Systemic Lupus Erythematosus
Conditions
Keywords
SLE, Belimumab, Antibodies, Systemic Lupus Erythematosus, Lupus, Autoimmune Diseases
Brief summary
This is a long-term continuation study to provide continuing treatment to subjects with SLE.
Detailed description
This trial is a long-term continuation study to provide continuing treatment to subjects with System Lupus Erythematosus (SLE).
Interventions
DRUGbelimumab
Recombinant, fully human, monoclonal antibody Comparison of the 1 mg/kg and 10 mg/kg dose of belimumab given IV every 28 days.
Sponsors
GlaxoSmithKline
Human Genome Sciences Inc., a GSK Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have completed the HGS 1006-C1056 or HGS 1006-C1057 protocol through the Week 72 or Week 48 visits, respectively.
Exclusion criteria
* Have developed any other medical disease or condition that has made the patient unsuitable for this study in the opinion of their physician.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AE) | Up to 9 years | An adverse event is defined as any unfavorable or unintended sign, symptom, or disease that is temporally associated with the use of a study agent but is not necessarily caused by the study agent. This includes worsening (example: increase in frequency or severity) of preexisting conditions. Participants with incidences of any event at any time post-baseline are presented by yearly interval. Only treatment-emergent AEs are summarized. |
| AE Rates by System Organ Class (SOC) During the Study | Up to 9 years | AE rates by SOC adjusting for participant-years on study drug anytime post Baseline are summarized, which included the follow up visits. Only treatment-emergent AEs are summarized. The event rate of an AE was calculated as the number of events per 100 participant years. Participant years were calculated as sum across all participants (\[last visit of interval day - first visit of interval day + 1\] divided by365). Participant years excluded between study gaps if participant had not started extension study on date of last visit of parent study. |
| Number of Participants With Serious Adverse Events (SAE) | Up to 9 years | An adverse event resulting in death, is life threatening (ie, an immediate threat to life), inpatient hospitalization, prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect or any other situation which is medically important is categorized as SAE. Only treatment-emergent AEs are summarized. |
| SAE Rates by SOC During the Study | Up to 9 years | SAE rates by SOC adjusting for participants-years on study drug anytime post Baseline are summarized, which included the follow up visits. Only treatment-emergent SAEs are summarized. The event rate of an SAE was calculated as the number of events per 100 participant years. Participants years were calculated as = sum across all participants (\[last visit of interval day - first visit of interval day + 1\] divided by 365). Participants years excluded between study gaps if participant had not started extension study on date of last visit of parent study. |
| Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | Baseline and up to 9 years | Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in APTT and PT is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point |
| Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Baseline and up to 9 years | Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Plt, Lymp, Leu, Eos, Baso, Mono, Neu, NeuBF, and NueS are summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point. |
| Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points | Baseline and up to 9 years | Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Hg is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point. |
| Change From Baseline in Hematocrit at the Indicated Time Points | Baseline and up to 9 years | Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks). Change from Baseline in Hematocrit is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point. |
| Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points | Baseline and up to 9 years | Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Erythrocytes is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point. |
| Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Baseline and up to 9 years | Electrolytes parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 electrolytes parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Ca,CO2, Chloride, Mg, Phos, K and Na were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point. |
| Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points | Baseline and up to 9 years | Other chemistries parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 other chemistries parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in BUN/Cr is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. |
| Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points | Baseline and up to 9 years | Other chemistries parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 other chemistries parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Alb and Protein were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point. |
| Change From Baseline in BUN and Glucose at the Indicated Time Points | Baseline and up to 9 years | Other chemistries parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 other chemistries were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in BUN and Glucose were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point. |
| Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points | Baseline and up to 9 years | Other chemistries parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 other chemistries were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Cr and Urate were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point. |
| Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | Baseline and up to 9 years | Liver function parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 liver function parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in ALT, ALP, AST, GGT and LDH were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.NA indicates standard deviation was not calculable for a single data point. |
| Change From Baseline in Bilirubin (Bili) Levels | Baseline and up to 9 years | Liver function parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 liver function parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Bili were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point. |
| Change From Baseline in Immunoglobulin G (IgG) Levels | Baseline and up to 9 years | Immunoglobulin (Ig) parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 Ig parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Ig G were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point. |
| Number of Participants With Immunogenic Response by Year | Up to 9 years | Immunogenic response was analyzed using serum samples for anti-belimumab antibody measurements in MITT population. Categories of response are Negative, Transient Positive (+) means single + response that does not occur at the final assessment, and Persistent + means + response that occurs at least 2 consecutive assessments or a single result at the final assessment. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. |
| Number of Participants With IgG Values Below the Lower Limit of Normal by Year | Up to 9 years | Blood samples were collected to evaluate IgG levels at Baseline and at Weeks 12, 24 and 48 during Year 1. From Year 2-9, IgG was evaluated at Week 24 and 48 ; Exit visit and at follow-up visit (up to 8 weeks post last infusion). Number of participants with IgG immunoglobulin values below the LLN at each one year interval are presented. Baseline includes Extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with Belimumab in the parent study. If a participant had more than one response within a year, then the last response within the year interval (usually the Week 48 assessment) was summarized. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. |
| Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Up to 9 years | Participants who had improving SLE disease activity for at least 8 weeks, at the investigator's discretion, the steroid dose was reduced by reduction to 7.5 mg/day. If the participant continued to have stable or improving disease activity after 4 weeks on a reduced dose, then the investigator considered reducing the dose again. Baseline includes extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with Belimumab in the parent study. Number of participants with shifts from Baseline total daily dose category by visit is summarized. |
| Number of Participants With Any SLICC/ ACR Damage Index Worsening (Change > 0) From Baseline by Visit | Up to 9 years | The SLICC/ACR Damage Index was assessed every 48 weeks and at the exit visit as a measure of disease activity. It was developed to assess the accumulated damage since the onset of the disease. The number of participants with worsening in their SLICC/ACR Damage Index score compared with Baseline have been presented. Worsening was defined as a change in score (post-Baseline visit score - Baseline score) \> 0. Baseline includes extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with Belimumab in the parent study. For years in which a participant was withdrawn from the study, the exit visit assessment was used in place of the Week 48 assessment for the year. This value was not carried forward through later years. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. |
Countries
Argentina, Austria, Belgium, Brazil, Canada, Chile, Colombia, Czechia, France, Germany, Hong Kong, India, Israel, Italy, Mexico, Netherlands, Peru, Philippines, Poland, Puerto Rico, Romania, Russia, Slovakia, South Korea, Spain, Sweden, Taiwan, United Kingdom
Participant flow
Recruitment details
This was a multi-center, continuation trial of belimumab and was conducted at 115 centers in 28 countries. Participants with Systemic Lupus Erythematosus (SLE), who had completed the Phase 3 HGS1006-C1056 or HGS1006-C1057 trial or participants who had previously received subcutaneous belimumab in Protocol HGS1006-C1070 were included in this trial.
Pre-assignment details
738 participants were enrolled in the study and 735 received at least one dose of belimumab.Out of 735 participants, 368 completed the study and 370 withdrew from the study.
Participants by arm
| Arm | Count |
|---|---|
| Belimumab 10mg/kg IV Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial. | 735 |
| Total | 735 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 69 |
| Overall Study | Death of patient | 1 |
| Overall Study | Hip replacement surgery | 1 |
| Overall Study | Involved in Clinical research | 3 |
| Overall Study | Lack of Efficacy | 6 |
| Overall Study | Lost to Follow-up | 22 |
| Overall Study | Non-compliance with study drug | 13 |
| Overall Study | Not committed to contraception | 1 |
| Overall Study | Other Physician decision | 1 |
| Overall Study | Other Pregnancy | 37 |
| Overall Study | Participant hospitalized | 1 |
| Overall Study | Participant received medication | 1 |
| Overall Study | Participant travelled overseas | 2 |
| Overall Study | Physician Decision | 36 |
| Overall Study | Protocol Violation | 4 |
| Overall Study | Sponsor decision | 14 |
| Overall Study | Withdrawal by Subject | 151 |
| Overall Study | Withdrew consent | 4 |
Baseline characteristics
| Characteristic | Belimumab 10mg/kg IV |
|---|---|
| Age, Continuous | 37.2 Years STANDARD_DEVIATION 11.17 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 225 Participants |
| Race/Ethnicity, Customized Black or African American/African Heritage | 18 Participants |
| Race/Ethnicity, Customized East Asian Heritage | 118 Participants |
| Race/Ethnicity, Customized Middle East/North African Heritage | 22 Participants |
| Race/Ethnicity, Customized South Asian Heritage | 38 Participants |
| Race/Ethnicity, Customized Southeast Asian Heritage | 58 Participants |
| Race/Ethnicity, Customized White/Caucasian/European Heritage | 256 Participants |
| Sex: Female, Male Female | 695 Participants |
| Sex: Female, Male Male | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 11 / 735 |
| other Total, other adverse events | 614 / 735 |
| serious Total, serious adverse events | 231 / 735 |
Outcome results
Primary
AE Rates by System Organ Class (SOC) During the Study
AE rates by SOC adjusting for participant-years on study drug anytime post Baseline are summarized, which included the follow up visits. Only treatment-emergent AEs are summarized. The event rate of an AE was calculated as the number of events per 100 participant years. Participant years were calculated as sum across all participants (\[last visit of interval day - first visit of interval day + 1\] divided by365). Participant years excluded between study gaps if participant had not started extension study on date of last visit of parent study.
Time frame: Up to 9 years
Population: MITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Belimumab 10mg/kg IV | AE Rates by System Organ Class (SOC) During the Study | Infections and infestations | 101.8 Adverse events per 100 participant years |
| Belimumab 10mg/kg IV | AE Rates by System Organ Class (SOC) During the Study | Gastrointestinal disorders | 32.8 Adverse events per 100 participant years |
| Belimumab 10mg/kg IV | AE Rates by System Organ Class (SOC) During the Study | Musculoskeletal and connective tissuedisorder | 32.8 Adverse events per 100 participant years |
| Belimumab 10mg/kg IV | AE Rates by System Organ Class (SOC) During the Study | Nervous system disorders | 22.6 Adverse events per 100 participant years |
| Belimumab 10mg/kg IV | AE Rates by System Organ Class (SOC) During the Study | Skin and subcutaneous and tissue disorders | 22.5 Adverse events per 100 participant years |
| Belimumab 10mg/kg IV | AE Rates by System Organ Class (SOC) During the Study | Respiratory,thoracic and mediastinal disorder | 14.9 Adverse events per 100 participant years |
| Belimumab 10mg/kg IV | AE Rates by System Organ Class (SOC) During the Study | Vascular disorders | 13.3 Adverse events per 100 participant years |
| Belimumab 10mg/kg IV | AE Rates by System Organ Class (SOC) During the Study | General disorders and administration sitecondition | 11.8 Adverse events per 100 participant years |
| Belimumab 10mg/kg IV | AE Rates by System Organ Class (SOC) During the Study | Injury, poisoning andprocedural complications | 11.5 Adverse events per 100 participant years |
| Belimumab 10mg/kg IV | AE Rates by System Organ Class (SOC) During the Study | Blood and lymphatic system disorders | 7.5 Adverse events per 100 participant years |
| Belimumab 10mg/kg IV | AE Rates by System Organ Class (SOC) During the Study | Eye disorders | 6.6 Adverse events per 100 participant years |
| Belimumab 10mg/kg IV | AE Rates by System Organ Class (SOC) During the Study | Reproductive system and breast disorders | 6.4 Adverse events per 100 participant years |
| Belimumab 10mg/kg IV | AE Rates by System Organ Class (SOC) During the Study | Investigations | 5.8 Adverse events per 100 participant years |
| Belimumab 10mg/kg IV | AE Rates by System Organ Class (SOC) During the Study | Psychiatric disorders | 5.6 Adverse events per 100 participant years |
| Belimumab 10mg/kg IV | AE Rates by System Organ Class (SOC) During the Study | Renal and urinary and disorder | 5.3 Adverse events per 100 participant years |
| Belimumab 10mg/kg IV | AE Rates by System Organ Class (SOC) During the Study | Metabolism and nutrition disorder | 3.6 Adverse events per 100 participant years |
| Belimumab 10mg/kg IV | AE Rates by System Organ Class (SOC) During the Study | Cardiac disorders | 3.0 Adverse events per 100 participant years |
| Belimumab 10mg/kg IV | AE Rates by System Organ Class (SOC) During the Study | Ear and labyrinth disorder | 2.4 Adverse events per 100 participant years |
| Belimumab 10mg/kg IV | AE Rates by System Organ Class (SOC) During the Study | Neoplasms benign,malignant andunspecified | 2.2 Adverse events per 100 participant years |
| Belimumab 10mg/kg IV | AE Rates by System Organ Class (SOC) During the Study | Hepatobiliary disorders | 1.8 Adverse events per 100 participant years |
| Belimumab 10mg/kg IV | AE Rates by System Organ Class (SOC) During the Study | Immune system disorder | 1.2 Adverse events per 100 participant years |
| Belimumab 10mg/kg IV | AE Rates by System Organ Class (SOC) During the Study | Endocrine disorders | 1.0 Adverse events per 100 participant years |
| Belimumab 10mg/kg IV | AE Rates by System Organ Class (SOC) During the Study | Social circumstances | 0.7 Adverse events per 100 participant years |
| Belimumab 10mg/kg IV | AE Rates by System Organ Class (SOC) During the Study | Congenital, familial and genetic disorders | 0.1 Adverse events per 100 participant years |
| Belimumab 10mg/kg IV | AE Rates by System Organ Class (SOC) During the Study | Pregnancy, puerperium and perinatal conditions | 0.1 Adverse events per 100 participant years |
| Belimumab 10mg/kg IV | AE Rates by System Organ Class (SOC) During the Study | Product Issues | 0.1 Adverse events per 100 participant years |
Primary
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in APTT and PT is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point
Time frame: Baseline and up to 9 years
Population: MITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | Year6,Week48,APTT,n=277 | 4.3 Seconds | Standard Deviation 7.91 |
| Belimumab 10mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | Year7,Week48,APTT,n=131 | 4.1 Seconds | Standard Deviation 6.23 |
| Belimumab 10mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | 8 Week,Follow up,n=524 | 3.4 Seconds | Standard Deviation 8.14 |
| Belimumab 10mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | Year1,Week12,PT,n=206 | 1.71 Seconds | Standard Deviation 19.533 |
| Belimumab 10mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | Year1,Week4,APTT,n=208 | 0.7 Seconds | Standard Deviation 5.27 |
| Belimumab 10mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | Year1,Week12,APTT,n=208 | 2.1 Seconds | Standard Deviation 12.31 |
| Belimumab 10mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | Year1,Week24,APTT,n=686 | 0.1 Seconds | Standard Deviation 9.1 |
| Belimumab 10mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | Year1,Week36,APTT,n=193 | 2.5 Seconds | Standard Deviation 5.75 |
| Belimumab 10mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | Year1,Week48,APTT,n=666 | 0.8 Seconds | Standard Deviation 9.48 |
| Belimumab 10mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | Year2,Week24,APTT,n=625 | 2.7 Seconds | Standard Deviation 9.74 |
| Belimumab 10mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | Year2,Week48,APTT,n=572 | 2.7 Seconds | Standard Deviation 9.66 |
| Belimumab 10mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | Year3,Week24,APTT,n=521 | 3.4 Seconds | Standard Deviation 10.01 |
| Belimumab 10mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | Year3,Week48,APTT,n=470 | 3.9 Seconds | Standard Deviation 11.41 |
| Belimumab 10mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | Year4,Week24,APTT,n=422 | 3.5 Seconds | Standard Deviation 10.7 |
| Belimumab 10mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | Year4,Week48,APTT,n=412 | 4.2 Seconds | Standard Deviation 6.63 |
| Belimumab 10mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | Year5,Week24,APTT,n=383 | 4.1 Seconds | Standard Deviation 10.71 |
| Belimumab 10mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | Year5,Week48,APTT,n=349 | 3.5 Seconds | Standard Deviation 6.35 |
| Belimumab 10mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | Year6,Week24,APTT,n=292 | 3.8 Seconds | Standard Deviation 6.58 |
| Belimumab 10mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | Year7,Week24,APTT,n=177 | 6.4 Seconds | Standard Deviation 14.52 |
| Belimumab 10mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | Year8,Week24,APTT,n=52 | 5.6 Seconds | Standard Deviation 7.54 |
| Belimumab 10mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | Year8,Week48,APTT,n=13 | 4.2 Seconds | Standard Deviation 3.98 |
| Belimumab 10mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | Year9,Week24,APTT,n=6 | 5.0 Seconds | Standard Deviation 6.39 |
| Belimumab 10mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | Year9,Week48,APTT,n=1 | 9.0 Seconds | — |
| Belimumab 10mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | Exit, APTT,n=586 | 3.2 Seconds | Standard Deviation 10.71 |
| Belimumab 10mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | Year1,Week4,PT,n=205 | -0.22 Seconds | Standard Deviation 5.139 |
| Belimumab 10mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | Year1,Week24,PT,n=686 | -0.43 Seconds | Standard Deviation 8.267 |
| Belimumab 10mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | Year1,Week36,PT,n=193 | 0.13 Seconds | Standard Deviation 3.357 |
| Belimumab 10mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | Year1,Week48,PT,n=666 | -0.45 Seconds | Standard Deviation 8.174 |
| Belimumab 10mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | Year2,Week24,PT,n=626 | 0.15 Seconds | Standard Deviation 11.528 |
| Belimumab 10mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | Year2,Week48,PT,n=572 | -0.26 Seconds | Standard Deviation 8.925 |
| Belimumab 10mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | Year3,Week24,PT,n=521 | 0.12 Seconds | Standard Deviation 9.609 |
| Belimumab 10mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | Year3,Week48,PT,n=469 | 0.63 Seconds | Standard Deviation 14.334 |
| Belimumab 10mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | Year4,Week24,PT,n=422 | 0.06 Seconds | Standard Deviation 10.458 |
| Belimumab 10mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | Year4,Week48,PT,n=412 | 0.40 Seconds | Standard Deviation 4.228 |
| Belimumab 10mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | Year5,Week24,PT,n=384 | -0.14 Seconds | Standard Deviation 10.81 |
| Belimumab 10mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | Year5,Week48,PT,n=349 | 0.61 Seconds | Standard Deviation 11.276 |
| Belimumab 10mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | Year6,Week24,PT,n=292 | 0.64 Seconds | Standard Deviation 8.023 |
| Belimumab 10mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | Year6,Week48,PT,n=278 | 0.85 Seconds | Standard Deviation 12.414 |
| Belimumab 10mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | Year7,Week24,PT,n=177 | 1.76 Seconds | Standard Deviation 14.272 |
| Belimumab 10mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | Year7,Week48,PT,n=131 | 0.36 Seconds | Standard Deviation 2.29 |
| Belimumab 10mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | Year8,Week24,PT,n=52 | 1.21 Seconds | Standard Deviation 6.716 |
| Belimumab 10mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | Year8,Week48,PT,n=13 | 0.52 Seconds | Standard Deviation 0.6 |
| Belimumab 10mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | Year9,Week24,PT,n=6 | 0.50 Seconds | Standard Deviation 0.657 |
| Belimumab 10mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | Year9,Week48,PT,n=1 | 1.00 Seconds | — |
| Belimumab 10mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | Exit,PT, n=587 | 0.25 Seconds | Standard Deviation 9.973 |
| Belimumab 10mg/kg IV | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | 8 Week, Follow up,n=524 | 0.50 Seconds | Standard Deviation 4.965 |
Primary
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
Liver function parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 liver function parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in ALT, ALP, AST, GGT and LDH were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.NA indicates standard deviation was not calculable for a single data point.
Time frame: Baseline and up to 9 years
Population: MITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | ALT, Year 1 Week 12, n=705 | -0.9 International Units/liter (IU/L) | Standard Deviation 12.31 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | ALT, Year 7 Week 24, n=183 | 1.3 International Units/liter (IU/L) | Standard Deviation 19.46 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | GGT, Year 2 Week 48, n=598 | 0.1 International Units/liter (IU/L) | Standard Deviation 34.63 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | GGT, Year 4 Week 48, n=421 | 1.1 International Units/liter (IU/L) | Standard Deviation 54.41 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | LDH, Year 1 Week 4, n=701 | -4.1 International Units/liter (IU/L) | Standard Deviation 77.93 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | LDH, Year 1 Week 12, n=700 | -6.0 International Units/liter (IU/L) | Standard Deviation 80.55 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | LDH, Year 4 Week 48, n=418 | -16.9 International Units/liter (IU/L) | Standard Deviation 102.11 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | LDH, Year 5 Week 24, n=393 | -17.5 International Units/liter (IU/L) | Standard Deviation 106.45 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | LDH, Year 9 Week 24, n=6 | -27.2 International Units/liter (IU/L) | Standard Deviation 32.64 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | ALP, Year 2 Week 24, n=643 | 5.1 International Units/liter (IU/L) | Standard Deviation 21.58 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | ALP, Year 2 Week 48, n=598 | 6.1 International Units/liter (IU/L) | Standard Deviation 23.23 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | ALP, Year 3 Week 24, n=535 | 5.9 International Units/liter (IU/L) | Standard Deviation 18.95 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | ALP, Year 3 Week 48, n=488 | 7.3 International Units/liter (IU/L) | Standard Deviation 22.22 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | ALP, Year 5 Week 48, n=362 | 8.5 International Units/liter (IU/L) | Standard Deviation 20.61 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | ALP, Year 6 Week 24, n=304 | 9.4 International Units/liter (IU/L) | Standard Deviation 23.28 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | ALP, Year 6 Week 48, n=286 | 11.5 International Units/liter (IU/L) | Standard Deviation 27.39 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | ALP, Year 7 Week 24, n=183 | 10.9 International Units/liter (IU/L) | Standard Deviation 28.08 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | ALT, Year 1 Week 4, n=707 | -0.4 International Units/liter (IU/L) | Standard Deviation 10.18 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | ALT, Year 1 Week 24, n=703 | -0.9 International Units/liter (IU/L) | Standard Deviation 19.46 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | ALT, Year 1 Week 36, n=684 | -1.0 International Units/liter (IU/L) | Standard Deviation 15.61 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | ALT, Year 1 Week 48, n=693 | -0.7 International Units/liter (IU/L) | Standard Deviation 15.04 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | ALT, Year 2 Week 24, n=643 | 0.2 International Units/liter (IU/L) | Standard Deviation 23.56 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | ALT, Year 2 Week 48, n=598 | 2.7 International Units/liter (IU/L) | Standard Deviation 57.67 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | ALT, Year 3 Week 24, n=535 | -1.3 International Units/liter (IU/L) | Standard Deviation 14.4 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | ALT, Year 3 Week 48, n=488 | 0.1 International Units/liter (IU/L) | Standard Deviation 21.21 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | ALT, Year 4 Week 24, n=439 | -0.1 International Units/liter (IU/L) | Standard Deviation 18.72 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | ALT, Year 4 Week 48, n=421 | -0.6 International Units/liter (IU/L) | Standard Deviation 17.59 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | ALT, Year 5 Week 24, n=393 | -1.3 International Units/liter (IU/L) | Standard Deviation 18.74 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | ALT, Year 5 Week 48, n=362 | -0.4 International Units/liter (IU/L) | Standard Deviation 22.72 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | ALT, Year 6 Week 24, n=304 | -0.2 International Units/liter (IU/L) | Standard Deviation 20.54 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | ALT, Year 6 Week 48, n=286 | 0.9 International Units/liter (IU/L) | Standard Deviation 20.94 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | ALP, Year 7 Week 48, n=130 | 7.5 International Units/liter (IU/L) | Standard Deviation 22.5 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | ALP, Year 8 Week 24, n=52 | 12.9 International Units/liter (IU/L) | Standard Deviation 26.64 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | ALP, Year 8 Week 48, n=13 | 6.1 International Units/liter (IU/L) | Standard Deviation 30.04 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | GGT, Year 1 Week 24, n=703 | -0.2 International Units/liter (IU/L) | Standard Deviation 39.5 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | GGT, Year 1 Week 36, n=684 | 1.0 International Units/liter (IU/L) | Standard Deviation 64.6 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | GGT, Year 1 Week 48, n=693 | 0.9 International Units/liter (IU/L) | Standard Deviation 35.99 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | GGT, Year 2 Week 24, n=643 | -0.7 International Units/liter (IU/L) | Standard Deviation 34.81 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | ALT, Year 7 Week 48, n=130 | -0.1 International Units/liter (IU/L) | Standard Deviation 16.79 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | ALT, Year 8 Week 24, n=52 | 2.7 International Units/liter (IU/L) | Standard Deviation 31.15 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | ALT, Year 8 Week 48, n=13 | 5.8 International Units/liter (IU/L) | Standard Deviation 33.54 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | ALT, Year 9 Week 24, n=6 | 9.3 International Units/liter (IU/L) | Standard Deviation 27.77 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | ALT, Year 9 Week 48, n=1 | -6.0 International Units/liter (IU/L) | — |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | ALP, Year 9 Week 24, n=6 | 4.2 International Units/liter (IU/L) | Standard Deviation 35.43 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | ALP, Year 9 Week 48, n=1 | 12.0 International Units/liter (IU/L) | — |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | ALP, Exit, n=625 | 7.5 International Units/liter (IU/L) | Standard Deviation 25.35 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | ALP, 8 Week follow-up, n=539 | 6.1 International Units/liter (IU/L) | Standard Deviation 23 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | AST, Year 1 Week 4, n=701 | -0.6 International Units/liter (IU/L) | Standard Deviation 10.56 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | ALT, Exit, n=624 | -0.6 International Units/liter (IU/L) | Standard Deviation 17.03 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | AST, Year 1 Week 12, n=700 | -1.3 International Units/liter (IU/L) | Standard Deviation 14.12 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | AST, Year 1 Week 24, n=701 | -1.0 International Units/liter (IU/L) | Standard Deviation 20.79 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | AST, Year 1 Week 36, n=682 | -1.0 International Units/liter (IU/L) | Standard Deviation 17.88 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | AST, Year 1 Week 48, n=692 | -0.9 International Units/liter (IU/L) | Standard Deviation 14.38 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | ALT, 8 Week follow-up, n=539 | -0.8 International Units/liter (IU/L) | Standard Deviation 17.06 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | AST, Year 2 Week 24, n=641 | -0.4 International Units/liter (IU/L) | Standard Deviation 22.22 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | ALP, Year 1 Week 4, n=707 | 0.0 International Units/liter (IU/L) | Standard Deviation 11.85 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | AST, Year 2 Week 48, n=592 | 2.9 International Units/liter (IU/L) | Standard Deviation 57.25 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | AST, Year 3 Week 24, n=531 | -1.4 International Units/liter (IU/L) | Standard Deviation 13.26 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | AST, Year 3 Week 48, n=486 | -0.5 International Units/liter (IU/L) | Standard Deviation 17.23 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | AST, Year 4 Week 24, n=438 | -0.9 International Units/liter (IU/L) | Standard Deviation 14.6 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | ALP, Year 1 Week 12, n=705 | 0.5 International Units/liter (IU/L) | Standard Deviation 13.31 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | ALP, Year 1 Week 24, n=703 | 2.1 International Units/liter (IU/L) | Standard Deviation 17.76 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | ALP, Year 1 Week 36, n=684 | 1.7 International Units/liter (IU/L) | Standard Deviation 22.81 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | ALP, Year 1 Week 48, n=693 | 4.6 International Units/liter (IU/L) | Standard Deviation 21.18 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | AST, Year 4 Week 48, n=418 | -0.7 International Units/liter (IU/L) | Standard Deviation 15.32 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | AST, Year 5 Week 24, n=393 | -1.3 International Units/liter (IU/L) | Standard Deviation 16.07 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | AST, Year 5 Week 48, n=362 | -0.8 International Units/liter (IU/L) | Standard Deviation 18.57 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | AST, Year 6 Week 24, n=303 | -0.5 International Units/liter (IU/L) | Standard Deviation 16.95 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | AST, Year 6 Week 48, n=284 | -0.2 International Units/liter (IU/L) | Standard Deviation 19 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | AST, Year 7 Week 24, n=182 | 0.6 International Units/liter (IU/L) | Standard Deviation 13.43 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | AST, Year 7 Week 48, n=130 | -0.3 International Units/liter (IU/L) | Standard Deviation 10.78 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | AST, Year 8 Week 24, n=52 | 3.0 International Units/liter (IU/L) | Standard Deviation 33.93 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | AST, Year 8 Week 48, n=13 | 5.8 International Units/liter (IU/L) | Standard Deviation 24.01 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | AST, Year 9 Week 24, n=6 | 7.7 International Units/liter (IU/L) | Standard Deviation 19.63 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | AST, Year 9 Week 48, n=1 | 0.0 International Units/liter (IU/L) | — |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | AST, Exit, n=625 | -0.6 International Units/liter (IU/L) | Standard Deviation 18.88 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | AST, 8 Week follow-up, n=539 | -1.1 International Units/liter (IU/L) | Standard Deviation 16.58 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | GGT, Year 1 Week 4, n=707 | -0.4 International Units/liter (IU/L) | Standard Deviation 23.39 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | GGT, Year 1 Week 12, n=705 | -1.4 International Units/liter (IU/L) | Standard Deviation 23.12 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | GGT, Year 3 Week 24, n=535 | -1.6 International Units/liter (IU/L) | Standard Deviation 33.88 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | GGT, Year 3 Week 48, n=488 | 1.7 International Units/liter (IU/L) | Standard Deviation 45.42 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | GGT, Year 4 Week 24, n=439 | 0.1 International Units/liter (IU/L) | Standard Deviation 39.13 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | GGT, Year 5 Week 24, n=393 | -2.0 International Units/liter (IU/L) | Standard Deviation 37.17 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | GGT, Year 5 Week 48, n=362 | -0.7 International Units/liter (IU/L) | Standard Deviation 43.39 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | GGT, Year 6 Week 24, n=304 | -1.0 International Units/liter (IU/L) | Standard Deviation 42.04 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | GGT, Year 6 Week 48, n=286 | 1.3 International Units/liter (IU/L) | Standard Deviation 41.84 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | GGT, Year 7 Week 24, n=183 | 1.8 International Units/liter (IU/L) | Standard Deviation 37.06 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | GGT, Year 7 Week 48, n=130 | -1.0 International Units/liter (IU/L) | Standard Deviation 27.86 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | GGT, Year 8 Week 24, n=52 | 2.7 International Units/liter (IU/L) | Standard Deviation 39.9 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | GGT, Year 8 Week 48, n=13 | -0.3 International Units/liter (IU/L) | Standard Deviation 27.97 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | GGT, Year 9 Week 24, n=6 | 13.3 International Units/liter (IU/L) | Standard Deviation 26.96 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | GGT, Year 9 Week 48, n=1 | -7.0 International Units/liter (IU/L) | — |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | GGT, Exit, n=625 | 0.7 International Units/liter (IU/L) | Standard Deviation 41.4 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | GGT, 8 Week follow-up, n=539 | 0.2 International Units/liter (IU/L) | Standard Deviation 39.22 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | LDH, Year 1 Week 24, n=701 | -6.6 International Units/liter (IU/L) | Standard Deviation 80.09 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | LDH, Year 1 Week 36, n=682 | -8.8 International Units/liter (IU/L) | Standard Deviation 80.05 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | LDH, Year 1 Week 48, n=692 | -7.3 International Units/liter (IU/L) | Standard Deviation 81.32 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | LDH, Year 2 Week 24, n=641 | -9.4 International Units/liter (IU/L) | Standard Deviation 85.83 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | LDH, Year 2 Week 48, n=592 | -9.6 International Units/liter (IU/L) | Standard Deviation 95.52 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | LDH, Year 3 Week 24, n=532 | -11.8 International Units/liter (IU/L) | Standard Deviation 93.9 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | LDH, Year 3 Week 48, n=486 | -15.1 International Units/liter (IU/L) | Standard Deviation 94.65 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | LDH, Year 4 Week 24, n=438 | -16.5 International Units/liter (IU/L) | Standard Deviation 99.93 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | LDH, Year 5 Week 48, n=362 | -19.8 International Units/liter (IU/L) | Standard Deviation 108.33 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | LDH, Year 6 Week 24, n=303 | -21.7 International Units/liter (IU/L) | Standard Deviation 115.77 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | LDH, Year 6 Week 48, n=284 | -21.3 International Units/liter (IU/L) | Standard Deviation 122.62 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | LDH, Year 7 Week 24, n=182 | -15.2 International Units/liter (IU/L) | Standard Deviation 44.05 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | LDH, Year 7 Week 48, n=130 | -16.3 International Units/liter (IU/L) | Standard Deviation 42.51 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | LDH, Year 8 Week 24, n=52 | -14.3 International Units/liter (IU/L) | Standard Deviation 40.14 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | LDH, Year 8 Week 48, n=13 | -31.5 International Units/liter (IU/L) | Standard Deviation 53.04 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | LDH, Year 9 Week 48, n=1 | -65.0 International Units/liter (IU/L) | — |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | LDH, Exit, n=624 | -13.1 International Units/liter (IU/L) | Standard Deviation 90.39 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | LDH, 8 Week follow-up, n=538 | -12.7 International Units/liter (IU/L) | Standard Deviation 95.65 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | ALP, Year 4 Week 24, n=439 | 7.2 International Units/liter (IU/L) | Standard Deviation 21.56 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | ALP, Year 4 Week 48, n=421 | 8.1 International Units/liter (IU/L) | Standard Deviation 27.35 |
| Belimumab 10mg/kg IV | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | ALP, Year 5 Week 24, n=393 | 7.2 International Units/liter (IU/L) | Standard Deviation 21.01 |
Primary
Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points
Other chemistries parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 other chemistries parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Alb and Protein were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.
Time frame: Baseline and up to 9 years
Population: MITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10mg/kg IV | Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points | Pro,Year9,Week48,n=1 | 0.0 Grams per liter (g/L) | — |
| Belimumab 10mg/kg IV | Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points | Pro,Exit,n=625 | -3.4 Grams per liter (g/L) | Standard Deviation 6.45 |
| Belimumab 10mg/kg IV | Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points | Pro,Year7,Week48,n=130 | -3.9 Grams per liter (g/L) | Standard Deviation 5.32 |
| Belimumab 10mg/kg IV | Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points | Pro,Year8,Week24,n=52 | -5.1 Grams per liter (g/L) | Standard Deviation 6.38 |
| Belimumab 10mg/kg IV | Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points | Pro,Year8,Week48,n=13 | -4.8 Grams per liter (g/L) | Standard Deviation 5.02 |
| Belimumab 10mg/kg IV | Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points | Pro,Year9,Week24,n=6 | -7.7 Grams per liter (g/L) | Standard Deviation 7.03 |
| Belimumab 10mg/kg IV | Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points | Alb,Year1,Week4,n=707 | -0.1 Grams per liter (g/L) | Standard Deviation 2.36 |
| Belimumab 10mg/kg IV | Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points | Alb,Year1,Week12,n=705 | 0.2 Grams per liter (g/L) | Standard Deviation 2.67 |
| Belimumab 10mg/kg IV | Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points | Alb,Year1,Week24,n=703 | 0.6 Grams per liter (g/L) | Standard Deviation 3.03 |
| Belimumab 10mg/kg IV | Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points | Alb,Year1,Week36,n=684 | 0.7 Grams per liter (g/L) | Standard Deviation 3.23 |
| Belimumab 10mg/kg IV | Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points | Alb,Year1,Week48,n=693 | 1.2 Grams per liter (g/L) | Standard Deviation 3.52 |
| Belimumab 10mg/kg IV | Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points | Alb,Year2,Week24,n=643 | 1.2 Grams per liter (g/L) | Standard Deviation 3.49 |
| Belimumab 10mg/kg IV | Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points | Alb,Year2,Week48,n=598 | 1.2 Grams per liter (g/L) | Standard Deviation 3.67 |
| Belimumab 10mg/kg IV | Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points | Alb,Year3,Week24,n=535 | 1.2 Grams per liter (g/L) | Standard Deviation 3.78 |
| Belimumab 10mg/kg IV | Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points | Alb,Year3,Week48,n=488 | 1.4 Grams per liter (g/L) | Standard Deviation 4.02 |
| Belimumab 10mg/kg IV | Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points | Alb,Year4,Week24,n=439 | 1.7 Grams per liter (g/L) | Standard Deviation 4.02 |
| Belimumab 10mg/kg IV | Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points | Alb,Year 4,Week48,n=421 | 1.9 Grams per liter (g/L) | Standard Deviation 4.04 |
| Belimumab 10mg/kg IV | Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points | Alb,Year5,Week24,n=393 | 1.9 Grams per liter (g/L) | Standard Deviation 3.85 |
| Belimumab 10mg/kg IV | Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points | Alb,Year5,Week48,n=362 | 2.3 Grams per liter (g/L) | Standard Deviation 3.89 |
| Belimumab 10mg/kg IV | Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points | Alb,Year6,Week24,n=304 | 2.2 Grams per liter (g/L) | Standard Deviation 3.78 |
| Belimumab 10mg/kg IV | Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points | Alb,Year6,Week48,n=286 | 2.1 Grams per liter (g/L) | Standard Deviation 4.07 |
| Belimumab 10mg/kg IV | Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points | Alb,Year7,Week24,n=183 | 2.0 Grams per liter (g/L) | Standard Deviation 3.6 |
| Belimumab 10mg/kg IV | Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points | Alb,Year7,Week48,n=130 | 2.3 Grams per liter (g/L) | Standard Deviation 3.92 |
| Belimumab 10mg/kg IV | Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points | Alb,Year8,Week24,n=52 | 1.9 Grams per liter (g/L) | Standard Deviation 4.16 |
| Belimumab 10mg/kg IV | Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points | Alb,Year8,Week48,n=13 | 1.1 Grams per liter (g/L) | Standard Deviation 4.11 |
| Belimumab 10mg/kg IV | Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points | Alb,Year9,Week24,n=6 | 0.7 Grams per liter (g/L) | Standard Deviation 3.01 |
| Belimumab 10mg/kg IV | Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points | Alb,Year9,Week48,n=1 | 1.0 Grams per liter (g/L) | — |
| Belimumab 10mg/kg IV | Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points | Alb,Exit,n=625 | 1.8 Grams per liter (g/L) | Standard Deviation 4.74 |
| Belimumab 10mg/kg IV | Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points | Alb,8 Week Follow up,n=539 | 1.7 Grams per liter (g/L) | Standard Deviation 4.66 |
| Belimumab 10mg/kg IV | Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points | Pro,Year1,Week4,n=707 | -1.4 Grams per liter (g/L) | Standard Deviation 3.81 |
| Belimumab 10mg/kg IV | Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points | Pro,Year1,Week12,n=705 | -2.0 Grams per liter (g/L) | Standard Deviation 4.3 |
| Belimumab 10mg/kg IV | Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points | Pro,Year1,Week24,n=703 | -1.9 Grams per liter (g/L) | Standard Deviation 4.68 |
| Belimumab 10mg/kg IV | Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points | Pro,Year1,Week36,n=684 | -2.3 Grams per liter (g/L) | Standard Deviation 4.75 |
| Belimumab 10mg/kg IV | Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points | Pro,Year1,Week48,n=693 | -1.8 Grams per liter (g/L) | Standard Deviation 4.94 |
| Belimumab 10mg/kg IV | Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points | Pro,Year2,Week24,n=643 | -2.3 Grams per liter (g/L) | Standard Deviation 5.05 |
| Belimumab 10mg/kg IV | Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points | Pro,Year2,Week48,n=598 | -2.7 Grams per liter (g/L) | Standard Deviation 5.53 |
| Belimumab 10mg/kg IV | Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points | Pro,Year3,Week24,n=535 | -3.1 Grams per liter (g/L) | Standard Deviation 5.62 |
| Belimumab 10mg/kg IV | Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points | Pro,Year3,Week48,n=488 | -3.5 Grams per liter (g/L) | Standard Deviation 5.91 |
| Belimumab 10mg/kg IV | Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points | Pro,Year4,Week24,n=439 | -3.2 Grams per liter (g/L) | Standard Deviation 5.87 |
| Belimumab 10mg/kg IV | Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points | Pro,Year 4,Week48,n=421 | -3.2 Grams per liter (g/L) | Standard Deviation 6.07 |
| Belimumab 10mg/kg IV | Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points | Pro,Year5,Week24,n=393 | -3.5 Grams per liter (g/L) | Standard Deviation 5.75 |
| Belimumab 10mg/kg IV | Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points | Pro,Year5,Week48,n=362 | -3.6 Grams per liter (g/L) | Standard Deviation 5.78 |
| Belimumab 10mg/kg IV | Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points | Pro,Year6,Week24,n=304 | -3.9 Grams per liter (g/L) | Standard Deviation 5.57 |
| Belimumab 10mg/kg IV | Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points | Pro,Year6,Week48,n=286 | -4.0 Grams per liter (g/L) | Standard Deviation 5.79 |
| Belimumab 10mg/kg IV | Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points | Pro,Year7,Week24,n=183 | -4.3 Grams per liter (g/L) | Standard Deviation 5.36 |
| Belimumab 10mg/kg IV | Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points | Pro,8 Week Follow up,n=539 | -3.7 Grams per liter (g/L) | Standard Deviation 6.42 |
Primary
Change From Baseline in Bilirubin (Bili) Levels
Liver function parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 liver function parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Bili were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.
Time frame: Baseline and up to 9 years
Population: MITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10mg/kg IV | Change From Baseline in Bilirubin (Bili) Levels | Year 1 Week 4, n=707 | 0.142 µmol/L | Standard Deviation 2.8398 |
| Belimumab 10mg/kg IV | Change From Baseline in Bilirubin (Bili) Levels | Year 1 Week 12, n=705 | 0.008 µmol/L | Standard Deviation 2.6383 |
| Belimumab 10mg/kg IV | Change From Baseline in Bilirubin (Bili) Levels | Year 1 Week 24, n=703 | 0.217 µmol/L | Standard Deviation 3.128 |
| Belimumab 10mg/kg IV | Change From Baseline in Bilirubin (Bili) Levels | Year 1 Week 36, n=684 | 0.173 µmol/L | Standard Deviation 2.7566 |
| Belimumab 10mg/kg IV | Change From Baseline in Bilirubin (Bili) Levels | Year 1 Week 48, n=693 | 0.367 µmol/L | Standard Deviation 2.8441 |
| Belimumab 10mg/kg IV | Change From Baseline in Bilirubin (Bili) Levels | Year 2 Week 24, n=643 | 0.488 µmol/L | Standard Deviation 2.9346 |
| Belimumab 10mg/kg IV | Change From Baseline in Bilirubin (Bili) Levels | Year 2 Week 48, n=598 | 0.540 µmol/L | Standard Deviation 3.2181 |
| Belimumab 10mg/kg IV | Change From Baseline in Bilirubin (Bili) Levels | Year 3 Week 24, n=535 | 0.606 µmol/L | Standard Deviation 3.1612 |
| Belimumab 10mg/kg IV | Change From Baseline in Bilirubin (Bili) Levels | Year 3 Week 48, n=488 | 0.637 µmol/L | Standard Deviation 3.2474 |
| Belimumab 10mg/kg IV | Change From Baseline in Bilirubin (Bili) Levels | Year 4 Week 24, n=439 | 0.548 µmol/L | Standard Deviation 2.9773 |
| Belimumab 10mg/kg IV | Change From Baseline in Bilirubin (Bili) Levels | Year 4 Week 48, n=421 | 0.629 µmol/L | Standard Deviation 3.468 |
| Belimumab 10mg/kg IV | Change From Baseline in Bilirubin (Bili) Levels | Year 5 Week 24, n=393 | 0.410 µmol/L | Standard Deviation 2.6931 |
| Belimumab 10mg/kg IV | Change From Baseline in Bilirubin (Bili) Levels | Year 5 Week 48, n=362 | 0.788 µmol/L | Standard Deviation 3.1324 |
| Belimumab 10mg/kg IV | Change From Baseline in Bilirubin (Bili) Levels | Year 6 Week 24, n=304 | 0.801 µmol/L | Standard Deviation 2.9946 |
| Belimumab 10mg/kg IV | Change From Baseline in Bilirubin (Bili) Levels | Year 6 Week 48, n=285 | 0.638 µmol/L | Standard Deviation 3.0669 |
| Belimumab 10mg/kg IV | Change From Baseline in Bilirubin (Bili) Levels | Year 7 Week 24, n=183 | 0.938 µmol/L | Standard Deviation 2.8158 |
| Belimumab 10mg/kg IV | Change From Baseline in Bilirubin (Bili) Levels | Year 7 Week 48, n=130 | 1.129 µmol/L | Standard Deviation 3.0314 |
| Belimumab 10mg/kg IV | Change From Baseline in Bilirubin (Bili) Levels | Year 8 Week 24, n=52 | 1.280 µmol/L | Standard Deviation 3.0707 |
| Belimumab 10mg/kg IV | Change From Baseline in Bilirubin (Bili) Levels | Year 8 Week 48, n=13 | 0.768 µmol/L | Standard Deviation 3.0434 |
| Belimumab 10mg/kg IV | Change From Baseline in Bilirubin (Bili) Levels | Year 9 Week 24, n=6 | 0.028 µmol/L | Standard Deviation 2.0182 |
| Belimumab 10mg/kg IV | Change From Baseline in Bilirubin (Bili) Levels | Year 9 Week 48, n=1 | -2.870 µmol/L | — |
| Belimumab 10mg/kg IV | Change From Baseline in Bilirubin (Bili) Levels | Exit, n=624 | 0.573 µmol/L | Standard Deviation 3.3274 |
| Belimumab 10mg/kg IV | Change From Baseline in Bilirubin (Bili) Levels | 8 Week follow-up, n=539 | 0.572 µmol/L | Standard Deviation 3.1052 |
Primary
Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points
Other chemistries parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 other chemistries parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in BUN/Cr is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Time frame: Baseline and up to 9 years
Population: MITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10mg/kg IV | Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points | BUN/Cr,Year8,Week24,n=52 | 3.3 Ratio | Standard Deviation 4.64 |
| Belimumab 10mg/kg IV | Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points | BUN/Cr,Year8,Week48,n=13 | 3.5 Ratio | Standard Deviation 6.04 |
| Belimumab 10mg/kg IV | Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points | BUN/Cr,Year9,Week24,n=6 | 3.5 Ratio | Standard Deviation 3.08 |
| Belimumab 10mg/kg IV | Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points | BUN/Cr,Year9,Week48,n=1 | 1 Ratio | Standard Deviation 2 |
| Belimumab 10mg/kg IV | Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points | BUN/Cr,Exit,n=625 | 0.9 Ratio | Standard Deviation 6.05 |
| Belimumab 10mg/kg IV | Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points | BUN/Cr,8 Week Follow up,n=539 | 0.9 Ratio | Standard Deviation 5.91 |
| Belimumab 10mg/kg IV | Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points | BUN/Cr,Year1,Week4,n=707 | -0.2 Ratio | Standard Deviation 4.66 |
| Belimumab 10mg/kg IV | Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points | BUN/Cr,Year1,Week12,n=705 | -0.3 Ratio | Standard Deviation 4.88 |
| Belimumab 10mg/kg IV | Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points | BUN/CrYear1,Week24,n=703 | -0.7 Ratio | Standard Deviation 5.02 |
| Belimumab 10mg/kg IV | Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points | BUN/Cr,Year1,Week36,n=683 | -0.5 Ratio | Standard Deviation 5.61 |
| Belimumab 10mg/kg IV | Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points | BUN/Cr,Year1,Week48,n=693 | -0.2 Ratio | Standard Deviation 5.26 |
| Belimumab 10mg/kg IV | Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points | BUN/Cr,Year2,Week24,n=643 | -0.1 Ratio | Standard Deviation 5.68 |
| Belimumab 10mg/kg IV | Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points | BUN/Cr,Year2,Week48,n=598 | 0.5 Ratio | Standard Deviation 5.55 |
| Belimumab 10mg/kg IV | Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points | BUN/Cr,Year3,Week24,n=535 | 1.4 Ratio | Standard Deviation 5.48 |
| Belimumab 10mg/kg IV | Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points | BUN/Cr,Year3,Week48,n=488 | 1.2 Ratio | Standard Deviation 5.92 |
| Belimumab 10mg/kg IV | Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points | BUN/Cr,Year4,Week24,n=439 | 1.4 Ratio | Standard Deviation 5.65 |
| Belimumab 10mg/kg IV | Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points | BUN/Cr,Year 4,Week48,n=421 | 1.0 Ratio | Standard Deviation 5.85 |
| Belimumab 10mg/kg IV | Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points | BUN/Cr,Year5,Week24,n=393 | 0.7 Ratio | Standard Deviation 5.51 |
| Belimumab 10mg/kg IV | Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points | BUN/Cr,Year5,Week48,n=362 | 1.0 Ratio | Standard Deviation 5.62 |
| Belimumab 10mg/kg IV | Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points | BUN/Cr,Year6,Week24,n=304 | 1.0 Ratio | Standard Deviation 5.35 |
| Belimumab 10mg/kg IV | Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points | BUN/Cr,Year6,Week48,n=286 | 1.3 Ratio | Standard Deviation 5.74 |
| Belimumab 10mg/kg IV | Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points | BUN/Cr,Year7,Week24,n=183 | 0.8 Ratio | Standard Deviation 5.68 |
| Belimumab 10mg/kg IV | Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points | BUN/Cr,Year7,Week48,n=130 | 1.2 Ratio | Standard Deviation 5.47 |
Primary
Change From Baseline in BUN and Glucose at the Indicated Time Points
Other chemistries parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 other chemistries were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in BUN and Glucose were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.
Time frame: Baseline and up to 9 years
Population: MITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10mg/kg IV | Change From Baseline in BUN and Glucose at the Indicated Time Points | BUN,Year1,Week4,n=707 | 0.0299 mmol/L | Standard Deviation 1.6783 |
| Belimumab 10mg/kg IV | Change From Baseline in BUN and Glucose at the Indicated Time Points | BUN,Year1,Week12,n=705 | 0.0402 mmol/L | Standard Deviation 1.9768 |
| Belimumab 10mg/kg IV | Change From Baseline in BUN and Glucose at the Indicated Time Points | BUN,Year1,Week24,n=703 | -0.1443 mmol/L | Standard Deviation 1.3723 |
| Belimumab 10mg/kg IV | Change From Baseline in BUN and Glucose at the Indicated Time Points | BUN,Year1,Week36,n=683 | -0.0592 mmol/L | Standard Deviation 1.6916 |
| Belimumab 10mg/kg IV | Change From Baseline in BUN and Glucose at the Indicated Time Points | BUN,Year1,Week48,n=693 | -0.0406 mmol/L | Standard Deviation 1.5541 |
| Belimumab 10mg/kg IV | Change From Baseline in BUN and Glucose at the Indicated Time Points | BUN,Year2,Week24,n=643 | -0.0760 mmol/L | Standard Deviation 1.6652 |
| Belimumab 10mg/kg IV | Change From Baseline in BUN and Glucose at the Indicated Time Points | BUN,Year2,Week48,n=598 | 0.0631 mmol/L | Standard Deviation 1.6429 |
| Belimumab 10mg/kg IV | Change From Baseline in BUN and Glucose at the Indicated Time Points | BUN,Year3,Week24,n=535 | 0.0524 mmol/L | Standard Deviation 1.685 |
| Belimumab 10mg/kg IV | Change From Baseline in BUN and Glucose at the Indicated Time Points | BUN,Year3,Week48,n=488 | -0.1013 mmol/L | Standard Deviation 1.691 |
| Belimumab 10mg/kg IV | Change From Baseline in BUN and Glucose at the Indicated Time Points | BUN,Year4,Week24,n=439 | 0.0967 mmol/L | Standard Deviation 1.9398 |
| Belimumab 10mg/kg IV | Change From Baseline in BUN and Glucose at the Indicated Time Points | BUN,Year 4,Week48,n=421 | 0.0672 mmol/L | Standard Deviation 2.1393 |
| Belimumab 10mg/kg IV | Change From Baseline in BUN and Glucose at the Indicated Time Points | BUN,Year5,Week24,n=393 | -0.0291 mmol/L | Standard Deviation 2.0169 |
| Belimumab 10mg/kg IV | Change From Baseline in BUN and Glucose at the Indicated Time Points | BUN,Year5,Week48,n=362 | 0.0899 mmol/L | Standard Deviation 2.0903 |
| Belimumab 10mg/kg IV | Change From Baseline in BUN and Glucose at the Indicated Time Points | BUN,Year6,Week24,n=304 | 0.0959 mmol/L | Standard Deviation 1.9852 |
| Belimumab 10mg/kg IV | Change From Baseline in BUN and Glucose at the Indicated Time Points | BUN,Year6,Week48,n=286 | 0.2325 mmol/L | Standard Deviation 2.2724 |
| Belimumab 10mg/kg IV | Change From Baseline in BUN and Glucose at the Indicated Time Points | BUN,Year7,Week24,n=183 | -0.0026 mmol/L | Standard Deviation 1.6623 |
| Belimumab 10mg/kg IV | Change From Baseline in BUN and Glucose at the Indicated Time Points | BUN,Year7,Week48,n=130 | 0.1455 mmol/L | Standard Deviation 1.7145 |
| Belimumab 10mg/kg IV | Change From Baseline in BUN and Glucose at the Indicated Time Points | BUN,Year8,Week24,n=52 | 0.5458 mmol/L | Standard Deviation 1.7299 |
| Belimumab 10mg/kg IV | Change From Baseline in BUN and Glucose at the Indicated Time Points | BUN,Year8,Week48,n=13 | 0.3883 mmol/L | Standard Deviation 1.4603 |
| Belimumab 10mg/kg IV | Change From Baseline in BUN and Glucose at the Indicated Time Points | BUN,Year9,Week24,n=6 | 0.1648 mmol/L | Standard Deviation 1.0466 |
| Belimumab 10mg/kg IV | Change From Baseline in BUN and Glucose at the Indicated Time Points | BUN,Year9,Week48,n=1 | 0.5700 mmol/L | — |
| Belimumab 10mg/kg IV | Change From Baseline in BUN and Glucose at the Indicated Time Points | BUN,Exit,n=625 | 0.2448 mmol/L | Standard Deviation 2.4618 |
| Belimumab 10mg/kg IV | Change From Baseline in BUN and Glucose at the Indicated Time Points | BUN,8 Week Follow up,n=539 | 0.0822 mmol/L | Standard Deviation 2.5567 |
| Belimumab 10mg/kg IV | Change From Baseline in BUN and Glucose at the Indicated Time Points | Glucose,Year1,Week4,n=707 | -0.0031 mmol/L | Standard Deviation 1.0221 |
| Belimumab 10mg/kg IV | Change From Baseline in BUN and Glucose at the Indicated Time Points | Glucose,Year1,Week12,n=705 | 0.0333 mmol/L | Standard Deviation 1.0627 |
| Belimumab 10mg/kg IV | Change From Baseline in BUN and Glucose at the Indicated Time Points | Glucose,Year1,Week24,n=702 | -0.0396 mmol/L | Standard Deviation 1.2656 |
| Belimumab 10mg/kg IV | Change From Baseline in BUN and Glucose at the Indicated Time Points | Glucose,Year1,Week36,n=684 | 0.0099 mmol/L | Standard Deviation 1.0269 |
| Belimumab 10mg/kg IV | Change From Baseline in BUN and Glucose at the Indicated Time Points | Glucose,Year1,Week48,n=693 | 0.0010 mmol/L | Standard Deviation 1.1726 |
| Belimumab 10mg/kg IV | Change From Baseline in BUN and Glucose at the Indicated Time Points | Glucose,Year2,Week24,n=643 | 0.0143 mmol/L | Standard Deviation 1.3227 |
| Belimumab 10mg/kg IV | Change From Baseline in BUN and Glucose at the Indicated Time Points | Glucose,Year2,Week48,n=598 | -0.0082 mmol/L | Standard Deviation 1.1352 |
| Belimumab 10mg/kg IV | Change From Baseline in BUN and Glucose at the Indicated Time Points | Glucose,Year3,Week24,n=535 | -0.0159 mmol/L | Standard Deviation 1.3222 |
| Belimumab 10mg/kg IV | Change From Baseline in BUN and Glucose at the Indicated Time Points | Glucose,Year3,Week48,n=488 | 0.0309 mmol/L | Standard Deviation 1.1841 |
| Belimumab 10mg/kg IV | Change From Baseline in BUN and Glucose at the Indicated Time Points | Glucose,Year4,Week24,n=439 | -0.0160 mmol/L | Standard Deviation 1.2213 |
| Belimumab 10mg/kg IV | Change From Baseline in BUN and Glucose at the Indicated Time Points | Glucose,Year 4,Week48,n=421 | -0.0259 mmol/L | Standard Deviation 1.1936 |
| Belimumab 10mg/kg IV | Change From Baseline in BUN and Glucose at the Indicated Time Points | Glucose,Year5,Week24,n=393 | 0.0554 mmol/L | Standard Deviation 1.1255 |
| Belimumab 10mg/kg IV | Change From Baseline in BUN and Glucose at the Indicated Time Points | Glucose,Year5,Week48,n=362 | 0.0655 mmol/L | Standard Deviation 1.2946 |
| Belimumab 10mg/kg IV | Change From Baseline in BUN and Glucose at the Indicated Time Points | Glucose,Year6,Week24,n=303 | 0.1290 mmol/L | Standard Deviation 1.1163 |
| Belimumab 10mg/kg IV | Change From Baseline in BUN and Glucose at the Indicated Time Points | Glucose,Year6,Week48,n=286 | 0.2001 mmol/L | Standard Deviation 1.2411 |
| Belimumab 10mg/kg IV | Change From Baseline in BUN and Glucose at the Indicated Time Points | Glucose,Year7,Week24,n=183 | 0.2303 mmol/L | Standard Deviation 1.0514 |
| Belimumab 10mg/kg IV | Change From Baseline in BUN and Glucose at the Indicated Time Points | Glucose,Year7,Week48,n=130 | 0.2335 mmol/L | Standard Deviation 0.8346 |
| Belimumab 10mg/kg IV | Change From Baseline in BUN and Glucose at the Indicated Time Points | Glucose,Year8,Week24,n=52 | 0.3301 mmol/L | Standard Deviation 0.9052 |
| Belimumab 10mg/kg IV | Change From Baseline in BUN and Glucose at the Indicated Time Points | Glucose,Year8,Week48,n=13 | 0.1431 mmol/L | Standard Deviation 0.8115 |
| Belimumab 10mg/kg IV | Change From Baseline in BUN and Glucose at the Indicated Time Points | Glucose,Year9,Week24,n=6 | 0.2128 mmol/L | Standard Deviation 0.4914 |
| Belimumab 10mg/kg IV | Change From Baseline in BUN and Glucose at the Indicated Time Points | Glucose,Year9,Week48,n=1 | 0.4739 mmol/L | — |
| Belimumab 10mg/kg IV | Change From Baseline in BUN and Glucose at the Indicated Time Points | Glucose,Exit,n=624 | 0.1842 mmol/L | Standard Deviation 1.8723 |
| Belimumab 10mg/kg IV | Change From Baseline in BUN and Glucose at the Indicated Time Points | Glucose,8 Week Follow up,n=539 | 0.0338 mmol/L | Standard Deviation 1.4139 |
Primary
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Electrolytes parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 electrolytes parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Ca,CO2, Chloride, Mg, Phos, K and Na were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.
Time frame: Baseline and up to 9 years
Population: MITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Chloride,Year3,Week48,n=488 | 0.6 Millimoles per liter (mmol/L) | Standard Deviation 2.73 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Ca,Year1,Week4,n=697 | 0.0030 Millimoles per liter (mmol/L) | Standard Deviation 0.0763 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Ca,Year1,Week12,n=696 | 0.0020 Millimoles per liter (mmol/L) | Standard Deviation 0.0749 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Ca,Year1,Week24,n=696 | -0.0035 Millimoles per liter (mmol/L) | Standard Deviation 0.075 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Ca,Year1,Week36,n=677 | 0.0024 Millimoles per liter (mmol/L) | Standard Deviation 0.0836 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Ca,Year1,Week48,n=687 | -0.0065 Millimoles per liter (mmol/L) | Standard Deviation 0.0778 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Ca,Year2,Week24,n=636 | -0.0075 Millimoles per liter (mmol/L) | Standard Deviation 0.0764 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Ca,Year2,Week48,n=587 | -0.0091 Millimoles per liter (mmol/L) | Standard Deviation 0.0837 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Ca,Year3,Week24,n=526 | -0.0047 Millimoles per liter (mmol/L) | Standard Deviation 0.081 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Ca,Year3,Week48,n=481 | -0.0123 Millimoles per liter (mmol/L) | Standard Deviation 0.08 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Ca,Year4,Week24,n=438 | -0.0056 Millimoles per liter (mmol/L) | Standard Deviation 0.0771 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Ca,Year,Week48,n=418 | -0.0193 Millimoles per liter (mmol/L) | Standard Deviation 0.0805 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Ca,Year5,Week24,n=387 | -0.0129 Millimoles per liter (mmol/L) | Standard Deviation 0.0885 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Ca,Year5,Week48,n=358 | -0.0140 Millimoles per liter (mmol/L) | Standard Deviation 0.0919 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Ca,Year6,Week24,n=303 | -0.0053 Millimoles per liter (mmol/L) | Standard Deviation 0.0903 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Ca,Year6,Week48,n=283 | -0.0146 Millimoles per liter (mmol/L) | Standard Deviation 0.087 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Ca,Year7,Week24,n=182 | -0.0076 Millimoles per liter (mmol/L) | Standard Deviation 0.0839 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Ca,Year7,Week48,n=130 | -0.0079 Millimoles per liter (mmol/L) | Standard Deviation 0.1172 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Ca,Year8,Week24,n=51 | 0.0003 Millimoles per liter (mmol/L) | Standard Deviation 0.0806 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Ca,Year8,Week48,n=13 | -0.0395 Millimoles per liter (mmol/L) | Standard Deviation 0.0611 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Ca,Year9,Week24,n=6 | -0.0402 Millimoles per liter (mmol/L) | Standard Deviation 0.0336 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Ca,Year9,Week48,n=1 | -0.0642 Millimoles per liter (mmol/L) | — |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Ca,Exit,n=619 | 0.0006 Millimoles per liter (mmol/L) | Standard Deviation 0.0864 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Ca,8 Week Follow up,n=534 | -0.0014 Millimoles per liter (mmol/L) | Standard Deviation 0.0909 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | CO2,Year1,Week4,n=701 | -0.0 Millimoles per liter (mmol/L) | Standard Deviation 2.77 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | CO2,Year1,Week12,n=700 | -0.1 Millimoles per liter (mmol/L) | Standard Deviation 2.76 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | CO2,Year1,Week24,n=701 | -0.1 Millimoles per liter (mmol/L) | Standard Deviation 2.73 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | CO2,Year1,Week36,n=682 | 0.1 Millimoles per liter (mmol/L) | Standard Deviation 2.73 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | CO2,Year1,Week48,n=692 | -0.1 Millimoles per liter (mmol/L) | Standard Deviation 2.78 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | CO2,Year2,Week24,n=641 | -0.3 Millimoles per liter (mmol/L) | Standard Deviation 2.94 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | CO2,Year2,Week48,n=692 | -0.3 Millimoles per liter (mmol/L) | Standard Deviation 2.87 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | CO2,Year3,Week24,n=531 | -0.2 Millimoles per liter (mmol/L) | Standard Deviation 2.9 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | CO2,Year3,Week48,n=486 | -0.4 Millimoles per liter (mmol/L) | Standard Deviation 2.75 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | CO2,Year4,Week24,n=438 | -0.0 Millimoles per liter (mmol/L) | Standard Deviation 2.76 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | CO2,Year4,Week48,n=418 | -0.5 Millimoles per liter (mmol/L) | Standard Deviation 3.04 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | CO2,Year5,Week24,n=393 | -0.2 Millimoles per liter (mmol/L) | Standard Deviation 2.9 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | CO2,Year5,Week48,n=361 | -0.8 Millimoles per liter (mmol/L) | Standard Deviation 2.82 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | CO2,Year6,Week24,n=303 | -0.0 Millimoles per liter (mmol/L) | Standard Deviation 2.86 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | CO2,Year6,Week48,n=284 | -0.5 Millimoles per liter (mmol/L) | Standard Deviation 2.76 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | CO2,Year7,Week24,n=182 | 0.2 Millimoles per liter (mmol/L) | Standard Deviation 2.78 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | CO2,Year7,Week48,n=130 | 0.2 Millimoles per liter (mmol/L) | Standard Deviation 2.67 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | CO2,Year8,Week24,n=52 | 1.0 Millimoles per liter (mmol/L) | Standard Deviation 2.78 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | CO2,Year8,Week48,n=13 | 0.4 Millimoles per liter (mmol/L) | Standard Deviation 3.38 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | CO2,Year9,Week24,n=6 | -0.3 Millimoles per liter (mmol/L) | Standard Deviation 0.82 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | CO2,Year9,Week48,n=1 | -3.0 Millimoles per liter (mmol/L) | — |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | CO2,Exit,n=625 | -0.3 Millimoles per liter (mmol/L) | Standard Deviation 3 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | CO2,8 week Follow up,n=538 | -0.2 Millimoles per liter (mmol/L) | Standard Deviation 3 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Chloride,Year1,Week4,n=707 | 0.3 Millimoles per liter (mmol/L) | Standard Deviation 2.33 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Chloride,Year1,Week12,n=704 | 0.6 Millimoles per liter (mmol/L) | Standard Deviation 2.56 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Chloride,Year1,Week24,n=703 | 0.6 Millimoles per liter (mmol/L) | Standard Deviation 2.42 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Chloride,Year1,Week36,n=684 | 0.6 Millimoles per liter (mmol/L) | Standard Deviation 2.47 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Chloride,Year1,Week48,n=693 | 0.4 Millimoles per liter (mmol/L) | Standard Deviation 2.44 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Chloride,Year2,Week24,n=643 | 0.5 Millimoles per liter (mmol/L) | Standard Deviation 2.62 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Chloride,Year2,Week48,n=598 | 0.5 Millimoles per liter (mmol/L) | Standard Deviation 2.81 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Chloride,Year3,Week24,n=535 | 0.7 Millimoles per liter (mmol/L) | Standard Deviation 3.04 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Chloride,Year4,Week24,n=439 | 0.5 Millimoles per liter (mmol/L) | Standard Deviation 2.74 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Chloride,Year4,Week48,n=421 | 0.7 Millimoles per liter (mmol/L) | Standard Deviation 2.84 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Chloride,Year5,Week24,n=392 | 0.6 Millimoles per liter (mmol/L) | Standard Deviation 2.95 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Chloride,Year5,Week48,n=362 | 0.6 Millimoles per liter (mmol/L) | Standard Deviation 2.77 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Chloride,Year6,Week24,n=304 | 1.0 Millimoles per liter (mmol/L) | Standard Deviation 2.74 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Chloride,Year6,Week48,n=286 | 0.8 Millimoles per liter (mmol/L) | Standard Deviation 2.67 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Chloride,Year7,Week24,n=183 | 0.7 Millimoles per liter (mmol/L) | Standard Deviation 2.57 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Chloride,Year7,Week48,n=130 | 1.1 Millimoles per liter (mmol/L) | Standard Deviation 2.73 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Chloride,Year8,Week24,n=52 | 1.3 Millimoles per liter (mmol/L) | Standard Deviation 2.86 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Chloride,Year8,Week48,n=13 | 1.2 Millimoles per liter (mmol/L) | Standard Deviation 3.54 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Chloride,Year9,Week24,n=6 | 3.2 Millimoles per liter (mmol/L) | Standard Deviation 1.47 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Chloride,Year9,Week48,n=1 | 1.0 Millimoles per liter (mmol/L) | — |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Chloride,Exit,n=624 | 0.4 Millimoles per liter (mmol/L) | Standard Deviation 3.06 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Chloride,8 Week Follow up,n=538 | 0.4 Millimoles per liter (mmol/L) | Standard Deviation 2.82 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Mg,Year1,Week4,n=707 | -0.003 Millimoles per liter (mmol/L) | Standard Deviation 0.0583 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Mg,Year1,Week 12,n=705 | -0.006 Millimoles per liter (mmol/L) | Standard Deviation 0.0647 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Mg,Year1,Week 24,n=703 | -0.003 Millimoles per liter (mmol/L) | Standard Deviation 0.0604 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Mg,Year1,Week 36,n=684 | -0.004 Millimoles per liter (mmol/L) | Standard Deviation 0.0616 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Mg,Year1,Week 48,n=693 | 0.002 Millimoles per liter (mmol/L) | Standard Deviation 0.0597 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Mg,Year2,Week 24,n=643 | 0.002 Millimoles per liter (mmol/L) | Standard Deviation 0.0694 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Mg,Year2,Week 48,n=598 | 0.001 Millimoles per liter (mmol/L) | Standard Deviation 0.0711 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Mg,Year3,Week 24,n=535 | 0.010 Millimoles per liter (mmol/L) | Standard Deviation 0.0668 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Mg,Year3,Week 48,n=488 | 0.010 Millimoles per liter (mmol/L) | Standard Deviation 0.0669 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Mg,Year4,Week 24,n=439 | 0.016 Millimoles per liter (mmol/L) | Standard Deviation 0.07 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Mg,Year4,Week 48,n=421 | 0.017 Millimoles per liter (mmol/L) | Standard Deviation 0.0709 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Mg,Year 5,Week 24,n=393 | 0.016 Millimoles per liter (mmol/L) | Standard Deviation 0.0673 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Mg,Year 5,Week 48,n=362 | 0.021 Millimoles per liter (mmol/L) | Standard Deviation 0.0688 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Mg,Year 6,Week 24,n=304 | 0.013 Millimoles per liter (mmol/L) | Standard Deviation 0.0718 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Mg,Year 6,Week 48,n=286 | 0.011 Millimoles per liter (mmol/L) | Standard Deviation 0.0639 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Mg,Year 7,Week 24,n=183 | 0.010 Millimoles per liter (mmol/L) | Standard Deviation 0.0692 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Mg,Year 7,Week 48,n=130 | 0.013 Millimoles per liter (mmol/L) | Standard Deviation 0.0635 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Mg,Year 8,Week 24,n=52 | 0.025 Millimoles per liter (mmol/L) | Standard Deviation 0.0702 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Mg,Year 8,Week 48,n=13 | 0.042 Millimoles per liter (mmol/L) | Standard Deviation 0.0685 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Mg,Year 9,Week 24,n=6 | 0.030 Millimoles per liter (mmol/L) | Standard Deviation 0.0613 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Mg,Year 9,Week 48,n=1 | 0.040 Millimoles per liter (mmol/L) | — |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Mg, Exit,n=625 | 0.022 Millimoles per liter (mmol/L) | Standard Deviation 0.0738 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Mg,8 Week Follow up,n=539 | 0.021 Millimoles per liter (mmol/L) | Standard Deviation 0.0729 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Phos, Year1, Week4,n=707 | 0.0102 Millimoles per liter (mmol/L) | Standard Deviation 0.1908 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Phos, Year1, Week12,n=705 | 0.0004 Millimoles per liter (mmol/L) | Standard Deviation 0.1999 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Phos, Year1, Week24,n=703 | -0.0126 Millimoles per liter (mmol/L) | Standard Deviation 0.1964 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Phos, Year1, Week 36,n=684 | 0.0101 Millimoles per liter (mmol/L) | Standard Deviation 0.1976 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Phos, Year1, Week48,n=693 | -0.0110 Millimoles per liter (mmol/L) | Standard Deviation 0.2086 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Phos, Year2, Week24,n=643 | -0.0026 Millimoles per liter (mmol/L) | Standard Deviation 0.2138 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Phos, Year2, Week48,n=598 | -0.0044 Millimoles per liter (mmol/L) | Standard Deviation 0.2062 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Phos, Year3, Week24,n=535 | -0.0109 Millimoles per liter (mmol/L) | Standard Deviation 0.2028 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Phos, Year3, Week48,n=488 | -0.0185 Millimoles per liter (mmol/L) | Standard Deviation 0.2138 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Phos, Year4, Week24,n=439 | -0.0072 Millimoles per liter (mmol/L) | Standard Deviation 0.2067 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Phos, Year4, Week48,n=421 | -0.0143 Millimoles per liter (mmol/L) | Standard Deviation 0.2118 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Phos, Year5, Week24,n=393 | -0.0199 Millimoles per liter (mmol/L) | Standard Deviation 0.2751 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Phos, Year5, Week48,n=362 | -0.0320 Millimoles per liter (mmol/L) | Standard Deviation 0.2145 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Phos, Year6, Week24,n=304 | -0.0238 Millimoles per liter (mmol/L) | Standard Deviation 0.2214 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Phos, Year6, Week48,n=286 | -0.0123 Millimoles per liter (mmol/L) | Standard Deviation 0.2113 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Phos, Year 7, Week 24,n=183 | -0.0196 Millimoles per liter (mmol/L) | Standard Deviation 0.197 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Phos, Year 7, Week 48,n=130 | -0.0101 Millimoles per liter (mmol/L) | Standard Deviation 0.1912 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Phos, Year 8, Week 24,n=52 | -0.0041 Millimoles per liter (mmol/L) | Standard Deviation 0.2038 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Phos, Year 8, Week48,n=13 | -0.0340 Millimoles per liter (mmol/L) | Standard Deviation 0.1337 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Phos, Year9, Week 24,n=6 | -0.0803 Millimoles per liter (mmol/L) | Standard Deviation 0.0823 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Phos, Year 9, Week 48,n=1 | 0.0447 Millimoles per liter (mmol/L) | — |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Phos, Exit, n=625 | -0.0111 Millimoles per liter (mmol/L) | Standard Deviation 0.2243 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Phos, 8 Week Follow up,n=539 | -0.0034 Millimoles per liter (mmol/L) | Standard Deviation 0.2233 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | K, Year 1, Week 4, n=701 | 0.07 Millimoles per liter (mmol/L) | Standard Deviation 0.411 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | K, Year 1, Week 12, n=700 | 0.03 Millimoles per liter (mmol/L) | Standard Deviation 0.38 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | K, Year 1, Week 24, n=701 | 0.01 Millimoles per liter (mmol/L) | Standard Deviation 0.377 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | K, Year 1, Week 36, n=682 | 0.04 Millimoles per liter (mmol/L) | Standard Deviation 0.387 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | K, Year 1, Week 48, n=692 | 0.01 Millimoles per liter (mmol/L) | Standard Deviation 0.377 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | K, Year 2, Week 24, n=641 | 0.01 Millimoles per liter (mmol/L) | Standard Deviation 0.393 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | K, Year 2, Week 48, n=592 | 0.02 Millimoles per liter (mmol/L) | Standard Deviation 0.372 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | K, Year 3, Week 24, n=531 | 0.05 Millimoles per liter (mmol/L) | Standard Deviation 0.401 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | K, Year 3, Week 48, n=486 | 0.06 Millimoles per liter (mmol/L) | Standard Deviation 0.421 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | K, Year 4, Week 24, n=438 | 0.06 Millimoles per liter (mmol/L) | Standard Deviation 0.408 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | K, Year 4, Week 48, n=418 | 0.03 Millimoles per liter (mmol/L) | Standard Deviation 0.397 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | K, Year 5, Week 24, n=393 | 0.08 Millimoles per liter (mmol/L) | Standard Deviation 0.427 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | K, Year 5, Week 48, n=362 | 0.02 Millimoles per liter (mmol/L) | Standard Deviation 0.404 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | K, Year 6, Week 24, n=303 | 0.06 Millimoles per liter (mmol/L) | Standard Deviation 0.429 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | K, Year 6, Week 48, n=284 | 0.05 Millimoles per liter (mmol/L) | Standard Deviation 0.437 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | K, Year 7, Week 24, n=182 | 0.05 Millimoles per liter (mmol/L) | Standard Deviation 0.445 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | K, Year 7, Week 48, n=130 | 0.05 Millimoles per liter (mmol/L) | Standard Deviation 0.413 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | K, Year 8, Week 24, n=52 | -0.02 Millimoles per liter (mmol/L) | Standard Deviation 0.418 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | K, Year 8, Week 48, n=13 | -0.12 Millimoles per liter (mmol/L) | Standard Deviation 0.3 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | K, Year 9, Week 24, n=6 | 0.05 Millimoles per liter (mmol/L) | Standard Deviation 0.259 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | K, Year 9, Week 48, n=1 | 0.00 Millimoles per liter (mmol/L) | — |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | K, Exit, n=624 | 0.06 Millimoles per liter (mmol/L) | Standard Deviation 0.435 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | K, 8 Week Follow up, n=537 | 0.07 Millimoles per liter (mmol/L) | Standard Deviation 0.452 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Na, Year 1, Week 4, n=707 | 0.1 Millimoles per liter (mmol/L) | Standard Deviation 2.07 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Na, Year 1, Week 12, n=705 | 0.3 Millimoles per liter (mmol/L) | Standard Deviation 2.25 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Na, Year 1, Week 24, n=703 | 0.4 Millimoles per liter (mmol/L) | Standard Deviation 2.16 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Na, Year 1, Week 36, n=684 | 0.4 Millimoles per liter (mmol/L) | Standard Deviation 2.1 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Na, Year 1, Week 48, n=693 | 0.1 Millimoles per liter (mmol/L) | Standard Deviation 2.09 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Na, Year 2, Week 24, n=643 | -0.0 Millimoles per liter (mmol/L) | Standard Deviation 2.3 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Na, Year 2, Week 48, n=598 | 0.1 Millimoles per liter (mmol/L) | Standard Deviation 2.63 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Na, Year 3, Week 24, n=535 | 0.2 Millimoles per liter (mmol/L) | Standard Deviation 2.54 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Na, Year 3, Week 48, n=488 | 0.3 Millimoles per liter (mmol/L) | Standard Deviation 2.36 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Na, Year 4, Week 24, n=439 | 0.1 Millimoles per liter (mmol/L) | Standard Deviation 2.31 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Na, Year 4, Week 48, n=421 | 0.3 Millimoles per liter (mmol/L) | Standard Deviation 2.36 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Na, Year 5, Week 24, n=393 | 0.3 Millimoles per liter (mmol/L) | Standard Deviation 2.61 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Na, Year 7, Week 48, n=130 | 0.1 Millimoles per liter (mmol/L) | Standard Deviation 2.38 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Na, Year 8, Week 24, n=52 | 0.2 Millimoles per liter (mmol/L) | Standard Deviation 2.67 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Na, Year 8, Week 48, n=13 | 0.1 Millimoles per liter (mmol/L) | Standard Deviation 2.14 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Na, Year 5, Week 48, n=362 | 0.3 Millimoles per liter (mmol/L) | Standard Deviation 2.18 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Na, Year 6, Week 24, n=304 | 0.3 Millimoles per liter (mmol/L) | Standard Deviation 2.22 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Na, Year 6, Week 48, n=286 | 0.4 Millimoles per liter (mmol/L) | Standard Deviation 2.44 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Na, Year 7, Week 24, n=183 | 0.1 Millimoles per liter (mmol/L) | Standard Deviation 2.22 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Na, Year 9, Week 24, n=6 | 1.0 Millimoles per liter (mmol/L) | Standard Deviation 1.79 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Na, Year 9, Week 48, n=1 | -3.0 Millimoles per liter (mmol/L) | — |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Na, Exist, n=624 | 0.1 Millimoles per liter (mmol/L) | Standard Deviation 2.55 |
| Belimumab 10mg/kg IV | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | Na, 8 Week Follow up, n=538 | 0.3 Millimoles per liter (mmol/L) | Standard Deviation 2.36 |
Primary
Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points
Other chemistries parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 other chemistries were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Cr and Urate were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.
Time frame: Baseline and up to 9 years
Population: MITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10mg/kg IV | Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points | Urate,Year3,Week24,n=535 | 6.7497 Micromoles per liter (µmol/L) | Standard Deviation 60.4118 |
| Belimumab 10mg/kg IV | Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points | Urate,Year5,Week48,n=362 | -0.8979 Micromoles per liter (µmol/L) | Standard Deviation 67.3843 |
| Belimumab 10mg/kg IV | Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points | Crea,Year4,Week24,n=439 | -3.196 Micromoles per liter (µmol/L) | Standard Deviation 22.2874 |
| Belimumab 10mg/kg IV | Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points | Cr,Year6,Week24,n=304 | -2.125 Micromoles per liter (µmol/L) | Standard Deviation 24.2374 |
| Belimumab 10mg/kg IV | Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points | Cr,Year7,Week24,n=183 | -2.511 Micromoles per liter (µmol/L) | Standard Deviation 15.6881 |
| Belimumab 10mg/kg IV | Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points | Cr,Year8,Week24,n=52 | -4.659 Micromoles per liter (µmol/L) | Standard Deviation 16.3056 |
| Belimumab 10mg/kg IV | Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points | Cr,Year9,Week24,n=6 | -8.933 Micromoles per liter (µmol/L) | Standard Deviation 5.6925 |
| Belimumab 10mg/kg IV | Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points | Cr,Year9,Week48,n=1 | 0.040 Micromoles per liter (µmol/L) | — |
| Belimumab 10mg/kg IV | Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points | Cr,Year1,Week24,n=703 | 0.823 Micromoles per liter (µmol/L) | Standard Deviation 9.5372 |
| Belimumab 10mg/kg IV | Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points | Cr,Year1,Week36,n=684 | 1.313 Micromoles per liter (µmol/L) | Standard Deviation 13.1107 |
| Belimumab 10mg/kg IV | Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points | Cr,Year1,Week48,n=693 | 0.439 Micromoles per liter (µmol/L) | Standard Deviation 11.1364 |
| Belimumab 10mg/kg IV | Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points | Cr,Year2,Week24,n=643 | -0.217 Micromoles per liter (µmol/L) | Standard Deviation 13.9502 |
| Belimumab 10mg/kg IV | Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points | Cr,Year2,Week48,n=598 | -0.922 Micromoles per liter (µmol/L) | Standard Deviation 13.6541 |
| Belimumab 10mg/kg IV | Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points | Cr,Year3,Week24,n=535 | -3.870 Micromoles per liter (µmol/L) | Standard Deviation 17.8146 |
| Belimumab 10mg/kg IV | Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points | Cr,Year3,Week48,n=488 | -4.844 Micromoles per liter (µmol/L) | Standard Deviation 17.7059 |
| Belimumab 10mg/kg IV | Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points | Crea,Year 4,Week48,n=421 | -2.145 Micromoles per liter (µmol/L) | Standard Deviation 30.937 |
| Belimumab 10mg/kg IV | Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points | Cr,Year5,Week24,n=393 | -1.999 Micromoles per liter (µmol/L) | Standard Deviation 32.6689 |
| Belimumab 10mg/kg IV | Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points | Cr,Year5,Week48,n=362 | -1.918 Micromoles per liter (µmol/L) | Standard Deviation 28.8788 |
| Belimumab 10mg/kg IV | Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points | Cr,Year6,Week48,n=286 | -1.534 Micromoles per liter (µmol/L) | Standard Deviation 28.8012 |
| Belimumab 10mg/kg IV | Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points | Cr,Year7,Week48,n=130 | -2.586 Micromoles per liter (µmol/L) | Standard Deviation 14.0864 |
| Belimumab 10mg/kg IV | Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points | Urate,Year1,Week4,n=707 | 1.0332 Micromoles per liter (µmol/L) | Standard Deviation 45.8504 |
| Belimumab 10mg/kg IV | Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points | Urate,Year1,Week12,n=704 | 0.4089 Micromoles per liter (µmol/L) | Standard Deviation 54.3182 |
| Belimumab 10mg/kg IV | Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points | Urate,Year1,Week24,n=703 | -0.0510 Micromoles per liter (µmol/L) | Standard Deviation 49.2328 |
| Belimumab 10mg/kg IV | Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points | Urate,Year1,Week36,n=684 | 0.6713 Micromoles per liter (µmol/L) | Standard Deviation 50.7341 |
| Belimumab 10mg/kg IV | Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points | Urate,Year1,Week48,n=693 | -1.5147 Micromoles per liter (µmol/L) | Standard Deviation 50.5928 |
| Belimumab 10mg/kg IV | Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points | Urate,Year2,Week24,n=643 | 2.7246 Micromoles per liter (µmol/L) | Standard Deviation 55.7467 |
| Belimumab 10mg/kg IV | Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points | Urate,Year2,Week48,n=598 | 4.1255 Micromoles per liter (µmol/L) | Standard Deviation 60.0251 |
| Belimumab 10mg/kg IV | Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points | Urate,Year3,Week48,n=488 | 6.9744 Micromoles per liter (µmol/L) | Standard Deviation 63.6876 |
| Belimumab 10mg/kg IV | Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points | Urate,Year4,Week24,n=439 | 5.9658 Micromoles per liter (µmol/L) | Standard Deviation 66.6167 |
| Belimumab 10mg/kg IV | Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points | Urate,Year 4,Week48,n=421 | 4.0772 Micromoles per liter (µmol/L) | Standard Deviation 67.9587 |
| Belimumab 10mg/kg IV | Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points | Urate,Year5,Week24,n=393 | -0.5634 Micromoles per liter (µmol/L) | Standard Deviation 66.913 |
| Belimumab 10mg/kg IV | Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points | Urate,Year6,Week24,n=304 | 2.9530 Micromoles per liter (µmol/L) | Standard Deviation 62.3168 |
| Belimumab 10mg/kg IV | Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points | Urate,Year6,Week48,n=286 | 1.1244 Micromoles per liter (µmol/L) | Standard Deviation 67.3175 |
| Belimumab 10mg/kg IV | Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points | Urate,Year7,Week24,n=183 | 2.1521 Micromoles per liter (µmol/L) | Standard Deviation 53.0854 |
| Belimumab 10mg/kg IV | Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points | Urate,Year7,Week48,n=130 | 4.0062 Micromoles per liter (µmol/L) | Standard Deviation 58.3577 |
| Belimumab 10mg/kg IV | Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points | Urate,Year8,Week24,n=52 | -1.1003 Micromoles per liter (µmol/L) | Standard Deviation 51.884 |
| Belimumab 10mg/kg IV | Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points | Urate,Year8,Week48,n=13 | 29.2043 Micromoles per liter (µmol/L) | Standard Deviation 80.1811 |
| Belimumab 10mg/kg IV | Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points | Urate,Year9,Week24,n=6 | 0.2187 Micromoles per liter (µmol/L) | Standard Deviation 45.1947 |
| Belimumab 10mg/kg IV | Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points | Urate,Year9,Week48,n=1 | -69.6640 Micromoles per liter (µmol/L) | — |
| Belimumab 10mg/kg IV | Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points | Urate,Exit,n=625 | 1.6479 Micromoles per liter (µmol/L) | Standard Deviation 74.4078 |
| Belimumab 10mg/kg IV | Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points | Urate,8 Week Follow up,n=539 | -2.7404 Micromoles per liter (µmol/L) | Standard Deviation 75.5887 |
| Belimumab 10mg/kg IV | Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points | Cr,Year1,Week4,n=707 | 0.913 Micromoles per liter (µmol/L) | Standard Deviation 14.2222 |
| Belimumab 10mg/kg IV | Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points | Cr,Year1,Week12,n=705 | 0.751 Micromoles per liter (µmol/L) | Standard Deviation 14.0933 |
| Belimumab 10mg/kg IV | Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points | Cr,Year8,Week48,n=13 | -6.175 Micromoles per liter (µmol/L) | Standard Deviation 6.6311 |
| Belimumab 10mg/kg IV | Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points | Cr,Exit,n=624 | 0.606 Micromoles per liter (µmol/L) | Standard Deviation 35.9813 |
| Belimumab 10mg/kg IV | Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points | Cr,8 Week Follow up,n=539 | -1.108 Micromoles per liter (µmol/L) | Standard Deviation 39.0635 |
Primary
Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points
Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Erythrocytes is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.
Time frame: Baseline and up to 9 years
Population: MITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10mg/kg IV | Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points | Eryth,Year8,Week24,n=52 | 0.21 Trillions cells per liter | Standard Deviation 0.375 |
| Belimumab 10mg/kg IV | Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points | Eryth,Year1,Week4,n=697 | -0.00 Trillions cells per liter | Standard Deviation 0.231 |
| Belimumab 10mg/kg IV | Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points | Eryth,Year1,Week12,n=698 | 0.04 Trillions cells per liter | Standard Deviation 0.28 |
| Belimumab 10mg/kg IV | Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points | Eryth,Year1,Week24,n=699 | 0.06 Trillions cells per liter | Standard Deviation 0.293 |
| Belimumab 10mg/kg IV | Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points | Eryth,Year1,Week36,n=688 | 0.06 Trillions cells per liter | Standard Deviation 0.299 |
| Belimumab 10mg/kg IV | Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points | Eryth,Year1,Week48,n=686 | 0.06 Trillions cells per liter | Standard Deviation 0.328 |
| Belimumab 10mg/kg IV | Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points | Eryth,Year2,Week24,n=635 | 0.07 Trillions cells per liter | Standard Deviation 0.335 |
| Belimumab 10mg/kg IV | Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points | Eryth,Year2,Week48,n=591 | 0.04 Trillions cells per liter | Standard Deviation 0.362 |
| Belimumab 10mg/kg IV | Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points | Eryth,Year3,Week24,n=534 | 0.04 Trillions cells per liter | Standard Deviation 0.364 |
| Belimumab 10mg/kg IV | Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points | Eryth,Year3,Week48,n=478 | 0.05 Trillions cells per liter | Standard Deviation 0.381 |
| Belimumab 10mg/kg IV | Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points | Eryth,Year4,Week24,n=446 | 0.06 Trillions cells per liter | Standard Deviation 0.372 |
| Belimumab 10mg/kg IV | Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points | Eryth,Year,Week48,n=424 | 0.05 Trillions cells per liter | Standard Deviation 0.379 |
| Belimumab 10mg/kg IV | Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points | Eryth,Year5,Week24,n=390 | 0.09 Trillions cells per liter | Standard Deviation 0.375 |
| Belimumab 10mg/kg IV | Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points | Eryth,Year5,Week48,n=362 | 0.11 Trillions cells per liter | Standard Deviation 0.383 |
| Belimumab 10mg/kg IV | Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points | Eryth,Year6,Week24,n=306 | 0.12 Trillions cells per liter | Standard Deviation 0.396 |
| Belimumab 10mg/kg IV | Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points | Eryth,Year6,Week48,n=282 | 0.17 Trillions cells per liter | Standard Deviation 0.408 |
| Belimumab 10mg/kg IV | Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points | Eryth,Year7,Week24,n=181 | 0.17 Trillions cells per liter | Standard Deviation 0.415 |
| Belimumab 10mg/kg IV | Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points | Eryth,Year7,Week48,n=130 | 0.22 Trillions cells per liter | Standard Deviation 0.387 |
| Belimumab 10mg/kg IV | Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points | Eryth,Year8,Week48,n=13 | 0.15 Trillions cells per liter | Standard Deviation 0.207 |
| Belimumab 10mg/kg IV | Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points | Eryth,Year9,Week24,n=6 | 0.30 Trillions cells per liter | Standard Deviation 0.374 |
| Belimumab 10mg/kg IV | Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points | Eryth,Year9,Week48,n=1 | 0.20 Trillions cells per liter | — |
| Belimumab 10mg/kg IV | Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points | Eryth,Exit,n=619 | 0.14 Trillions cells per liter | Standard Deviation 0.431 |
| Belimumab 10mg/kg IV | Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points | Eryth,8 Week Follow up,n=534 | 0.13 Trillions cells per liter | Standard Deviation 0.411 |
Primary
Change From Baseline in Hematocrit at the Indicated Time Points
Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks). Change from Baseline in Hematocrit is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.
Time frame: Baseline and up to 9 years
Population: MITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10mg/kg IV | Change From Baseline in Hematocrit at the Indicated Time Points | Hematocrit,Year1,Week4,n=697 | 0.01 Percentage of blood by volume | Standard Deviation 2.25 |
| Belimumab 10mg/kg IV | Change From Baseline in Hematocrit at the Indicated Time Points | Hematocrit,Year1,Week12,n=698 | 0.38 Percentage of blood by volume | Standard Deviation 2.729 |
| Belimumab 10mg/kg IV | Change From Baseline in Hematocrit at the Indicated Time Points | Hematocrit,Year1,Week24,n=699 | 0.75 Percentage of blood by volume | Standard Deviation 2.928 |
| Belimumab 10mg/kg IV | Change From Baseline in Hematocrit at the Indicated Time Points | Hematocrit,Year1,Week36,n=688 | 0.53 Percentage of blood by volume | Standard Deviation 2.954 |
| Belimumab 10mg/kg IV | Change From Baseline in Hematocrit at the Indicated Time Points | Hematocrit,Year1,Week48,n=686 | 0.35 Percentage of blood by volume | Standard Deviation 3.286 |
| Belimumab 10mg/kg IV | Change From Baseline in Hematocrit at the Indicated Time Points | Hematocrit,Year2,Week24,n=635 | 0.94 Percentage of blood by volume | Standard Deviation 3.427 |
| Belimumab 10mg/kg IV | Change From Baseline in Hematocrit at the Indicated Time Points | Hematocrit,Year2,Week48,n=591 | 0.78 Percentage of blood by volume | Standard Deviation 3.584 |
| Belimumab 10mg/kg IV | Change From Baseline in Hematocrit at the Indicated Time Points | Hematocrit,Year3,Week24,n=534 | 1.29 Percentage of blood by volume | Standard Deviation 3.828 |
| Belimumab 10mg/kg IV | Change From Baseline in Hematocrit at the Indicated Time Points | Hematocrit,Year3,Week48,n=478 | 1.39 Percentage of blood by volume | Standard Deviation 3.8 |
| Belimumab 10mg/kg IV | Change From Baseline in Hematocrit at the Indicated Time Points | Hematocrit,Year4,Week24,n=446 | 1.67 Percentage of blood by volume | Standard Deviation 3.834 |
| Belimumab 10mg/kg IV | Change From Baseline in Hematocrit at the Indicated Time Points | Hematocrit,Year4,Week48,n=424 | 1.15 Percentage of blood by volume | Standard Deviation 3.998 |
| Belimumab 10mg/kg IV | Change From Baseline in Hematocrit at the Indicated Time Points | Hematocrit,Year5,Week24,n=390 | 1.69 Percentage of blood by volume | Standard Deviation 3.776 |
| Belimumab 10mg/kg IV | Change From Baseline in Hematocrit at the Indicated Time Points | Hematocrit,Year5,Week48,n=362 | 1.98 Percentage of blood by volume | Standard Deviation 3.842 |
| Belimumab 10mg/kg IV | Change From Baseline in Hematocrit at the Indicated Time Points | Hematocrit,Year6,Week24,n=306 | 1.93 Percentage of blood by volume | Standard Deviation 3.939 |
| Belimumab 10mg/kg IV | Change From Baseline in Hematocrit at the Indicated Time Points | Hematocrit,Year6,Week48,n=282 | 2.07 Percentage of blood by volume | Standard Deviation 4.023 |
| Belimumab 10mg/kg IV | Change From Baseline in Hematocrit at the Indicated Time Points | Hematocrit,Year7,Week24,n=181 | 1.81 Percentage of blood by volume | Standard Deviation 4.251 |
| Belimumab 10mg/kg IV | Change From Baseline in Hematocrit at the Indicated Time Points | Hematocrit,Year7,Week48,n=130 | 2.11 Percentage of blood by volume | Standard Deviation 4.238 |
| Belimumab 10mg/kg IV | Change From Baseline in Hematocrit at the Indicated Time Points | Hematocrit,Year8,Week24,n=52 | 1.42 Percentage of blood by volume | Standard Deviation 4.39 |
| Belimumab 10mg/kg IV | Change From Baseline in Hematocrit at the Indicated Time Points | Hematocrit,Year8,Week48,n=13 | 1.48 Percentage of blood by volume | Standard Deviation 4.234 |
| Belimumab 10mg/kg IV | Change From Baseline in Hematocrit at the Indicated Time Points | Hematocrit,Year9,Week24,n=6 | 2.03 Percentage of blood by volume | Standard Deviation 6.001 |
| Belimumab 10mg/kg IV | Change From Baseline in Hematocrit at the Indicated Time Points | Hematocrit,Year9,Week48,n=1 | -6.00 Percentage of blood by volume | — |
| Belimumab 10mg/kg IV | Change From Baseline in Hematocrit at the Indicated Time Points | Hematocrit,Exit,n=619 | 1.91 Percentage of blood by volume | Standard Deviation 4.202 |
| Belimumab 10mg/kg IV | Change From Baseline in Hematocrit at the Indicated Time Points | Hematocrit,8 Week Follow up,n=534 | 1.85 Percentage of blood by volume | Standard Deviation 4.077 |
Primary
Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points
Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Hg is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.
Time frame: Baseline and up to 9 years
Population: MITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10mg/kg IV | Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points | Hg,Year1, Week 4,n=697 | -0.3 Gram per liter (g/L) | Standard Deviation 7.05 |
| Belimumab 10mg/kg IV | Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points | Hg,Year1,Week12,n=698 | 0.1 Gram per liter (g/L) | Standard Deviation 8.75 |
| Belimumab 10mg/kg IV | Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points | Hg,Year1,Week24,n=699 | 0.1 Gram per liter (g/L) | Standard Deviation 9.48 |
| Belimumab 10mg/kg IV | Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points | Hg,Year1,Week36,n=688 | 0.3 Gram per liter (g/L) | Standard Deviation 9.9 |
| Belimumab 10mg/kg IV | Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points | Hg,Year1,Week48,n=686 | 1.0 Gram per liter (g/L) | Standard Deviation 11.03 |
| Belimumab 10mg/kg IV | Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points | Hg,Year2,Week24,n=635 | 1.0 Gram per liter (g/L) | Standard Deviation 11.31 |
| Belimumab 10mg/kg IV | Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points | Hg,Year2,Week48,n=591 | 1.3 Gram per liter (g/L) | Standard Deviation 12.12 |
| Belimumab 10mg/kg IV | Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points | Hg,Year3,Week24,n=534 | 2.2 Gram per liter (g/L) | Standard Deviation 12.79 |
| Belimumab 10mg/kg IV | Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points | Hg,Year3,Week48,n=478 | 2.9 Gram per liter (g/L) | Standard Deviation 12.67 |
| Belimumab 10mg/kg IV | Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points | Hg,Year4,Week24,n=446 | 2.6 Gram per liter (g/L) | Standard Deviation 12.93 |
| Belimumab 10mg/kg IV | Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points | Hg,Year,Week48,n=424 | 2.4 Gram per liter (g/L) | Standard Deviation 13.59 |
| Belimumab 10mg/kg IV | Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points | Hg,Year5,Week24,n=390 | 2.9 Gram per liter (g/L) | Standard Deviation 12.76 |
| Belimumab 10mg/kg IV | Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points | Hg,Year5,Week48,n=362 | 3.2 Gram per liter (g/L) | Standard Deviation 13.26 |
| Belimumab 10mg/kg IV | Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points | Hg,Year6,Week24,n=306 | 2.7 Gram per liter (g/L) | Standard Deviation 13.19 |
| Belimumab 10mg/kg IV | Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points | Hg,Year6,Week48,n=282 | 2.3 Gram per liter (g/L) | Standard Deviation 13.83 |
| Belimumab 10mg/kg IV | Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points | Hg,Year7,Week24,n=181 | 2.9 Gram per liter (g/L) | Standard Deviation 14.54 |
| Belimumab 10mg/kg IV | Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points | Hg,Year7,Week48,n=130 | 4.0 Gram per liter (g/L) | Standard Deviation 14.66 |
| Belimumab 10mg/kg IV | Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points | Hg,Year8,Week24,n=52 | 1.5 Gram per liter (g/L) | Standard Deviation 14.84 |
| Belimumab 10mg/kg IV | Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points | Hg,Year8,Week48,n=13 | -0.2 Gram per liter (g/L) | Standard Deviation 13.95 |
| Belimumab 10mg/kg IV | Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points | Hg,Year9,Week24,n=6 | -0.7 Gram per liter (g/L) | Standard Deviation 20.67 |
| Belimumab 10mg/kg IV | Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points | Hg,Year9,Week48,n=1 | -29.0 Gram per liter (g/L) | — |
| Belimumab 10mg/kg IV | Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points | Hg,Exit,n=619 | 3.2 Gram per liter (g/L) | Standard Deviation 13.9 |
| Belimumab 10mg/kg IV | Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points | Hg,8 Week Follow up,n=534 | 2.8 Gram per liter (g/L) | Standard Deviation 13.71 |
Primary
Change From Baseline in Immunoglobulin G (IgG) Levels
Immunoglobulin (Ig) parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 Ig parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Ig G were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.
Time frame: Baseline and up to 9 years
Population: MITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10mg/kg IV | Change From Baseline in Immunoglobulin G (IgG) Levels | Year 6 Week 48, n=268 | -4.697 g/L | Standard Deviation 3.9599 |
| Belimumab 10mg/kg IV | Change From Baseline in Immunoglobulin G (IgG) Levels | Year 7 Week 24, n=50 | -4.803 g/L | Standard Deviation 3.5908 |
| Belimumab 10mg/kg IV | Change From Baseline in Immunoglobulin G (IgG) Levels | Year 7 Week 48, n=115 | -4.982 g/L | Standard Deviation 4.0769 |
| Belimumab 10mg/kg IV | Change From Baseline in Immunoglobulin G (IgG) Levels | Year 8 Week 24, n=18 | -6.016 g/L | Standard Deviation 3.845 |
| Belimumab 10mg/kg IV | Change From Baseline in Immunoglobulin G (IgG) Levels | Year 8 Week 48, n=12 | -5.520 g/L | Standard Deviation 5.1564 |
| Belimumab 10mg/kg IV | Change From Baseline in Immunoglobulin G (IgG) Levels | Year 9 Week 48, n=1 | 0.710 g/L | — |
| Belimumab 10mg/kg IV | Change From Baseline in Immunoglobulin G (IgG) Levels | Exit, n=627 | -4.138 g/L | Standard Deviation 4.0025 |
| Belimumab 10mg/kg IV | Change From Baseline in Immunoglobulin G (IgG) Levels | 8 Week Follow up, n=543 | -4.325 g/L | Standard Deviation 4.0246 |
| Belimumab 10mg/kg IV | Change From Baseline in Immunoglobulin G (IgG) Levels | Year 1 Week 12, n=213 | -1.571 g/L | Standard Deviation 2.297 |
| Belimumab 10mg/kg IV | Change From Baseline in Immunoglobulin G (IgG) Levels | Year 1 Week 24, n=709 | -1.963 g/L | Standard Deviation 2.7334 |
| Belimumab 10mg/kg IV | Change From Baseline in Immunoglobulin G (IgG) Levels | Year 1 Week 48, n=695 | -2.507 g/L | Standard Deviation 3.1054 |
| Belimumab 10mg/kg IV | Change From Baseline in Immunoglobulin G (IgG) Levels | Year 2 Week 24, n=482 | -3.058 g/L | Standard Deviation 3.6147 |
| Belimumab 10mg/kg IV | Change From Baseline in Immunoglobulin G (IgG) Levels | Year 2 Week 48, n=605 | -3.232 g/L | Standard Deviation 3.7414 |
| Belimumab 10mg/kg IV | Change From Baseline in Immunoglobulin G (IgG) Levels | Year 3 Week 24, n=143 | -3.453 g/L | Standard Deviation 3.7073 |
| Belimumab 10mg/kg IV | Change From Baseline in Immunoglobulin G (IgG) Levels | Year 3 Week 48, n=405 | -3.791 g/L | Standard Deviation 4.045 |
| Belimumab 10mg/kg IV | Change From Baseline in Immunoglobulin G (IgG) Levels | Year 4 Week 24, n=146 | -3.839 g/L | Standard Deviation 4.1411 |
| Belimumab 10mg/kg IV | Change From Baseline in Immunoglobulin G (IgG) Levels | Year 4 Week 48, n=362 | -3.794 g/L | Standard Deviation 3.878 |
| Belimumab 10mg/kg IV | Change From Baseline in Immunoglobulin G (IgG) Levels | Year 5 Week 24, n=111 | -4.356 g/L | Standard Deviation 3.6399 |
| Belimumab 10mg/kg IV | Change From Baseline in Immunoglobulin G (IgG) Levels | Year 5 Week 48, n=322 | -4.323 g/L | Standard Deviation 4.0169 |
| Belimumab 10mg/kg IV | Change From Baseline in Immunoglobulin G (IgG) Levels | Year 6 Week 24, n=71 | -5.111 g/L | Standard Deviation 3.8846 |
Primary
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Plt, Lymp, Leu, Eos, Baso, Mono, Neu, NeuBF, and NueS are summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.
Time frame: Baseline and up to 9 years
Population: MITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Neu,Year1,Week48,n=679 | -0.078 Billion cells per liter | Standard Deviation 2.3164 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | NeuS,Year2,Week48,n=589 | -0.226 Billion cells per liter | Standard Deviation 2.3846 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | NeuS,Exit,n=614 | -0.008 Billion cells per liter | Standard Deviation 2.5501 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | NeuS,8 Week Followup,n=532 | 0.007 Billion cells per liter | Standard Deviation 2.3824 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Plt,Year1,Week4,n=683 | 8.1 Billion cells per liter | Standard Deviation 38.82 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Plt,Year1,Week12,n=690 | 4.6 Billion cells per liter | Standard Deviation 43.63 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Plt,Year1,Week24,n=687 | -0.5 Billion cells per liter | Standard Deviation 47.73 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Plt,Year1,Week36,n=680 | -2.9 Billion cells per liter | Standard Deviation 50.25 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Plt,Year1,Week48,n=677 | -9.3 Billion cells per liter | Standard Deviation 50.81 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Plt,Year2,Week24,n=631 | -15.4 Billion cells per liter | Standard Deviation 53.8 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Plt,Year2,Week48,n=583 | -20.3 Billion cells per liter | Standard Deviation 56.39 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Plt,Year3,Week24,n=526 | -19.9 Billion cells per liter | Standard Deviation 57.88 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Plt,Year3,Week48,n=476 | -13.4 Billion cells per liter | Standard Deviation 65.16 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Plt,Year4,Week24,n=441 | -14.0 Billion cells per liter | Standard Deviation 59.05 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Plt,Year4,Week48,n=420 | -18.2 Billion cells per liter | Standard Deviation 63.8 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Plt,Year5,Week24,n=388 | -19.3 Billion cells per liter | Standard Deviation 61.49 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Plt,Year5,Week48,n=360 | -17.9 Billion cells per liter | Standard Deviation 63.36 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Plt,Year6,Week24,n=305 | -13.3 Billion cells per liter | Standard Deviation 61.54 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Plt,Year6,Week48,n=282 | -13.4 Billion cells per liter | Standard Deviation 60.89 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Plt,Year7,Week24,n=181 | -15.3 Billion cells per liter | Standard Deviation 63.95 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Plt,Year7,Week48,n=130 | -16.3 Billion cells per liter | Standard Deviation 70.75 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Plt,Year8,Week24,n=52 | -2.3 Billion cells per liter | Standard Deviation 80.69 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Plt,Year8,Week48,n=13 | -29.9 Billion cells per liter | Standard Deviation 88.66 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Plt,Year9,Week24,n=6 | -5.0 Billion cells per liter | Standard Deviation 82.67 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Plt,Year9,Week48,n=1 | 57.0 Billion cells per liter | — |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Plt,Exit,n=613 | -11.0 Billion cells per liter | Standard Deviation 64.36 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Plt,8Week Followup,n=530 | -11.2 Billion cells per liter | Standard Deviation 60.57 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Baso,Year1,Week4,n=693 | 0.002 Billion cells per liter | Standard Deviation 0.0172 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Baso,Year1,Week12,n=694 | 0.002 Billion cells per liter | Standard Deviation 0.0187 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Baso,Year1,Week24,n=696 | 0.002 Billion cells per liter | Standard Deviation 0.0176 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Baso,Year1,Week36,n=682 | 0.002 Billion cells per liter | Standard Deviation 0.0179 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Baso,Year1,Week48,n=684 | 0.003 Billion cells per liter | Standard Deviation 0.0183 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Baso,Year2,Week24,n=629 | 0.004 Billion cells per liter | Standard Deviation 0.019 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Baso,Year2,Week48,n=589 | 0.004 Billion cells per liter | Standard Deviation 0.02 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Baso,Year3,Week24,n=533 | 0.005 Billion cells per liter | Standard Deviation 0.0165 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Baso,Year3,Week48,n=476 | 0.008 Billion cells per liter | Standard Deviation 0.0194 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Baso,Year4,Week24,n=446 | 0.007 Billion cells per liter | Standard Deviation 0.0192 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Baso,Year4,Week48,n=423 | 0.008 Billion cells per liter | Standard Deviation 0.0202 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Baso,Year5,Week24,n=389 | 0.007 Billion cells per liter | Standard Deviation 0.0191 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Baso,Year5,Week48,n=360 | 0.005 Billion cells per liter | Standard Deviation 0.0191 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Baso,Year6,Week24,n=306 | 0.006 Billion cells per liter | Standard Deviation 0.0184 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Baso,Year6,Week48,n=282 | 0.007 Billion cells per liter | Standard Deviation 0.0198 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Baso,Year7,Week24,n=181 | 0.007 Billion cells per liter | Standard Deviation 0.0211 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Baso,Year7,Week48,n=130 | 0.012 Billion cells per liter | Standard Deviation 0.0259 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Baso,Year8,Week24,n=52 | 0.014 Billion cells per liter | Standard Deviation 0.0187 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Baso,Year8,Week48,n=13 | 0.001 Billion cells per liter | Standard Deviation 0.0166 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Baso,Year9,Week24,n=6 | 0.003 Billion cells per liter | Standard Deviation 0.0082 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Baso,Year9,Week48,n=1 | 0.010 Billion cells per liter | — |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Baso,Exit,n=614 | 0.005 Billion cells per liter | Standard Deviation 0.0204 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Baso,8 Week,Follow up,n=532 | 0.009 Billion cells per liter | Standard Deviation 0.0253 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Eos,Year1,Week4,n=693 | 0.007 Billion cells per liter | Standard Deviation 0.1597 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Eos,Year1,Week12,n=694 | 0.003 Billion cells per liter | Standard Deviation 0.1595 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Eos,Year1,Week24,n=696 | 0.000 Billion cells per liter | Standard Deviation 0.1614 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Eos,Year1,Week36,n=682 | 0.020 Billion cells per liter | Standard Deviation 0.1866 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Eos,Year1,Week48,n=684 | 0.001 Billion cells per liter | Standard Deviation 0.1763 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Eos,Year2,Week24,n=629 | 0.004 Billion cells per liter | Standard Deviation 0.1605 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Eos,Year2,Week48,n=589 | -0.004 Billion cells per liter | Standard Deviation 0.1858 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Eos,Year3,Week24,n=533 | -0.011 Billion cells per liter | Standard Deviation 0.2074 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Eos,Year3,Week48,n=476 | -0.026 Billion cells per liter | Standard Deviation 0.2053 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Eos,Year4,Week24,n=446 | -0.041 Billion cells per liter | Standard Deviation 0.1792 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Eos,Year4,Week48,n=423 | -0.047 Billion cells per liter | Standard Deviation 0.1676 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Eos,Year5,Week24,n=389 | -0.035 Billion cells per liter | Standard Deviation 0.1949 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Eos,Year5,Week48,n=360 | -0.045 Billion cells per liter | Standard Deviation 0.1807 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Eos,Year6,Week24,n=306 | -0.046 Billion cells per liter | Standard Deviation 0.1801 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Eos,Year6,Week48,n=282 | -0.037 Billion cells per liter | Standard Deviation 0.1976 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Eos,Year7,Week24,n=181 | -0.046 Billion cells per liter | Standard Deviation 0.171 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Eos,Year7,Week48,n=130 | -0.020 Billion cells per liter | Standard Deviation 0.2276 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Eos,Year8,Week24,n=52 | -0.017 Billion cells per liter | Standard Deviation 0.1753 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Eos,Year8,Week48,n=13 | -0.041 Billion cells per liter | Standard Deviation 0.113 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Eos,Year9,Week24,n=6 | -0.088 Billion cells per liter | Standard Deviation 0.1078 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Eos,Year9,Week48,n=1 | -0.040 Billion cells per liter | — |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Eos, Exit, n=614 | -0.026 Billion cells per liter | Standard Deviation 0.1754 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Eso, 8 Week Follow up, n=532 | -0.030 Billion cells per liter | Standard Deviation 0.192 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Leu,Year1,Week4,n=696 | 0.16 Billion cells per liter | Standard Deviation 1.928 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Leu,Year1,Week12,n=697 | 0.19 Billion cells per liter | Standard Deviation 2.106 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Leu,Year1,Week24,n=697 | 0.04 Billion cells per liter | Standard Deviation 2.142 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Leu,Year1,Week36,n=682 | 0.05 Billion cells per liter | Standard Deviation 2.19 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Leu,Year1,Week48,n=684 | 0.02 Billion cells per liter | Standard Deviation 2.274 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Leu,Year2,Week24,n=630 | -0.19 Billion cells per liter | Standard Deviation 2.287 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Leu,Year2,Week48,n=589 | -0.11 Billion cells per liter | Standard Deviation 2.449 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Leu,Year3,Week24,n=533 | -0.03 Billion cells per liter | Standard Deviation 2.544 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Leu,Year3,Week24,n=476 | 0.06 Billion cells per liter | Standard Deviation 2.393 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Leu,Year4,Week24,n=446 | -0.01 Billion cells per liter | Standard Deviation 2.52 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Leu,Year4,Week48,n=423 | -0.06 Billion cells per liter | Standard Deviation 2.661 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Leu,Year5,Week24,n=389 | 0.05 Billion cells per liter | Standard Deviation 2.43 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Leu,Year5,Week48,n=360 | -0.06 Billion cells per liter | Standard Deviation 2.463 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Leu,Year6,Week24,n=306 | 0.04 Billion cells per liter | Standard Deviation 2.449 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Leu,Year6,Week48,n=282 | 0.17 Billion cells per liter | Standard Deviation 2.579 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Leu,Year7,Week24,n=181 | 0.12 Billion cells per liter | Standard Deviation 2.395 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Leu,Year7,Week48,n=130 | 0.48 Billion cells per liter | Standard Deviation 2.354 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Leu,Year8,Week24,n=52 | 0.38 Billion cells per liter | Standard Deviation 2.761 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Leu,Year8,Week48,n=13 | -0.65 Billion cells per liter | Standard Deviation 3.136 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Leu,Year9,Week24,n=6 | -0.35 Billion cells per liter | Standard Deviation 3.422 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Leu,Year9,Week48,n=1 | -3.90 Billion cells per liter | — |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Leu, Exit, n=614 | 0.18 Billion cells per liter | Standard Deviation 2.65 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Leu, 8 Week Follow up,n=532 | 0.21 Billion cells per liter | Standard Deviation 2.496 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Lymp,Year1,Week4,n=693 | 0.093 Billion cells per liter | Standard Deviation 0.5986 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Lymp,Year1,Week12,n=694 | 0.107 Billion cells per liter | Standard Deviation 0.6607 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Lymp,Year1,Week24,n=696 | 0.066 Billion cells per liter | Standard Deviation 0.6544 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Lymp,Year1,Week36,n=682 | 0.119 Billion cells per liter | Standard Deviation 0.6583 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Lymp,Year1,Week48,n=684 | 0.048 Billion cells per liter | Standard Deviation 0.6361 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Lymp,Year2,Week24,n=629 | 0.051 Billion cells per liter | Standard Deviation 0.6898 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Lymp,Year2,Week48,n=589 | 0.067 Billion cells per liter | Standard Deviation 0.6971 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Lymp,Year3,Week24,n=533 | 0.057 Billion cells per liter | Standard Deviation 0.6717 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Lymp,Year3,Week48,n=476 | 0.038 Billion cells per liter | Standard Deviation 0.6676 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Lymp,Year4,Week24,n=446 | 0.054 Billion cells per liter | Standard Deviation 0.6858 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Lymp,Year4,Week48,n=423 | 0.067 Billion cells per liter | Standard Deviation 0.7186 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Lymp,Year5,Week24,n=389 | 0.023 Billion cells per liter | Standard Deviation 0.681 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Lymp,Year5,Week48,n=360 | 0.078 Billion cells per liter | Standard Deviation 0.7485 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Lymp,Year6,Week24,n=306 | 0.147 Billion cells per liter | Standard Deviation 0.7251 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Lymp,Year6,Week48,n=282 | 0.168 Billion cells per liter | Standard Deviation 0.7523 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Lymp,Year7,Week24,n=181 | 0.175 Billion cells per liter | Standard Deviation 0.767 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Lymp,Year7,Week48,n=130 | 0.169 Billion cells per liter | Standard Deviation 0.6639 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Lymp,Year8,Week24,n=52 | 0.300 Billion cells per liter | Standard Deviation 0.7553 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Lymp,Year8,Week48,n=13 | 0.052 Billion cells per liter | Standard Deviation 0.5252 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Lymp,Year9,Week24,n=6 | -0.032 Billion cells per liter | Standard Deviation 0.6156 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Lymp,Year9,Week48,n=1 | -0.460 Billion cells per liter | — |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Lymp,Exit,n=614 | 0.128 Billion cells per liter | Standard Deviation 0.7808 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Lymp,8 Week Follow up,n=532 | 0.140 Billion cells per liter | Standard Deviation 0.7453 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Mono,Year1,Week4,n=693 | 0.025 Billion cells per liter | Standard Deviation 0.2108 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Mono,Year1,Week12,n=694 | 0.036 Billion cells per liter | Standard Deviation 0.2043 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Mono,Year1,Week24,n=696 | 0.028 Billion cells per liter | Standard Deviation 0.2127 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Mono,Year1,Week36,n=682 | 0.053 Billion cells per liter | Standard Deviation 0.2053 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Mono,Year1,Week48,n=684 | 0.050 Billion cells per liter | Standard Deviation 0.2069 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Mono,Year2,Week24,n=629 | 0.034 Billion cells per liter | Standard Deviation 0.1992 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Mono,Year2,Week48,n=589 | 0.050 Billion cells per liter | Standard Deviation 0.2172 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Mono,Year3,Week24,n=533 | 0.053 Billion cells per liter | Standard Deviation 0.2314 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Mono,Year3,Week48,n=476 | 0.084 Billion cells per liter | Standard Deviation 0.1994 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Mono,Year4,Week24,n=446 | 0.071 Billion cells per liter | Standard Deviation 0.2085 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Mono,Year4,Week48,n=423 | 0.076 Billion cells per liter | Standard Deviation 0.204 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Mono,Year5,Week24,n=389 | 0.089 Billion cells per liter | Standard Deviation 0.2015 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Mono,Year5,Week48,n=360 | 0.088 Billion cells per liter | Standard Deviation 0.2044 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Mono,Year6,Week24,n=306 | 0.087 Billion cells per liter | Standard Deviation 0.2043 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Mono,Year6,Week48,n=282 | 0.086 Billion cells per liter | Standard Deviation 0.2063 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Mono,Year7,Week24,n=181 | 0.113 Billion cells per liter | Standard Deviation 0.2155 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Mono,Year7,Week48,n=130 | 0.134 Billion cells per liter | Standard Deviation 0.209 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Mono,Year8,Week24,n=52 | 0.173 Billion cells per liter | Standard Deviation 0.2014 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Mono,Year8,Week48,n=13 | 0.021 Billion cells per liter | Standard Deviation 0.1503 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Mono,Year9,Week24,n=6 | 0.022 Billion cells per liter | Standard Deviation 0.1931 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Mono,Year9,Week48,n=1 | -0.120 Billion cells per liter | — |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Mono, Exit,n=614 | 0.083 Billion cells per liter | Standard Deviation 0.2157 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Mono, 8 Week Follow up, n=532 | 0.084 Billion cells per liter | Standard Deviation 0.2189 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Neu,Yaer1,Week4,n=688 | 0.024 Billion cells per liter | Standard Deviation 2.0482 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Neru,Year1,Week12,n=690 | 0.047 Billion cells per liter | Standard Deviation 2.1575 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Neu,Year1,Week24,n=691 | -0.059 Billion cells per liter | Standard Deviation 2.1845 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Neu,Year1,Week36,n=677 | -0.141 Billion cells per liter | Standard Deviation 2.1907 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Neu,Year2,Week24,n=624 | -0.286 Billion cells per liter | Standard Deviation 2.2746 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Neu,Year2,Week48,n=584 | -0.230 Billion cells per liter | Standard Deviation 2.3963 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Neu,Year3,Week24,n=528 | -0.135 Billion cells per liter | Standard Deviation 2.4914 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Neu,Year3,Week48,n=471 | -0.049 Billion cells per liter | Standard Deviation 2.3683 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Neu,Year4,Week24,n=446 | -0.104 Billion cells per liter | Standard Deviation 2.3846 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Neu,Year4,Week48,n=423 | -0.160 Billion cells per liter | Standard Deviation 2.5563 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Neu,Year5,Week24,n=384 | -0.031 Billion cells per liter | Standard Deviation 2.306 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Neu,Year5,Week48,n=356 | -0.198 Billion cells per liter | Standard Deviation 2.3952 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Neu,Year6,Week24,n=306 | -0.151 Billion cells per liter | Standard Deviation 2.3083 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Neu,Year6,Week48,n=282 | -0.060 Billion cells per liter | Standard Deviation 2.4314 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Neu,Year7,Week24,n=181 | -0.129 Billion cells per liter | Standard Deviation 2.3908 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Neu,Year7,Week48,n=130 | -0.687 Billion cells per liter | Standard Deviation 3.0412 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Neu,Year8,Week24,n=52 | -0.092 Billion cells per liter | Standard Deviation 2.3908 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Neu,Year8,Week48,n=13 | -0.687 Billion cells per liter | Standard Deviation 3.0412 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Neu,Year9,Week24,n=6 | -0.257 Billion cells per liter | Standard Deviation 2.9192 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Neu,Year9,Week48,n=1 | -3.300 Billion cells per liter | — |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Neu, Exit, n=609 | -0.006 Billion cells per liter | Standard Deviation 2.5612 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | Neu,8 Week Follow up,n=528 | 0.001 Billion cells per liter | Standard Deviation 2.3935 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | NeuBF,Year1,Week4,n=4 | 0.013 Billion cells per liter | Standard Deviation 0.1473 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | NeuBF,Year1,Week12,n=4 | 0.073 Billion cells per liter | Standard Deviation 0.1106 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | NeuBF,Year1,Week24,n=5 | -0.000 Billion cells per liter | Standard Deviation 0.2699 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | NeuBF,Year1,Week36,n=4 | 0.045 Billion cells per liter | Standard Deviation 0.0465 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | NeuBF,Year1,Week48,n=2 | 0.105 Billion cells per liter | Standard Deviation 0.1909 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | NeuBF,Year2,Week24,n=1 | 0.120 Billion cells per liter | — |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | NeuBF,Year3,Week24,n=1 | 0.070 Billion cells per liter | — |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | NeuBF,Exit,n=2 | 0.465 Billion cells per liter | Standard Deviation 0.6435 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | NeuS,Year1,Week4,n=693 | 0.021 Billion cells per liter | Standard Deviation 2.045 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | NeuS,Year1,Week12,n=694 | 0.051 Billion cells per liter | Standard Deviation 2.1519 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | NeuS,Year1,Week24,n=696 | -0.055 Billion cells per liter | Standard Deviation 2.1757 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | NeuS,Year1,Week36,n=682 | -0.139 Billion cells per liter | Standard Deviation 2.1819 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | NeuS,Year1,Week48,n=684 | -0.079 Billion cells per liter | Standard Deviation 2.3128 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | NeuS,Year2,Week24,n=629 | -0.289 Billion cells per liter | Standard Deviation 2.2609 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | NeuS,Year3,Week24,n=533 | -0.130 Billion cells per liter | Standard Deviation 2.4736 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | NeuS,Year3,Week48,n=476 | -0.041 Billion cells per liter | Standard Deviation 2.3547 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | NeuS,Year4,Week24,n=446 | -0.097 Billion cells per liter | Standard Deviation 2.3804 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | NeuS,Year4,Week48,n=423 | -0.158 Billion cells per liter | Standard Deviation 2.5542 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | NeuS,Year5,Week24,n=389 | -0.024 Billion cells per liter | Standard Deviation 2.2893 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | NeuS,Year5,Week48,n=360 | -0.184 Billion cells per liter | Standard Deviation 2.3831 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | NeuS,Year6,Week24,n=306 | -0.147 Billion cells per liter | Standard Deviation 2.3029 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | NeuS,Year6,Week48,n=282 | -0.058 Billion cells per liter | Standard Deviation 2.431 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | NeuS,Year7,Week24,n=181 | -0.151 Billion cells per liter | Standard Deviation 2.2248 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | NeuS,Year7,Week48,n=130 | 0.191 Billion cells per liter | Standard Deviation 2.2514 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | NeuS,Year8,Week24,n=52 | -0.092 Billion cells per liter | Standard Deviation 2.3908 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | NeuS,Year8,Week48,n=13 | -0.687 Billion cells per liter | Standard Deviation 3.0412 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | NeuS,Year9,Week24,n=6 | -0.257 Billion cells per liter | Standard Deviation 2.9192 |
| Belimumab 10mg/kg IV | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points | NeuS,Year9,Week48,n=1 | -3.300 Billion cells per liter | — |
Primary
Number of Participants With Adverse Events (AE)
An adverse event is defined as any unfavorable or unintended sign, symptom, or disease that is temporally associated with the use of a study agent but is not necessarily caused by the study agent. This includes worsening (example: increase in frequency or severity) of preexisting conditions. Participants with incidences of any event at any time post-baseline are presented by yearly interval. Only treatment-emergent AEs are summarized.
Time frame: Up to 9 years
Population: MITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Belimumab 10mg/kg IV | Number of Participants With Adverse Events (AE) | Year 6-7, n= 219 | 92 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Adverse Events (AE) | Year 7-8, n = 65 | 26 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Adverse Events (AE) | Year 8 plus,n = 6 | 3 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Adverse Events (AE) | Any-time post Baseline,n=735 | 706 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Adverse Events (AE) | Year 0-1,n=735 | 617 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Adverse Events (AE) | Year 1-2 ,n =701 | 502 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Adverse Events (AE) | Year 2-3, n= 620 | 441 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Adverse Events (AE) | Year 3-4,n= 514 | 344 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Adverse Events (AE) | Year 4-5,n= 442 | 261 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Adverse Events (AE) | Year 5-6, n =345 | 181 Participants |
Primary
Number of Participants With Any SLICC/ ACR Damage Index Worsening (Change > 0) From Baseline by Visit
The SLICC/ACR Damage Index was assessed every 48 weeks and at the exit visit as a measure of disease activity. It was developed to assess the accumulated damage since the onset of the disease. The number of participants with worsening in their SLICC/ACR Damage Index score compared with Baseline have been presented. Worsening was defined as a change in score (post-Baseline visit score - Baseline score) \> 0. Baseline includes extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with Belimumab in the parent study. For years in which a participant was withdrawn from the study, the exit visit assessment was used in place of the Week 48 assessment for the year. This value was not carried forward through later years. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Time frame: Up to 9 years
Population: MITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Belimumab 10mg/kg IV | Number of Participants With Any SLICC/ ACR Damage Index Worsening (Change > 0) From Baseline by Visit | Year 1,Week 48, n=716 | 39 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Any SLICC/ ACR Damage Index Worsening (Change > 0) From Baseline by Visit | Year 3,Week 48, n=580 | 56 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Any SLICC/ ACR Damage Index Worsening (Change > 0) From Baseline by Visit | Year 4,Week 48, n=488 | 57 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Any SLICC/ ACR Damage Index Worsening (Change > 0) From Baseline by Visit | Year 5,Week 48, n=423 | 51 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Any SLICC/ ACR Damage Index Worsening (Change > 0) From Baseline by Visit | Year 6,Week 48, n=330 | 41 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Any SLICC/ ACR Damage Index Worsening (Change > 0) From Baseline by Visit | Year 7,Week 48, n=213 | 28 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Any SLICC/ ACR Damage Index Worsening (Change > 0) From Baseline by Visit | Year 8,Week 48, n=65 | 8 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Any SLICC/ ACR Damage Index Worsening (Change > 0) From Baseline by Visit | Year 9,Week 48, n=6 | 0 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Any SLICC/ ACR Damage Index Worsening (Change > 0) From Baseline by Visit | Year 2,Week 48, n=667 | 50 Participants |
Primary
Number of Participants With IgG Values Below the Lower Limit of Normal by Year
Blood samples were collected to evaluate IgG levels at Baseline and at Weeks 12, 24 and 48 during Year 1. From Year 2-9, IgG was evaluated at Week 24 and 48 ; Exit visit and at follow-up visit (up to 8 weeks post last infusion). Number of participants with IgG immunoglobulin values below the LLN at each one year interval are presented. Baseline includes Extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with Belimumab in the parent study. If a participant had more than one response within a year, then the last response within the year interval (usually the Week 48 assessment) was summarized. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Time frame: Up to 9 years
Population: MITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Belimumab 10mg/kg IV | Number of Participants With IgG Values Below the Lower Limit of Normal by Year | Baseline, n=735 | 6 Participants |
| Belimumab 10mg/kg IV | Number of Participants With IgG Values Below the Lower Limit of Normal by Year | Any Time Post Baseline, n=735 | 64 Participants |
| Belimumab 10mg/kg IV | Number of Participants With IgG Values Below the Lower Limit of Normal by Year | Year 0-1, n=735 | 22 Participants |
| Belimumab 10mg/kg IV | Number of Participants With IgG Values Below the Lower Limit of Normal by Year | Year 1-2, n=701 | 24 Participants |
| Belimumab 10mg/kg IV | Number of Participants With IgG Values Below the Lower Limit of Normal by Year | Year 2-3, n=620 | 22 Participants |
| Belimumab 10mg/kg IV | Number of Participants With IgG Values Below the Lower Limit of Normal by Year | Year 3-4, n=514 | 19 Participants |
| Belimumab 10mg/kg IV | Number of Participants With IgG Values Below the Lower Limit of Normal by Year | Year 4-5, n=442 | 15 Participants |
| Belimumab 10mg/kg IV | Number of Participants With IgG Values Below the Lower Limit of Normal by Year | Year 5-6, n=345 | 10 Participants |
| Belimumab 10mg/kg IV | Number of Participants With IgG Values Below the Lower Limit of Normal by Year | Year 6-7, n=219 | 8 Participants |
| Belimumab 10mg/kg IV | Number of Participants With IgG Values Below the Lower Limit of Normal by Year | Year 7-8, n=65 | 2 Participants |
| Belimumab 10mg/kg IV | Number of Participants With IgG Values Below the Lower Limit of Normal by Year | More than 8 Years, n=6 | 0 Participants |
Primary
Number of Participants With Immunogenic Response by Year
Immunogenic response was analyzed using serum samples for anti-belimumab antibody measurements in MITT population. Categories of response are Negative, Transient Positive (+) means single + response that does not occur at the final assessment, and Persistent + means + response that occurs at least 2 consecutive assessments or a single result at the final assessment. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Time frame: Up to 9 years
Population: MITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Belimumab 10mg/kg IV | Number of Participants With Immunogenic Response by Year | Year 0-1 Negative, n=717 | 707 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Immunogenic Response by Year | Year 1-2 Negative, n=684 | 656 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Immunogenic Response by Year | Year 2-3 Negative, n=590 | 577 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Immunogenic Response by Year | Year 3-4, Negative, n=502 | 498 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Immunogenic Response by Year | Year 4-5 Negative, n=432 | 432 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Immunogenic Response by Year | Year 5-6 Negative, n=336 | 336 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Immunogenic Response by Year | Year 7-8 Negative, n=64 | 64 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Immunogenic Response by Year | Year 6-7 Negative, n=212 | 212 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Immunogenic Response by Year | Year 8 plus Negative, n=6 | 6 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Immunogenic Response by Year | Year 0-1 Transient +, n=717 | 10 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Immunogenic Response by Year | Year 1-2 Transient + n=684 | 18 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Immunogenic Response by Year | Year 2-3 Transient +, n=590 | 9 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Immunogenic Response by Year | Year 3-4 Transient +, n=502 | 4 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Immunogenic Response by Year | Year 4-5 Transient +, n=432 | 0 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Immunogenic Response by Year | Year 5-6 Transient +, n=336 | 0 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Immunogenic Response by Year | Year 6-7 Transient +, n=212 | 0 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Immunogenic Response by Year | Year 7-8 Transient +, n=64 | 0 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Immunogenic Response by Year | Year 8 plus Transient +, n=6 | 0 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Immunogenic Response by Year | Year 0-1 Persistent+,n=717 | 0 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Immunogenic Response by Year | Year 1-2 Persistent+,n=684 | 10 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Immunogenic Response by Year | Year 2-3 Persistent+,n=590 | 3 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Immunogenic Response by Year | Year 3-4 Persistent+,n=502 | 0 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Immunogenic Response by Year | Year 4-5 Persistent+,n=432 | 0 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Immunogenic Response by Year | Year 5-6 Persistent+,n=336 | 0 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Immunogenic Response by Year | Year 6-7 Persistent+,n=212 | 0 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Immunogenic Response by Year | Year 7-8 Persistent+,n=64 | 0 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Immunogenic Response by Year | Year 8 plus Persistent+,n=6 | 0 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Immunogenic Response by Year | Year 0-1 Unknown, n=717 | 0 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Immunogenic Response by Year | Year 1-2 Unknown, n=684 | 0 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Immunogenic Response by Year | Year 2-3 Unknown, n=590 | 1 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Immunogenic Response by Year | Year 3-4 Unknown, n=502 | 0 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Immunogenic Response by Year | Year 4-5 Unknown, n=432 | 0 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Immunogenic Response by Year | Year 5-6 Unknown, n=336 | 0 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Immunogenic Response by Year | Year 6-7 Unknown, n=212 | 0 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Immunogenic Response by Year | Year 7-8 Unknown, n=64 | 0 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Immunogenic Response by Year | Year 8 plus Unknown, n=6 | 0 Participants |
Primary
Number of Participants With Serious Adverse Events (SAE)
An adverse event resulting in death, is life threatening (ie, an immediate threat to life), inpatient hospitalization, prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect or any other situation which is medically important is categorized as SAE. Only treatment-emergent AEs are summarized.
Time frame: Up to 9 years
Population: MITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Belimumab 10mg/kg IV | Number of Participants With Serious Adverse Events (SAE) | Any post-Baseline,n=735 | 231 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Serious Adverse Events (SAE) | Year 0-1,n=735 | 78 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Serious Adverse Events (SAE) | Year 1-2,n = 701 | 58 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Serious Adverse Events (SAE) | Year 2-3,n = 620 | 66 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Serious Adverse Events (SAE) | Year 3-4,n= 514 | 44 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Serious Adverse Events (SAE) | Year 4-5 ,n= 442 | 27 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Serious Adverse Events (SAE) | Year 5-6,n=345 | 16 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Serious Adverse Events (SAE) | Year 6-7,n= 219 | 11 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Serious Adverse Events (SAE) | Year 7-8,n= 65 | 1 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Serious Adverse Events (SAE) | Year 8 plus,n= 6 | 0 Participants |
Primary
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Participants who had improving SLE disease activity for at least 8 weeks, at the investigator's discretion, the steroid dose was reduced by reduction to 7.5 mg/day. If the participant continued to have stable or improving disease activity after 4 weeks on a reduced dose, then the investigator considered reducing the dose again. Baseline includes extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with Belimumab in the parent study. Number of participants with shifts from Baseline total daily dose category by visit is summarized.
Time frame: Up to 9 years
Population: MITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 7, Week 24 | 4 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 4, Week 48 | 22 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 1, Week 48 | 1 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 6, Week 48 | 0 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 6, Week 48 | 0 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 4, Week 48 | 3 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 1, Week 48 | 0 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 6, Week 48 | 1 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 6, Week 24 | 0 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 4, Week 48 | 1 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 1, Week 48 | 2 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 6, Week 24 | 0 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 6, Week 24 | 2 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 4, Week 24 | 28 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 6, Week 24 | 10 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 5, Week 48 | 0 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 5, Week 24 | 19 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 1, Week 48 | 40 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 5, Week 48 | 1 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 5, Week 24 | 3 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 5, Week 48 | 1 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 5, Week 24 | 1 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 1, Week 24 | 0 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 5, Week 48 | 17 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 5, Week 24 | 0 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 1, Week 24 | 2 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 2, Week 48 | 36 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 3, Week 24 | 0 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 1, Week 24 | 1 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 1, Week 24 | 40 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 2, Week 48 | 1 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 3, Week 24 | 1 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 9, Week 48 | 0 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 9, Week 48 | 0 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 2, Week 48 | 1 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 2, Week 24 | 0 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 9, Week 48 | 0 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 9, Week 48 | 0 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 2, Week 48 | 0 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 6, Week 48 | 10 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 9, Week 24 | 0 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 9, Week 24 | 0 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 3, Week 24 | 33 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 3, Week 48 | 3 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 9, Week 24 | 0 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 9, Week 24 | 0 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 3, Week 24 | 3 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 2, Week 24 | 0 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 4, Week 48 | 0 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 8, Week 48 | 0 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 8, Week 48 | 0 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 3, Week 48 | 0 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 2, Week 24 | 3 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 8, Week 48 | 0 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 8, Week 48 | 1 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 3, Week 48 | 0 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 2, Week 24 | 39 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 8, Week 24 | 0 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 7, Week 48 | 0 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 8, Week 24 | 2 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 7, Week 48 | 0 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 4, Week 24 | 3 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 8, Week 24 | 0 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 7, Week 48 | 0 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 7, Week 48 | 4 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 4, Week 24 | 2 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 8, Week 24 | 0 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 7, Week 24 | 0 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 7, Week 24 | 1 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 4, Week 24 | 0 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 3, Week 48 | 31 Participants |
| Belimumab 10mg/kg IV | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 7, Week 24 | 0 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 8, Week 24 | 2 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 5, Week 24 | 84 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 6, Week 48 | 24 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 7, Week 24 | 41 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 8, Week 24 | 0 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 9, Week 48 | 0 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 2, Week 48 | 24 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 2, Week 48 | 143 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 2, Week 48 | 26 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 2, Week 48 | 0 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 3, Week 24 | 19 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 3, Week 24 | 130 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 3, Week 48 | 122 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 3, Week 48 | 23 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 3, Week 48 | 0 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 4, Week 24 | 17 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 4, Week 24 | 110 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 4, Week 24 | 23 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 4, Week 24 | 0 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 4, Week 48 | 18 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 4, Week 48 | 100 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 4, Week 48 | 16 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 4, Week 48 | 1 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 5, Week 24 | 28 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 5, Week 24 | 16 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 5, Week 24 | 0 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 5, Week 48 | 26 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 5, Week 48 | 75 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 5, Week 48 | 13 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 5, Week 48 | 0 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 6, Week 24 | 25 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 6, Week 24 | 62 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 6, Week 24 | 10 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 6, Week 24 | 0 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 6, Week 48 | 54 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 6, Week 48 | 11 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 6, Week 48 | 0 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 7, Week 24 | 10 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 7, Week 24 | 3 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 7, Week 24 | 0 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 7, Week 48 | 3 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 7, Week 48 | 32 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 7, Week 48 | 6 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 7, Week 48 | 0 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 8, Week 24 | 1 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 8, Week 24 | 13 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 8, Week 48 | 0 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 8, Week 48 | 3 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 8, Week 48 | 2 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 8, Week 48 | 0 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 9, Week 24 | 0 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 9, Week 24 | 1 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 9, Week 24 | 1 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 9, Week 24 | 0 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 9, Week 48 | 0 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 9, Week 48 | 1 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 9, Week 48 | 1 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 1, Week 24 | 5 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 1, Week 24 | 194 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 1, Week 24 | 18 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 1, Week 24 | 0 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 1, Week 48 | 13 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 1, Week 48 | 180 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 1, Week 48 | 19 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 1, Week 48 | 0 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 2, Week 24 | 19 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 2, Week 24 | 157 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 2, Week 24 | 25 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 2, Week 24 | 0 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 3, Week 24 | 27 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 3, Week 24 | 0 Participants |
| Participants With Baseline Daily Dose of >0 to <=7.5 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 3, Week 48 | 20 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 7, Week 24 | 29 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 3, Week 48 | 2 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 9, Week 48 | 0 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 2, Week 24 | 5 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 2, Week 48 | 195 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 6, Week 24 | 76 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 8, Week 24 | 11 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 4, Week 24 | 134 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 8, Week 24 | 0 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 9, Week 48 | 0 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 2, Week 48 | 163 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 1, Week 48 | 4 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 3, Week 24 | 159 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 1, Week 24 | 1 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 7, Week 48 | 34 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 2, Week 48 | 21 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 4, Week 24 | 120 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 1, Week 24 | 71 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 8, Week 48 | 5 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 4, Week 24 | 34 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 3, Week 48 | 145 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 1, Week 24 | 376 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 7, Week 24 | 64 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 8, Week 48 | 6 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 3, Week 48 | 30 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 9, Week 24 | 3 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 1, Week 24 | 1 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 5, Week 24 | 2 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 7, Week 48 | 29 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 5, Week 24 | 99 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 1, Week 48 | 301 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 5, Week 48 | 34 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 8, Week 48 | 1 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 5, Week 24 | 124 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 9, Week 48 | 0 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 5, Week 48 | 119 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 4, Week 24 | 2 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 3, Week 48 | 127 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 3, Week 24 | 157 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 5, Week 48 | 85 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 2, Week 24 | 145 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 8, Week 48 | 0 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 1, Week 48 | 13 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 5, Week 48 | 0 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 7, Week 24 | 0 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 4, Week 48 | 0 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 7, Week 48 | 0 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 6, Week 24 | 33 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 7, Week 24 | 40 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 9, Week 24 | 1 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 6, Week 24 | 99 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 3, Week 24 | 0 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 4, Week 48 | 108 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 3, Week 24 | 25 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 6, Week 48 | 68 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 8, Week 24 | 8 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 1, Week 48 | 123 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 6, Week 24 | 2 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 7, Week 48 | 24 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 6, Week 48 | 35 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 5, Week 24 | 33 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 4, Week 48 | 129 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 9, Week 24 | 0 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 6, Week 48 | 90 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 2, Week 24 | 20 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 2, Week 48 | 1 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 9, Week 48 | 4 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 2, Week 24 | 237 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 4, Week 48 | 40 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 9, Week 24 | 0 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 6, Week 48 | 0 Participants |
| Participants With Baseline Daily Dose of >7.5 to <=40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 8, Week 24 | 15 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 6, Week 48 | 0 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 7, Week 24 | 0 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 7, Week 24 | 1 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 4, Week 24 | 1 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 1, Week 48 | 1 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 7, Week 24 | 0 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 7, Week 24 | 0 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 4, Week 24 | 0 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 3, Week 48 | 0 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 7, Week 48 | 0 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 7, Week 48 | 1 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 1, Week 48 | 0 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 7, Week 48 | 0 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 3, Week 48 | 0 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 7, Week 48 | 0 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 8, Week 24 | 0 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 8, Week 24 | 1 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 8, Week 24 | 0 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 8, Week 24 | 0 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 3, Week 48 | 1 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 2, Week 24 | 0 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 8, Week 48 | 0 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 8, Week 48 | 0 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 3, Week 48 | 0 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 3, Week 24 | 0 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 8, Week 48 | 0 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 8, Week 48 | 0 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 3, Week 24 | 0 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 2, Week 24 | 0 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 9, Week 24 | 0 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 9, Week 24 | 0 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 2, Week 48 | 0 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 9, Week 24 | 0 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 9, Week 24 | 0 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 2, Week 48 | 1 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 2, Week 24 | 1 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 9, Week 48 | 0 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 9, Week 48 | 0 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 2, Week 48 | 0 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 4, Week 24 | 0 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 2, Week 48 | 0 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 1, Week 24 | 0 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 3, Week 24 | 0 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 1, Week 24 | 0 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 2, Week 24 | 0 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 6, Week 24 | 0 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 1, Week 24 | 1 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 9, Week 48 | 0 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 5, Week 24 | 0 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 5, Week 24 | 0 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 1, Week 24 | 0 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 5, Week 48 | 0 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 5, Week 48 | 1 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 5, Week 24 | 0 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 5, Week 48 | 0 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 4, Week 48 | 0 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 5, Week 48 | 0 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 1, Week 48 | 0 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 4, Week 48 | 0 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 9, Week 48 | 0 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 6, Week 24 | 1 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 3, Week 24 | 1 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 6, Week 24 | 0 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 4, Week 48 | 1 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 6, Week 24 | 0 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 6, Week 48 | 0 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 1, Week 48 | 0 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 6, Week 48 | 1 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose=0, Year 4, Week 48 | 0 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >7.5 to <=40, Year 6, Week 48 | 0 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >0 to <=7.5, Year 5, Week 24 | 1 Participants |
| Participants With Baseline Daily Dose of >40 mg | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | Total daily dose >40, Year 4, Week 24 | 0 Participants |
Primary
SAE Rates by SOC During the Study
SAE rates by SOC adjusting for participants-years on study drug anytime post Baseline are summarized, which included the follow up visits. Only treatment-emergent SAEs are summarized. The event rate of an SAE was calculated as the number of events per 100 participant years. Participants years were calculated as = sum across all participants (\[last visit of interval day - first visit of interval day + 1\] divided by 365). Participants years excluded between study gaps if participant had not started extension study on date of last visit of parent study.
Time frame: Up to 9 years
Population: MITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Belimumab 10mg/kg IV | SAE Rates by SOC During the Study | Infections and infestations | 5.1 Adverse events per 100 participant years |
| Belimumab 10mg/kg IV | SAE Rates by SOC During the Study | Blood and lymphatic system disorders | 1.0 Adverse events per 100 participant years |
| Belimumab 10mg/kg IV | SAE Rates by SOC During the Study | Musculoskeletal and connective tissue disorder | 1.0 Adverse events per 100 participant years |
| Belimumab 10mg/kg IV | SAE Rates by SOC During the Study | Gastrointestinal disorders | 1.0 Adverse events per 100 participant years |
| Belimumab 10mg/kg IV | SAE Rates by SOC During the Study | Renal and urinary disorders | 0.8 Adverse events per 100 participant years |
| Belimumab 10mg/kg IV | SAE Rates by SOC During the Study | Vascular disorders | 0.8 Adverse events per 100 participant years |
| Belimumab 10mg/kg IV | SAE Rates by SOC During the Study | Injury, poisoning andprocedural complications | 0.8 Adverse events per 100 participant years |
| Belimumab 10mg/kg IV | SAE Rates by SOC During the Study | General disorders and administration sitecondition | 0.6 Adverse events per 100 participant years |
| Belimumab 10mg/kg IV | SAE Rates by SOC During the Study | Nervous system disorders | 0.6 Adverse events per 100 participant years |
| Belimumab 10mg/kg IV | SAE Rates by SOC During the Study | Respiratory, thoracic and mediastinal disorder | 0.5 Adverse events per 100 participant years |
| Belimumab 10mg/kg IV | SAE Rates by SOC During the Study | Cardiac disorders | 0.5 Adverse events per 100 participant years |
| Belimumab 10mg/kg IV | SAE Rates by SOC During the Study | Skin and subcutaneous tissue disorders | 0.5 Adverse events per 100 participant years |
| Belimumab 10mg/kg IV | SAE Rates by SOC During the Study | Neoplasms benign, malignant and unspecified | 0.4 Adverse events per 100 participant years |
| Belimumab 10mg/kg IV | SAE Rates by SOC During the Study | Reproductive system and breast disorder | 0.4 Adverse events per 100 participant years |
| Belimumab 10mg/kg IV | SAE Rates by SOC During the Study | Psychiatric disorders | 0.4 Adverse events per 100 participant years |
| Belimumab 10mg/kg IV | SAE Rates by SOC During the Study | Hepatobiliary disorders | 0.3 Adverse events per 100 participant years |
| Belimumab 10mg/kg IV | SAE Rates by SOC During the Study | Metabolism and nutrition disorders | 0.1 Adverse events per 100 participant years |
| Belimumab 10mg/kg IV | SAE Rates by SOC During the Study | Pregnancy, puerperium and perinatal condition | 0.1 Adverse events per 100 participant years |
| Belimumab 10mg/kg IV | SAE Rates by SOC During the Study | Endocrine disorders | 0.1 Adverse events per 100 participant years |
| Belimumab 10mg/kg IV | SAE Rates by SOC During the Study | Immune system disorders | 0.1 Adverse events per 100 participant years |
| Belimumab 10mg/kg IV | SAE Rates by SOC During the Study | Ear and labyrinth disorders | 0.1 Adverse events per 100 participant years |
| Belimumab 10mg/kg IV | SAE Rates by SOC During the Study | Eye disorders | 0.1 Adverse events per 100 participant years |