 was excluded from the analysis. | Posted | Count of Participants | Participants | Baseline (Day 0) and Week 52 |
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| Secondary | Number of Participants With AEs and Serious Adverse Events (SAEs) Through Week 52 | An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a birth defect or congenital anomaly, or other situations as per the medical or scientific judgment of the investigator. Number of participants with AEs and SAEs has been reported. | ITT population consisted of all participants who received at least one dose of study treatment. | Posted | Count of Participants | Participants | Up to Week 52 |
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| Secondary | Percentage of Participants With >=4 Points Reduction From Baseline in SELENA-SLEDAI Score by Each Visit | The SELENA-SLEDAI score is a cumulative and weighted index for assessing SLE disease activity in participants with SLE. It consists of 24 disease descriptors related to signs and symptoms, laboratory tests, and physician's assessment across 9 organ systems. Each descriptor is assigned a weighted score (8 descriptors with a weight of 8 each, 6 descriptors with a weight of 4 each, 7 descriptors with a weight of 2 each, and 3 descriptors with a weight of 1 each) which is added up if the descriptor is observed during a visit or within the preceding 10 days. The total score ranges from 0 (no disease activity) to 105 (all 24 descriptors present simultaneously). A higher score indicates a more significant degree of disease activity. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Percentage of participants with a decrease of 4 points or more in the score at each visit compared to their Baseline score is presented. | ITT population. 1 participant with Baseline SELENA-SLEDAI score below 4 was excluded. All 66 participants served as denominator to calculate percentages at each visit. For all visits except Week 52 (where percentage value was rounded off as no data was missing), missing data from missed visits were handled by multiple imputation. Estimates generated for every imputed dataset were combined by Rubin's rules to obtain percentages. So reported percentages may not yield whole number of participants. | Posted | Number | Percentage of Participants | Baseline (Day 0) and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 |
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| Secondary | Change From Baseline to Week 52 in Physician Global Assessment (PGA) | The PGA is used to assess the participant's current disease activity by investigator. It is collected on a 10 centimeter (cm) visual analogue scale. The score ranges from 0 (no activity) to 3 (severe activity). Lower score means no disease activity, higher score means severe disease activity. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. | ITT population consisted of all participants who received at least one dose of study treatment. | Posted | Mean | Standard Deviation | Scores on scale | Baseline (Day 0) and Week 52 |
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| Secondary | Change From Baseline to Week 52 in Parent Global Assessment (ParentGA) | The ParentGA is used to assess the participant's overall well-being at the moment rated on a 21-numbered circle visual analog scale by the parent. The score ranges from 0 (very well) to 10 (very poorly). Higher score indicates worse effect of the illness on the child. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. | ITT population consisted of all participants who received at least one dose of study treatment. | Posted | Mean | Standard Deviation | Scores on scale | Baseline (Day 0) and Week 52 |
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| Secondary | Change From Baseline in Average Daily Prednisone Equivalent Dose at Week 52 | The average daily prednisone equivalent dose accounted for all steroids taken IV, intramuscularly (IM), subcutaneously (SC), intradermally, and orally for both SLE and non-SLE reasons. All steroid dosages were converted to a prednisone equivalent in mg at each visit. The daily prednisone equivalent dose for a steroid was calculated as follows: collected dose of the steroid in mg multiplied by (*) conversion factor * frequency factor. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. At Baseline, the average daily prednisone equivalent dose was the sum of all prednisone doses over 7 consecutive days up to but not including Day 0, divided by 7. The average daily prednisone dose at Week 52 visit was the sum of all prednisone doses over 7 consecutive days up to and including the Week 52 visit, divided by 7. Average daily prednisone equivalent dose was expressed in milligrams per day. | ITT population consisted of all participants who received at least one dose of study treatment. 'Overall Number of Participants Analyzed' included only those participants who were analyzed (i.e., contributed data reported in table). | Posted | Mean | Standard Deviation | milligrams per day | Baseline (Day 0) and Week 52 |
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| Secondary | Time to First Flare Over 52 Weeks | The SLE flare index (SFI) is used to categorize SLE flares as mild/moderate or severe. A mild/moderate SFI flare involves: a SELENA-SLEDAI score increase of 3 to 12 points (higher score means greater disease activity); SLE symptom development; prednisone dose increase (but not above 0.5 milligrams per kilogram per day [mg/kg/day]); non-steroidal anti-inflammatory drugs (NSAIDs)/hydroxychloroquine addition; or PGA score increase by 1 or more, but not to more than 2.5 (higher score means greater disease activity). A severe SFI flare involves: SELENA-SLEDAI score increase over 12 points; onset or worsening of severe SLE symptoms; prednisone dose increase above 0.5 mg/kg/day; introduction of potent immunosuppressants; hospitalization; or PGA score reaching 2.5 or higher. Time to first SLE flare (mild/moderate or severe) was the number of days from treatment start date until the participant met an event. Time to first flare was defined as event date minus treatment start date plus 1. | ITT population consisted of all participants who received at least one dose of study treatment. 'Overall number of participants analyzed' included those participants who experienced a post-baseline SFI flare over 52 weeks. | Posted | Median | Inter-Quartile Range | days | Up to Week 52 |
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| Secondary | Time to First Severe Flare Over 52 Weeks | The SFI is used to categorize SLE flares as mild/moderate or severe. A severe SFI flare involves SELENA-SLEDAI score increase over 12 points (higher score means greater disease activity), onset or worsening of severe SLE symptoms, prednisone dose increase above 0.5 mg/kg/day, introduction of potent immunosuppressants, hospitalization, or PGA score reaching 2.5 or higher (higher score means higher disease activity). Time to first severe SLE flare was the number of days from treatment start date until the participant met an event. Time to first severe flare was defined as event date minus treatment start date plus 1. | ITT population consisted of all participants who received at least one dose of study treatment. 'Overall number of participants analyzed' included those participants who experienced a post-baseline severe SFI flare over 52 weeks. | Posted | Median | Inter-Quartile Range | days | Up to Week 52 |
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| Secondary | Median Belimumab Concentration Levels at Day 0, 7, and 14 Days Post First Dose, and Pre-infusion and Post-infusion at Day 84 | Blood samples were collected at indicated time points for measurement of plasma concentrations of belimumab. | Pharmacokinetic (PK) population consisted of all the participants who received at least one dose of study treatment and for whom at least one post belimumab treatment PK sample was obtained and analyzed. 'Overall number of participants analyzed' included only those participants who were analyzed (i.e., contributed data reported in table). 'Number analyzed' included participants evaluable for specified time points. | Posted | Median | Full Range | Micrograms per milliliter | Days 0, 7, and 14 days post first dose, and pre-infusion and post-infusion at Day 84 |
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| Secondary | Apparent Total Clearance of Belimumab | Blood samples were collected at indicated time points for PK analysis of belimumab. | PK population consisted of all the participants who received at least one dose of study treatment and for whom at least one post belimumab treatment PK sample was obtained and analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Milliliters per day | Days 0, 7, and 14 days post first dose, and pre-infusion and post-infusion at Day 84 |
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| Secondary | Volume of Distribution of Belimumab | Blood samples were collected at indicated time points for PK analysis of belimumab. | PK population consisted of all the participants who received at least one dose of study treatment and for whom at least one post belimumab treatment PK sample was obtained and analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Milliliters | Days 0, 7, and 14 days post first dose, and pre-infusion and post-infusion at Day 84 |
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| Secondary | Terminal Half-life (t1/2) of Belimumab | Blood samples were collected at indicated time points for PK analysis of belimumab. | PK population consisted of all the participants who received at least one dose of study treatment and for whom at least one post belimumab treatment PK sample was obtained and analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Days | Days 0, 7, and 14 days post first dose, and pre-infusion and post-infusion at Day 84 |
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| Secondary | Maximum Plasma Concentration (Cmax) of Belimumab at Steady State | Blood samples were collected at indicated time points for PK analysis of belimumab. | PK population consisted of all the participants who received at least one dose of study treatment and for whom at least one post belimumab treatment PK sample was obtained and analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Micrograms per milliliter | Days 0, 7, and 14 days post first dose, and pre-infusion and post-infusion at Day 84 |
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| Secondary | Minimum Plasma Concentration Reached Prior to Administration of Next Dose (Cmin) of Belimumab at Steady State | Blood samples were collected at indicated time points for PK analysis of belimumab. | PK population consisted of all the participants who received at least one dose of study treatment and for whom at least one post belimumab treatment PK sample was obtained and analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Micrograms per milliliter | Days 0, 7, and 14 days post first dose, and pre-infusion and post-infusion at Day 84 |
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| Secondary | Average Plasma Concentration (Cavg) of Belimumab at Steady State | Blood samples were collected at indicated time points for PK analysis of belimumab. | PK population consisted of all the participants who received at least one dose of study treatment and for whom at least one post belimumab treatment PK sample was obtained and analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Micrograms per milliliter | Days 0, 7, and 14 days post first dose, and pre-infusion and post-infusion at Day 84 |
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| Secondary | Area Under the Concentration Curve (AUC) of Belimumab at Steady State | Blood samples were collected at indicated time points for PK analysis of belimumab. | PK population consisted of all the participants who received at least one dose of study treatment and for whom at least one post belimumab treatment PK sample was obtained and analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Days*micrograms per milliliter | Days 0, 7, and 14 days post first dose, and pre-infusion and post-infusion at Day 84 |
|
|
All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64
All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
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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 | Belimumab | Participants with active SLE received belimumab at 10 mg/kg body weight by IV infusion over a minimum of 1 hour on Days 0, 14, 28, and then every 28 days through Week 48 in combination with standard therapy. | 0 | 67 | 20 | 67 | 57 | 67 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| H1N1 influenza | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Pulmonary arterial hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Eyelid oedema | Eye disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Hypogammaglobulinaemia | Immune system disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Neuromyelitis optica spectrum disorder | Nervous system disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Pancreatitis necrotising | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Coronavirus pneumonia | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA v27.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA v27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Autoimmune thyroiditis | Endocrine disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Cerumen impaction | Ear and labyrinth disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Tinea versicolour | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Abscess soft tissue | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Adenovirus infection | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Helicobacter infection | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Herpangina | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Mumps | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Tinea pedis | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Varicella | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Functional gastrointestinal disorder | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Anal fissure | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Cheilitis | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Faeces discoloured | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Pancreatic pseudocyst | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Hepatic steatosis | Hepatobiliary disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Hepatomegaly | Hepatobiliary disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Hepatic lesion | Hepatobiliary disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Intraocular pressure increased | Investigations | MedDRA v27.0 | Systematic Assessment |
| |
| Neutrophil count increased | Investigations | MedDRA v27.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA v27.0 | Systematic Assessment |
| |
| Blood immunoglobulin M decreased | Investigations | MedDRA v27.0 | Systematic Assessment |
| |
| Blood phosphorus decreased | Investigations | MedDRA v27.0 | Systematic Assessment |
| |
| Bone density decreased | Investigations | MedDRA v27.0 | Systematic Assessment |
| |
| CD19 lymphocytes decreased | Investigations | MedDRA v27.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA v27.0 | Systematic Assessment |
| |
| Reticulocyte count increased | Investigations | MedDRA v27.0 | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA v27.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Cutaneous vasculitis | Skin and subcutaneous tissue disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Polycythaemia | Blood and lymphatic system disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Xerophthalmia | Eye disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Conjunctivitis allergic | Eye disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Eyelid oedema | Eye disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Ocular hypertension | Eye disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Retinal haemorrhage | Eye disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Animal bite | Injury, poisoning and procedural complications | MedDRA v27.0 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA v27.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA v27.0 | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA v27.0 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA v27.0 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Myocardial injury | Cardiac disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Endocrine hypertension | Vascular disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Hypogammaglobulinaemia | Immune system disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA v27.0 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 30, 2024 | May 7, 2026 | SAP_002.pdf |
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C511911 | belimumab |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| Depression (including mood disorders and anxiety)/suicide/self-injury |
|
|
|
|
Participants with active SLE received belimumab at 10 mg/kg body weight by IV infusion over a minimum of 1 hour on Days 0, 14, 28, and then every 28 days through Week 48 in combination with standard therapy.
|
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|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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