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    Clinical Trial Results:
    A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057

    Summary
    EudraCT number
    		 2007-007648-85
    Trial protocol
    		 DE   AT   NL   BE   GB   CZ   ES   IT   SE   SK   FR  
    Global end of trial date
    09 Dec 2016

    Results information
    Results version number
    		 v2(current)
    This version publication date
    31 Dec 2017
    First version publication date
    24 Nov 2017
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    112234
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    980 Great West Road, Brentford, Middlesex, United Kingdom,
    Public contact
    GSK Response Center, GlaxoSmithKline, 1 866-435-7343,
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 1 866-435-7343,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    23 Feb 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Dec 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To provide continuing treatment to subjects with SLE who complete HGS1006-C1056 or HGS1006-C1057. To evaluate the long-term safety and tolerability of belimumab in subjects with SLE.
    Protection of trial subjects
    The study protocol, any amendments, the informed consent, and other information that required pre-approval were reviewed and approved by a national, regional, or investigational center ethics committee or institutional review board, in accordance with the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) and applicable country-specific requirements, including US 21 Code of Federal Regulations (CFR) 312.3(b) for constitution of independent ethics committees. Ethics committee or institutional review board approvals are maintained in the Sponsor’s study file. Investigators were trained to conduct the study in accordance with GCPs and the study protocol, as defined in ICH E3, Section 9.6. Written commitments were obtained from investigators to conduct the study in accordance with ICH GCP and all applicable subject privacy requirements, and the ethical principles that are outlined in the Declaration of Helsinki, and to conduct the study in accordance with the protocol. The study was monitored in accordance with ICH E6, Section 5.18. At the time of this report, no GCP noncompliance issues were identified by monitoring or audit. Written informed consent was obtained from each subject prior to the performance of any study-specific procedures. The investigator agreed to provide the subject as much time as necessary to review the document, to inquire about details of the trial, and to decide whether or not to participate in the study. The informed consent was signed and dated by the study subject and by the person who conducted the informed consent.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 May 2008
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 8 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 55
    Country: Number of subjects enrolled
    Austria: 23
    Country: Number of subjects enrolled
    Belgium: 3
    Country: Number of subjects enrolled
    Brazil: 44
    Country: Number of subjects enrolled
    Canada: 11
    Country: Number of subjects enrolled
    Chile: 25
    Country: Number of subjects enrolled
    Colombia: 137
    Country: Number of subjects enrolled
    Czech Republic: 25
    Country: Number of subjects enrolled
    France: 1
    Country: Number of subjects enrolled
    Germany: 44
    Country: Number of subjects enrolled
    Hong Kong: 6
    Country: Number of subjects enrolled
    India: 37
    Country: Number of subjects enrolled
    Israel: 20
    Country: Number of subjects enrolled
    Italy: 2
    Country: Number of subjects enrolled
    Korea, Republic of: 38
    Country: Number of subjects enrolled
    Mexico: 26
    Country: Number of subjects enrolled
    Netherlands: 7
    Country: Number of subjects enrolled
    Peru: 24
    Country: Number of subjects enrolled
    Philippines: 52
    Country: Number of subjects enrolled
    Poland: 5
    Country: Number of subjects enrolled
    Puerto Rico: 5
    Country: Number of subjects enrolled
    Romania: 11
    Country: Number of subjects enrolled
    Russian Federation: 46
    Country: Number of subjects enrolled
    Slovakia: 4
    Country: Number of subjects enrolled
    Spain: 2
    Country: Number of subjects enrolled
    Sweden: 1
    Country: Number of subjects enrolled
    Taiwan: 77
    Country: Number of subjects enrolled
    United Kingdom: 4
    Worldwide total number of subjects
    735
    EEA total number of subjects
    132
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    726
    From 65 to 84 years
    9
    85 years and over
    0

    Subject disposition

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    Recruitment
    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 trail.

    Pre-assignment
    Screening 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.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Belimumab 10mg/kg IV
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Belimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Belimumab was administered every 28 days by IV infusion at 1 mg/kg or 10 mg/kg body weight.

    Number of subjects in period 1
    		Belimumab 10mg/kg IV
    Started
    735
    Completed
    368
    Not completed
    367
         Adverse event, serious fatal
    8
         Other Hip replacement surgery
    1
         Other Involved in Clinical research
    3
         Physician decision
    36
         Other Physician decision
    1
         Other Non-compliance with study drug
    13
         Other Participant travelled overseas
    2
         Other Not committed to contraception
    1
         Other Death of patient
    1
         Other Participant received medication
    1
         Consent withdrawn by subject
    151
         Adverse event, non-fatal
    61
         Other Pregnancy
    37
         Other Participant hospitalized
    1
         Lost to follow-up
    22
         Other Sponsor decision
    14
         Other Withdrew consent
    4
         Lack of efficacy
    6
         Protocol deviation
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Belimumab 10mg/kg IV
    Reporting group description
    		 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.

    Reporting group values
    		 Belimumab 10mg/kg IV Total
    Number of subjects
    		 735
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 37.2 ± 11.17 -
    Gender categorical
    Units: Subjects
        Female
    		 695 695
        Male
    		 40 40
    Race/Ethnicity, Customized
    Units: Subjects
        Black or African American/African Heritage
    		 18 18
        American Indian or Alaska Native
    		 225 225
        East Asian Heritage
    		 118 118
        South Asian Heritage
    		 38 38
        Southeast Asian Heritage
    		 58 58
        Middle East/North African Heritage
    		 22 22
        White/Caucasian/European Heritage
    		 256 256

    End points

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    End points reporting groups
    Reporting group title
    Belimumab 10mg/kg IV
    Reporting group description
    		 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.

    Subject analysis set title
    participants with no prednisone and other steroids at baseline
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Participants were not receiving prednisone and other steroids at Baseline.

    Subject analysis set title
    participants with baseline daily dose of >0 to <=7.5 mg
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Participants were receiving a daily dose of >0 to <=7.5 mg of prednisone and other steroids at Baseline.

    Subject analysis set title
    participants with baseline daily dose of >7.5 to <=40 mg
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Participants were receiving a daily dose of >7.5 to <=40 mg of prednisone and other steroids at Baseline.

    Subject analysis set title
    participants with baseline daily dose of >40 mg
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Participants were receiving a daily dose of >40 mg of prednisone and other steroids at Baseline.

    Primary: Number of participants with Adverse events (AE)

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    End point title
    		 Number of participants with Adverse events (AE) [1]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Up to 9 years
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report.
    End point values
    		 Belimumab 10mg/kg IV
    Number of subjects analysed
    735
    Units: Participants
        Any-time post Baseline,n=735
    706
        Year 0-1,n=735
    617
        Year 1-2 ,n =701
    502
        Year 2-3, n= 620
    441
        Year 3-4,n= 514
    344
        Year 4-5,n= 442
    261
        Year 5-6, n =345
    181
        Year 6-7, n= 219
    92
        Year 7-8, n = 65
    26
        Year 8 plus,n = 6
    3
    No statistical analyses for this end point

    Primary: AE rates by System Organ Class (SOC) During the Study

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    End point title
    		 AE rates by System Organ Class (SOC) During the Study [2]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Up to 9 years
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report.
    End point values
    		 Belimumab 10mg/kg IV
    Number of subjects analysed
    735
    Units: Adverse events per 100 participant years
    number (not applicable)
        Infections and infestations
    101.8
        Gastrointestinal disorders
    32.8
        Musculoskeletal and connective tissuedisorder
    32.8
        Nervous system disorders
    22.6
        Skin and subcutaneous and tissue disorders
    22.5
        Respiratory,thoracic and mediastinal disorder
    14.9
        Vascular disorders
    13.3
        General disorders and administration sitecondition
    11.8
        Injury, poisoning andprocedural complications
    11.5
        Blood and lymphatic system disorders
    7.5
        Eye disorders
    6.6
        Reproductive system and breast disorders
    6.4
        Investigations
    5.8
        Psychiatric disorders
    5.6
        Renal and urinary and disorder
    5.3
        Metabolism and nutrition disorder
    3.6
        Cardiac disorders
    3.0
        Ear and labyrinth disorder
    2.4
        Neoplasms benign,malignant andunspecified
    2.2
        Hepatobiliary disorders
    1.8
        Immune system disorder
    1.2
        Endocrine disorders
    1.0
        Social circumstances
    0.7
        Congenital, familial and genetic disorders
    0.1
        Pregnancy, puerperium and perinatal conditions
    0.1
        Product Issues
    0.1
    No statistical analyses for this end point

    Primary: Number of participants with Serious Adverse events (SAE)

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    End point title
    		 Number of participants with Serious Adverse events (SAE) [3]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Up to 9 years
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report.
    End point values
    		 Belimumab 10mg/kg IV
    Number of subjects analysed
    735
    Units: Participants
        Any post-Baseline,n=735
    231
        Year 0-1,n=735
    78
        Year 1-2,n = 701
    58
        Year 2-3,n = 620
    66
        Year 3-4,n= 514
    44
        Year 4-5 ,n= 442
    27
        Year 5-6,n=345
    16
        Year 6-7,n= 219
    11
        Year 7-8,n= 65
    1
        Year 8 plus,n= 6
    0
    No statistical analyses for this end point

    Primary: SAE rates by SOC During the Study

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    End point title
    		 SAE rates by SOC During the Study [4]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Up to 9 years
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report.
    End point values
    		 Belimumab 10mg/kg IV
    Number of subjects analysed
    735
    Units: Adverse events per 100 participant years
    number (not applicable)
        Infections and infestations
    5.1
        Blood and lymphatic system disorders
    1.0
        Musculoskeletal and connective tissue disorder
    1.0
        Gastrointestinal disorders
    1.0
        Renal and urinary disorders
    0.8
        Vascular disorders
    0.8
        Injury, poisoning andprocedural complications
    0.8
        General disorders and administration sitecondition
    0.6
        Nervous system disorders
    0.6
        Respiratory, thoracic and mediastinal disorder
    0.5
        Cardiac disorders
    0.5
        Skin and subcutaneous tissue disorders
    0.5
        Neoplasms benign, malignant and unspecified
    0.4
        Reproductive system and breast disorder
    0.4
        Psychiatric disorders
    0.4
        Hepatobiliary disorders
    0.3
        Metabolism and nutrition disorders
    0.1
        Pregnancy, puerperium and perinatal condition
    0.1
        Endocrine disorders
    0.1
        Immune system disorders
    0.1
        Ear and labyrinth disorders
    0.1
        Eye disorders
    0.1
    No statistical analyses for this end point

    Primary: Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points

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    End point title
    		 Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points [5]
    End point description
    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. 99999 indicates standard deviation was not calculable for a single data point.
    End point type
    Primary
    End point timeframe
    Baseline and up to 9 years
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report.
    End point values
    		 Belimumab 10mg/kg IV
    Number of subjects analysed
    735
    Units: Seconds
    arithmetic mean (standard deviation)
        Year1,Week4,APTT,n=208
    0.7 ± 5.27
        Year1,Week12,APTT,n=208
    2.1 ± 12.31
        Year1,Week24,APTT,n=686
    0.1 ± 9.10
        Year1,Week36,APTT,n=193
    2.5 ± 5.75
        Year1,Week48,APTT,n=666
    0.8 ± 9.48
        Year2,Week24,APTT,n=625
    2.7 ± 9.74
        Year2,Week48,APTT,n=572
    2.7 ± 9.66
        Year3,Week24,APTT,n=521
    3.4 ± 10.01
        Year3,Week48,APTT,n=470
    3.9 ± 11.41
        Year4,Week24,APTT,n=422
    3.5 ± 10.70
        Year4,Week48,APTT,n=412
    4.2 ± 6.63
        Year5,Week24,APTT,n=383
    4.1 ± 10.71
        Year5,Week48,APTT,n=349
    3.5 ± 6.35
        Year6,Week24,APTT,n=292
    3.8 ± 6.58
        Year6,Week48,APTT,n=277
    4.3 ± 7.91
        Year7,Week24,APTT,n=177
    6.4 ± 14.52
        Year7,Week48,APTT,n=131
    4.1 ± 6.23
        Year8,Week24,APTT,n=52
    5.6 ± 7.54
        Year8,Week48,APTT,n=13
    4.2 ± 3.98
        Year9,Week24,APTT,n=6
    5.0 ± 6.39
        Year9,Week48,APTT,n=1
    9.0 ± 99999
        Exit, APTT,n=586
    3.2 ± 10.71
        8 Week,Follow up,n=524
    3.4 ± 8.14
        Year1,Week4,PT,n=205
    -0.22 ± 5.139
        Year1,Week12,PT,n=206
    1.71 ± 19.533
        Year1,Week24,PT,n=686
    -0.43 ± 8.267
        Year1,Week36,PT,n=193
    0.13 ± 3.357
        Year1,Week48,PT,n=666
    -0.45 ± 8.174
        Year2,Week24,PT,n=626
    0.15 ± 11.528
        Year2,Week48,PT,n=572
    -0.26 ± 8.925
        Year3,Week24,PT,n=521
    0.12 ± 9.609
        Year3,Week48,PT,n=469
    0.63 ± 14.334
        Year4,Week24,PT,n=422
    0.06 ± 10.458
        Year4,Week48,PT,n=412
    0.40 ± 4.228
        Year5,Week24,PT,n=384
    -0.14 ± 10.810
        Year5,Week48,PT,n=349
    0.61 ± 11.276
        Year6,Week24,PT,n=292
    0.64 ± 8.023
        Year6,Week48,PT,n=278
    0.85 ± 12.414
        Year7,Week24,PT,n=177
    1.76 ± 14.272
        Year7,Week48,PT,n=131
    0.36 ± 2.290
        Year8,Week24,PT,n=52
    1.21 ± 6.716
        Year8,Week48,PT,n=13
    0.52 ± 0.600
        Year9,Week24,PT,n=6
    0.50 ± 0.657
        Year9,Week48,PT,n=1
    1.00 ± 99999
        Exit,PT, n=587
    0.25 ± 9.973
        8 Week, Follow up,n=524
    0.50 ± 4.965
    No statistical analyses for this end point

    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

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    End point title
    		 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 [6]
    End point description
    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. 99999 indicates standard deviation was not calculable for a single data point.
    End point type
    Primary
    End point timeframe
    Baseline and up to 9 years
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report.
    End point values
    		 Belimumab 10mg/kg IV
    Number of subjects analysed
    735
    Units: Billion cells per liter
    arithmetic mean (standard deviation)
        Baso,Year1,Week4,n=693
    0.002 ± 0.0172
        Baso,Year1,Week12,n=694
    0.002 ± 0.0187
        Baso,Year1,Week24,n=696
    0.002 ± 0.0176
        Baso,Year1,Week36,n=682
    0.002 ± 0.0179
        Baso,Year1,Week48,n=684
    0.003 ± 0.0183
        Baso,Year2,Week24,n=629
    0.004 ± 0.0190
        Baso,Year2,Week48,n=589
    0.004 ± 0.0200
        Baso,Year3,Week24,n=533
    0.005 ± 0.0165
        Baso,Year3,Week48,n=476
    0.008 ± 0.0194
        Baso,Year4,Week24,n=446
    0.007 ± 0.0192
        Baso,Year4,Week48,n=423
    0.008 ± 0.0202
        Baso,Year5,Week24,n=389
    0.007 ± 0.0191
        Baso,Year5,Week48,n=360
    0.005 ± 0.0191
        Baso,Year6,Week24,n=306
    0.006 ± 0.0184
        Baso,Year6,Week48,n=282
    0.007 ± 0.0198
        Baso,Year7,Week24,n=181
    0.007 ± 0.0211
        Baso,Year7,Week48,n=130
    0.012 ± 0.0259
        Baso,Year8,Week24,n=52
    0.014 ± 0.0187
        Baso,Year8,Week48,n=13
    0.001 ± 0.0166
        Baso,Year9,Week24,n=6
    0.003 ± 0.0082
        Baso,Year9,Week48,n=1
    0.010 ± 99999
        Baso,Exit,n=614
    0.005 ± 0.0204
        Baso,8 Week,Follow up,n=532
    0.009 ± 0.0253
        Eos,Year1,Week4,n=693
    0.007 ± 0.1597
        Eos,Year1,Week12,n=694
    0.003 ± 0.1595
        Eos,Year1,Week24,n=696
    0.000 ± 0.1614
        Eos,Year1,Week36,n=682
    0.020 ± 0.1866
        Eos,Year1,Week48,n=684
    0.001 ± 0.1763
        Eos,Year2,Week24,n=629
    0.004 ± 0.1605
        Eos,Year2,Week48,n=589
    -0.004 ± 0.1858
        Eos,Year3,Week24,n=533
    -0.011 ± 0.2074
        Eos,Year3,Week48,n=476
    -0.026 ± 0.2053
        Eos,Year4,Week24,n=446
    -0.041 ± 0.1792
        Eos,Year4,Week48,n=423
    -0.047 ± 0.1676
        Eos,Year5,Week24,n=389
    -0.035 ± 0.1949
        Eos,Year5,Week48,n=360
    -0.045 ± 0.1807
        Eos,Year6,Week24,n=306
    -0.046 ± 0.1801
        Eos,Year6,Week48,n=282
    -0.037 ± 0.1976
        Eos,Year7,Week24,n=181
    -0.046 ± 0.1710
        Eos,Year7,Week48,n=130
    -0.020 ± 0.2276
        Eos,Year8,Week24,n=52
    -0.017 ± 0.1753
        Eos,Year8,Week48,n=13
    -0.041 ± 0.1130
        Eos,Year9,Week24,n=6
    -0.088 ± 0.1078
        Eos,Year9,Week48,n=1
    -0.040 ± 99999
        Eos, Exit, n=614
    -0.026 ± 0.1754
        Eso, 8 Week Follow up, n=532
    -0.030 ± 0.1920
        Leu,Year1,Week4,n=696
    0.16 ± 1.928
        Leu,Year1,Week12,n=697
    0.19 ± 2.106
        Leu,Year1,Week24,n=697
    0.04 ± 2.142
        Leu,Year1,Week36,n=682
    0.05 ± 2.190
        Leu,Year1,Week48,n=684
    0.02 ± 2.274
        Leu,Year2,Week24,n=630
    -0.19 ± 2.287
        Leu,Year2,Week48,n=589
    -0.11 ± 2.449
        Leu,Year3,Week24,n=533
    -0.03 ± 2.544
        Leu,Year3,Week24,n=476
    0.06 ± 2.393
        Leu,Year4,Week24,n=446
    -0.01 ± 2.520
        Leu,Year4,Week48,n=423
    -0.06 ± 2.661
        Leu,Year5,Week24,n=389
    0.05 ± 2.430
        Leu,Year5,Week48,n=360
    -0.06 ± 2.463
        Leu,Year6,Week24,n=306
    0.04 ± 2.449
        Leu,Year6,Week48,n=282
    0.17 ± 2.579
        Leu,Year7,Week24,n=181
    0.12 ± 2.395
        Leu,Year7,Week48,n=130
    0.48 ± 2.354
        Leu,Year8,Week24,n=52
    0.38 ± 2.761
        Leu,Year8,Week48,n=13
    -0.65 ± 3.136
        Leu,Year9,Week24,n=6
    -0.35 ± 3.422
        Leu,Year9,Week48,n=1
    -3.90 ± 99999
        Leu, Exit, n=614
    0.18 ± 2.650
        Leu, 8 Week Follow up,n=532
    0.21 ± 2.496
        Lymp,Year1,Week4,n=693
    0.093 ± 0.5986
        Lymp,Year1,Week12,n=694
    0.107 ± 0.6607
        Lymp,Year1,Week24,n=696
    0.066 ± 0.6544
        Lymp,Year1,Week36,n=682
    0.119 ± 0.6583
        Lymp,Year1,Week48,n=684
    0.048 ± 0.6361
        Lymp,Year2,Week24,n=629
    0.051 ± 0.6898
        Lymp,Year2,Week48,n=589
    0.067 ± 0.6971
        Lymp,Year3,Week24,n=533
    0.057 ± 0.6717
        Lymp,Year3,Week48,n=476
    0.038 ± 0.6676
        Lymp,Year4,Week24,n=446
    0.054 ± 0.6858
        Lymp,Year4,Week48,n=423
    0.067 ± 0.7186
        Lymp,Year5,Week24,n=389
    0.023 ± 0.6810
        Lymp,Year5,Week48,n=360
    0.078 ± 0.7485
        Lymp,Year6,Week24,n=306
    0.147 ± 0.7251
        Lymp,Year6,Week48,n=282
    0.168 ± 0.7523
        Lymp,Year7,Week24,n=181
    0.175 ± 0.7670
        Lymp,Year7,Week48,n=130
    0.169 ± 0.6639
        Lymp,Year8,Week24,n=52
    0.300 ± 0.7553
        Lymp,Year8,Week48,n=13
    0.052 ± 0.5252
        Lymp,Year9,Week24,n=6
    -0.032 ± 0.6156
        Lymp,Year9,Week48,n=1
    -0.460 ± 99999
        Lymp,Exit,n=614
    0.128 ± 0.7808
        Lymp,8 Week Follow up,n=532
    0.140 ± 0.7453
        Mono,Year1,Week4,n=693
    0.025 ± 0.2108
        Mono,Year1,Week12,n=694
    0.036 ± 0.2043
        Mono,Year1,Week24,n=696
    0.028 ± 0.2127
        Mono,Year1,Week36,n=682
    0.053 ± 0.2053
        Mono,Year1,Week48,n=684
    0.050 ± 0.2069
        Mono,Year2,Week24,n=629
    0.034 ± 0.1992
        Mono,Year2,Week48,n=589
    0.050 ± 0.2172
        Mono,Year3,Week24,n=533
    0.053 ± 0.2314
        Mono,Year3,Week48,n=476
    0.084 ± 0.1994
        Mono,Year4,Week24,n=446
    0.071 ± 0.2085
        Mono,Year4,Week48,n=423
    0.076 ± 0.2040
        Mono,Year5,Week24,n=389
    0.089 ± 0.2015
        Mono,Year5,Week48,n=360
    0.088 ± 0.2044
        Mono,Year6,Week24,n=306
    0.087 ± 0.2043
        Mono,Year6,Week48,n=282
    0.086 ± 0.2063
        Mono,Year7,Week24,n=181
    0.113 ± 0.2155
        Mono,Year7,Week48,n=130
    0.134 ± 0.2090
        Mono,Year8,Week24,n=52
    0.173 ± 0.2014
        Mono,Year8,Week48,n=13
    0.021 ± 0.1503
        Mono,Year9,Week24,n=6
    0.022 ± 0.1931
        Mono,Year9,Week48,n=1
    -0.120 ± 99999
        Mono, Exit,n=614
    0.083 ± 0.2157
        Mono, 8 Week Follow up, n=532
    0.084 ± 0.2189
        Neu,Yaer1,Week4,n=688
    0.024 ± 2.0482
        Neru,Year1,Week12,n=690
    0.047 ± 2.1575
        Neu,Year1,Week24,n=691
    -0.059 ± 2.1845
        Neu,Year1,Week36,n=677
    -0.141 ± 2.1907
        Neu,Year1,Week48,n=679
    -0.078 ± 2.3164
        Neu,Year2,Week24,n=624
    -0.286 ± 2.2746
        Neu,Year2,Week48,n=584
    -0.230 ± 2.3963
        Neu,Year3,Week24,n=528
    -0.135 ± 2.4914
        Neu,Year3,Week48,n=471
    -0.049 ± 2.3683
        Neu,Year4,Week24,n=446
    -0.104 ± 2.3846
        Neu,Year4,Week48,n=423
    -0.160 ± 2.5563
        Neu,Year5,Week24,n=384
    -0.031 ± 2.3060
        Neu,Year5,Week48,n=356
    -0.198 ± 2.3952
        Neu,Year6,Week24,n=306
    -0.151 ± 2.3083
        Neu,Year6,Week48,n=282
    -0.060 ± 2.4314
        Neu,Year7,Week24,n=181
    -0.129 ± 2.3908
        Neu,Year7,Week48,n=130
    -0.687 ± 3.0412
        Neu,Year8,Week24,n=52
    -0.092 ± 2.3908
        Neu,Year8,Week48,n=13
    -0.687 ± 3.0412
        Neu,Year9,Week24,n=6
    -0.257 ± 2.9192
        Neu,Year9,Week48,n=1
    -3.300 ± 99999
        Neu, Exit, n=609
    -0.006 ± 2.5612
        Neu,8 Week Follow up,n=528
    0.001 ± 2.3935
        NeuBF,Year1,Week4,n=4
    0.013 ± 0.1473
        NeuBF,Year1,Week12,n=4
    0.073 ± 0.1106
        NeuBF,Year1,Week24,n=5
    0.000 ± 0.2699
        NeuBF,Year1,Week36,n=4
    0.045 ± 0.0465
        NeuBF,Year1,Week48,n=2
    0.105 ± 0.1909
        NeuBF,Year2,Week24,n=1
    0.120 ± 99999
        NeuBF,Year2,Week48,n=0
    99999 ± 99999
        NeuBF,Year3,Week24,n=1
    0.070 ± 99999
        NeuBF,Year3,Week48,n=0
    99999 ± 99999
        NeuBF,Year7,Week24,n=0
    99999 ± 99999
        NeuBF,Exit,n=2
    0.465 ± 0.6435
        NeuS,Year1,Week4,n=693
    0.021 ± 2.0450
        NeuS,Year1,Week12,n=694
    0.051 ± 2.1519
        NeuS,Year1,Week24,n=696
    -0.055 ± 2.1757
        NeuS,Year1,Week36,n=682
    -0.139 ± 2.1819
        NeuS,Year1,Week48,n=684
    -0.079 ± 2.3128
        NeuS,Year2,Week24,n=629
    -0.289 ± 2.2609
        NeuS,Year2,Week48,n=589
    -0.226 ± 2.3846
        NeuS,Year3,Week24,n=533
    -0.130 ± 2.4736
        NeuS,Year3,Week48,n=476
    -0.041 ± 2.3547
        NeuS,Year4,Week24,n=446
    -0.097 ± 2.3804
        NeuS,Year4,Week48,n=423
    -0.158 ± 2.5542
        NeuS,Year5,Week24,n=389
    -0.024 ± 2.2893
        NeuS,Year5,Week48,n=360
    -0.184 ± 2.3831
        NeuS,Year6,Week24,n=306
    -0.147 ± 2.3029
        NeuS,Year6,Week48,n=282
    -0.058 ± 2.4310
        NeuS,Year7,Week24,n=181
    -0.151 ± 2.2248
        NeuS,Year7,Week48,n=130
    0.191 ± 2.2514
        NeuS,Year8,Week24,n=52
    -0.092 ± 2.3908
        NeuS,Year8,Week48,n=13
    -0.687 ± 3.0412
        NeuS,Year9,Week24,n=6
    -0.257 ± 2.9192
        NeuS,Year9,Week48,n=1
    -3.300 ± 99999
        NeuS,Exit,n=614
    -0.008 ± 2.5501
        NeuS,8 Week Followup,n=532
    0.007 ± 2.3824
        Plt,Year1,Week4,n=683
    8.1 ± 38.82
        Plt,Year1,Week12,n=690
    4.6 ± 43.63
        Plt,Year1,Week24,n=687
    -0.5 ± 47.73
        Plt,Year1,Week36,n=680
    -2.9 ± 50.25
        Plt,Year1,Week48,n=677
    -9.3 ± 50.81
        Plt,Year2,Week24,n=631
    -15.4 ± 53.80
        Plt,Year2,Week48,n=583
    -20.3 ± 56.39
        Plt,Year3,Week24,n=526
    -19.9 ± 57.88
        Plt,Year3,Week48,n=476
    -13.4 ± 65.16
        Plt,Year4,Week24,n=441
    -14.0 ± 59.05
        Plt,Year4,Week48,n=420
    -18.2 ± 63.80
        Plt,Year5,Week24,n=388
    -19.3 ± 61.49
        Plt,Year5,Week48,n=360
    -17.9 ± 63.36
        Plt,Year6,Week24,n=305
    -13.3 ± 61.54
        Plt,Year6,Week48,n=282
    -13.4 ± 60.89
        Plt,Year7,Week24,n=181
    -15.3 ± 63.95
        Plt,Year7,Week48,n=130
    -16.3 ± 70.75
        Plt,Year8,Week24,n=52
    -2.3 ± 80.69
        Plt,Year8,Week48,n=13
    -29.9 ± 88.66
        Plt,Year9,Week24,n=6
    -5.0 ± 82.67
        Plt,Year9,Week48,n=1
    57.0 ± 99999
        Plt,Exit,n=613
    -11.0 ± 64.36
        Plt,8Week Followup,n=530
    -11.2 ± 60.57
    No statistical analyses for this end point

    Primary: Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points

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    End point title
    		 Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points [7]
    End point description
    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. 99999 indicates standard deviation was not calculable for a single data point.
    End point type
    Primary
    End point timeframe
    Baseline and up to 9 years
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report.
    End point values
    		 Belimumab 10mg/kg IV
    Number of subjects analysed
    735
    Units: Gram per liter (g/L)
    arithmetic mean (standard deviation)
        Hg,Year1, Week 4,n=697
    -0.3 ± 7.05
        Hg,Year1,Week12,n=698
    0.1 ± 8.75
        Hg,Year1,Week24,n=699
    0.1 ± 9.48
        Hg,Year1,Week36,n=688
    0.3 ± 9.90
        Hg,Year1,Week48,n=686
    1.0 ± 11.03
        Hg,Year2,Week24,n=635
    1.0 ± 11.31
        Hg,Year2,Week48,n=591
    1.3 ± 12.12
        Hg,Year3,Week24,n=534
    2.2 ± 12.79
        Hg,Year3,Week48,n=478
    2.9 ± 12.67
        Hg,Year4,Week24,n=446
    2.6 ± 12.93
        Hg,Year,Week48,n=424
    2.4 ± 13.59
        Hg,Year5,Week24,n=390
    2.9 ± 12.76
        Hg,Year5,Week48,n=362
    3.2 ± 13.26
        Hg,Year6,Week24,n=306
    2.7 ± 13.19
        Hg,Year6,Week48,n=282
    2.3 ± 13.83
        Hg,Year7,Week24,n=181
    2.9 ± 14.54
        Hg,Year7,Week48,n=130
    4.0 ± 14.66
        Hg,Year8,Week24,n=52
    1.5 ± 14.84
        Hg,Year8,Week48,n=13
    -0.2 ± 13.95
        Hg,Year9,Week24,n=6
    -0.7 ± 20.67
        Hg,Year9,Week48,n=1
    -29.0 ± 99999
        Hg,Exit,n=619
    3.2 ± 13.90
        Hg,8 Week Follow up,n=534
    2.8 ± 13.71
    No statistical analyses for this end point

    Primary: Change From Baseline in Hematocrit at the Indicated Time Points

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    End point title
    		 Change From Baseline in Hematocrit at the Indicated Time Points [8]
    End point description
    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. 99999 indicates standard deviation was not calculable for a single data point.
    End point type
    Primary
    End point timeframe
    Baseline and up to 9 years
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report.
    End point values
    		 Belimumab 10mg/kg IV
    Number of subjects analysed
    735
    Units: Percentage of blood by volume
    arithmetic mean (standard deviation)
        Hematocrit,Year1,Week4,n=697
    0.01 ± 2.250
        Hematocrit,Year1,Week12,n=698
    0.38 ± 2.729
        Hematocrit,Year1,Week24,n=699
    0.75 ± 2.928
        Hematocrit,Year1,Week36,n=688
    0.53 ± 2.954
        Hematocrit,Year1,Week48,n=686
    0.35 ± 3.286
        Hematocrit,Year2,Week24,n=635
    0.94 ± 3.427
        Hematocrit,Year2,Week48,n=591
    0.78 ± 3.584
        Hematocrit,Year3,Week24,n=534
    1.29 ± 3.828
        Hematocrit,Year3,Week48,n=478
    1.39 ± 3.800
        Hematocrit,Year4,Week24,n=446
    1.67 ± 3.834
        Hematocrit,Year4,Week48,n=424
    1.15 ± 3.998
        Hematocrit,Year5,Week24,n=390
    1.69 ± 3.776
        Hematocrit,Year5,Week48,n=362
    1.98 ± 3.842
        Hematocrit,Year6,Week24,n=306
    1.93 ± 3.939
        Hematocrit,Year6,Week48,n=282
    2.07 ± 4.023
        Hematocrit,Year7,Week24,n=181
    1.81 ± 4.251
        Hematocrit,Year7,Week48,n=130
    2.11 ± 4.238
        Hematocrit,Year8,Week24,n=52
    1.42 ± 4.390
        Hematocrit,Year8,Week48,n=13
    1.48 ± 4.234
        Hematocrit,Year9,Week24,n=6
    2.03 ± 6.001
        Hematocrit,Year9,Week48,n=1
    -6.00 ± 99999
        Hematocrit,Exit,n=619
    1.91 ± 4.202
        Hematocrit,8 Week Follow up,n=534
    1.85 ± 4.077
    No statistical analyses for this end point

    Primary: Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points

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    End point title
    		 Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points [9]
    End point description
    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. 99999 indicates standard deviation was not calculable for a single data point.
    End point type
    Primary
    End point timeframe
    Baseline and up to 9 years
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report.
    End point values
    		 Belimumab 10mg/kg IV
    Number of subjects analysed
    735
    Units: Trillions cells per liter
    arithmetic mean (standard deviation)
        Eryth,Year1,Week4,n=697
    0.00 ± 0.231
        Eryth,Year1,Week12,n=698
    0.04 ± 0.280
        Eryth,Year1,Week24,n=699
    0.06 ± 0.293
        Eryth,Year1,Week36,n=688
    0.06 ± 0.299
        Eryth,Year1,Week48,n=686
    0.06 ± 0.328
        Eryth,Year2,Week24,n=635
    0.07 ± 0.335
        Eryth,Year2,Week48,n=591
    0.04 ± 0.362
        Eryth,Year3,Week24,n=534
    0.04 ± 0.364
        Eryth,Year3,Week48,n=478
    0.05 ± 0.381
        Eryth,Year4,Week24,n=446
    0.06 ± 0.372
        Eryth,Year,Week48,n=424
    0.05 ± 0.379
        Eryth,Year5,Week24,n=390
    0.09 ± 0.375
        Eryth,Year5,Week48,n=362
    0.11 ± 0.383
        Eryth,Year6,Week24,n=306
    0.12 ± 0.396
        Eryth,Year6,Week48,n=282
    0.17 ± 0.408
        Eryth,Year7,Week24,n=181
    0.17 ± 0.415
        Eryth,Year7,Week48,n=130
    0.22 ± 0.387
        Eryth,Year8,Week24,n=52
    0.21 ± 0.375
        Eryth,Year8,Week48,n=13
    0.15 ± 0.207
        Eryth,Year9,Week24,n=6
    0.30 ± 0.374
        Eryth,Year9,Week48,n=1
    0.20 ± 99999
        Eryth,Exit,n=619
    0.14 ± 0.431
        Eryth,8 Week Follow up,n=534
    0.13 ± 0.411
    No statistical analyses for this end point

    Primary: Change From Baseline in Calcium (Ca), Carbon dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points

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    End point title
    		 Change From Baseline in Calcium (Ca), Carbon dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points [10]
    End point description
    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. 99999 indicates standard deviation was not calculable for a single data point.
    End point type
    Primary
    End point timeframe
    Baseline and up to 9 years
    Notes
    [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report.
    End point values
    		 Belimumab 10mg/kg IV
    Number of subjects analysed
    735
    Units: Millimoles per liter (mmol/L)
    arithmetic mean (standard deviation)
        Ca,Year1,Week4,n=697
    0.0030 ± 0.0763
        Ca,Year1,Week12,n=696
    0.0020 ± 0.0749
        Ca,Year1,Week24,n=696
    -0.0035 ± 0.0750
        Ca,Year1,Week36,n=677
    0.0024 ± 0.0836
        Ca,Year1,Week48,n=687
    -0.0065 ± 0.0778
        Ca,Year2,Week24,n=636
    -0.0075 ± 0.0764
        Ca,Year2,Week48,n=587
    -0.0091 ± 0.0837
        Ca,Year3,Week24,n=526
    -0.0047 ± 0.0810
        Ca,Year3,Week48,n=481
    -0.0123 ± 0.0800
        Ca,Year4,Week24,n=438
    -0.0056 ± 0.0771
        Ca,Year,Week48,n=418
    -0.0193 ± 0.0805
        Ca,Year5,Week24,n=387
    -0.0129 ± 0.0885
        Ca,Year5,Week48,n=358
    -0.0140 ± 0.0919
        Ca,Year6,Week24,n=303
    -0.0053 ± 0.0903
        Ca,Year6,Week48,n=283
    -0.0146 ± 0.0870
        Ca,Year7,Week24,n=182
    -0.0076 ± 0.0839
        Ca,Year7,Week48,n=130
    -0.0079 ± 0.1172
        Ca,Year8,Week24,n=51
    0.0003 ± 0.0806
        Ca,Year8,Week48,n=13
    -0.0395 ± 0.0611
        Ca,Year9,Week24,n=6
    -0.0402 ± 0.0336
        Ca,Year9,Week48,n=1
    -0.0642 ± 99999
        Ca,Exit,n=619
    0.0006 ± 0.0864
        Ca,8 Week Follow up,n=534
    -0.0014 ± 0.0909
        CO2,Year1,Week4,n=701
    0.0 ± 2.77
        CO2,Year1,Week12,n=700
    -0.1 ± 2.76
        CO2,Year1,Week24,n=701
    -0.1 ± 2.73
        CO2,Year1,Week36,n=682
    0.1 ± 2.73
        CO2,Year1,Week48,n=692
    -0.1 ± 2.78
        CO2,Year2,Week24,n=641
    -0.3 ± 2.94
        CO2,Year2,Week48,n=692
    -0.3 ± 2.87
        CO2,Year3,Week24,n=531
    -0.2 ± 2.90
        CO2,Year3,Week48,n=486
    -0.4 ± 2.75
        CO2,Year4,Week24,n=438
    0.0 ± 2.76
        CO2,Year4,Week48,n=418
    -0.5 ± 3.04
        CO2,Year5,Week24,n=393
    -0.2 ± 2.90
        CO2,Year5,Week48,n=361
    -0.8 ± 2.82
        CO2,Year6,Week24,n=303
    0.0 ± 2.86
        CO2,Year6,Week48,n=284
    -0.5 ± 2.76
        CO2,Year7,Week24,n=182
    0.2 ± 2.78
        CO2,Year7,Week48,n=130
    0.2 ± 2.67
        CO2,Year8,Week24,n=52
    1.0 ± 2.78
        CO2,Year8,Week48,n=13
    0.4 ± 3.38
        CO2,Year9,Week24,n=6
    -0.3 ± 0.82
        CO2,Year9,Week48,n=1
    -3.0 ± 99999
        CO2,Exit,n=625
    -0.3 ± 3.00
        CO2,8 week Follow up,n=538
    -0.2 ± 3.00
        Chloride,Year1,Week4,n=707
    0.3 ± 2.33
        Chloride,Year1,Week12,n=704
    0.6 ± 2.56
        Chloride,Year1,Week24,n=703
    0.6 ± 2.42
        Chloride,Year1,Week36,n=684
    0.6 ± 2.47
        Chloride,Year1,Week48,n=693
    0.4 ± 2.44
        Chloride,Year2,Week24,n=643
    0.5 ± 2.62
        Chloride,Year2,Week48,n=598
    0.5 ± 2.81
        Chloride,Year3,Week24,n=535
    0.7 ± 3.04
        Chloride,Year3,Week48,n=488
    0.6 ± 2.73
        Chloride,Year4,Week24,n=439
    0.5 ± 2.74
        Chloride,Year4,Week48,n=421
    0.7 ± 2.84
        Chloride,Year5,Week24,n=392
    0.6 ± 2.95
        Chloride,Year5,Week48,n=362
    0.6 ± 2.77
        Chloride,Year6,Week24,n=304
    1.0 ± 2.74
        Chloride,Year6,Week48,n=286
    0.8 ± 2.67
        Chloride,Year7,Week24,n=183
    0.7 ± 2.57
        Chloride,Year7,Week48,n=130
    1.1 ± 2.73
        Chloride,Year8,Week24,n=52
    1.3 ± 2.86
        Chloride,Year8,Week48,n=13
    1.2 ± 3.54
        Chloride,Year9,Week24,n=6
    3.2 ± 1.47
        Chloride,Year9,Week48,n=1
    1.0 ± 99999
        Chloride,Exit,n=624
    0.4 ± 3.06
        Chloride,8 Week Follow up,n=538
    0.4 ± 2.82
        Mg,Year1,Week4,n=707
    -0.003 ± 0.0583
        Mg,Year1,Week 12,n=705
    -0.006 ± 0.0647
        Mg,Year1,Week 24,n=703
    -0.003 ± 0.0604
        Mg,Year1,Week 36,n=684
    -0.004 ± 0.0616
        Mg,Year1,Week 48,n=693
    0.002 ± 0.0597
        Mg,Year2,Week 24,n=643
    0.002 ± 0.0694
        Mg,Year2,Week 48,n=598
    0.001 ± 0.0711
        Mg,Year3,Week 24,n=535
    0.010 ± 0.0668
        Mg,Year3,Week 48,n=488
    0.010 ± 0.0669
        Mg,Year4,Week 24,n=439
    0.016 ± 0.0700
        Mg,Year4,Week 48,n=421
    0.017 ± 0.0709
        Mg,Year 5,Week 24,n=393
    0.016 ± 0.0673
        Mg,Year 5,Week 48,n=362
    0.021 ± 0.0688
        Mg,Year 6,Week 24,n=304
    0.013 ± 0.0718
        Mg,Year 6,Week 48,n=286
    0.011 ± 0.0639
        Mg,Year 7,Week 24,n=183
    0.010 ± 0.0692
        Mg,Year 7,Week 48,n=130
    0.013 ± 0.0635
        Mg,Year 8,Week 24,n=52
    0.025 ± 0.0702
        Mg,Year 8,Week 48,n=13
    0.042 ± 0.0685
        Mg,Year 9,Week 24,n=6
    0.030 ± 0.0613
        Mg,Year 9,Week 48,n=1
    0.040 ± 99999
        Mg, Exit,n=625
    0.022 ± 0.0738
        Mg,8 Week Follow up,n=539
    0.021 ± 0.0729
        Phos, Year1, Week4,n=707
    0.0102 ± 0.1908
        Phos, Year1, Week12,n=705
    0.0004 ± 0.1999
        Phos, Year1, Week24,n=703
    -0.0126 ± 0.1964
        Phos, Year1, Week 36,n=684
    0.0101 ± 0.1976
        Phos, Year1, Week48,n=693
    -0.0110 ± 0.2086
        Phos, Year2, Week24,n=643
    -0.0026 ± 0.2138
        Phos, Year2, Week48,n=598
    -0.0044 ± 0.2062
        Phos, Year3, Week24,n=535
    -0.0109 ± 0.2028
        Phos, Year3, Week48,n=488
    -0.0185 ± 0.2138
        Phos, Year4, Week24,n=439
    -0.0072 ± 0.2067
        Phos, Year4, Week48,n=421
    -0.0143 ± 0.2118
        Phos, Year5, Week24,n=393
    -0.0199 ± 0.2751
        Phos, Year5, Week48,n=362
    -0.0320 ± 0.2145
        Phos, Year6, Week24,n=304
    -0.0238 ± 0.2214
        Phos, Year6, Week48,n=286
    -0.0123 ± 0.2113
        Phos, Year 7, Week 24,n=183
    -0.0196 ± 0.1970
        Phos, Year 7, Week 48,n=130
    -0.0101 ± 0.1912
        Phos, Year 8, Week 24,n=52
    -0.0041 ± 0.2038
        Phos, Year 8, Week48,n=13
    -0.0340 ± 0.1337
        Phos, Year9, Week 24,n=6
    -0.0803 ± 0.0823
        Phos, Year 9, Week 48,n=1
    0.0447 ± 99999
        Phos, Exit, n=625
    -0.0111 ± 0.2243
        Phos, 8 Week Follow up,n=539
    -0.0034 ± 0.2233
        K, Year 1, Week 4, n=701
    0.07 ± 0.411
        K, Year 1, Week 12, n=700
    0.03 ± 0.380
        K, Year 1, Week 24, n=701
    0.01 ± 0.377
        K, Year 1, Week 36, n=682
    0.04 ± 0.387
        K, Year 1, Week 48, n=692
    0.01 ± 0.377
        K, Year 2, Week 24, n=641
    0.01 ± 0.393
        K, Year 2, Week 48, n=592
    0.02 ± 0.372
        K, Year 3, Week 24, n=531
    0.05 ± 0.401
        K, Year 3, Week 48, n=486
    0.06 ± 0.421
        K, Year 4, Week 24, n=438
    0.06 ± 0.408
        K, Year 4, Week 48, n=418
    0.03 ± 0.397
        K, Year 5, Week 24, n=393
    0.08 ± 0.427
        K, Year 5, Week 48, n=362
    0.02 ± 0.404
        K, Year 6, Week 24, n=303
    0.06 ± 0.429
        K, Year 6, Week 48, n=284
    0.05 ± 0.437
        K, Year 7, Week 24, n=182
    0.05 ± 0.445
        K, Year 7, Week 48, n=130
    0.05 ± 0.413
        K, Year 8, Week 24, n=52
    -0.02 ± 0.418
        K, Year 8, Week 48, n=13
    -0.12 ± 0.300
        K, Year 9, Week 24, n=6
    0.05 ± 0.259
        K, Year 9, Week 48, n=1
    0.00 ± 99999
        K, Exit, n=624
    0.06 ± 0.435
        K, 8 Week Follow up, n=537
    0.07 ± 0.452
        Na, Year 1, Week 4, n=707
    0.1 ± 2.07
        Na, Year 1, Week 12, n=705
    0.3 ± 2.25
        Na, Year 1, Week 24, n=703
    0.4 ± 2.16
        Na, Year 1, Week 36, n=684
    0.4 ± 2.10
        Na, Year 1, Week 48, n=693
    0.1 ± 2.09
        Na, Year 2, Week 24, n=643
    0.0 ± 2.30
        Na, Year 2, Week 48, n=598
    0.1 ± 2.63
        Na, Year 3, Week 24, n=535
    0.2 ± 2.54
        Na, Year 3, Week 48, n=488
    0.3 ± 2.36
        Na, Year 4, Week 24, n=439
    0.1 ± 2.31
        Na, Year 4, Week 48, n=421
    0.3 ± 2.36
        Na, Year 5, Week 24, n=393
    0.3 ± 2.61
        Na, Year 5, Week 48, n=362
    0.3 ± 2.18
        Na, Year 6, Week 24, n=304
    0.3 ± 2.22
        Na, Year 6, Week 48, n=286
    0.4 ± 2.44
        Na, Year 7, Week 24, n=183
    0.1 ± 2.22
        Na, Year 7, Week 48, n=130
    0.1 ± 2.38
        Na, Year 8, Week 24, n=52
    0.2 ± 2.67
        Na, Year 8, Week 48, n=13
    0.1 ± 2.14
        Na, Year 9, Week 24, n=6
    1.0 ± 1.79
        Na, Year 9, Week 48, n=1
    -3.0 ± 99999
        Na, Exist, n=624
    0.1 ± 2.55
        Na, 8 Week Follow up, n=538
    0.3 ± 2.36
    No statistical analyses for this end point

    Primary: Change From Baseline in Blood urea nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points

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    End point title
    		 Change From Baseline in Blood urea nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points [11]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Baseline and up to 9 years
    Notes
    [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report.
    End point values
    		 Belimumab 10mg/kg IV
    Number of subjects analysed
    735
    Units: Ratio
    arithmetic mean (standard deviation)
        BUN/Cr,Year1,Week4,n=707
    -0.2 ± 4.66
        BUN/Cr,Year1,Week12,n=705
    -0.3 ± 4.88
        BUN/CrYear1,Week24,n=703
    -0.7 ± 5.02
        BUN/Cr,Year1,Week36,n=683
    -0.5 ± 5.61
        BUN/Cr,Year1,Week48,n=693
    -0.2 ± 5.26
        BUN/Cr,Year2,Week24,n=643
    -0.1 ± 5.68
        BUN/Cr,Year2,Week48,n=598
    0.5 ± 5.55
        BUN/Cr,Year3,Week24,n=535
    1.4 ± 5.48
        BUN/Cr,Year3,Week48,n=488
    1.2 ± 5.92
        BUN/Cr,Year4,Week24,n=439
    1.4 ± 5.65
        BUN/Cr,Year 4,Week48,n=421
    1.0 ± 5.85
        BUN/Cr,Year5,Week24,n=393
    0.7 ± 5.51
        BUN/Cr,Year5,Week48,n=362
    1.0 ± 5.62
        BUN/Cr,Year6,Week24,n=304
    1.0 ± 5.35
        BUN/Cr,Year6,Week48,n=286
    1.3 ± 5.74
        BUN/Cr,Year7,Week24,n=183
    0.8 ± 5.68
        BUN/Cr,Year7,Week48,n=130
    1.2 ± 5.47
        BUN/Cr,Year8,Week24,n=52
    3.3 ± 4.64
        BUN/Cr,Year8,Week48,n=13
    3.5 ± 6.04
        BUN/Cr,Year9,Week24,n=6
    3.5 ± 3.08
        BUN/Cr,Year9,Week48,n=1
    1 ± 2.0
        BUN/Cr,Exit,n=625
    0.9 ± 6.05
        BUN/Cr,8 Week Follow up,n=539
    0.9 ± 5.91
    No statistical analyses for this end point

    Primary: Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points

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    End point title
    		 Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points [12]
    End point description
    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. 99999 indicates standard deviation was not calculable for a single data point.
    End point type
    Primary
    End point timeframe
    Baseline and up to 9 years
    Notes
    [12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report.
    End point values
    		 Belimumab 10mg/kg IV
    Number of subjects analysed
    735
    Units: Grams per liter (g/L)
    arithmetic mean (standard deviation)
        Alb,Year1,Week4,n=707
    -0.1 ± 2.36
        Alb,Year1,Week12,n=705
    0.2 ± 2.67
        Alb,Year1,Week24,n=703
    0.6 ± 3.03
        Alb,Year1,Week36,n=684
    0.7 ± 3.23
        Alb,Year1,Week48,n=693
    1.2 ± 3.52
        Alb,Year2,Week24,n=643
    1.2 ± 3.49
        Alb,Year2,Week48,n=598
    1.2 ± 3.67
        Alb,Year3,Week24,n=535
    1.2 ± 3.78
        Alb,Year3,Week48,n=488
    1.4 ± 4.02
        Alb,Year4,Week24,n=439
    1.7 ± 4.02
        Alb,Year 4,Week48,n=421
    1.9 ± 4.04
        Alb,Year5,Week24,n=393
    1.9 ± 3.85
        Alb,Year5,Week48,n=362
    2.3 ± 3.89
        Alb,Year6,Week24,n=304
    2.2 ± 3.78
        Alb,Year6,Week48,n=286
    2.1 ± 4.07
        Alb,Year7,Week24,n=183
    2.0 ± 3.60
        Alb,Year7,Week48,n=130
    2.3 ± 3.92
        Alb,Year8,Week24,n=52
    1.9 ± 4.16
        Alb,Year8,Week48,n=13
    1.1 ± 4.11
        Alb,Year9,Week24,n=6
    0.7 ± 3.01
        Alb,Year9,Week48,n=1
    1.0 ± 99999
        Alb,Exit,n=625
    1.8 ± 4.74
        Alb,8 Week Follow up,n=539
    1.7 ± 4.66
        Pro,Year1,Week4,n=707
    -1.4 ± 3.81
        Pro,Year1,Week12,n=705
    -2.0 ± 4.30
        Pro,Year1,Week24,n=703
    -1.9 ± 4.68
        Pro,Year1,Week36,n=684
    -2.3 ± 4.75
        Pro,Year1,Week48,n=693
    -1.8 ± 4.94
        Pro,Year2,Week24,n=643
    -2.3 ± 5.05
        Pro,Year2,Week48,n=598
    -2.7 ± 5.53
        Pro,Year3,Week24,n=535
    -3.1 ± 5.62
        Pro,Year3,Week48,n=488
    -3.5 ± 5.91
        Pro,Year4,Week24,n=439
    -3.2 ± 5.87
        Pro,Year 4,Week48,n=421
    -3.2 ± 6.07
        Pro,Year5,Week24,n=393
    -3.5 ± 5.75
        Pro,Year5,Week48,n=362
    -3.6 ± 5.78
        Pro,Year6,Week24,n=304
    -3.9 ± 5.57
        Pro,Year6,Week48,n=286
    -4.0 ± 5.79
        Pro,Year7,Week24,n=183
    -4.3 ± 5.36
        Pro,Year7,Week48,n=130
    -3.9 ± 5.32
        Pro,Year8,Week24,n=52
    -5.1 ± 6.38
        Pro,Year8,Week48,n=13
    -4.8 ± 5.02
        Pro,Year9,Week24,n=6
    -7.7 ± 7.03
        Pro,Year9,Week48,n=1
    0.0 ± 99999
        Pro,Exit,n=625
    -3.4 ± 6.45
        Pro,8 Week Follow up,n=539
    -3.7 ± 6.42
    No statistical analyses for this end point

    Primary: Change From Baseline in BUN and Glucose at the Indicated Time Points

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    End point title
    		 Change From Baseline in BUN and Glucose at the Indicated Time Points [13]
    End point description
    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. 99999 indicates standard deviation was not calculable for a single data point.
    End point type
    Primary
    End point timeframe
    Baseline and up to 9 years
    Notes
    [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report.
    End point values
    		 Belimumab 10mg/kg IV
    Number of subjects analysed
    735
    Units: mmol/L
    arithmetic mean (standard deviation)
        BUN,Year1,Week4,n=707
    0.0299 ± 1.6783
        BUN,Year1,Week12,n=705
    0.0402 ± 1.9768
        BUN,Year1,Week24,n=703
    -0.1443 ± 1.3723
        BUN,Year1,Week36,n=683
    -0.0592 ± 1.6916
        BUN,Year1,Week48,n=693
    -0.0406 ± 1.5541
        BUN,Year2,Week24,n=643
    -0.0760 ± 1.6652
        BUN,Year2,Week48,n=598
    0.0631 ± 1.6429
        BUN,Year3,Week24,n=535
    0.0524 ± 1.6850
        BUN,Year3,Week48,n=488
    -0.1013 ± 1.6910
        BUN,Year4,Week24,n=439
    0.0967 ± 1.9398
        BUN,Year 4,Week48,n=421
    0.0672 ± 2.1393
        BUN,Year5,Week24,n=393
    -0.0291 ± 2.0169
        BUN,Year5,Week48,n=362
    0.0899 ± 2.0903
        BUN,Year6,Week24,n=304
    0.0959 ± 1.9852
        BUN,Year6,Week48,n=286
    0.2325 ± 2.2724
        BUN,Year7,Week24,n=183
    -0.0026 ± 1.6623
        BUN,Year7,Week48,n=130
    0.1455 ± 1.7145
        BUN,Year8,Week24,n=52
    0.5458 ± 1.7299
        BUN,Year8,Week48,n=13
    0.3883 ± 1.4603
        BUN,Year9,Week24,n=6
    0.1648 ± 1.0466
        BUN,Year9,Week48,n=1
    0.5700 ± 99999
        BUN,Exit,n=625
    0.2448 ± 2.4618
        BUN,8 Week Follow up,n=539
    0.0822 ± 2.5567
        Glucose,Year1,Week4,n=707
    -0.0031 ± 1.0221
        Glucose,Year1,Week12,n=705
    0.0333 ± 1.0627
        Glucose,Year1,Week24,n=702
    -0.0396 ± 1.2656
        Glucose,Year1,Week36,n=684
    0.0099 ± 1.0269
        Glucose,Year1,Week48,n=693
    0.0010 ± 1.1726
        Glucose,Year2,Week24,n=643
    0.0143 ± 1.3227
        Glucose,Year2,Week48,n=598
    -0.0082 ± 1.1352
        Glucose,Year3,Week24,n=535
    -0.0159 ± 1.3222
        Glucose,Year3,Week48,n=488
    0.0309 ± 1.1841
        Glucose,Year4,Week24,n=439
    -0.0160 ± 1.2213
        Glucose,Year 4,Week48,n=421
    -0.0259 ± 1.1936
        Glucose,Year5,Week24,n=393
    0.0554 ± 1.1255
        Glucose,Year5,Week48,n=362
    0.0655 ± 1.2946
        Glucose,Year6,Week24,n=303
    0.1290 ± 1.1163
        Glucose,Year6,Week48,n=286
    0.2001 ± 1.2411
        Glucose,Year7,Week24,n=183
    0.2303 ± 1.0514
        Glucose,Year7,Week48,n=130
    0.2335 ± 0.8346
        Glucose,Year8,Week24,n=52
    0.3301 ± 0.9052
        Glucose,Year8,Week48,n=13
    0.1431 ± 0.8115
        Glucose,Year9,Week24,n=6
    0.2128 ± 0.4914
        Glucose,Year9,Week48,n=1
    0.4739 ± 99999
        Glucose,Exit,n=624
    0.1842 ± 1.8723
        Glucose,8 Week Follow up,n=539
    0.0338 ± 1.4139
    No statistical analyses for this end point

    Primary: Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points

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    End point title
    		 Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points [14]
    End point description
    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. 99999 indicates standard deviation was not calculable for a single data point.
    End point type
    Primary
    End point timeframe
    Baseline and up to 9 years
    Notes
    [14] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report.
    End point values
    		 Belimumab 10mg/kg IV
    Number of subjects analysed
    735
    Units: Micromoles per liter (µmol/L)
    arithmetic mean (standard deviation)
        Urate,Year1,Week4,n=707
    1.0332 ± 45.8504
        Urate,Year1,Week12,n=704
    0.4089 ± 54.3182
        Urate,Year1,Week24,n=703
    -0.0510 ± 49.2328
        Urate,Year1,Week36,n=684
    0.6713 ± 50.7341
        Urate,Year1,Week48,n=693
    -1.5147 ± 50.5928
        Urate,Year2,Week24,n=643
    2.7246 ± 55.7467
        Urate,Year2,Week48,n=598
    4.1255 ± 60.0251
        Urate,Year3,Week24,n=535
    6.7497 ± 60.4118
        Urate,Year3,Week48,n=488
    6.9744 ± 63.6876
        Urate,Year4,Week24,n=439
    5.9658 ± 66.6167
        Urate,Year 4,Week48,n=421
    4.0772 ± 67.9587
        Urate,Year5,Week24,n=393
    -0.5634 ± 66.9130
        Urate,Year5,Week48,n=362
    -0.8979 ± 67.3843
        Urate,Year6,Week24,n=304
    2.9530 ± 62.3168
        Urate,Year6,Week48,n=286
    1.1244 ± 67.3175
        Urate,Year7,Week24,n=183
    2.1521 ± 53.0854
        Urate,Year7,Week48,n=130
    4.0062 ± 58.3577
        Urate,Year8,Week24,n=52
    -1.1003 ± 51.8840
        Urate,Year8,Week48,n=13
    29.2043 ± 80.1811
        Urate,Year9,Week24,n=6
    0.2187 ± 45.1947
        Urate,Year9,Week48,n=1
    -69.6640 ± 99999
        Urate,Exit,n=625
    1.6479 ± 74.4078
        Urate,8 Week Follow up,n=539
    -2.7404 ± 75.5887
        Cr,Year1,Week4,n=707
    0.913 ± 14.2222
        Cr,Year1,Week12,n=705
    0.751 ± 14.0933
        Cr,Year1,Week24,n=703
    0.823 ± 9.5372
        Cr,Year1,Week36,n=684
    1.313 ± 13.1107
        Cr,Year1,Week48,n=693
    0.439 ± 11.1364
        Cr,Year2,Week24,n=643
    -0.217 ± 13.9502
        Cr,Year2,Week48,n=598
    -0.922 ± 13.6541
        Cr,Year3,Week24,n=535
    -3.870 ± 17.8146
        Cr,Year3,Week48,n=488
    -4.844 ± 17.7059
        Crea,Year4,Week24,n=439
    -3.196 ± 22.2874
        Crea,Year 4,Week48,n=421
    -2.145 ± 30.9370
        Cr,Year5,Week24,n=393
    -1.999 ± 32.6689
        Cr,Year5,Week48,n=362
    -1.918 ± 28.8788
        Cr,Year6,Week24,n=304
    -2.125 ± 24.2374
        Cr,Year6,Week48,n=286
    -1.534 ± 28.8012
        Cr,Year7,Week24,n=183
    -2.511 ± 15.6881
        Cr,Year7,Week48,n=130
    -2.586 ± 14.0864
        Cr,Year8,Week24,n=52
    -4.659 ± 16.3056
        Cr,Year8,Week48,n=13
    -6.175 ± 6.6311
        Cr,Year9,Week24,n=6
    -8.933 ± 5.6925
        Cr,Year9,Week48,n=1
    0.040 ± 99999
        Cr,Exit,n=624
    0.606 ± 35.9813
        Cr,8 Week Follow up,n=539
    -1.108 ± 39.0635
    No statistical analyses for this end point

    Primary: Change from Baseline in alanine aminotransferase (ALT), alkaline phosphatase (ALP), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT) and lactate dehydrogenase (LDH) levels

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    End point title
    		 Change from Baseline in alanine aminotransferase (ALT), alkaline phosphatase (ALP), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT) and lactate dehydrogenase (LDH) levels [15]
    End point description
    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. 99999 indicates standard deviation was not calculable for a single data point.
    End point type
    Primary
    End point timeframe
    Baseline and up to 9 years
    Notes
    [15] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report.
    End point values
    		 Belimumab 10mg/kg IV
    Number of subjects analysed
    735
    Units: International Units/liter (IU/L)
    arithmetic mean (standard deviation)
        ALT, Year 1 Week 4, n=707
    -0.4 ± 10.18
        ALT, Year 1 Week 12, n=705
    -0.9 ± 12.31
        ALT, Year 1 Week 24, n=703
    -0.9 ± 19.46
        ALT, Year 1 Week 36, n=684
    -1.0 ± 15.61
        ALT, Year 1 Week 48, n=693
    -0.7 ± 15.04
        ALT, Year 2 Week 24, n=643
    0.2 ± 23.56
        ALT, Year 2 Week 48, n=598
    2.7 ± 57.67
        ALT, Year 3 Week 24, n=535
    -1.3 ± 14.40
        ALT, Year 3 Week 48, n=488
    0.1 ± 21.21
        ALT, Year 4 Week 24, n=439
    -0.1 ± 18.72
        ALT, Year 4 Week 48, n=421
    -0.6 ± 17.59
        ALT, Year 5 Week 24, n=393
    -1.3 ± 18.74
        ALT, Year 5 Week 48, n=362
    -0.4 ± 22.72
        ALT, Year 6 Week 24, n=304
    -0.2 ± 20.54
        ALT, Year 6 Week 48, n=286
    0.9 ± 20.94
        ALT, Year 7 Week 24, n=183
    1.3 ± 19.46
        ALT, Year 7 Week 48, n=130
    -0.1 ± 16.79
        ALT, Year 8 Week 24, n=52
    2.7 ± 31.15
        ALT, Year 8 Week 48, n=13
    5.8 ± 33.54
        ALT, Year 9 Week 24, n=6
    9.3 ± 27.77
        ALT, Year 9 Week 48, n=1
    -6.0 ± 99999
        ALT, Exit, n=624
    -0.6 ± 17.03
        ALT, 8 Week follow-up, n=539
    -0.8 ± 17.06
        ALP, Year 1 Week 4, n=707
    0.0 ± 11.85
        ALP, Year 1 Week 12, n=705
    0.5 ± 13.31
        ALP, Year 1 Week 24, n=703
    2.1 ± 17.76
        ALP, Year 1 Week 36, n=684
    1.7 ± 22.81
        ALP, Year 1 Week 48, n=693
    4.6 ± 21.18
        ALP, Year 2 Week 24, n=643
    5.1 ± 21.58
        ALP, Year 2 Week 48, n=598
    6.1 ± 23.23
        ALP, Year 3 Week 24, n=535
    5.9 ± 18.95
        ALP, Year 3 Week 48, n=488
    7.3 ± 22.22
        ALP, Year 4 Week 24, n=439
    7.2 ± 21.56
        ALP, Year 4 Week 48, n=421
    8.1 ± 27.35
        ALP, Year 5 Week 24, n=393
    7.2 ± 21.01
        ALP, Year 5 Week 48, n=362
    8.5 ± 20.61
        ALP, Year 6 Week 24, n=304
    9.4 ± 23.28
        ALP, Year 6 Week 48, n=286
    11.5 ± 27.39
        ALP, Year 7 Week 24, n=183
    10.9 ± 28.08
        ALP, Year 7 Week 48, n=130
    7.5 ± 22.50
        ALP, Year 8 Week 24, n=52
    12.9 ± 26.64
        ALP, Year 8 Week 48, n=13
    6.1 ± 30.04
        ALP, Year 9 Week 24, n=6
    4.2 ± 35.43
        ALP, Year 9 Week 48, n=1
    12.0 ± 99999
        ALP, Exit, n=625
    7.5 ± 25.35
        ALP, 8 Week follow-up, n=539
    6.1 ± 23.00
        AST, Year 1 Week 4, n=701
    -0.6 ± 10.56
        AST, Year 1 Week 12, n=700
    -1.3 ± 14.12
        AST, Year 1 Week 24, n=701
    -1.0 ± 20.79
        AST, Year 1 Week 36, n=682
    -1.0 ± 17.88
        AST, Year 1 Week 48, n=692
    -0.9 ± 14.38
        AST, Year 2 Week 24, n=641
    -0.4 ± 22.22
        AST, Year 2 Week 48, n=592
    2.9 ± 57.25
        AST, Year 3 Week 24, n=531
    -1.4 ± 13.26
        AST, Year 3 Week 48, n=486
    -0.5 ± 17.23
        AST, Year 4 Week 24, n=438
    -0.9 ± 14.60
        AST, Year 4 Week 48, n=418
    -0.7 ± 15.32
        AST, Year 5 Week 24, n=393
    -1.3 ± 16.07
        AST, Year 5 Week 48, n=362
    -0.8 ± 18.57
        AST, Year 6 Week 24, n=303
    -0.5 ± 16.95
        AST, Year 6 Week 48, n=284
    -0.2 ± 19.00
        AST, Year 7 Week 24, n=182
    0.6 ± 13.43
        AST, Year 7 Week 48, n=130
    -0.3 ± 10.78
        AST, Year 8 Week 24, n=52
    3.0 ± 33.93
        AST, Year 8 Week 48, n=13
    5.8 ± 24.01
        AST, Year 9 Week 24, n=6
    7.7 ± 19.63
        AST, Year 9 Week 48, n=1
    0.0 ± 99999
        AST, Exit, n=625
    -0.6 ± 18.88
        AST, 8 Week follow-up, n=539
    -1.1 ± 16.58
        GGT, Year 1 Week 4, n=707
    -0.4 ± 23.39
        GGT, Year 1 Week 12, n=705
    -1.4 ± 23.12
        GGT, Year 1 Week 24, n=703
    -0.2 ± 39.50
        GGT, Year 1 Week 36, n=684
    1.0 ± 64.60
        GGT, Year 1 Week 48, n=693
    0.9 ± 35.99
        GGT, Year 2 Week 24, n=643
    -0.7 ± 34.81
        GGT, Year 2 Week 48, n=598
    0.1 ± 34.63
        GGT, Year 3 Week 24, n=535
    -1.6 ± 33.88
        GGT, Year 3 Week 48, n=488
    1.7 ± 45.42
        GGT, Year 4 Week 24, n=439
    0.1 ± 39.13
        GGT, Year 4 Week 48, n=421
    1.1 ± 54.41
        GGT, Year 5 Week 24, n=393
    -2.0 ± 37.17
        GGT, Year 5 Week 48, n=362
    -0.7 ± 43.39
        GGT, Year 6 Week 24, n=304
    -1.0 ± 42.04
        GGT, Year 6 Week 48, n=286
    1.3 ± 41.84
        GGT, Year 7 Week 24, n=183
    1.8 ± 37.06
        GGT, Year 7 Week 48, n=130
    -1.0 ± 27.86
        GGT, Year 8 Week 24, n=52
    2.7 ± 39.90
        GGT, Year 8 Week 48, n=13
    -0.3 ± 27.97
        GGT, Year 9 Week 24, n=6
    13.3 ± 26.96
        GGT, Year 9 Week 48, n=1
    -7.0 ± 99999
        GGT, Exit, n=625
    0.7 ± 41.40
        GGT, 8 Week follow-up, n=539
    0.2 ± 39.22
        LDH, Year 1 Week 4, n=701
    -4.1 ± 77.93
        LDH, Year 1 Week 12, n=700
    -6.0 ± 80.55
        LDH, Year 1 Week 24, n=701
    -6.6 ± 80.09
        LDH, Year 1 Week 36, n=682
    -8.8 ± 80.05
        LDH, Year 1 Week 48, n=692
    -7.3 ± 81.32
        LDH, Year 2 Week 24, n=641
    -9.4 ± 85.83
        LDH, Year 2 Week 48, n=592
    -9.6 ± 95.52
        LDH, Year 3 Week 24, n=532
    -11.8 ± 93.90
        LDH, Year 3 Week 48, n=486
    -15.1 ± 94.65
        LDH, Year 4 Week 24, n=438
    -16.5 ± 99.93
        LDH, Year 4 Week 48, n=418
    -16.9 ± 102.11
        LDH, Year 5 Week 24, n=393
    -17.5 ± 106.45
        LDH, Year 5 Week 48, n=362
    -19.8 ± 108.33
        LDH, Year 6 Week 24, n=303
    -21.7 ± 115.77
        LDH, Year 6 Week 48, n=284
    -21.3 ± 122.62
        LDH, Year 7 Week 24, n=182
    -15.2 ± 44.05
        LDH, Year 7 Week 48, n=130
    -16.3 ± 42.51
        LDH, Year 8 Week 24, n=52
    -14.3 ± 40.14
        LDH, Year 8 Week 48, n=13
    -31.5 ± 53.04
        LDH, Year 9 Week 24, n=6
    -27.2 ± 32.64
        LDH, Year 9 Week 48, n=1
    -65.0 ± 99999
        LDH, Exit, n=624
    -13.1 ± 90.39
        LDH, 8 Week follow-up, n=538
    -12.7 ± 95.65
    No statistical analyses for this end point

    Primary: Change from Baseline in bilirubin (bili) levels

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    End point title
    		 Change from Baseline in bilirubin (bili) levels [16]
    End point description
    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. 99999 indicates standard deviation was not calculable for a single data point.
    End point type
    Primary
    End point timeframe
    Baseline and up to 9 years
    Notes
    [16] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report.
    End point values
    		 Belimumab 10mg/kg IV
    Number of subjects analysed
    735
    Units: µmol/L
    arithmetic mean (standard deviation)
        Year 1 Week 4, n=707
    0.142 ± 2.8398
        Year 1 Week 12, n=705
    0.008 ± 2.6383
        Year 1 Week 24, n=703
    0.217 ± 3.1280
        Year 1 Week 36, n=684
    0.173 ± 2.7566
        Year 1 Week 48, n=693
    0.367 ± 2.8441
        Year 2 Week 24, n=643
    0.488 ± 2.9346
        Year 2 Week 48, n=598
    0.540 ± 3.2181
        Year 3 Week 24, n=535
    0.606 ± 3.1612
        Year 3 Week 48, n=488
    0.637 ± 3.2474
        Year 4 Week 24, n=439
    0.548 ± 2.9773
        Year 4 Week 48, n=421
    0.629 ± 3.4680
        Year 5 Week 24, n=393
    0.410 ± 2.6931
        Year 5 Week 48, n=362
    0.788 ± 3.1324
        Year 6 Week 24, n=304
    0.801 ± 2.9946
        Year 6 Week 48, n=285
    0.638 ± 3.0669
        Year 7 Week 24, n=183
    0.938 ± 2.8158
        Year 7 Week 48, n=130
    1.129 ± 3.0314
        Year 8 Week 24, n=52
    1.280 ± 3.0707
        Year 8 Week 48, n=13
    0.768 ± 3.0434
        Year 9 Week 24, n=6
    0.028 ± 2.0182
        Year 9 Week 48, n=1
    -2.870 ± 99999
        Exit, n=624
    0.573 ± 3.3274
        8 Week follow-up, n=539
    0.572 ± 3.1052
    No statistical analyses for this end point

    Primary: Change from Baseline in immunoglobulin G (IgG) levels

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    End point title
    		 Change from Baseline in immunoglobulin G (IgG) levels [17]
    End point description
    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. 99999 indicates standard deviation was not calculable for a single data point.
    End point type
    Primary
    End point timeframe
    Baseline and up to 9 years
    Notes
    [17] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report.
    End point values
    		 Belimumab 10mg/kg IV
    Number of subjects analysed
    735
    Units: g/L
    arithmetic mean (standard deviation)
        Year 1 Week 12, n=213
    -1.571 ± 2.2970
        Year 1 Week 24, n=709
    -1.963 ± 2.7334
        Year 1 Week 48, n=695
    -2.507 ± 3.1054
        Year 2 Week 24, n=482
    -3.058 ± 3.6147
        Year 2 Week 48, n=605
    -3.232 ± 3.7414
        Year 3 Week 24, n=143
    -3.453 ± 3.7073
        Year 3 Week 48, n=405
    -3.791 ± 4.0450
        Year 4 Week 24, n=146
    -3.839 ± 4.1411
        Year 4 Week 48, n=362
    -3.794 ± 3.8780
        Year 5 Week 24, n=111
    -4.356 ± 3.6399
        Year 5 Week 48, n=322
    -4.323 ± 4.0169
        Year 6 Week 24, n=71
    -5.111 ± 3.8846
        Year 6 Week 48, n=268
    -4.697 ± 3.9599
        Year 7 Week 24, n=50
    -4.803 ± 3.5908
        Year 7 Week 48, n=115
    -4.982 ± 4.0769
        Year 8 Week 24, n=18
    -6.016 ± 3.8450
        Year 8 Week 48, n=12
    -5.520 ± 5.1564
        Year 9 Week 48, n=1
    0.710 ± 99999
        Exit, n=627
    -4.138 ± 4.0025
        8 Week Follow up, n=543
    -4.325 ± 4.0246
    No statistical analyses for this end point

    Primary: Number of participants with immunogenic response by year

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    End point title
    		 Number of participants with immunogenic response by year [18]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Up to 9 years
    Notes
    [18] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report.
    End point values
    		 Belimumab 10mg/kg IV
    Number of subjects analysed
    735
    Units: Participants
        Year 0-1 Negative, n=717
    707
        Year 1-2 Negative, n=684
    656
        Year 2-3 Negative, n=590
    577
        Year 3-4, Negative, n=502
    498
        Year 4-5 Negative, n=432
    432
        Year 5-6 Negative, n=336
    336
        Year 6-7 Negative, n=212
    212
        Year 7-8 Negative, n=64
    64
        Year 8 plus Negative, n=6
    6
        Year 0-1 Transient +, n=717
    10
        Year 1-2 Transient + n=684
    18
        Year 2-3 Transient +, n=590
    9
        Year 3-4 Transient +, n=502
    4
        Year 4-5 Transient +, n=432
    0
        Year 5-6 Transient +, n=336
    0
        Year 6-7 Transient +, n=212
    0
        Year 7-8 Transient +, n=64
    0
        Year 8 plus Transient +, n=6
    0
        Year 0-1 Persistent+,n=717
    0
        Year 1-2 Persistent+,n=684
    10
        Year 2-3 Persistent+,n=590
    3
        Year 3-4 Persistent+,n=502
    0
        Year 4-5 Persistent+,n=432
    0
        Year 5-6 Persistent+,n=336
    0
        Year 6-7 Persistent+,n=212
    0
        Year 7-8 Persistent+,n=64
    0
        Year 8 plus Persistent+,n=6
    0
        Year 0-1 Unknown, n=717
    0
        Year 1-2 Unknown, n=684
    0
        Year 2-3 Unknown, n=590
    1
        Year 3-4 Unknown, n=502
    0
        Year 4-5 Unknown, n=432
    0
        Year 5-6 Unknown, n=336
    0
        Year 6-7 Unknown, n=212
    0
        Year 7-8 Unknown, n=64
    0
        Year 8 plus Unknown, n=6
    0
    No statistical analyses for this end point

    Primary: Number of participants with IgG values below the lower limit of normal by year

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    End point title
    		 Number of participants with IgG values below the lower limit of normal by year [19]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Up to 9 years
    Notes
    [19] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report.
    End point values
    		 Belimumab 10mg/kg IV
    Number of subjects analysed
    735
    Units: Participants
        Baseline, n=735
    6
        Any Time Post Baseline, n=735
    64
        Year 0-1, n=735
    22
        Year 1-2, n=701
    24
        Year 2-3, n=620
    22
        Year 3-4, n=514
    19
        Year 4-5, n=442
    15
        Year 5-6, n=345
    10
        Year 6-7, n=219
    8
        Year 7-8, n=65
    2
        More than 8 Years, n=6
    0
    No statistical analyses for this end point

    Primary: Number of participants with shifts from Baseline in Prednisone and other steroids dose by visit

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    End point title
    		 Number of participants with shifts from Baseline in Prednisone and other steroids dose by visit [20]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Up to 9 years
    Notes
    [20] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report.
    End point values
    		 participants with no prednisone and other steroids at baseline participants with baseline daily dose of >0 to <=7.5 mg participants with baseline daily dose of >7.5 to <=40 mg participants with baseline daily dose of >40 mg
    Number of subjects analysed
    43
    227
    462
    1
    Units: Participants
        Total daily dose=0, Year 1, Week 24
    40
    5
    1
    0
        Total daily dose >0 to <=7.5, Year 1, Week 24
    1
    194
    71
    0
        Total daily dose >7.5 to <=40, Year 1, Week 24
    2
    18
    376
    1
        Total daily dose >40, Year 1, Week 24
    0
    0
    1
    0
        Total daily dose=0, Year 1, Week 48
    40
    13
    13
    0
        Total daily dose >0 to <=7.5, Year 1, Week 48
    2
    180
    123
    0
        Total daily dose >7.5 to <=40, Year 1, Week 48
    0
    19
    301
    1
        Total daily dose >40, Year 1, Week 48
    1
    0
    4
    0
        Total daily dose=0, Year 2, Week 24
    39
    19
    20
    0
        Total daily dose >0 to <=7.5, Year 2, Week 24
    3
    157
    145
    0
        Total daily dose >7.5 to <=40, Year 2, Week 24
    0
    25
    237
    1
        Total daily dose >40, Year 2, Week 24
    0
    0
    5
    0
        Total daily dose=0, Year 2, Week 48
    36
    24
    21
    0
        Total daily dose >0 to <=7.5, Year 2, Week 48
    1
    143
    163
    0
        Total daily dose >7.5 to <=40, Year 2, Week 48
    1
    26
    195
    1
        Total daily dose >40, Year 2, Week 48
    0
    0
    1
    0
        Total daily dose=0, Year 3, Week 24
    33
    19
    25
    0
        Total daily dose >0 to <=7.5, Year 3, Week 24
    3
    130
    159
    0
        Total daily dose >7.5 to <=40, Year 3, Week 24
    1
    27
    157
    1
        Total daily dose >40, Year 3, Week 24
    0
    0
    0
    0
        Total daily dose=0, Year 3, Week 48
    31
    20
    30
    0
        Total daily dose >0 to <=7.5, Year 3, Week 48
    3
    122
    127
    0
        Total daily dose >7.5 to <=40, Year 3, Week 48
    0
    23
    145
    1
        Total daily dose >40, Year 3, Week 48
    0
    0
    2
    0
        Total daily dose=0, Year 4, Week 24
    28
    17
    34
    0
        Total daily dose >0 to <=7.5, Year 4, Week 24
    3
    110
    134
    0
        Total daily dose >7.5 to <=40, Year 4, Week 24
    2
    23
    120
    1
        Total daily dose >40, Year 4, Week 24
    0
    0
    2
    0
        Total daily dose=0, Year 4, Week 48
    22
    18
    40
    0
        Total daily dose >0 to <=7.5, Year 4, Week 48
    3
    100
    129
    1
        Total daily dose >7.5 to <=40, Year 4, Week 48
    1
    16
    108
    0
        Total daily dose >40, Year 4, Week 48
    0
    1
    0
    0
        Total daily dose=0, Year 5, Week 24
    19
    28
    33
    0
        Total daily dose >0 to <=7.5, Year 5, Week 24
    3
    84
    124
    1
        Total daily dose >7.5 to <=40, Year 5, Week 24
    1
    16
    99
    0
        Total daily dose >40, Year 5, Week 24
    0
    0
    2
    0
        Total daily dose=0, Year 5, Week 48
    17
    26
    34
    0
        Total daily dose >0 to <=7.5, Year 5, Week 48
    1
    75
    119
    1
        Total daily dose >7.5 to <=40, Year 5, Week 48
    1
    13
    85
    0
        Total daily dose >40, Year 5, Week 48
    0
    0
    0
    0
        Total daily dose=0, Year 6, Week 24
    10
    25
    33
    0
        Total daily dose >0 to <=7.5, Year 6, Week 24
    2
    62
    99
    1
        Total daily dose >7.5 to <=40, Year 6, Week 24
    0
    10
    76
    0
        Total daily dose >40, Year 6, Week 24
    0
    0
    2
    0
        Total daily dose=0, Year 6, Week 48
    10
    24
    35
    0
        Total daily dose >0 to <=7.5, Year 6, Week 48
    1
    54
    90
    1
        Total daily dose >7.5 to <=40, Year 6, Week 48
    0
    11
    68
    0
        Total daily dose >40, Year 6, Week 48
    0
    0
    0
    0
        Total daily dose=0, Year 7, Week 24
    4
    10
    29
    0
        Total daily dose >0 to <=7.5, Year 7, Week 24
    0
    41
    64
    1
        Total daily dose >7.5 to <=40, Year 7, Week 24
    1
    3
    40
    0
        Total daily dose >40, Year 7, Week 24
    0
    0
    0
    0
        Total daily dose=0, Year 7, Week 48
    4
    3
    24
    0
        Total daily dose >0 to <=7.5, Year 7, Week 48
    0
    32
    34
    1
        Total daily dose >7.5 to <=40, Year 7, Week 48
    0
    6
    29
    0
        Total daily dose >40, Year 7, Week 48
    0
    0
    0
    0
        Total daily dose=0, Year 8, Week 24
    2
    1
    8
    0
        Total daily dose >0 to <=7.5, Year 8, Week 24
    0
    13
    15
    1
        Total daily dose >7.5 to <=40, Year 8, Week 24
    0
    2
    11
    0
        Total daily dose >40, Year 8, Week 24
    0
    0
    0
    0
        Total daily dose=0, Year 8, Week 48
    1
    0
    5
    0
        Total daily dose >0 to <=7.5, Year 8, Week 48
    0
    3
    6
    0
        Total daily dose >7.5 to <=40, Year 8, Week 48
    0
    2
    1
    0
        Total daily dose >40, Year 8, Week 48
    0
    0
    0
    0
        Total daily dose=0, Year 9, Week 24
    0
    0
    1
    0
        Total daily dose >0 to <=7.5, Year 9, Week 24
    0
    1
    3
    0
        Total daily dose >7.5 to <=40, Year 9, Week 24
    0
    1
    0
    0
        Total daily dose >40, Year 9, Week 24
    0
    0
    0
    0
        Total daily dose=0, Year 9, Week 48
    0
    0
    0
    0
        Total daily dose >0 to <=7.5, Year 9, Week 48
    0
    1
    4
    0
        Total daily dose >7.5 to <=40, Year 9, Week 48
    0
    1
    0
    0
        Total daily dose >40, Year 9, Week 48
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of participants with any SLICC/ ACR Damage Index worsening (change > 0) from Baseline by visit

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    End point title
    		 Number of participants with any SLICC/ ACR Damage Index worsening (change > 0) from Baseline by visit [21]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Up to 9 years
    Notes
    [21] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report.
    End point values
    		 Belimumab 10mg/kg IV
    Number of subjects analysed
    735
    Units: Participants
        Year 1,Week 48, n=716
    39
        Year 2,Week 48, n=667
    50
        Year 3,Week 48, n=580
    56
        Year 4,Week 48, n=488
    57
        Year 5,Week 48, n=423
    51
        Year 6,Week 48, n=330
    41
        Year 7,Week 48, n=213
    28
        Year 8,Week 48, n=65
    8
        Year 9,Week 48, n=6
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
    Adverse event reporting additional description
    The MITT consisted of all randomized participants who received at least one dose of trial medication.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Belimumab 10mg/kg IV
    Reporting group description
    		 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.

    Serious adverse events
    		 Belimumab 10mg/kg IV
    Total subjects affected by serious adverse events
         subjects affected / exposed
    231 / 735 (31.43%)
         number of deaths (all causes)
    11
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cervix carcinoma stage 0
         subjects affected / exposed
    2 / 735 (0.27%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Uterine leiomyoma
         subjects affected / exposed
    2 / 735 (0.27%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Benign breast neoplasm
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Benign neoplasm of skin
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bowen's disease
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Intraductal papilloma of breast
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Papillary thyroid cancer
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Rectal adenocarcinoma
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Rectal cancer
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Vulval cancer stage 0
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Raynaud's phenomenon
         subjects affected / exposed
    5 / 735 (0.68%)
         occurrences causally related to treatment / all
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    Lupus vasculitis
         subjects affected / exposed
    4 / 735 (0.54%)
         occurrences causally related to treatment / all
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    Hypertension
         subjects affected / exposed
    3 / 735 (0.41%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    2 / 735 (0.27%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Vasculitis
         subjects affected / exposed
    2 / 735 (0.27%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Aortic dissection
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Aortic stenosis
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Peripheral ischaemia
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Peripheral artery stenosis
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Varicose vein
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    2 / 735 (0.27%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Gestational diabetes
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    9 / 735 (1.22%)
         occurrences causally related to treatment / all
    1 / 10
         deaths causally related to treatment / all
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    4 / 735 (0.54%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Complication associated with device
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cyst
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Face oedema
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Fatigue
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pain
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Peripheral swelling
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    2 / 735 (0.27%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Reproductive system and breast disorders
    Cervical dysplasia
         subjects affected / exposed
    2 / 735 (0.27%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Ovarian cyst
         subjects affected / exposed
    2 / 735 (0.27%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Dysfunctional uterine bleeding
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Endometriosis
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Haemorrhagic ovarian cyst
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ovarian cyst ruptured
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Ovarian cyst torsion
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Parovarian cyst
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Uterine haemorrhage
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Uterine polyp
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    2 / 735 (0.27%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Acute respiratory distress syndrome
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Asthma
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Atelectasis
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Epistaxis
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Haemoptysis
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Haemothorax
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Interstitial lung disease
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lower respiratory tract inflammation
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lupus pneumonitis
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pleural effusion
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pulmonary congestion
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pulmonary haemorrhage
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Respiratory distress
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Rhinitis hypertrophic
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    2 / 735 (0.27%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Depression
         subjects affected / exposed
    2 / 735 (0.27%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Suicide attempt
         subjects affected / exposed
    2 / 735 (0.27%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Confusional state
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Mania
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Panic attack
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Foot fracture
         subjects affected / exposed
    2 / 735 (0.27%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Humerus fracture
         subjects affected / exposed
    2 / 735 (0.27%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    2 / 735 (0.27%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Radius fracture
         subjects affected / exposed
    2 / 735 (0.27%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Ankle fracture
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Contusion
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Craniocerebral injury
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Fibula fracture
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hip fracture
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Joint dislocation
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Laceration
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ligament sprain
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Post procedural fistula
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tendon rupture
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tibia fracture
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ulna fracture
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Myocardial ischaemia
         subjects affected / exposed
    2 / 735 (0.27%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Angina pectoris
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Angina unstable
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Aortic valve sclerosis
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Atrioventricular block second degree
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Cardiac tamponade
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiogenic shock
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Coronary artery occlusion
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lupus myocarditis
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pericarditis
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pericarditis lupus
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Sinus tachycardia
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 735 (0.41%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Syncope
         subjects affected / exposed
    2 / 735 (0.27%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Cerebral infarction
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cerebral thrombosis
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Extrapyramidal disorder
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypoaesthesia
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Intracranial pressure increased
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Lacunar stroke
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Migraine
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Myasthenia gravis
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Neuropsychiatric lupus
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Paraesthesia
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Paraplegia
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tension headache
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    8 / 735 (1.09%)
         occurrences causally related to treatment / all
    3 / 9
         deaths causally related to treatment / all
    0 / 0
    Anaemia
         subjects affected / exposed
    7 / 735 (0.95%)
         occurrences causally related to treatment / all
    1 / 7
         deaths causally related to treatment / all
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    6 / 735 (0.82%)
         occurrences causally related to treatment / all
    1 / 7
         deaths causally related to treatment / all
    0 / 0
    Haemolytic anaemia
         subjects affected / exposed
    2 / 735 (0.27%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Lymphadenopathy
         subjects affected / exposed
    2 / 735 (0.27%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Neutropenia
         subjects affected / exposed
    2 / 735 (0.27%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Agranulocytosis
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Disseminated intravascular coagulation
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Haemorrhagic disorder
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Thrombotic thrombocytopenic purpura
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Ear and labyrinth disorders
    Vertigo positional
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Eye disorders
    Maculopathy
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Gastritis
         subjects affected / exposed
    5 / 735 (0.68%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Abdominal pain
         subjects affected / exposed
    3 / 735 (0.41%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    3 / 735 (0.41%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    Haemorrhoids
         subjects affected / exposed
    2 / 735 (0.27%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Oesophagitis
         subjects affected / exposed
    2 / 735 (0.27%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Vomiting
         subjects affected / exposed
    2 / 735 (0.27%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Abdominal adhesions
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Abdominal hernia
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Duodenitis
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Food poisoning
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Haematemesis
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ileus
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lupus enteritis
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Mouth ulceration
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Proctitis
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Rectal ulcer
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    5 / 735 (0.68%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Biliary dilatation
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cholangitis acute
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gallbladder non-functioning
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lupus hepatitis
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Portal vein thrombosis
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Systemic lupus erythematosus rash
         subjects affected / exposed
    3 / 735 (0.41%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Urticaria
         subjects affected / exposed
    3 / 735 (0.41%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    Alopecia
         subjects affected / exposed
    2 / 735 (0.27%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Skin ulcer
         subjects affected / exposed
    2 / 735 (0.27%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Drug eruption
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Erythema
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hyperhidrosis
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pemphigoid
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pyoderma gangrenosum
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Lupus nephritis
         subjects affected / exposed
    12 / 735 (1.63%)
         occurrences causally related to treatment / all
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    Acute kidney injury
         subjects affected / exposed
    2 / 735 (0.27%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Nephrotic syndrome
         subjects affected / exposed
    2 / 735 (0.27%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Proteinuria
         subjects affected / exposed
    2 / 735 (0.27%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Bladder diverticulum
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cystitis haemorrhagic
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal colic
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal impairment
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal tubular acidosis
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal tubular necrosis
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Endocrine disorders
    Hyperthyroidism
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypothyroidism
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    5 / 735 (0.68%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Osteonecrosis
         subjects affected / exposed
    5 / 735 (0.68%)
         occurrences causally related to treatment / all
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    Arthralgia
         subjects affected / exposed
    4 / 735 (0.54%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    SLE arthritis
         subjects affected / exposed
    3 / 735 (0.41%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Fibromyalgia
         subjects affected / exposed
    2 / 735 (0.27%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Myalgia
         subjects affected / exposed
    2 / 735 (0.27%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Arthritis
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Kyphosis
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Neck pain
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Osteochondrosis
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pain in extremity
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pathological fracture
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Pneumonia bacterial
         subjects affected / exposed
    14 / 735 (1.90%)
         occurrences causally related to treatment / all
    9 / 16
         deaths causally related to treatment / all
    0 / 1
    Cellulitis
         subjects affected / exposed
    12 / 735 (1.63%)
         occurrences causally related to treatment / all
    4 / 14
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    9 / 735 (1.22%)
         occurrences causally related to treatment / all
    3 / 9
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection bacterial
         subjects affected / exposed
    9 / 735 (1.22%)
         occurrences causally related to treatment / all
    2 / 11
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    8 / 735 (1.09%)
         occurrences causally related to treatment / all
    5 / 8
         deaths causally related to treatment / all
    0 / 1
    Appendicitis
         subjects affected / exposed
    6 / 735 (0.82%)
         occurrences causally related to treatment / all
    2 / 6
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    5 / 735 (0.68%)
         occurrences causally related to treatment / all
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    Herpes zoster
         subjects affected / exposed
    5 / 735 (0.68%)
         occurrences causally related to treatment / all
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    Bacterial pyelonephritis
         subjects affected / exposed
    3 / 735 (0.41%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    Bacterial sepsis
         subjects affected / exposed
    3 / 735 (0.41%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Septic shock
         subjects affected / exposed
    3 / 735 (0.41%)
         occurrences causally related to treatment / all
    1 / 4
         deaths causally related to treatment / all
    0 / 1
    Viral upper respiratory tract infection
         subjects affected / exposed
    3 / 735 (0.41%)
         occurrences causally related to treatment / all
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    Abscess soft tissue
         subjects affected / exposed
    2 / 735 (0.27%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Acute sinusitis
         subjects affected / exposed
    2 / 735 (0.27%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Bronchitis
         subjects affected / exposed
    2 / 735 (0.27%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Bronchitis bacterial
         subjects affected / exposed
    2 / 735 (0.27%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Cytomegalovirus infection
         subjects affected / exposed
    2 / 735 (0.27%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Diarrhoea infectious
         subjects affected / exposed
    2 / 735 (0.27%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Escherichia infection
         subjects affected / exposed
    2 / 735 (0.27%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    2 / 735 (0.27%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Influenza
         subjects affected / exposed
    2 / 735 (0.27%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    2 / 735 (0.27%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Respiratory tract infection viral
         subjects affected / exposed
    2 / 735 (0.27%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Soft tissue infection
         subjects affected / exposed
    2 / 735 (0.27%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    2 / 735 (0.27%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Wound infection bacterial
         subjects affected / exposed
    2 / 735 (0.27%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Abdominal infection
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Abscess of salivary gland
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Acinetobacter bacteraemia
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Acinetobacter infection
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Amoebic dysentery
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Anal abscess
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Bronchitis viral
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bursitis infective
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bursitis infective staphylococcal
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cellulitis staphylococcal
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Cutaneous tuberculosis
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Enterococcal bacteraemia
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Enterocolitis infectious
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Erysipelas
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Escherichia bacteraemia
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Escherichia sepsis
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Fungaemia
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis bacterial
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal fungal infection
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal infection
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal viral infection
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatitis A
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Herpes zoster cutaneous disseminated
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infectious colitis
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infectious pleural effusion
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Joint abscess
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Joint tuberculosis
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Kidney infection
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Latent tuberculosis
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Meningitis aseptic
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Osteomyelitis chronic
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Parasitic gastroenteritis
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pelvic inflammatory disease
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Peritonitis
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Peritonitis bacterial
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pulmonary tuberculosis
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pulmonary mycosis
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Salmonella bacteraemia
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Sialoadenitis
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Skin candida
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Staphylococcal abscess
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Streptococcal bacteraemia
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tracheitis
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tubo-ovarian abscess
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Upper respiratory tract infection bacterial
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection fungal
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urosepsis
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypoalbuminaemia
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Obesity
         subjects affected / exposed
    1 / 735 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Belimumab 10mg/kg IV
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    614 / 735 (83.54%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    67 / 735 (9.12%)
         occurrences all number
    111
    Hypotension
         subjects affected / exposed
    39 / 735 (5.31%)
         occurrences all number
    192
    Nervous system disorders
    Headache
         subjects affected / exposed
    205 / 735 (27.89%)
         occurrences all number
    407
    Dizziness
         subjects affected / exposed
    61 / 735 (8.30%)
         occurrences all number
    82
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    73 / 735 (9.93%)
         occurrences all number
    92
    Fatigue
         subjects affected / exposed
    56 / 735 (7.62%)
         occurrences all number
    61
    Oedema peripheral
         subjects affected / exposed
    47 / 735 (6.39%)
         occurrences all number
    56
    Non-cardiac chest pain
         subjects affected / exposed
    38 / 735 (5.17%)
         occurrences all number
    41
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    45 / 735 (6.12%)
         occurrences all number
    56
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    143 / 735 (19.46%)
         occurrences all number
    235
    Nausea
         subjects affected / exposed
    64 / 735 (8.71%)
         occurrences all number
    97
    Abdominal pain
         subjects affected / exposed
    60 / 735 (8.16%)
         occurrences all number
    78
    Abdominal pain upper
         subjects affected / exposed
    60 / 735 (8.16%)
         occurrences all number
    80
    Gastritis
         subjects affected / exposed
    52 / 735 (7.07%)
         occurrences all number
    59
    Vomiting
         subjects affected / exposed
    50 / 735 (6.80%)
         occurrences all number
    70
    Dyspepsia
         subjects affected / exposed
    39 / 735 (5.31%)
         occurrences all number
    50
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    120 / 735 (16.33%)
         occurrences all number
    176
    Rhinitis allergic
         subjects affected / exposed
    37 / 735 (5.03%)
         occurrences all number
    47
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    56 / 735 (7.62%)
         occurrences all number
    77
    Alopecia
         subjects affected / exposed
    48 / 735 (6.53%)
         occurrences all number
    62
    Pruritus
         subjects affected / exposed
    44 / 735 (5.99%)
         occurrences all number
    55
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    55 / 735 (7.48%)
         occurrences all number
    64
    Depression
         subjects affected / exposed
    49 / 735 (6.67%)
         occurrences all number
    57
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    134 / 735 (18.23%)
         occurrences all number
    217
    Back pain
         subjects affected / exposed
    102 / 735 (13.88%)
         occurrences all number
    141
    Myalgia
         subjects affected / exposed
    64 / 735 (8.71%)
         occurrences all number
    77
    Pain in extremity
         subjects affected / exposed
    49 / 735 (6.67%)
         occurrences all number
    73
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    155 / 735 (21.09%)
         occurrences all number
    396
    Influenza
         subjects affected / exposed
    132 / 735 (17.96%)
         occurrences all number
    274
    Urinary tract infection bacterial
         subjects affected / exposed
    87 / 735 (11.84%)
         occurrences all number
    163
    Viral upper respiratory tract infection
         subjects affected / exposed
    84 / 735 (11.43%)
         occurrences all number
    196
    Upper respiratory tract infection
         subjects affected / exposed
    82 / 735 (11.16%)
         occurrences all number
    151
    Urinary tract infection
         subjects affected / exposed
    68 / 735 (9.25%)
         occurrences all number
    99
    Herpes zoster
         subjects affected / exposed
    55 / 735 (7.48%)
         occurrences all number
    56
    Upper respiratory tract infection bacterial
         subjects affected / exposed
    54 / 735 (7.35%)
         occurrences all number
    108
    Gastroenteritis
         subjects affected / exposed
    49 / 735 (6.67%)
         occurrences all number
    59
    Bronchitis bacterial
         subjects affected / exposed
    48 / 735 (6.53%)
         occurrences all number
    81
    Bronchitis
         subjects affected / exposed
    46 / 735 (6.26%)
         occurrences all number
    64
    Oral herpes
         subjects affected / exposed
    45 / 735 (6.12%)
         occurrences all number
    89
    Pharyngitis bacterial
         subjects affected / exposed
    39 / 735 (5.31%)
         occurrences all number
    85

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Jul 2011
    Amendment 01 The main purposes of this amendment were to switch all subjects receiving 1 mg/kg belimumab to a 10 mg/kg dose of belimumab since that was the dose that has been approved for the treatment of systemic lupus erythematosus (SLE) in the United States, Canada, and Europe, and to define a list of serious adverse event terms that occurred in the study population of SLE patients irrespective of drug exposure that may not have been reported to regulatory authorities or participating investigators if the sponsor determines there was not a reasonable possibility that the drug caused the event. In addition, the requirement for contraceptive use in male study participants was eliminated, and the period after last dose of study agent during which a female study participant must agree to use adequate contraception and during which an investigator was asked to report any pregnancies in female subjects to the sponsor was increased to 16 weeks.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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