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A Continuation Trial for Subjects With Systemic Lupus Erythematosus That Have Completed Protocol LBSL02

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00583362
Recruitment Status : Completed
First Posted : December 31, 2007
Results First Posted : April 28, 2017
Last Update Posted : July 23, 2019
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Systemic Lupus Erythematosus
Intervention Biological: Belimumab
Enrollment 298
Recruitment Details Participants who completed the parent study LBSL02 (NCT00071487) through the 24-week extension period, who received belimumab 1 milligram (mg)/kilogram (kg), 4 mg/kg, 10 mg/kg or placebo in the parent study and achieved a satisfactory response were enrolled in the study.
Pre-assignment Details  
Arm/Group Title Belimumab 10 mg/kg IV
Hide Arm/Group Description Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
Period Title: Overall Study
Started 298
Completed 96
Not Completed 202
Reason Not Completed
Adverse Event             44
Lack of Efficacy             22
Lost to Follow-up             4
Non-compliance with study drug             28
Pregnancy             7
Miscommunication of visit window             5
Current site closed             7
Subject not dosed in LBSL99             1
Subject moved out of the country/state             2
Missed visits due to staff changes             1
Misunderstanding of protocol             1
Behavioral problems and non-compliance             1
Sponsor request due to missed doses             1
Physician Decision             19
Protocol Violation             2
Withdrawal by Subject             57
Arm/Group Title Belimumab 10 mg/kg IV
Hide Arm/Group Description Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
Overall Number of Baseline Participants 296
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 296 participants
43  (11.58)
[1]
Measure Description: Modified Intent to Treat (MITT) Population: All participants who were enrolled in the study and were treated with at least one dose of belimumab in the study.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 296 participants
Female
276
  93.2%
Male
20
   6.8%
[1]
Measure Description: MITT Population
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 296 participants
American Indian or Alaska Native 6
Asian 6
Black or African American 68
Native Hawaiian or Other Pacific Islander 1
White 215
[1]
Measure Description: MITT Population
1.Primary Outcome
Title Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)
Hide Description An AE 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 [eg], increase in frequency or severity) of pre-existing conditions. An SAE is defined as an AE resulting in any of the following outcomes: death, is life threatening (that is, an immediate threat to life), inpatient hospitalization, prolongation of an existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, and is medically important.
Time Frame Approximately up to 13 years
Hide Outcome Measure Data
Hide Analysis Population Description
MITT Population. Only those participants available at the specified time points (represented by n=X, in the category titles) were analyzed.
Arm/Group Title Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
Overall Number of Participants Analyzed 296
Measure Type: Number
Unit of Measure: Participants
AE, Any time post baseline, n=296 294
AE, Year 0-1, n=296 291
AE, Year 1-2, n=294 283
AE, Year 2-3, n=276 260
AE, Year 3-4, n=250 239
AE, Year 4-5, n=223 203
AE, Year 5-6, n=209 190
AE, Year 6-7, n=192 182
AE, Year 7-8, n=178 162
AE, Year 8-9, n=169 157
AE, Year 9-10, n=152 137
AE, Year 10-11, n=131 105
AE, Year 11 plus, n=88 45
SAE, Any time post baseline, n=296 182
SAE, Year 0-1, n=296 41
SAE, Year 1-2, n=294 43
SAE, Year 2-3, n=276 50
SAE, Year 3-4, n=250 30
SAE, Year 4-5, n=223 40
SAE, Year 5-6, n=209 33
SAE, Year 6-7, n=192 35
SAE, Year 7-8, n=178 34
SAE, Year 8-9, n=169 28
SAE, Year 9-10, n=152 25
SAE, Year 10-11, n=131 14
SAE, Year 11 plus, n=88 7
2.Primary Outcome
Title Adverse Event (AE) Rates by System Organ Class (SOC) During the Study
Hide Description AE rates by SOC adjusting for participant-years on study drug anytime post Baseline are summarized, which included the follow up visits. Only treatmentemergent AEs are summarized. The Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. The event rate of an AE was calculated as the number of events per 100 participant years: Event Rate=100* number of events divided by participant years. Participant years were calculated as sum across all participants ([last visit of interval day minus first visit of interval day plus 1] divided by 365).
Time Frame Approximately up to 13 years
Hide Outcome Measure Data
Hide Analysis Population Description
MITT Population
Arm/Group Title Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
Overall Number of Participants Analyzed 296
Measure Type: Number
Unit of Measure: Events per 100 participant years
Infections and infestations 285
Musculoskeletal and connective tissue disorders 276
Gastrointestinal disorders 257
Skin and subcutaneous tissue disorders 256
General disorders, administration site conditions 247
Nervous system disorders 244
Respiratory, thoracic and mediastinal disorders 241
Investigations 227
Injury, poisoning and procedural complications 221
Psychiatric disorders 180
Metabolism and nutrition disorders 144
Vascular disorders 134
Eye disorders 133
Blood and lymphatic system disorders 127
Reproductive system and breast disorders 114
Renal and urinary disorders 109
Immune system disorders 101
Neoplasms benign, malignant and unspecified 100
Cardiac disorders 86
Ear and labyrinth disorders 69
Endocrine disorders 40
Hepatobiliary disorders 27
Social circumstances 15
Congenital, familial and genetic disorders 7
Pregnancy, puerperium and perinatal conditions 5
3.Primary Outcome
Title SAE Rates by System Organ Class (SOC) During the Study
Hide Description SAE rates by SOC adjusting for participant-years on study drug anytime post Baseline are summarized, which included the follow up visits. Only treatmentemergent SAEs are summarized. The Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pretreatment value in the parent study for participants treated with belimumab in the parent study. The event rate of an SAE was calculated as the number of events per 100 participant years: Event Rate=100* number of events divided by participant years. Participant years were calculated as sum across all participants ([last visit of interval day minus first visit of interval day plus 1] divided by 365).
Time Frame Approximately up to 13 years
Hide Outcome Measure Data
Hide Analysis Population Description
MITT population
Arm/Group Title Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
Overall Number of Participants Analyzed 296
Measure Type: Number
Unit of Measure: Events per 100 participant years
Infections and infestations 69
Musculoskeletal and connective tissue disorders 44
Gastrointestinal disorders 38
Nervous system disorders 35
General disorders, administration site conditions 31
Injury, poisoning and procedural complications 29
Respiratory, thoracic and mediastinal disorders 25
Cardiac disorders 23
Neoplasms benign, malignant and unspecified 23
Renal and urinary disorders 20
Vascular disorders 19
Reproductive system and breast disorders 18
Metabolism and nutrition disorders 14
Hepatobiliary disorders 10
Blood and lymphatic system disorders 8
Skin and subcutaneous tissue disorders 8
Investigations 7
Psychiatric disorders 6
Immune system disorders 2
Pregnancy, puerperium and perinatal conditions 2
Congenital, familial and genetic disorders 1
Eye disorders 1
Social circumstances 1
4.Primary Outcome
Title Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
Hide Description Hematology parameters were assessed at Baseline, Week 8, 16, 24, 40, and 48 during Year 1 to 8; Week 8, 16, 24, and 40 during Year 9; Week 24 and 40 during Year 10; Week 48 during Year 11; Week 32 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in APTT and PT is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants 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.
Time Frame Baseline and approximately up to 13 years
Hide Outcome Measure Data
Hide Analysis Population Description
MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Arm/Group Title Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
Overall Number of Participants Analyzed 296
Mean (Standard Deviation)
Unit of Measure: Seconds
APTT, Year 1, Week 8, n=274 0.3  (12.60)
APTT, Year 1, Week 16, n=276 -1.3  (7.46)
APTT, Year 1, Week 24, n=222 -1.6  (13.61)
APTT, Year 1, Week 32, n=221 -1.9  (7.24)
APTT, Year 1, Week 40, n=219 -1.6  (7.00)
APTT, Year 1, Week 48, n=218 -1.0  (7.29)
APTT, Year 2, Week 8, n=220 -0.3  (6.73)
APTT, Year 2, Week 16, n=214 -0.2  (8.79)
APTT, Year 2, Week 24, n=212 0.6  (13.81)
APTT, Year 2, Week 32, n=35 1.5  (9.20)
APTT, Year 2, Week 40, n=28 2.6  (7.53)
APTT, Year 2, Week 48, n=21 3.0  (8.69)
APTT, Year 3, Week 8, n=25 2.4  (10.70)
APTT, Year 3, Week 16, n=23 2.3  (7.77)
APTT, Year 3, Week 24, n=23 1.7  (6.30)
APTT, Year 3, Week 32, n=22 5.4  (10.01)
APTT, Year 3, Week 40, n=18 2.1  (9.62)
APTT, Year 3, Week 48, n=18 3.9  (17.23)
APTT, Year 4, Week 8, n=14 2.9  (11.42)
APTT, Year 4, Week 16, n=16 3.1  (8.97)
APTT, Year 4, Week 24, n=10 1.1  (10.29)
APTT, Year 4, Week 32, n=18 2.1  (11.37)
APTT, Year 4, Week 40, n=13 -2.1  (10.02)
APTT, Year 4, Week 48, n=11 2.2  (11.83)
APTT, Year 5, Week 8, n=4 3.0  (14.76)
APTT, Year 5, Week 16, n=11 1.3  (5.62)
APTT, Year 5, Week 24, n=3 13.0  (11.53)
APTT, Year 5, Week 32, n=12 3.1  (6.64)
APTT, Year 5, Week 40, n=10 -0.5  (8.03)
APTT, Year 5, Week 48, n=3 12.3  (5.51)
APTT, Year 6, Week 8, n=3 -2.3  (19.50)
APTT, Year 6, Week 16, n=3 9.0  (12.12)
APTT, Year 6, Week 24, n=3 14.0  (16.52)
APTT, Year 6, Week 32, n=2 6.5  (17.68)
APTT, Year 6, Week 40, n=8 9.9  (9.11)
APTT, Year 6, Week 48, n=4 18.3  (4.99)
APTT, Year 7, Week 8, n=1 27.0 [1]   (NA)
APTT, Year 7, Week 16, n=2 24.5  (14.85)
APTT, Year 7, Week 24, n=2 19.5  (6.36)
APTT, Year 7, Week 32, n=1 7.0 [1]   (NA)
APTT, Year 7, Week 40, n=2 16.5  (16.26)
APTT, Year 7, Week 48, n=2 18.5  (2.12)
APTT, Year 8, Week 8, n=3 11.7  (18.04)
APTT, Year 8, Week 16, n=3 15.7  (10.07)
APTT, Year 8, Week 24, n=3 21.3  (22.50)
APTT, Year 8, Week 32, n=3 8.7  (14.36)
APTT, Year 8, Week 40, n=2 25.0  (5.66)
APTT, Year 8, Week 48, n=3 13.3  (15.01)
APTT, Year 9, Week 8, n=3 10.3  (9.07)
APTT, Year 9, Week 16, n=3 11.0  (9.85)
APTT, Year 9, Week 24, n=2 24.0  (25.46)
APTT, Year 9, Week 32, n=4 -11.0  (21.91)
APTT, Year 9, Week 40, n=1 20.0 [2]   (NA)
APTT, Year 10, Week 24, n=1 10.0 [2]   (NA)
APTT, Year 10, Week 40, n=1 -9 [2]   (NA)
APTT, Year 11, Week 48, n=1 -27.0 [2]   (NA)
APTT, Year 13, Week 32, n=1 26 [2]   (NA)
APTT, Exit, n=10 2.3  (9.66)
APTT, 8-Week Follow-up, n=6 3.8  (6.24)
APTT, 24-Week Follow-up, n=3 -12.3  (16.56)
PT, Year 1, Week 8, n=278 -0.67  (12.222)
PT, Year 1, Week 16, n=276 -0.98  (12.134)
PT, Year 1, Week 24, n=222 -1.00  (13.859)
PT, Year 1, Week 32, n=223 -0.89  (13.887)
PT, Year 1, Week 40, n=221 -0.67  (14.262)
PT, Year 1, Week 48, n=219 -0.95  (13.496)
PT, Year 2, Week 8, n=221 -0.87  (13.364)
PT, Year 2, Week 16, n=215 -0.84  (13.682)
PT, Year 2, Week 24, n=214 -0.66  (14.156)
PT, Year 2, Week 32, n=35 0.85  (6.887)
PT, Year 2, Week 40, n=28 3.28  (11.046)
PT, Year 2, Week 48, n=22 1.75  (8.747)
PT, Year 3, Week 8, n=25 1.75  (12.409)
PT, Year 3, Week 16, n=23 0.39  (5.469)
PT, Year 3, Week 24, n=23 0.98  (3.120)
PT, Year 3, Week 32, n=22 4.29  (10.640)
PT, Year 3, Week 40, n=18 2.02  (8.833)
PT, Year 3, Week 48, n=18 3.23  (15.863)
PT, Year 4, Week 8, n=14 4.14  (9.948)
PT, Year 4, Week 16, n=16 0.69  (8.188)
PT, Year 4, Week 24, n=10 2.10  (8.506)
PT, Year 4, Week 32, n=18 1.87  (11.251)
PT, Year 4, Week 40, n=13 -2.70  (6.698)
PT, Year 4, Week 48, n=11 0.60  (9.651)
PT, Year 5, Week 8, n=4 -0.43  (12.189)
PT, Year 5, Week 16, n=11 2.52  (6.118)
PT, Year 5, Week 24, n=3 9.90  (8.347)
PT, Year 5, Week 32, n=12 0.67  (3.731)
PT, Year 5, Week 40, n=10 -0.33  (5.443)
PT, Year 5, Week 48, n=3 13.23  (9.064)
PT, Year 6, Week 8, n=3 -2.93  (7.859)
PT, Year 6, Week 16, n=3 2.10  (5.336)
PT, Year 6, Week 24, n=3 7.60  (11.623)
PT, Year 6, Week 32, n=2 4.55  (21.425)
PT, Year 6, Week 40, n=8 2.30  (5.865)
PT, Year 6, Week 48, n=4 6.18  (10.637)
PT, Year 7, Week 8, n=1 19.90 [2]   (NA)
PT, Year 7, Week 16, n=2 18.20  (14.425)
PT, Year 7, Week 24, n=2 7.35  (0.636)
PT, Year 7, Week 32, n=1 4.00 [2]   (NA)
PT, Year 7, Week 40, n=2 11.15  (19.587)
PT, Year 7, Week 48, n=2 11.50  (4.808)
PT, Year 8, Week 8, n=3 12.47  (15.546)
PT, Year 8, Week 16, n=3 7.57  (6.799)
PT, Year 8, Week 24, n=3 12.87  (13.787)
PT, Year 8, Week 32, n=3 5.63  (9.850)
PT, Year 8, Week 40, n=2 26.60  (13.435)
PT, Year 8, Week 48, n=3 11.07  (9.845)
PT, Year 9, Week 8, n=3 8.23  (7.976)
PT, Year 9, Week 16, n=3 4.60  (6.773)
PT, Year 9, Week 24, n=2 25.75  (36.416)
PT, Year 9, Week 32, n=4 -10.08  (8.139)
PT, Year 9, Week 40, n=1 21.40 [2]   (NA)
PT, Year 10, Week 24, n=1 1.30 [2]   (NA)
PT, Year 10, Week 40, n=1 -8.00 [2]   (NA)
PT, Year 11, Week 48, n=1 -22.80 [2]   (NA)
PT, Year 13, Week 32, n=1 14.80 [2]   (NA)
PT, Exit, n=10 0.64  (5.559)
PT, 8-Week Follow-up, n=6 -0.95  (4.561)
PT, 24-Week Follow-up, n=3 -10.23  (11.657)
[1]
No value as only one participant was analyzed.
[2]
No value as only one participant was analyzed
5.Primary Outcome
Title Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Hide Description Hematology parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in basophils, eosinophils, lymphocytes, monocytes, neutrophils segmented and platelets is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants 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.
Time Frame Baseline and approximately up to 13 years
Hide Outcome Measure Data
Hide Analysis Population Description
MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Arm/Group Title Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
Overall Number of Participants Analyzed 296
Mean (Standard Deviation)
Unit of Measure: 10^9 per liter
Basophils, Year 1, Week 8, n=287 0.001  (0.0163)
Basophils, Year 1, Week 16, n=288 0.000  (0.0181)
Basophils, Year 1, Week 24, n=293 0.000  (0.0171)
Basophils, Year 1, Week 32, n=290 0.002  (0.0166)
Basophils, Year 1, Week 40, n=287 0.001  (0.0159)
Basophils, Year 1, Week 48, n=287 0.001  (0.0178)
Basophils, Year 2, Week 8, n=288 0.001  (0.0164)
Basophils, Year 2, Week 16, n=279 0.002  (0.0172)
Basophils, Year 2, Week 24, n=276 0.001  (0.0168)
Basophils, Year 2, Week 32, n=281 0.003  (0.0179)
Basophils, Year 2, Week 40, n=262 0.002  (0.0162)
Basophils, Year 2, Week 48, n=260 0.003  (0.0174)
Basophils, Year 3, Week 8, n=260 0.003  (0.0167)
Basophils, Year 3, Week 16, n=258 0.004  (0.0177)
Basophils, Year 3, Week 24, n=242 0.002  (0.0160)
Basophils, Year 3, Week 32, n=248 0.004  (0.0204)
Basophils, Year 3, Week 40, n=242 0.004  (0.0178)
Basophils, Year 3, Week 48, n=240 0.002  (0.0172)
Basophils, Year 4, Week 8, n=234 0.001  (0.0189)
Basophils, Year 4, Week 16, n=238 0.003  (0.0183)
Basophils, Year 4, Week 24, n=227 0.003  (0.0160)
Basophils, Year 4, Week 32, n=229 0.003  (0.0174)
Basophils, Year 4, Week 40, n=216 0.004  (0.0174)
Basophils, Year 4, Week 48, n=220 0.002  (0.0181)
Basophils, Year 5, Week 8, n=215 0.004  (0.0173)
Basophils, Year 5, Week 16, n=214 0.003  (0.0182)
Basophils, Year 5, Week 24, n=207 0.003  (0.0174)
Basophils, Year 5, Week 32, n=207 0.002  (0.0159)
Basophils, Year 5, Week 40, n=196 0.003  (0.0184)
Basophils, Year 5, Week 48, n=209 0.004  (0.0177)
Basophils, Year 6, Week 8, n=206 0.004  (0.0183)
Basophils, Year 6, Week 16, n=195 0.004  (0.0203)
Basophils, Year 6, Week 24, n=192 0.003  (0.0212)
Basophils, Year 6, Week 32, n=197 0.004  (0.0177)
Basophils, Year 6, Week 40, n=183 0.003  (0.0157)
Basophils, Year 6, Week 48, n=188 0.002  (0.0174)
Basophils, Year 7, Week 8, n=180 0.002  (0.0194)
Basophils, Year 7, Week 16, n=181 0.001  (0.0186)
Basophils, Year 7, Week 24, n=176 0.003  (0.0178)
Basophils, Year 7, Week 32, n=179 0.004  (0.0173)
Basophils, Year 7, Week 40, n=177 0.004  (0.0172)
Basophils, Year 7, Week 48, n=173 0.004  (0.0171)
Basophils, Year 8, Week 8, n=172 0.003  (0.0184)
Basophils, Year 8, Week 16, n=173 0.005  (0.0167)
Basophils, Year 8, Week 24, n=170 0.005  (0.0160)
Basophils, Year 8, Week 32, n=169 0.003  (0.0165)
Basophils, Year 8, Week 40, n=162 0.005  (0.0177)
Basophils, Year 8, Week 48, n=161 0.004  (0.0187)
Basophils, Year 9, Week 8, n=164 0.006  (0.0227)
Basophils, Year 9, Week 16, n=161 0.005  (0.0194)
Basophils, Year 9, Week 24, n=163 0.004  (0.0170)
Basophils, Year 9, Week 32, n=159 0.004  (0.0167)
Basophils, Year 9, Week 40, n=156 0.004  (0.0180)
Basophils, Year 9, Week 48, n=151 0.003  (0.0153)
Basophils, Year 10, Week 8, n=149 0.002  (0.0183)
Basophils, Year 10, Week 16, n=145 0.006  (0.0205)
Basophils, Year 10, Week 24, n=147 0.003  (0.0186)
Basophils, Year 10, Week 32, n=142 0.005  (0.0214)
Basophils, Year 10, Week 40, n=137 0.004  (0.0192)
Basophils, Year 10, Week 48, n=137 0.006  (0.0185)
Basophils, Year 11, Week 8, n=137 0.004  (0.0200)
Basophils, Year 11, Week 16, n=130 0.004  (0.0188)
Basophils, Year 11, Week 24, n=130 0.005  (0.0176)
Basophils, Year 11, Week 32, n=128 0.006  (0.0187)
Basophils, Year 11, Week 40, n=122 0.006  (0.0232)
Basophils, Year 11, Week 48, n=106 0.005  (0.0189)
Basophils, Year 12, Week 8, n=109 0.007  (0.0209)
Basophils, Year 12, Week 16, n=97 0.004  (0.0197)
Basophils, Year 12, Week 24, n=86 0.007  (0.0204)
Basophils, Year 12, Week 32, n=88 0.004  (0.0213)
Basophils, Year 12, Week 40, n=83 0.007  (0.0201)
Basophils, Year 12, Week 48, n=72 0.006  (0.0172)
Basophils, Year 13, Week 8, n=53 0.005  (0.0173)
Basophils, Year 13, Week 16, n=42 0.006  (0.0178)
Basophils, Year 13, Week 24, n=20 0.008  (0.0170)
Basophils, Year 13, Week 32, n=7 0.014  (0.0151)
Basophils, Year 13, Week 40, n=1 0.020 [1]   (NA)
Basophils, Exit, n=241 0.005  (0.0171)
Basophils, 8-Week Follow-up, n=219 0.006  (0.0205)
Basophils, 24-Week Follow-up, n=198 0.006  (0.0213)
Eosinophils, Year 1, Week 8, n=287 0.003  (0.0999)
Eosinophils, Year 1, Week 16, n=288 0.007  (0.1213)
Eosinophils, Year 1, Week 24, n=293 0.008  (0.1222)
Eosinophils, Year 1, Week 32, n=290 0.011  (0.1219)
Eosinophils, Year 1, Week 40, n=287 0.007  (0.1070)
Eosinophils, Year 1, Week 48, n=287 0.006  (0.1130)
Eosinophils, Year 2, Week 8, n=288 0.003  (0.1135)
Eosinophils, Year 2, Week 16, n=279 0.034  (0.1312)
Eosinophils, Year 2, Week 24, n=276 0.023  (0.1375)
Eosinophils, Year 2, Week 32, n=281 0.028  (0.1423)
Eosinophils, Year 2, Week 40, n=262 0.028  (0.1280)
Eosinophils, Year 2, Week 48, n=260 0.042  (0.1635)
Eosinophils, Year 3, Week 8, n=260 0.033  (0.1353)
Eosinophils, Year 3, Week 16, n=258 0.038  (0.1391)
Eosinophils, Year 3, Week 24, n=242 0.038  (0.1610)
Eosinophils, Year 3, Week 32, n=248 0.029  (0.1427)
Eosinophils, Year 3, Week 40, n=242 0.035  (0.1539)
Eosinophils, Year 3, Week 48, n=240 0.033  (0.1369)
Eosinophils, Year 4, Week 8, n=234 0.035  (0.1331)
Eosinophils, Year 4, Week 16, n=238 0.034  (0.1273)
Eosinophils, Year 4, Week 24, n=227 0.033  (0.1384)
Eosinophils, Year 4, Week 32, n=229 0.039  (0.1381)
Eosinophils, Year 4, Week 40, n=216 0.038  (0.1284)
Eosinophils, Year 4, Week 48, n=220 0.030  (0.1261)
Eosinophils, Year 5, Week 8, n=215 0.035  (0.1242)
Eosinophils, Year 5, Week 16, n=214 0.019  (0.1294)
Eosinophils, Year 5, Week 24, n=207 0.023  (0.1078)
Eosinophils, Year 5, Week 32, n=207 0.027  (0.1201)
Eosinophils, Year 5, Week 40, n=196 0.019  (0.1224)
Eosinophils, Year 5, Week 48, n=209 0.022  (0.1224)
Eosinophils, Year 6, Week 8, n=206 0.020  (0.1288)
Eosinophils, Year 6, Week 16, n=195 0.021  (0.1103)
Eosinophils, Year 6, Week 24, n=192 0.034  (0.1335)
Eosinophils, Year 6, Week 32, n=197 0.026  (0.1171)
Eosinophils, Year 6, Week 40, n=183 0.044  (0.1580)
Eosinophils, Year 6, Week 48, n=188 0.026  (0.1299)
Eosinophils, Year 7, Week 8, n=180 0.021  (0.1317)
Eosinophils, Year 7, Week 16, n=181 0.015  (0.1170)
Eosinophils, Year 7, Week 24, n=176 0.014  (0.1239)
Eosinophils, Year 7, Week 32, n=179 0.010  (0.1149)
Eosinophils, Year 7, Week 40, n=177 0.009  (0.1167)
Eosinophils, Year 7, Week 48, n=173 -0.008  (0.1176)
Eosinophils, Year 8, Week 8, n=172 -0.003  (0.1389)
Eosinophils, Year 8, Week 16, n=173 -0.009  (0.1234)
Eosinophils, Year 8, Week 24, n=170 -0.007  (0.1309)
Eosinophils, Year 8, Week 32, n=169 -0.023  (0.1136)
Eosinophils, Year 8, Week 40, n=162 -0.009  (0.1263)
Eosinophils, Year 8, Week 48, n=161 -0.011  (0.1341)
Eosinophils, Year 9, Week 8, n=164 -0.004  (0.1373)
Eosinophils, Year 9, Week 16, n=161 -0.020  (0.1204)
Eosinophils, Year 9, Week 24, n=163 -0.020  (0.1134)
Eosinophils, Year 9, Week 32, n=159 -0.012  (0.1154)
Eosinophils, Year 9, Week 40, n=156 -0.029  (0.1200)
Eosinophils, Year 9, Week 48, n=151 -0.018  (0.1307)
Eosinophils, Year 10, Week 8, n=149 -0.020  (0.1343)
Eosinophils, Year 10, Week 16, n=145 -0.010  (0.1438)
Eosinophils, Year 10, Week 24, n=147 -0.019  (0.1237)
Eosinophils, Year 10, Week 32, n=142 -0.002  (0.1332)
Eosinophils, Year 10, Week 40, n=137 -0.021  (0.1184)
Eosinophils, Year 10, Week 48, n=137 -0.021  (0.1274)
Eosinophils, Year 11, Week 8, n=137 -0.018  (0.1167)
Eosinophils, Year 11, Week 16, n=130 -0.004  (0.1336)
Eosinophils, Year 11, Week 24, n=130 0.004  (0.1445)
Eosinophils, Year 11, Week 32, n=128 0.003  (0.1360)
Eosinophils, Year 11, Week 40, n=122 -0.013  (0.1298)
Eosinophils, Year 11, Week 48, n=106 -0.021  (0.1435)
Eosinophils, Year 12, Week 8, n=109 -0.021  (0.1242)
Eosinophils, Year 12, Week 16, n=97 -0.020  (0.1349)
Eosinophils, Year 12, Week 24, n=86 -0.000  (0.1535)
Eosinophils, Year 12, Week 32, n=88 -0.008  (0.1356)
Eosinophils, Year 12, Week 40, n=83 -0.020  (0.1242)
Eosinophils, Year 12, Week 48, n=72 -0.016  (0.1319)
Eosinophils, Year 13, Week 8, n=53 -0.001  (0.1436)
Eosinophils, Year 13, Week 16, n=42 -0.009  (0.1244)
Eosinophils, Year 13, Week 24, n=20 0.035  (0.1810)
Eosinophils, Year 13, Week 32, n=7 0.081  (0.0722)
Eosinophils, Year 13, Week 40, n=1 0.080 [1]   (NA)
Eosinophils, Exit, n=241 0.006  (0.1430)
Eosinophils, 8-Week Follow-up, n=219 -0.002  (0.1436)
Eosinophils, 24-Week Follow-up, n=198 0.013  (0.2255)
Lymphocytes, Year 1, Week 8, n=287 0.006  (0.4143)
Lymphocytes, Year 1, Week 16, n=288 -0.046  (0.4612)
Lymphocytes, Year 1, Week 24, n=293 -0.035  (0.4725)
Lymphocytes, Year 1, Week 32, n=290 -0.057  (0.4425)
Lymphocytes, Year 1, Week 40, n=287 -0.074  (0.5084)
Lymphocytes, Year 1, Week 48, n=287 -0.075  (0.4832)
Lymphocytes, Year 2, Week 8, n=288 -0.049  (0.4324)
Lymphocytes, Year 2, Week 16, n=279 -0.025  (0.4774)
Lymphocytes, Year 2, Week 24, n=276 -0.053  (0.4949)
Lymphocytes, Year 2, Week 32, n=281 -0.038  (0.5080)
Lymphocytes, Year 2, Week 40, n=262 -0.025  (0.5046)
Lymphocytes, Year 2, Week 48, n=260 0.006  (0.4874)
Lymphocytes, Year 3, Week 8, n=260 -0.037  (0.5202)
Lymphocytes, Year 3, Week 16, n=258 -0.019  (0.5004)
Lymphocytes, Year 3, Week 24, n=242 -0.045  (0.5131)
Lymphocytes, Year 3, Week 32, n=248 -0.008  (0.4702)
Lymphocytes, Year 3, Week 40, n=242 -0.015  (0.5407)
Lymphocytes, Year 3, Week 48, n=240 -0.016  (0.5858)
Lymphocytes, Year 4, Week 8, n=234 -0.041  (0.4933)
Lymphocytes, Year 4, Week 16, n=238 -0.012  (0.4974)
Lymphocytes, Year 4, Week 24, n=227 0.034  (0.5406)
Lymphocytes, Year 4, Week 32, n=229 0.017  (0.5270)
Lymphocytes, Year 4, Week 40, n=216 0.003  (0.4347)
Lymphocytes, Year 4, Week 48, n=220 0.017  (0.4826)
Lymphocytes, Year 5, Week 8, n=215 0.012  (0.4654)
Lymphocytes, Year 5, Week 16, n=214 0.050  (0.5205)
Lymphocytes, Year 5, Week 24, n=207 0.052  (0.5355)
Lymphocytes, Year 5, Week 32, n=207 0.031  (0.5323)
Lymphocytes, Year 5, Week 40, n=196 0.057  (0.5482)
Lymphocytes, Year 5, Week 48, n=209 0.031  (0.5125)
Lymphocytes, Year 6, Week 8, n=206 0.059  (0.5734)
Lymphocytes, Year 6, Week 16, n=195 0.045  (0.5931)
Lymphocytes, Year 6, Week 24, n=192 0.087  (0.5757)
Lymphocytes, Year 6, Week 32, n=197 0.066  (0.5970)
Lymphocytes, Year 6, Week 40, n=183 0.075  (0.5984)
Lymphocytes, Year 6, Week 48, n=188 0.043  (0.5839)
Lymphocytes, Year 7, Week 8, n=180 0.110  (0.6114)
Lymphocytes, Year 7, Week 16, n=181 0.077  (0.6114)
Lymphocytes, Year 7, Week 24, n=176 0.091  (0.5944)
Lymphocytes, Year 7, Week 32, n=179 0.104  (0.5944)
Lymphocytes, Year 7, Week 40, n=177 0.075  (0.5385)
Lymphocytes, Year 7, Week 48, n=173 0.060  (0.6039)
Lymphocytes, Year 8, Week 8, n=172 0.036  (0.5942)
Lymphocytes, Year 8, Week 16, n=173 -0.005  (0.5480)
Lymphocytes, Year 8, Week 24, n=170 0.030  (0.6126)
Lymphocytes, Year 8, Week 32, n=169 -0.020  (0.5269)
Lymphocytes, Year 8, Week 40, n=162 0.065  (0.6260)
Lymphocytes, Year 8, Week 48, n=161 0.087  (0.7204)
Lymphocytes, Year 9, Week 8, n=164 0.090  (0.6612)
Lymphocytes, Year 9, Week 16, n=161 0.022  (0.5664)
Lymphocytes, Year 9, Week 24, n=163 0.062  (0.5704)
Lymphocytes, Year 9, Week 32, n=159 0.017  (0.5326)
Lymphocytes, Year 9, Week 40, n=156 0.069  (0.6410)
Lymphocytes, Year 9, Week 48, n=151 0.064  (0.5979)
Lymphocytes, Year 10, Week 8, n=149 0.046  (0.5547)
Lymphocytes, Year 10, Week 16, n=145 0.089  (0.6336)
Lymphocytes, Year 10, Week 24, n=147 0.033  (0.5811)
Lymphocytes, Year 10, Week 32, n=142 0.076  (0.5914)
Lymphocytes, Year 10, Week 40, n=137 0.071  (0.5621)
Lymphocytes, Year 10, Week 48, n=137 0.073  (0.5807)
Lymphocytes, Year 11, Week 8, n=137 0.112  (0.5764)
Lymphocytes, Year 11, Week 16, n=130 0.112  (0.6926)
Lymphocytes, Year 11, Week 24, n=130 0.129  (0.7026)
Lymphocytes, Year 11, Week 32, n=128 0.139  (0.6249)
Lymphocytes, Year 11, Week 40, n=122 0.143  (0.6927)
Lymphocytes, Year 11, Week 48, n=106 0.133  (0.5942)
Lymphocytes, Year 12, Week 8, n=109 0.145  (0.5976)
Lymphocytes, Year 12, Week 16, n=97 0.179  (0.5839)
Lymphocytes, Year 12, Week 24, n=86 0.150  (0.5857)
Lymphocytes, Year 12, Week 32, n=88 0.135  (0.6319)
Lymphocytes, Year 12, Week 40, n=83 0.150  (0.6512)
Lymphocytes, Year 12, Week 48, n=72 0.106  (0.5855)
Lymphocytes, Year 13, Week 8, n=53 0.133  (0.6269)
Lymphocytes, Year 13, Week 16, n=42 0.078  (0.6783)
Lymphocytes, Year 13, Week 24, n=20 0.131  (0.6760)
Lymphocytes, Year 13, Week 32, n=7 0.293  (0.8019)
Lymphocytes, Year 13, Week 40, n=1 0.160 [2]   (NA)
Lymphocytes, Exit, n=241 0.088  (0.6208)
Lymphocytes, 8-Week Follow-up, n=219 0.119  (0.6554)
Lymphocytes, 24-Week Follow-up, n=198 0.054  (0.6847)
Monocytes, Year 1, Week 8, n=287 0.014  (0.1795)
Monocytes, Year 1, Week 16, n=288 0.018  (0.1903)
Monocytes, Year 1, Week 24, n=293 0.007  (0.1834)
Monocytes, Year 1, Week 32, n=290 0.016  (0.1666)
Monocytes, Year 1, Week 40, n=287 0.020  (0.1750)
Monocytes, Year 1, Week 48, n=287 0.018  (0.1739)
Monocytes, Year 2, Week 8, n=288 0.009  (0.1718)
Monocytes, Year 2, Week 16, n=279 0.016  (0.1783)
Monocytes, Year 2, Week 24, n=276 0.029  (0.1764)
Monocytes, Year 2, Week 32, n=281 0.018  (0.1842)
Monocytes, Year 2, Week 40, n=262 0.014  (0.1848)
Monocytes, Year 2, Week 48, n=260 0.030  (0.1594)
Monocytes, Year 3, Week 8, n=260 0.024  (0.1677)
Monocytes, Year 3, Week 16, n=258 0.038  (0.1705)
Monocytes, Year 3, Week 24, n=242 0.034  (0.1632)
Monocytes, Year 3, Week 32, n=248 0.022  (0.1776)
Monocytes, Year 3, Week 40, n=242 0.044  (0.1650)
Monocytes, Year 3, Week 48, n=240 0.039  (0.1855)
Monocytes, Year 4, Week 8, n=234 0.035  (0.1687)
Monocytes, Year 4, Week 16, n=238 0.039  (0.1665)
Monocytes, Year 4, Week 24, n=227 0.032  (0.1667)
Monocytes, Year 4, Week 32, n=229 0.027  (0.1566)
Monocytes, Year 4, Week 40, n=216 0.035  (0.1688)
Monocytes, Year 4, Week 48, n=220 0.015  (0.1771)
Monocytes, Year 5, Week 8, n=215 0.018  (0.1824)
Monocytes, Year 5, Week 16, n=214 0.036  (0.1527)
Monocytes, Year 5, Week 24, n=207 0.041  (0.1632)
Monocytes, Year 5, Week 32, n=207 0.039  (0.1625)
Monocytes, Year 5, Week 40, n=196 0.049  (0.1510)
Monocytes, Year 5, Week 48, n=209 0.050  (0.1628)
Monocytes, Year 6, Week 8, n=206 0.045  (0.1670)
Monocytes, Year 6, Week 16, n=195 0.033  (0.1700)
Monocytes, Year 6, Week 24, n=192 0.030  (0.1556)
Monocytes, Year 6, Week 32, n=197 0.048  (0.1635)
Monocytes, Year 6, Week 40, n=183 0.051  (0.1342)
Monocytes, Year 6, Week 48, n=188 0.038  (0.1665)
Monocytes, Year 7, Week 8, n=180 0.028  (0.1507)
Monocytes, Year 7, Week 16, n=181 0.030  (0.1482)
Monocytes, Year 7, Week 24, n=176 0.033  (0.1583)
Monocytes, Year 7, Week 32, n=179 0.039  (0.1534)
Monocytes, Year 7, Week 40, n=177 0.047  (0.1391)
Monocytes, Year 7, Week 48, n=173 0.055  (0.1508)
Monocytes, Year 8, Week 8, n=172 0.071  (0.1536)
Monocytes, Year 8, Week 16, n=173 0.072  (0.1464)
Monocytes, Year 8, Week 24, n=170 0.075  (0.1545)
Monocytes, Year 8, Week 32, n=169 0.049  (0.1414)
Monocytes, Year 8, Week 40, n=162 0.070  (0.1480)
Monocytes, Year 8, Week 48, n=161 0.072  (0.1744)
Monocytes, Year 9, Week 8, n=164 0.069  (0.1513)
Monocytes, Year 9, Week 16, n=161 0.063  (0.1462)
Monocytes, Year 9, Week 24, n=163 0.077  (0.1603)
Monocytes, Year 9, Week 32, n=159 0.074  (0.1393)
Monocytes, Year 9, Week 40, n=156 0.075  (0.1440)
Monocytes, Year 9, Week 48, n=151 0.063  (0.1576)
Monocytes, Year 10, Week 8, n=149 0.084  (0.1511)
Monocytes, Year 10, Week 16, n=145 0.083  (0.1439)
Monocytes, Year 10, Week 24, n=147 0.087  (0.1874)
Monocytes, Year 10, Week 32, n=142 0.077  (0.1517)
Monocytes, Year 10, Week 40, n=137 0.064  (0.1522)
Monocytes, Year 10, Week 48, n=137 0.070  (0.1454)
Monocytes, Year 11, Week 8, n=137 0.077  (0.1622)
Monocytes, Year 11, Week 16, n=130 0.077  (0.1484)
Monocytes, Year 11, Week 24, n=130 0.079  (0.1775)
Monocytes, Year 11, Week 32, n=128 0.080  (0.1849)
Monocytes, Year 11, Week 40, n=122 0.075  (0.1435)
Monocytes, Year 11, Week 48, n=106 0.075  (0.1854)
Monocytes, Year 12, Week 8, n=109 0.088  (0.2166)
Monocytes, Year 12, Week 16, n=97 0.104  (0.1829)
Monocytes, Year 12, Week 24, n=86 0.073  (0.1616)
Monocytes, Year 12, Week 32, n=88 0.065  (0.1682)
Monocytes, Year 12, Week 40, n=83 0.078  (0.1734)
Monocytes, Year 12, Week 48, n=72 0.060  (0.1635)
Monocytes, Year 13, Week 8, n=53 0.013  (0.1453)
Monocytes, Year 13, Week 16, n=42 0.061  (0.1882)
Monocytes, Year 13, Week 24, n=20 0.074  (0.1471)
Monocytes, Year 13, Week 32, n=7 0.097  (0.1452)
Monocytes, Year 13, Week 40, n=1 0.120 [2]   (NA)
Monocytes, Exit, n=241 0.062  (0.1813)
Monocytes, 8-Week Follow-up, n=219 0.061  (0.2153)
Monocytes, 24-Week Follow-up , n=198 0.049  (0.2118)
Neutrophils segmented, Year 1, Week 8, n=287 0.003  (1.7881)
Neutrophils segmented, Year 1, Week 16, n=288 -0.107  (1.7909)
Neutrophils segmented, Year 1, Week 24, n=293 -0.166  (1.9241)
Neutrophils segmented, Year 1, Week 32, n=290 -0.129  (2.0814)
Neutrophils segmented, Year 1, Week 40, n=287 -0.140  (1.7884)
Neutrophils segmented, Year 1, Week 48, n=287 -0.223  (1.7187)
Neutrophils segmented, Year 2, Week 8, n=288 -0.301  (2.0434)
Neutrophils segmented, Year 2, Week 16, n=279 -0.392  (2.0076)
Neutrophils segmented, Year 2, Week 24, n=276 -0.250  (2.2163)
Neutrophils segmented, Year 2, Week 32, n=281 -0.129  (2.1622)
Neutrophils segmented, Year 2, Week 40, n=262 -0.236  (2.1413)
Neutrophils segmented, Year 2, Week 48, n=260 -0.148  (2.1176)
Neutrophils segmented, Year 3, Week 8, n=260 -0.333  (2.1308)
Neutrophils segmented, Year 3, Week 16, n=258 -0.308  (2.2022)
Neutrophils segmented, Year 3, Week 24, n=242 -0.129  (1.9829)
Neutrophils segmented, Year 3, Week 32, n=248 -0.211  (2.2333)
Neutrophils segmented, Year 3, Week 40, n=242 -0.161  (1.9939)
Neutrophils segmented, Year 3, Week 48, n=240 -0.159  (2.1315)
Neutrophils segmented, Year 4, Week 8, n=234 -0.119  (2.0635)
Neutrophils segmented, Year 4, Week 16, n=238 -0.177  (2.1063)
Neutrophils segmented, Year 4, Week 24, n=227 -0.136  (1.9402)
Neutrophils segmented, Year 4, Week 32, n=229 -0.123  (2.2231)
Neutrophils segmented, Year 4, Week 40, n=216 -0.119  (1.9639)
Neutrophils segmented, Year 4, Week 48, n=220 -0.024  (2.2228)
Neutrophils segmented, Year 5, Week 8, n=215 -0.169  (2.2107)
Neutrophils segmented, Year 5, Week 16, n=214 -0.189  (2.0362)
Neutrophils segmented, Year 5, Week 24, n=207 -0.120  (2.0997)
Neutrophils segmented, Year 5, Week 32, n=207 -0.088  (2.1895)
Neutrophils segmented, Year 5, Week 40, n=196 -0.064  (2.1536)
Neutrophils segmented, Year 5, Week 48, n=209 0.014  (2.0473)
Neutrophils segmented, Year 6, Week 8, n=206 -0.097  (1.9542)
Neutrophils segmented, Year 6, Week 16, n=195 -0.218  (2.2682)
Neutrophils segmented, Year 6, Week 24, n=192 -0.226  (2.1749)
Neutrophils segmented, Year 6, Week 32, n=197 -0.144  (2.0689)
Neutrophils segmented, Year 6, Week 40, n=183 -0.359  (2.2241)
Neutrophils segmented, Year 6, Week 48, n=188 -0.306  (2.1609)
Neutrophils segmented, Year 7, Week 8, n=180 -0.371  (2.1016)
Neutrophils segmented, Year 7, Week 16, n=181 -0.410  (2.0287)
Neutrophils segmented, Year 7, Week 24, n=176 -0.363  (2.2018)
Neutrophils segmented, Year 7, Week 32, n=179 -0.214  (2.2148)
Neutrophils segmented, Year 7, Week 40, n=177 -0.360  (2.2393)
Neutrophils segmented, Year 7, Week 48, n=173 -0.423  (2.1389)
Neutrophils segmented, Year 8, Week 8, n=172 -0.387  (2.1621)
Neutrophils segmented, Year 8, Week 16, n=173 -0.310  (2.1373)
Neutrophils segmented, Year 8, Week 24, n=170 -0.152  (2.3134)
Neutrophils segmented, Year 8, Week 32, n=169 -0.218  (2.1233)
Neutrophils segmented, Year 8, Week 40, n=162 -0.281  (2.2042)
Neutrophils segmented, Year 8, Week 48, n=161 -0.407  (2.2558)
Neutrophils segmented, Year 9, Week 8, n=164 -0.161  (2.1968)
Neutrophils segmented, Year 9, Week 16, n=161 -0.332  (2.0436)
Neutrophils segmented, Year 9, Week 24, n=163 -0.240  (2.1439)
Neutrophils segmented, Year 9, Week 32, n=159 -0.114  (2.3286)
Neutrophils segmented, Year 9, Week 40, n=156 -0.252  (2.2301)
Neutrophils segmented, Year 9, Week 48, n=151 -0.268  (2.4153)
Neutrophils segmented, Year 10, Week 8, n=149 0.049  (2.4409)
Neutrophils segmented, Year 10, Week 16, n=145 0.008  (2.7611)
Neutrophils segmented, Year 10, Week 24, n=147 -0.166  (2.2970)
Neutrophils segmented, Year 10, Week 32, n=142 -0.299  (2.1597)
Neutrophils segmented, Year 10, Week 40, n=137 -0.051  (2.1023)
Neutrophils segmented, Year 10, Week 48, n=137 -0.176  (2.0628)
Neutrophils segmented, Year 11, Week 8, n=137 -0.077  (2.4456)
Neutrophils segmented, Year 11, Week 16, n=130 -0.035  (2.3922)
Neutrophils segmented, Year 11, Week 24, n=130 -0.031  (2.2826)
Neutrophils segmented, Year 11, Week 32, n=128 0.145  (2.4689)
Neutrophils segmented, Year 11, Week 40, n=122 -0.043  (2.2994)
Neutrophils segmented, Year 11, Week 48, n=106 -0.004  (2.5913)
Neutrophils segmented, Year 12, Week 8, n=109 -0.011  (2.5216)
Neutrophils segmented, Year 12, Week 16, n=97 -0.032  (2.6750)
Neutrophils segmented, Year 12, Week 24, n=86 -0.126  (2.2583)
Neutrophils segmented, Year 12, Week 32, n=88 -0.081  (2.5744)
Neutrophils segmented, Year 12, Week 40, n=83 -0.293  (2.2448)
Neutrophils segmented, Year 12, Week 48, n=72 -0.126  (2.9212)
Neutrophils segmented, Year 13, Week 8, n=53 -0.747  (2.7599)
Neutrophils segmented, Year 13, Week 16, n=42 0.169  (2.5731)
Neutrophils segmented, Year 13, Week 24, n=20 -0.121  (2.8499)
Neutrophils segmented, Year 13, Week 32, n=7 -0.927  (2.9565)
Neutrophils segmented, Year 13, Week 40, n=1 -0.680 [2]   (NA)
Neutrophils segmented, Exit, n=241 0.436  (2.6133)
Neutrophils segmented, 8-Week Follow-up, n=219 0.514  (3.6918)
Neutrophils segmented, 24-Week Follow-up, n=198 0.369  (2.6988)
Platelets, Year 1, Week ,8 n=279 3.7  (34.73)
Platelets, Year 1, Week 16, n=279 4.5  (34.48)
Platelets, Year 1, Week 24, n=286 7.9  (36.76)
Platelets, Year 1, Week 32, n=285 10.3  (41.03)
Platelets, Year 1, Week 40, n=283 13.1  (39.75)
Platelets, Year 1, Week 48, n=282 13.2  (46.13)
Platelets, Year 2, Week 8, n=280 18.1  (48.14)
Platelets, Year 2, Week 16, n=276 15.4  (45.99)
Platelets, Year 2, Week 24, n=273 16.7  (49.67)
Platelets, Year 2, Week 32, n=277 24.0  (50.04)
Platelets, Year 2, Week 40, n=259 21.9  (46.95)
Platelets, Year 2, Week 48, n=255 21.2  (50.63)
Platelets, Year 3, Week 8, n=256 22.0  (53.16)
Platelets, Year 3, Week 16, n=253 22.7  (55.76)
Platelets, Year 3, Week 24, n=239 18.4  (50.97)
Platelets, Year 3, Week 32, n=243 14.1  (50.03)
Platelets, Year 3, Week 40, n=240 14.3  (55.47)
Platelets, Year 3, Week 48, n=235 12.6  (56.20)
Platelets, Year 4, Week 8, n=230 11.5  (48.78)
Platelets, Year 4, Week 16, n=234 11.7  (54.46)
Platelets, Year 4, Week 24, n=226 11.7  (51.12)
Platelets, Year 4, Week 32, n=220 9.6  (55.85)
Platelets, Year 4, Week 40, n=214 5.6  (54.44)
Platelets, Year 4, Week 48, n=216 6.7  (56.74)
Platelets, Year 5, Week 8, n=211 4.6  (62.04)
Platelets, Year 5, Week 16, n=212 -2.1  (54.06)
Platelets, Year 5, Week 24, n=206 -3.0  (52.05)
Platelets, Year 5, Week 32, n=203 -4.8  (53.16)
Platelets, Year 5, Week 40, n=194 -7.7  (51.97)
Platelets, Year 5, Week 48, n=206 -3.4  (54.93)
Platelets, Year 6, Week 8, n=203 -10.8  (56.67)
Platelets, Year 6, Week 16, n=193 -12.7  (56.99)
Platelets, Year 6, Week 24, n=190 -15.6  (51.76)
Platelets, Year 6, Week 32, n=194 -12.2  (52.69)
Platelets, Year 6, Week 40, n=182 -15.8  (56.24)
Platelets, Year 6, Week 48, n=186 -19.5  (52.68)
Platelets, Year 7, Week 8, n=179 -17.3  (53.81)
Platelets, Year 7, Week 16, n=179 -24.2  (49.52)
Platelets, Year 7, Week 24, n=175 -22.0  (52.19)
Platelets, Year 7, Week 32, n=178 -19.4  (59.77)
Platelets, Year 7, Week 40, n=176 -16.6  (63.50)
Platelets, Year 7, Week 48, n=171 -14.3  (60.69)
Platelets, Year 8, Week 8, n=168 -11.5  (54.16)
Platelets, Year 8, Week 16, n=172 -15.0  (58.24)
Platelets, Year 8, Week 24, n=169 -11.0  (56.12)
Platelets, Year 8, Week 32, n=168 -13.9  (55.53)
Platelets, Year 8, Week 40, n=161 -12.0  (62.73)
Platelets, Year 8, Week 48, n=161 -8.9  (80.44)
Platelets, Year 9, Week 8, n=162 -8.4  (64.02)
Platelets, Year 9, Week 16, n=160 -11.7  (68.06)
Platelets, Year 9, Week 24, n=162 -13.6  (60.20)
Platelets, Year 9, Week 32, n=158 -16.8  (62.14)
Platelets, Year 9, Week 40, n=156 -13.4  (63.09)
Platelets, Year 9, Week 48, n=150 -13.0  (65.20)
Platelets, Year 10, Week 8, n=149 -10.9  (60.24)
Platelets, Year 10, Week 16, n=144 -9.7  (62.61)
Platelets, Year 10, Week 24, n=146 -9.7  (60.67)
Platelets, Year 10, Week 32, n=141 -10.6  (62.35)
Platelets, Year 10, Week 40, n=136 -9.5  (61.80)
Platelets, Year 10, Week 48, n=136 -11.7  (61.81)
Platelets, Year 11, Week 8, n=136 -8.4  (69.58)
Platelets, Year 11, Week 16, n=129 -6.4  (63.81)
Platelets, Year 11, Week 24, n=129 -6.7  (61.75)
Platelets, Year 11, Week 32, n=127 -3.0  (65.54)
Platelets, Year 11, Week 40, n=121 -5.8  (68.01)
Platelets, Year 11, Week 48, n=105 -7.8  (62.13)
Platelets, Year 12, Week 8, n=108 -4.1  (73.02)
Platelets, Year 12, Week 16, n=96 -10.6  (68.02)
Platelets, Year 12, Week 24, n=84 -11.5  (60.94)
Platelets, Year 12, Week 32, n=87 -5.7  (70.98)
Platelets, Year 12, Week 40, n=82 -10.7  (67.51)
Platelets, Year 12, Week 48, n=72 -8.7  (80.99)
Platelets, Year 13, Week 8, n=53 -8.6  (70.53)
Platelets, Year 13, Week 16, n=41 -6.2  (61.57)
Platelets, Year 13, Week 24, n=20 -7.1  (47.37)
Platelets, Year 13, Week 32, n=7 -6.7  (51.61)
Platelets, Year 13, Week 40, n=1 -29.0 [2]   (NA)
Platelets, Exit, n=236 8.4  (77.24)
Platelets, 8-Week Follow-up, n=217 8.2  (71.32)
Platelets, 24-Week Follow-up, n=194 4.0  (67.29)
[1]
No value as only one participant was analyzed
[2]
No value as only one participant was analyzed.
6.Primary Outcome
Title Change From Baseline in Erythrocytes at the Indicated Time Points
Hide Description Hematology parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in erythrocytes is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants 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.
Time Frame Baseline and approximately up to 13 years
Hide Outcome Measure Data
Hide Analysis Population Description
MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Arm/Group Title Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
Overall Number of Participants Analyzed 296
Mean (Standard Deviation)
Unit of Measure: 10^12 per liter
Erythrocytes, Year 1, Week 8, n=287 0.01  (0.313)
Erythrocytes, Year 1, Week 16, n=288 0.04  (0.361)
Erythrocytes, Year 1, Week 24, n=293 0.05  (0.309)
Erythrocytes, Year 1, Week 32, n=291 0.07  (0.301)
Erythrocytes, Year 1, Week 40, n=287 0.10  (0.321)
Erythrocytes, Year 1, Week 48, n=287 0.11  (0.338)
Erythrocytes, Year 2, Week 8, n=288 0.07  (0.339)
Erythrocytes, Year 2, Week 16, n=280 0.09  (0.320)
Erythrocytes, Year 2, Week 24, n=278 0.12  (0.331)
Erythrocytes, Year 2, Week 32, n=281 0.15  (0.331)
Erythrocytes, Year 2, Week 40, n=262 0.17  (0.330)
Erythrocytes, Year 2, Week 48, n=260 0.19  (0.336)
Erythrocytes, Year 3, Week 8, n=260 0.18  (0.331)
Erythrocytes, Year 3, Week 16, n=258 0.19  (0.347)
Erythrocytes, Year 3, Week 24, n=242 0.17  (0.384)
Erythrocytes, Year 3, Week 32, n=248 0.16  (0.356)
Erythrocytes, Year 3, Week 40, n=243 0.17  (0.369)
Erythrocytes, Year 3, Week 48, n=240 0.15  (0.368)
Erythrocytes, Year 4, Week 8, n=235 0.15  (0.392)
Erythrocytes, Year 4, Week 16, n=238 0.15  (0.367)
Erythrocytes, Year 4, Week 24, n=227 0.12  (0.363)
Erythrocytes, Year 4, Week 32, n=229 0.14  (0.394)
Erythrocytes, Year 4, Week 40, n=216 0.14  (0.383)
Erythrocytes, Year 4, Week 48, n=220 0.14  (0.420)
Erythrocytes, Year 5, Week 8, n=215 0.13  (0.435)
Erythrocytes, Year 5, Week 16, n=214 0.15  (0.432)
Erythrocytes, Year 5, Week 24, n=207 0.13  (0.426)
Erythrocytes, Year 5, Week 32, n=207 0.12  (0.430)
Erythrocytes, Year 5, Week 40, n=196 0.15  (0.417)
Erythrocytes, Year 5, Week 48, n=209 0.15  (0.420)
Erythrocytes, Year 6, Week 8, n=206 0.13  (0.441)
Erythrocytes, Year 6, Week 16, n=195 0.10  (0.448)
Erythrocytes, Year 6, Week 24, n=192 0.13  (0.380)
Erythrocytes, Year 6, Week 32, n=197 0.14  (0.420)
Erythrocytes, Year 6, Week 40, n=184 0.15  (0.430)
Erythrocytes, Year 6, Week 48, n=188 0.13  (0.401)
Erythrocytes, Year 7, Week 8, n=180 0.12  (0.397)
Erythrocytes, Year 7, Week 16, n=181 0.09  (0.407)
Erythrocytes, Year 7, Week 24, n=176 0.11  (0.390)
Erythrocytes, Year 7, Week 32, n=179 0.14  (0.395)
Erythrocytes, Year 7, Week 40, n=177 0.09  (0.391)
Erythrocytes, Year 7, Week 48, n=173 0.09  (0.394)
Erythrocytes, Year 8, Week 8, n=172 0.09  (0.378)
Erythrocytes, Year 8, Week 16, n=173 0.08  (0.368)
Erythrocytes, Year 8, Week 24, n=170 0.10  (0.388)
Erythrocytes, Year 8, Week 32, n=169 0.11  (0.373)
Erythrocytes, Year 8, Week 40, n=162 0.10  (0.415)
Erythrocytes, Year 8, Week 48, n=161 0.12  (0.411)
Erythrocytes, Year 9, Week 8, n=164 0.11  (0.402)
Erythrocytes, Year 9, Week 16, n=161 0.09  (0.396)
Erythrocytes, Year 9, Week 24, n=163 0.08  (0.387)
Erythrocytes, Year 9, Week 32, n=160 0.11  (0.409)
Erythrocytes, Year 9, Week 40, n=156 0.09  (0.407)
Erythrocytes, Year 9, Week 48, n=151 0.11  (0.431)
Erythrocytes, Year 10, Week 8, n=150 0.16  (0.442)
Erythrocytes, Year 10, Week 16, n=145 0.17  (0.411)
Erythrocytes, Year 10, Week 24, n=147 0.21  (0.427)
Erythrocytes, Year 10, Week 32, n=142 0.18  (0.419)
Erythrocytes, Year 10, Week 40, n=137 0.20  (0.417)
Erythrocytes, Year 10, Week 48, n=137 0.19  (0.429)
Erythrocytes, Year 11, Week 8, n=137 0.20  (0.430)
Erythrocytes, Year 11, Week 16, n=130 0.24  (0.422)
Erythrocytes, Year 11, Week 24, n=130 0.25  (0.436)
Erythrocytes, Year 11, Week 32, n=128 0.27  (0.410)
Erythrocytes, Year 11, Week 40, n=122 0.27  (0.426)
Erythrocytes, Year 11, Week 48, n=106 0.25  (0.426)
Erythrocytes, Year 12, Week 8, n=109 0.29  (0.422)
Erythrocytes, Year 12, Week 16, n=97 0.28  (0.435)
Erythrocytes, Year 12, Week 24, n=86 0.33  (0.483)
Erythrocytes, Year 12, Week 32, n=88 0.26  (0.512)
Erythrocytes, Year 12, Week 40, n=83 0.31  (0.428)
Erythrocytes, Year 12, Week 48, n=72 0.32  (0.467)
Erythrocytes, Year 13, Week 8, n=53 0.35  (0.400)
Erythrocytes, Year 13, Week 16, n=42 0.34  (0.387)
Erythrocytes, Year 13, Week 24, n=20 0.30  (0.407)
Erythrocytes, Year 13, Week 32, n=7 0.20  (0.379)
Erythrocytes, Year 13, Week 40, n=1 0.30 [1]   (NA)
Erythrocytes, Exit, n=241 0.27  (0.473)
Erythrocytes, 8-Week Follow-up, n=220 0.28  (0.478)
Erythrocytes, 24-Week Follow-up , n=198 0.33  (0.539)
[1]
No value as only one participant was analyzed.
7.Primary Outcome
Title Change From Baseline in Hematocrit at the Indicated Time Points
Hide Description Hematology parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in hematocrit is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants 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.
Time Frame Baseline and approximately up to 13 years
Hide Outcome Measure Data
Hide Analysis Population Description
MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Arm/Group Title Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
Overall Number of Participants Analyzed 296
Mean (Standard Deviation)
Unit of Measure: Percentage of blood by volume
Hematocrit, Year 1, Week 8, n=287 0.11  (2.908)
Hematocrit, Year 1, Week 16, n=288 0.23  (3.109)
Hematocrit, Year 1, Week 24, n=293 0.28  (2.917)
Hematocrit, Year 1, Week 32, n=291 0.44  (2.973)
Hematocrit, Year 1, Week 40, n=287 0.60  (3.199)
Hematocrit, Year 1, Week 48, n=287 0.84  (3.431)
Hematocrit, Year 2, Week 8, n=288 0.67  (3.415)
Hematocrit, Year 2, Week 16, n=280 0.93  (3.332)
Hematocrit, Year 2, Week 24, n=278 0.96  (3.435)
Hematocrit, Year 2, Week 32, n=281 1.34  (3.496)
Hematocrit, Year 2, Week 40, n=262 1.43  (3.476)
Hematocrit, Year 2, Week 48, n=260 1.65  (3.444)
Hematocrit, Year 3, Week 8, n=260 1.54  (3.453)
Hematocrit, Year 3, Week 16, n=258 1.76  (3.508)
Hematocrit, Year 3, Week 24, n=242 1.68  (3.709)
Hematocrit, Year 3, Week 32, n=248 1.55  (3.676)
Hematocrit, Year 3, Week 40, n=243 1.55  (3.703)
Hematocrit, Year 3, Week 48, n=240 1.26  (3.726)
Hematocrit, Year 4, Week 8, n=235 1.33  (3.908)
Hematocrit, Year 4, Week 16, n=238 1.37  (3.759)
Hematocrit, Year 4, Week 24, n=227 1.27  (3.680)
Hematocrit, Year 4, Week 32, n=229 1.34  (3.955)
Hematocrit, Year 4, Week 40, n=216 1.39  (3.779)
Hematocrit, Year 4, Week 48, n=220 1.37  (4.033)
Hematocrit, Year 5, Week 8, n=215 1.27  (4.031)
Hematocrit, Year 5, Week 16, n=214 1.58  (3.917)
Hematocrit, Year 5, Week 24, n=207 1.45  (3.905)
Hematocrit, Year 5, Week 32, n=207 1.39  (3.979)
Hematocrit, Year 5, Week 40, n=196 1.59  (4.031)
Hematocrit, Year 5, Week 48, n=209 1.35  (3.929)
Hematocrit, Year 6, Week 8, n=206 1.24  (4.128)
Hematocrit, Year 6, Week 16, n=195 1.07  (4.114)
Hematocrit, Year 6, Week 24, n=192 1.43  (3.648)
Hematocrit, Year 6, Week 32, n=197 1.77  (3.822)
Hematocrit, Year 6, Week 40, n=184 2.07  (4.089)
Hematocrit, Year 6, Week 48, n=188 2.02  (3.961)
Hematocrit, Year 7, Week 8, n=180 1.80  (3.808)
Hematocrit, Year 7, Week 16, n=181 1.50  (3.883)
Hematocrit, Year 7, Week 24, n=176 1.88  (3.840)
Hematocrit, Year 7, Week 32, n=179 2.25  (3.824)
Hematocrit, Year 7, Week 40, n=177 2.07  (3.907)
Hematocrit, Year 7, Week 48, n=173 1.97  (3.958)
Hematocrit, Year 8, Week 8, n=172 1.89  (3.909)
Hematocrit, Year 8, Week 16, n=173 1.87  (3.729)
Hematocrit, Year 8, Week 24, n=170 2.12  (4.065)
Hematocrit, Year 8, Week 32, n=169 2.20  (3.954)
Hematocrit, Year 8, Week 40, n=162 2.10  (4.122)
Hematocrit, Year 8, Week 48, n=161 2.18  (4.029)
Hematocrit, Year 9, Week 8, n=164 1.99  (3.995)
Hematocrit, Year 9, Week 16, n=161 1.76  (4.114)
Hematocrit, Year 9, Week 24, n=163 1.70  (4.020)
Hematocrit, Year 9, Week 32, n=160 1.95  (4.171)
Hematocrit, Year 9, Week 40, n=156 1.88  (4.302)
Hematocrit, Year 9, Week 48, n=151 2.32  (4.174)
Hematocrit, Year 10, Week 8, n=150 2.87  (4.087)
Hematocrit, Year 10, Week 16, n=145 2.80  (4.050)
Hematocrit, Year 10, Week 24, n=147 2.94  (4.046)
Hematocrit, Year 10, Week 32, n=142 2.78  (4.046)
Hematocrit, Year 10, Week 40, n=137 2.95  (3.884)
Hematocrit, Year 10, Week 48, n=137 3.00  (4.245)
Hematocrit, Year 11, Week 8, n=137 3.04  (4.176)
Hematocrit, Year 11, Week 16, n=130 3.20  (4.155)
Hematocrit, Year 11, Week 24, n=130 2.93  (4.331)
Hematocrit, Year 11, Week 32, n=128 3.06  (3.976)
Hematocrit, Year 11, Week 40, n=122 3.15  (4.098)
Hematocrit, Year 11, Week 48, n=106 2.93  (4.356)
Hematocrit, Year 12, Week 8, n=109 3.12  (4.223)
Hematocrit, Year 12, Week 16, n=97 3.43  (4.321)
Hematocrit, Year 12, Week 24, n=86 3.74  (4.867)
Hematocrit, Year 12, Week 32, n=88 2.99  (4.826)
Hematocrit, Year 12, Week 40, n=83 3.57  (4.377)
Hematocrit, Year 12, Week 48, n=72 3.88  (4.439)
Hematocrit, Year 13, Week 8, n=53 4.20  (3.776)
Hematocrit, Year 13, Week 16, n=42 4.26  (3.803)
Hematocrit, Year 13, Week 24, n=20 3.81  (3.930)
Hematocrit, Year 13, Week 32, n=7 3.26  (4.547)
Hematocrit, Year 13, Week 40, n=1 2.20 [1]   (NA)
Hematocrit, Exit, n=241 3.35  (4.596)
Hematocrit, 8-Week Follow-up, n=220 3.46  (4.690)
Hematocrit, 24-Week Follow-up , n=198 3.51  (4.627)
[1]
No value as only one participant was analyzed.
8.Primary Outcome
Title Change From Baseline in Hemoglobin at the Indicated Time Points
Hide Description Hematology parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in hemoglobin is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants 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.
Time Frame Baseline and approximately up to 13 years
Hide Outcome Measure Data
Hide Analysis Population Description
MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Arm/Group Title Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
Overall Number of Participants Analyzed 296
Mean (Standard Deviation)
Unit of Measure: grams per liter
Hemoglobin, Year 1, Week 8, n=287 0.1  (9.42)
Hemoglobin, Year 1, Week 16, n=288 0.6  (10.60)
Hemoglobin, Year 1, Week 24, n=293 1.5  (9.86)
Hemoglobin, Year 1, Week 32, n=291 2.2  (10.37)
Hemoglobin, Year 1, Week 40, n=287 2.8  (10.84)
Hemoglobin, Year 1, Week 48, n=287 2.9  (11.39)
Hemoglobin, Year 2, Week 8, n=288 2.2  (11.62)
Hemoglobin, Year 2, Week 16, n=280 2.8  (11.54)
Hemoglobin, Year 2, Week 24, n=278 3.2  (12.20)
Hemoglobin, Year 2, Week 32, n=281 4.5  (12.19)
Hemoglobin, Year 2, Week 40, n=262 4.9  (12.15)
Hemoglobin, Year 2, Week 48, n=260 5.6  (12.10)
Hemoglobin, Year 3, Week 8, n=260 4.8  (12.01)
Hemoglobin, Year 3, Week 16, n=258 5.2  (12.15)
Hemoglobin, Year 3, Week 24, n=242 5.4  (12.47)
Hemoglobin, Year 3, Week 32, n=248 5.6  (12.59)
Hemoglobin, Year 3, Week 40, n=243 5.9  (12.90)
Hemoglobin, Year 3, Week 48, n=240 5.1  (12.97)
Hemoglobin, Year 4, Week 8, n=235 5.2  (13.49)
Hemoglobin, Year 4, Week 16, n=238 5.2  (13.11)
Hemoglobin, Year 4, Week 24, n=227 4.1  (13.05)
Hemoglobin, Year 4, Week 32, n=229 4.9  (13.64)
Hemoglobin, Year 4, Week 40, n=216 4.9  (13.25)
Hemoglobin, Year 4, Week 48, n=220 5.3  (13.94)
Hemoglobin, Year 5, Week 8, n=215 5.1  (14.20)
Hemoglobin, Year 5, Week 16, n=214 5.5  (13.44)
Hemoglobin, Year 5, Week 24, n=207 4.4  (13.73)
Hemoglobin, Year 5, Week 32, n=207 4.1  (13.39)
Hemoglobin, Year 5, Week 40, n=196 5.2  (14.31)
Hemoglobin, Year 5, Week 48, n=209 5.4  (14.20)
Hemoglobin, Year 6, Week 8, n=206 5.5  (14.72)
Hemoglobin, Year 6, Week 16, n=195 4.8  (14.82)
Hemoglobin, Year 6, Week 24, n=192 5.6  (12.80)
Hemoglobin, Year 6, Week 32, n=197 5.9  (13.12)
Hemoglobin, Year 6, Week 40, n=184 6.6  (13.96)
Hemoglobin, Year 6, Week 48, n=188 6.4  (13.78)
Hemoglobin, Year 7, Week 8, n=180 6.3  (13.58)
Hemoglobin, Year 7, Week 16, n=181 5.5  (13.83)
Hemoglobin, Year 7, Week 24, n=176 6.0  (13.51)
Hemoglobin, Year 7, Week 32, n=179 7.0  (13.37)
Hemoglobin, Year 7, Week 40, n=177 6.4  (13.61)
Hemoglobin, Year 7, Week 48, n=173 5.6  (13.91)
Hemoglobin, Year 8, Week 8, n=172 5.7  (13.69)
Hemoglobin, Year 8, Week 16, n=173 5.3  (13.09)
Hemoglobin, Year 8, Week 24, n=170 6.1  (14.13)
Hemoglobin, Year 8, Week 32, n=169 5.8  (13.33)
Hemoglobin, Year 8, Week 40, n=162 4.9  (13.93)
Hemoglobin, Year 8, Week 48, n=161 5.5  (13.95)
Hemoglobin, Year 9, Week 8, n=164 5.5  (13.79)
Hemoglobin, Year 9, Week 16, n=161 4.9  (14.60)
Hemoglobin, Year 9, Week 24, n=163 4.6  (14.32)
Hemoglobin, Year 9, Week 32, n=160 5.2  (14.39)
Hemoglobin, Year 9, Week 40, n=156 3.9  (15.20)
Hemoglobin, Year 9, Week 48, n=151 4.8  (14.50)
Hemoglobin, Year 10, Week 8, n=150 6.5  (14.46)
Hemoglobin, Year 10, Week 16, n=145 6.5  (14.05)
Hemoglobin, Year 10, Week 24, n=147 6.5  (14.20)
Hemoglobin, Year 10, Week 32, n=142 5.9  (14.02)
Hemoglobin, Year 10, Week 40, n=137 6.0  (13.29)
Hemoglobin, Year 10, Week 48, n=137 5.7  (14.86)
Hemoglobin, Year 11, Week 8, n=137 5.9  (14.40)
Hemoglobin, Year 11, Week 16, n=130 6.4  (14.50)
Hemoglobin, Year 11, Week 24, n=130 5.9  (15.02)
Hemoglobin, Year 11, Week 32, n=128 6.3  (13.79)
Hemoglobin, Year 11, Week 40, n=122 6.7  (14.03)
Hemoglobin, Year 11, Week 48, n=106 6.2  (14.95)
Hemoglobin, Year 12, Week 8, n=109 6.8  (14.55)
Hemoglobin, Year 12, Week 16, n=97 8.1  (15.12)
Hemoglobin, Year 12, Week 24, n=86 8.9  (16.83)
Hemoglobin, Year 12, Week 32, n=88 6.6  (17.18)
Hemoglobin, Year 12, Week 40, n=83 7.0  (15.41)
Hemoglobin, Year 12, Week 48, n=72 8.3  (14.80)
Hemoglobin, Year 13, Week 8, n=53 8.4  (12.37)
Hemoglobin, Year 13, Week 16, n=42 8.0  (12.81)
Hemoglobin, Year 13, Week 24, n=20 6.3  (12.01)
Hemoglobin, Year 13, Week 32, n=7 5.4  (14.27)
Hemoglobin, Year 13, Week 40, n=1 3.0 [1]   (NA)
Hemoglobin, Exit, n=241 7.4  (15.11)
Hemoglobin, 8-Week Follow-up, n=220 6.7  (15.46)
Hemoglobin, 24-Week Follow-up , n=198 6.8  (14.91)
[1]
No value as only one participant was analyzed.
9.Primary Outcome
Title Change From Baseline in Albumin and Protein at the Indicated Time Points
Hide Description Clinical chemistry parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in albumin and protein is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants 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.
Time Frame Baseline and approximately up to 13 years
Hide Outcome Measure Data
Hide Analysis Population Description
MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Arm/Group Title Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
Overall Number of Participants Analyzed 296
Mean (Standard Deviation)
Unit of Measure: grams/liter
Albumin, Year 1, Week 8, n=284 0.1  (2.36)
Albumin, Year 1, Week 16, n=286 -0.2  (2.68)
Albumin, Year 1, Week 24, n=292 0.2  (2.74)
Albumin, Year 1, Week 32, n=287 0.1  (2.91)
Albumin, Year 1, Week 40, n=284 0.2  (3.06)
Albumin, Year 1, Week 48, n=287 0.3  (3.21)
Albumin, Year 2, Week 8, n=288 0.4  (2.84)
Albumin, Year 2, Week 16, n=278 0.4  (2.95)
Albumin, Year 2, Week 24, n=273 0.1  (3.17)
Albumin, Year 2, Week 32, n=284 0.7  (3.08)
Albumin, Year 2, Week 40, n=264 0.8  (2.92)
Albumin, Year 2, Week 48, n=269 1.1  (3.25)
Albumin, Year 3, Week 8, n=265 0.7  (3.39)
Albumin, Year 3, Week 16, n=260 1.0  (3.05)
Albumin, Year 3, Week 24, n=244 1.2  (3.23)
Albumin, Year 3, Week 32, n=249 1.3  (3.13)
Albumin, Year 3, Week 40, n=245 1.4  (3.11)
Albumin, Year 3, Week 48, n=244 1.5  (3.12)
Albumin, Year 4, Week 8, n=239 1.4  (3.36)
Albumin, Year 4, Week 16, n=238 1.3  (3.21)
Albumin, Year 4, Week 24, n=227 1.2  (3.15)
Albumin, Year 4, Week 32, n=233 1.3  (3.31)
Albumin, Year 4, Week 40, n=220 1.2  (3.29)
Albumin, Year 4, Week 48, n=218 1.6  (3.57)
Albumin, Year 5, Week 8, n=218 1.6  (3.37)
Albumin, Year 5, Week 16, n=214 1.5  (3.07)
Albumin, Year 5, Week 24, n=211 1.5  (3.36)
Albumin, Year 5, Week 32, n=211 1.9  (3.34)
Albumin, Year 5, Week 40, n=198 1.8  (3.40)
Albumin, Year 5, Week 48, n=207 1.7  (3.41)
Albumin, Year 6, Week 8, n=206 1.8  (3.27)
Albumin, Year 6, Week 16, n=198 1.5  (3.72)
Albumin, Year 6, Week 24, n=190 1.6  (3.32)
Albumin, Year 6, Week 32, n=193 2.0  (3.71)
Albumin, Year 6, Week 40, n=185 1.9  (3.52)
Albumin, Year 6, Week 48, n=186 1.9  (3.64)
Albumin, Year 7, Week 8, n=179 1.9  (3.36)
Albumin, Year 7, Week 16, n=179 1.7  (3.57)
Albumin, Year 7, Week 24, n=173 1.7  (3.88)
Albumin, Year 7, Week 32, n=180 1.9  (3.53)
Albumin, Year 7, Week 40, n=175 1.6  (3.41)
Albumin, Year 7, Week 48, n=175 1.6  (3.60)
Albumin, Year 8, Week 8, n=171 1.7  (3.61)
Albumin, Year 8, Week 16, n=170 1.5  (3.31)
Albumin, Year 8, Week 24, n=168 1.6  (3.47)
Albumin, Year 8, Week 32, n=168 1.7  (3.25)
Albumin, Year 8, Week 40, n=162 1.3  (3.46)
Albumin, Year 8, Week 48, n=159 1.7  (3.56)
Albumin, Year 9, Week 8, n=164 2.0  (3.97)
Albumin, Year 9, Week 16, n=162 1.9  (3.58)
Albumin, Year 9, Week 24, n=161 1.6  (3.38)
Albumin, Year 9, Week 32, n=163 1.9  (3.27)
Albumin, Year 9, Week 40, n=156 1.6  (3.54)
Albumin, Year 9, Week 48, n=151 1.9  (3.55)
Albumin, Year 10, Week 8, n=152 1.9  (3.64)
Albumin, Year 10, Week 16, n=143 2.1  (3.55)
Albumin, Year 10, Week 24, n=145 2.0  (3.85)
Albumin, Year 10, Week 32, n=142 2.1  (4.05)
Albumin, Year 10, Week 40, n=138 1.8  (3.78)
Albumin, Year 10, Week 48, n=135 2.0  (3.52)
Albumin, Year 11, Week 8, n=138 2.0  (3.74)
Albumin, Year 11, Week 16, n=128 2.2  (3.58)
Albumin, Year 11, Week 24, n=130 2.1  (3.87)
Albumin, Year 11, Week 32, n=125 1.8  (3.89)
Albumin, Year 11, Week 40, n=124 1.7  (3.69)
Albumin, Year 11, Week 48, n=108 1.8  (3.91)
Albumin, Year 12, Week 8, n=110 1.8  (3.43)
Albumin, Year 12, Week 16, n=97 1.9  (3.68)
Albumin, Year 12, Week 24, n=87 2.5  (4.01)
Albumin, Year 12, Week 32, n=84 1.9  (4.01)
Albumin, Year 12, Week 40, n=82 1.7  (3.76)
Albumin, Year 12, Week 48, n=72 2.1  (3.67)
Albumin, Year 13, Week 8, n=53 2.8  (3.68)
Albumin, Year 13, Week 16, n=42 2.3  (3.61)
Albumin, Year 13, Week 24, n=20 2.5  (3.30)
Albumin, Year 13, Week 32, n=7 1.1  (2.67)
Albumin, Year 13, Week 40, n=1 5.0 [1]   (NA)
Albumin, Exit, n=248 2.0  (4.02)
Albumin, 8-Week Follow-up, n=220 1.6  (3.92)
Albumin, 24-Week Follow-up , n=200 2.2  (4.24)
Protein, Year 1, Week 8, n=284 -1.3  (4.31)
Protein, Year 1, Week 16, n=286 -1.8  (4.63)
Protein, Year 1, Week 24, n=292 -1.5  (4.76)
Protein, Year 1, Week 32, n=287 -1.7  (4.69)
Protein, Year 1, Week 40, n=284 -1.6  (5.0)
Protein, Year 1, Week 48, n=287 -2.0  (5.01)
Protein, Year 2, Week 8, n=288 -2.1  (4.74)
Protein, Year 2, Week 16, n=278 -2.5  (4.66)
Protein, Year 2, Week 24, n=273 -2.9  (5.07)
Protein, Year 2, Week 32, n=284 -2.4  (5.13)
Protein, Year 2, Week 40, n=264 -2.4  (4.87)
Protein, Year 2, Week 48, n=269 -1.5  (5.18)
Protein, Year 3, Week 8, n=265 -2.2  (5.49)
Protein, Year 3, Week 16, n=260 -2.0  (5.19)
Protein, Year 3, Week 24, n=244 -1.9  (5.63)
Protein, Year 3, Week 32, n=249 -1.8  (5.19)
Protein, Year 3, Week 40, n=245 -1.6  (5.34)
Protein, Year 3, Week 48, n=244 -1.8  (5.16)
Protein, Year 4, Week 8, n=239 -2.1  (5.27)
Protein, Year 4, Week 16, n=238 -1.8  (4.93)
Protein, Year 4, Week 24, n=227 -2.5  (5.06)
Protein, Year 4, Week 32, n=233 -2.3  (5.02)
Protein, Year 4, Week 40, n=220 -2.8  (4.97)
Protein, Year 4, Week 48, n=218 -2.2  (5.44)
Protein, Year 5, Week 8, n=218 -2.5  (5.34)
Protein, Year 5, Week 16, n=214 -2.6  (5.09)
Protein, Year 5, Week 24, n=211 -3.2  (5.22)
Protein, Year 5, Week 32, n=211 -2.5  (5.05)
Protein, Year 5, Week 40, n=198 -2.9  (5.47)
Protein, Year 5, Week 48, n=207 -2.8  (5.67)
Protein, Year 6, Week 8, n=206 -3.1  (5.39)
Protein, Year 6, Week 16, n=198 -3.4  (5.75)
Protein, Year 6, Week 24, n=190 -3.5  (5.6)
Protein, Year 6, Week 32, n=193 -3.0  (5.77)
Protein, Year 6, Week 40, n=185 -3.4  (5.84)
Protein, Year 6, Week 48, n=186 -3.5  (6.0)
Protein, Year 7, Week 8, n=179 -3.6  (5.52)
Protein, Year 7, Week 16, n=179 -4.1  (5.87)
Protein, Year 7, Week 24, n=173 -3.9  (5.96)
Protein, Year 7, Week 32, n=180 -3.7  (5.68)
Protein, Year 7, Week 40, n=175 -4.2  (5.39)
Protein, Year 7, Week 48, n=175 -4.5  (5.6)
Protein, Year 8, Week 8, n=171 -4.6  (5.75)
Protein, Year 8, Week 16, n=170 -4.7  (5.37)
Protein, Year 8, Week 24, n=168 -4.7  (5.54)
Protein, Year 8, Week 32, n=168 -4.5  (5.46)
Protein, Year 8, Week 40, n=162 -5.2  (5.36)
Protein, Year 8, Week 48, n=159 -4.5  (5.3)
Protein, Year 9, Week 8, n=164 -4.5  (5.75)
Protein, Year 9, Week 16, n=162 -4.8  (5.34)
Protein, Year 9, Week 24, n=161 -5.0  (5.32)
Protein, Year 9, Week 32, n=163 -4.8  (5.18)
Protein, Year 9, Week 40, n=156 -5.4  (5.51)
Protein, Year 9, Week 48, n=151 -5.1  (5.6)
Protein, Year 10, Week 8, n=152 -5.2  (5.86)
Protein, Year 10, Week 16, n=143 -5.0  (5.79)
Protein, Year 10, Week 24, n=145 -5.2  (5.88)
Protein, Year 10, Week 32, n=142 -5.1  (5.98)
Protein, Year 10, Week 40, n=138 -5.4  (5.98)
Protein, Year 10, Week 48, n=135 -5.4  (5.62)
Protein, Year 11, Week 8, n=138 -5.4  (6.15)
Protein, Year 11, Week 16, n=128 -5.1  (5.51)
Protein, Year 11, Week 24, n=130 -5.1  (6.15)
Protein, Year 11, Week 32, n=125 -5.6  (6.12)
Protein, Year 11, Week 40, n=124 -5.6  (5.81)
Protein, Year 11, Week 48, n=108 -5.4  (6.42)
Protein, Year 12, Week 8, n=110 -5.0  (5.65)
Protein, Year 12, Week 16, n=97 -5.1  (5.86)
Protein, Year 12, Week 24, n=87 -4.6  (6.26)
Protein, Year 12, Week 32, n=84 -5.1  (5.82)
Protein, Year 12, Week 40, n=82 -5.7  (5.35)
Protein, Year 12, Week 48, n=72 -5.0  (5.86)
Protein, Year 13, Week 8, n=53 -4.8  (6.0)
Protein, Year 13, Week 16, n=42 -5.6  (6.04)
Protein, Year 13, Week 24, n=20 -4.4  (6.3)
Protein, Year 13, Week 32, n=7 -8.9  (5.08)
Protein, Year 13, Week 40, n=1 1.0 [1]   (NA)
Protein, Exit, n=248 -3.2  (6.12)
Protein, 8-Week Follow-up, n=220 -3.7  (6.39)
Protein, 24-Week Follow-up , n=200 -2.6  (6.72)
[1]
No value as only one participant was analyzed.
10.Primary Outcome
Title Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Hide Description Clinical chemistry parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in BUN, glucose, calcium, carbon dioxide, chloride, magnesium, phosphate, potassium and sodium is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants 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.
Time Frame Baseline and approximately up to 13 years
Hide Outcome Measure Data
Hide Analysis Population Description
MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Arm/Group Title Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
Overall Number of Participants Analyzed 296
Mean (Standard Deviation)
Unit of Measure: millimoles per liter
BUN, Year 1, Week 8, n=284 0.0189  (1.4412)
BUN, Year 1, Week 16, n=286 -0.0836  (1.4928)
BUN, Year 1, Week 24, n=292 -0.0281  (1.5612)
BUN, Year 1, Week 32, n=287 -0.0199  (1.4020)
BUN, Year 1, Week 40, n=284 -0.1823  (1.3626)
BUN, Year 1, Week 48, n=287 0.0224  (1.6607)
BUN, Year 2, Week 8, n=288 -0.0607  (1.5714)
BUN, Year 2, Week 16, n=278 -0.0796  (1.6220)
BUN, Year 2, Week 24, n=273 -0.0850  (1.6900)
BUN, Year 2, Week 32, n=284 -0.0779  (1.8263)
BUN, Year 2, Week 40, n=264 -0.1136  (1.7293)
BUN, Year 2, Week 48, n=269 -0.0571  (1.7035)
BUN, Year 3, Week 8, n=265 -0.0620  (1.6580)
BUN, Year 3, Week 16, n=260 -0.0357  (1.7963)
BUN, Year 3, Week 24, n=244 0.0775  (1.9949)
BUN, Year 3, Week 32, n=249 0.0129  (1.8758)
BUN, Year 3, Week 40, n=245 0.0903  (1.9922)
BUN, Year 3, Week 48, n=244 0.1346  (2.1131)
BUN, Year 4, Week 8, n=239 0.1658  (1.9076)
BUN, Year 4, Week 16, n=238 0.0900  (1.7799)
BUN, Year 4, Week 24, n=227 0.1258  (2.0386)
BUN, Year 4, Week 32, n=233 0.0812  (1.8611)
BUN, Year 4, Week 40, n=220 0.0325  (2.0164)
BUN, Year 4, Week 48, n=218 0.2948  (2.3008)
BUN, Year 5, Week 8, n=218 0.2047  (2.0007)
BUN, Year 5, Week 16, n=214 0.2669  (1.8316)
BUN, Year 5, Week 24, n=211 0.2064  (2.0558)
BUN, Year 5, Week 32, n=211 0.0558  (1.7962)
BUN, Year 5, Week 40, n=198 0.2632  (2.0944)
BUN, Year 5, Week 48, n=207 0.1794  (2.0505)
BUN, Year 6, Week 8, n=206 0.2773  (1.8758)
BUN, Year 6, Week 16, n=198 0.2632  (1.8983)
BUN, Year 6, Week 24, n=190 0.1447  (2.0291)
BUN, Year 6, Week 32, n=193 0.2960  (2.1213)
BUN, Year 6, Week 40, n=185 0.3184  (2.1795)
BUN, Year 6, Week 48, n=186 0.3647  (1.9359)
BUN, Year 7, Week 8, n=179 0.2852  (2.1528)
BUN, Year 7, Week 16, n=179 0.3191  (2.0398)
BUN, Year 7, Week 24, n=173 0.2683  (2.5539)
BUN, Year 7, Week 32, n=180 0.1686  (2.1547)
BUN, Year 7, Week 40, n=175 0.2285  (1.9007)
BUN, Year 7, Week 48, n=175 0.2326  (2.3098)
BUN, Year 8, Week 8, n=171 0.2234  (2.3330)
BUN, Year 8, Week 16, n=170 0.1932  (2.1219)
BUN, Year 8, Week 24, n=168 0.2189  (2.0413)
BUN, Year 8, Week 32, n=168 0.0680  (2.0995)
BUN, Year 8, Week 40, n=162 0.1234  (2.0504)
BUN, Year 8, Week 48, n=159 0.2560  (1.8494)
BUN, Year 9, Week 8, n=164 0.1197  (1.6667)
BUN, Year 9, Week 16, n=162 0.1719  (1.8226)
BUN, Year 9, Week 24, n=161 0.1397  (1.9255)
BUN, Year 9, Week 32, n=163 0.2979  (1.9020)
BUN, Year 9, Week 40, n=156 0.1304  (1.8027)
BUN, Year 9, Week 48, n=151 0.0804  (1.9432)
BUN, Year 10, Week 8, n=152 0.1973  (2.1517)
BUN, Year 10, Week 16, n=143 0.1098  (1.8916)
BUN, Year 10, Week 24, n=145 0.1847  (1.8330)
BUN, Year 10, Week 32, n=142 0.1911  (1.8808)
BUN, Year 10, Week 40, n=138 -0.0440  (1.8103)
BUN, Year 10, Week 48, n=135 0.0926  (1.8219)
BUN, Year 11, Week 8, n=138 0.1837  (2.0925)
BUN, Year 11, Week 16, n=128 0.1060  (1.9866)
BUN, Year 11, Week 24, n=130 0.1291  (1.8654)
BUN, Year 11, Week 32, n=125 0.0029  (1.7563)
BUN, Year 11, Week 40, n=124 0.0576  (1.9364)
BUN, Year 11, Week 48, n=108 -0.0926  (1.8134)
BUN, Year 12, Week 8, n=110 0.1266  (2.0325)
BUN, Year 12, Week 16, n=97 0.2687  (1.9561)
BUN, Year 12, Week 24, n=87 0.0780  (1.8996)
BUN, Year 12, Week 32, n=84 -0.2167  (1.6336)
BUN, Year 12, Week 40, n=82 -0.1741  (1.8725)
BUN, Year 12, Week 48, n=72 -0.0992  (1.8146)
BUN, Year 13, Week 8, n=53 0.0808  (1.7244)
BUN, Year 13, Week 16, n=42 0.5695  (1.6690)
BUN, Year 13, Week 24, n=20 0.1964  (1.0708)
BUN, Year 13, Week 32, n=7 -0.4590  (1.6961)
BUN, Year 13, Week 40, n=1 -1.7850 [1]   (NA)
BUN, Exit, n=248 0.2519  (2.3492)
BUN, 8-Week Follow-up, n=220 0.0471  (2.3709)
BUN, 24-Week Follow-up , n=200 -0.0268  (2.1652)
Glucose, Year 1, Week 8, n=284 -0.0264  (1.4683)
Glucose, Year 1, Week 16, n=286 0.0314  (1.5221)
Glucose, Year 1, Week 24, n=292 -0.0375  (1.6213)
Glucose, Year 1, Week 32, n=287 -0.0265  (1.6241)
Glucose, Year 1, Week 40, n=284 0.0031  (1.4590)
Glucose, Year 1, Week 48, n=287 0.0232  (1.8176)
Glucose, Year 2, Week 8, n=288 0.0168  (1.6196)
Glucose, Year 2, Week 16, n=278 0.0327  (1.6027)
Glucose, Year 2, Week 24, n=273 0.1194  (1.6450)
Glucose, Year 2, Week 32, n=284 0.0510  (1.4905)
Glucose, Year 2, Week 40, n=264 0.0639  (1.5995)
Glucose, Year 2, Week 48, n=269 0.0017  (1.6178)
Glucose, Year 3, Week 8, n=265 -0.0161  (1.3878)
Glucose, Year 3, Week 16, n=260 -0.1223  (1.5965)
Glucose, Year 3, Week 24, n=244 0.0348  (1.9713)
Glucose, Year 3, Week 32, n=249 -0.0887  (1.7057)
Glucose, Year 3, Week 40, n=245 -0.0242  (1.3532)
Glucose, Year 3, Week 48, n=244 -0.0271  (2.1535)
Glucose, Year 4, Week 8, n=239 -0.0451  (1.6912)
Glucose, Year 4, Week 16, n=238 -0.1199  (1.7495)
Glucose, Year 4, Week 24, n=227 -0.1142  (1.8087)
Glucose, Year 4, Week 32, n=233 0.0741  (1.7592)
Glucose, Year 4, Week 40, n=220 0.1204  (2.0200)
Glucose, Year 4, Week 48, n=218 -0.0410  (1.9212)
Glucose, Year 5, Week 8, n=218 0.1350  (1.8331)
Glucose, Year 5, Week 16, n=214 0.0999  (1.9373)
Glucose, Year 5, Week 24, n=211 0.2402  (1.7548)
Glucose, Year 5, Week 32, n=211 -0.0873  (1.5258)
Glucose, Year 5, Week 40, n=198 0.0535  (1.7957)
Glucose, Year 5, Week 48, n=207 -0.0107  (1.3758)
Glucose, Year 6, Week 8, n=206 0.0385  (2.0336)
Glucose, Year 6, Week 16, n=198 0.0112  (1.6676)
Glucose, Year 6, Week 24, n=190 0.0894  (2.1875)
Glucose, Year 6, Week 32, n=193 0.0380  (1.9025)
Glucose, Year 6, Week 40, n=185 0.0939  (1.9242)
Glucose, Year 6, Week 48, n=186 -0.0176  (1.7507)
Glucose, Year 7, Week 8, n=179 0.1098  (1.9999)
Glucose, Year 7, Week 16, n=179 0.0558  (2.0164)
Glucose, Year 7, Week 24, n=173 0.2118  (2.3731)
Glucose, Year 7, Week 32, n=180 0.1588  (1.6939)
Glucose, Year 7, Week 40, n=175 0.1380  (2.1777)
Glucose, Year 7, Week 48, n=175 0.0698  (1.9178)
Glucose, Year 8, Week 8, n=171 0.0217  (2.0227)
Glucose, Year 8, Week 16, n=170 0.0307  (1.9951)
Glucose, Year 8, Week 24, n=168 0.0430  (1.5670)
Glucose, Year 8, Week 32, n=168 0.2029  (2.1886)
Glucose, Year 8, Week 40, n=162 0.3481  (1.8895)
Glucose, Year 8, Week 48, n=159 0.2821  (2.3294)
Glucose, Year 9, Week 8, n=164 0.2065  (2.3063)
Glucose, Year 9, Week 16, n=162 0.2457  (2.2362)
Glucose, Year 9, Week 24, n=161 0.2065  (2.3096)
Glucose, Year 9, Week 32, n=163 0.1437  (1.7266)
Glucose, Year 9, Week 40, n=156 0.2619  (2.4664)
Glucose, Year 9, Week 48, n=151 0.3110  (1.7497)
Glucose, Year 10, Week 8, n=152 0.2184  (2.5367)
Glucose, Year 10, Week 16, n=143 0.2713  (2.2189)
Glucose, Year 10, Week 24, n=145 0.2695  (1.9119)
Glucose, Year 10, Week 32, n=142 0.0192  (2.0309)
Glucose, Year 10, Week 40, n=138 0.2277  (1.8718)
Glucose, Year 10, Week 48, n=135 0.2919  (2.2420)
Glucose, Year 11, Week 8, n=138 0.3524  (2.4257)
Glucose, Year 11, Week 16, n=128 0.1778  (2.4430)
Glucose, Year 11, Week 24, n=130 0.2818  (1.9155)
Glucose, Year 11, Week 32, n=125 0.2203  (2.2945)
Glucose, Year 11, Week 40, n=124 0.0877  (2.0564)
Glucose, Year 11, Week 48, n=108 0.1778  (2.2984)
Glucose, Year 12, Week 8, n=110 0.2861  (2.5700)
Glucose, Year 12, Week 16, n=97 0.0830  (2.1347)
Glucose, Year 12, Week 24, n=87 0.1448  (1.8433)
Glucose, Year 12, Week 32, n=84 -0.0886  (2.2813)
Glucose, Year 12, Week 40, n=82 0.3209  (1.4176)
Glucose, Year 12, Week 48, n=72 0.3870  (1.4519)
Glucose, Year 13, Week 8, n=53 0.3561  (1.1963)
Glucose, Year 13, Week 16, n=42 0.2498  (1.2196)
Glucose, Year 13, Week 24, n=20 0.4663  (1.6396)
Glucose, Year 13, Week 32, n=7 0.3727  (0.8144)
Glucose, Year 13, Week 40, n=1 -0.8326 [1]   (NA)
Glucose, Exit, n=248 0.1744  (1.9656)
Glucose, 8-Week Follow-up, n=220 0.2707  (1.5879)
Glucose, 24-Week Follow-up , n=200 0.3295  (2.1561)
Calcium, Year 1, Week 8, n=281 -0.0033  (0.1012)
Calcium, Year 1, Week 16, n=283 -0.0025  (0.1175)
Calcium, Year 1, Week 24, n=287 0.0156  (0.1036)
Calcium, Year 1, Week 32, n=283 0.0159  (0.1067)
Calcium, Year 1, Week 40, n=282 0.0203  (0.1102)
Calcium, Year 1, Week 48, n=284 0.0011  (0.1193)
Calcium, Year 2, Week 8, n=288 0.0010  (0.1093)
Calcium, Year 2, Week 16, n=276 -0.0080  (0.1104)
Calcium, Year 2, Week 24, n=269 -0.0180  (0.1171)
Calcium, Year 2, Week 32, n=284 -0.0131  (0.1120)
Calcium, Year 2, Week 40, n=261 -0.0071  (0.1091)
Calcium, Year 2, Week 48, n=267 -0.0081  (0.1158)
Calcium, Year 3, Week 8, n=262 -0.0273  (0.1291)
Calcium, Year 3, Week 16, n=258 -0.0189  (0.1102)
Calcium, Year 3, Week 24, n=241 -0.0205  (0.1165)
Calcium, Year 3, Week 32, n=245 -0.0205  (0.1044)
Calcium, Year 3, Week 40, n=242 -0.0121  (0.1122)
Calcium, Year 3, Week 48, n=239 -0.0156  (0.1112)
Calcium, Year 4, Week 8, n=237 -0.0183  (0.1147)
Calcium, Year 4, Week 16, n=235 -0.0264  (0.1118)
Calcium, Year 4, Week 24, n=225 -0.0250  (0.1140)
Calcium, Year 4, Week 32, n=230 -0.0221  (0.1074)
Calcium, Year 4, Week 40, n=218 -0.0220  (0.1105)
Calcium, Year 4, Week 48, n=214 -0.0192  (0.1162)
Calcium, Year 5, Week 8, n=217 -0.0297  (0.1112)
Calcium, Year 5, Week 16, n=213 -0.0274  (0.1149)
Calcium, Year 5, Week 24, n=206 -0.0292  (0.1179)
Calcium, Year 5, Week 32, n=211 -0.0104  (0.1132)
Calcium, Year 5, Week 40, n=196 -0.0140  (0.1166)
Calcium, Year 5, Week 48, n=207 -0.0036  (0.1133)
Calcium, Year 6, Week 8, n=205 -0.0127  (0.1086)
Calcium, Year 6, Week 16, n=198 -0.0263  (0.1269)
Calcium, Year 6, Week 24, n=189 -0.0037  (0.1155)
Calcium, Year 6, Week 32, n=192 -0.0044  (0.1150)
Calcium, Year 6, Week 40, n=181 -0.0123  (0.1068)
Calcium, Year 6, Week 48, n=186 -0.0025  (0.1107)
Calcium, Year 7, Week 8, n=177 -0.0162  (0.1076)
Calcium, Year 7, Week 16, n=178 -0.0175  (0.1217)
Calcium, Year 7, Week 24, n=171 -0.0163  (0.1169)
Calcium, Year 7, Week 32, n=179 -0.0114  (0.1097)
Calcium, Year 7, Week 40, n=172 -0.0144  (0.1111)
Calcium, Year 7, Week 48, n=175 -0.0234  (0.1058)
Calcium, Year 8, Week 8, n=170 -0.0203  (0.1144)
Calcium, Year 8, Week 16, n=169 -0.0176  (0.1099)
Calcium, Year 8, Week 24, n=167 -0.0121  (0.1047)
Calcium, Year 8, Week 32, n=166 -0.0153  (0.1015)
Calcium, Year 8, Week 40, n=161 -0.0254  (0.1111)
Calcium, Year 8, Week 48, n=159 -0.0210  (0.1138)
Calcium, Year 9, Week 8, n=163 -0.0167  (0.1283)
Calcium, Year 9, Week 16, n=160 -0.0198  (0.1181)
Calcium, Year 9, Week 24, n=160 -0.0253  (0.1231)
Calcium, Year 9, Week 32, n=162 -0.0205  (0.1150)
Calcium, Year 9, Week 40, n=156 -0.0157  (0.1246)
Calcium, Year 9, Week 48, n=150 -0.0075  (0.1116)
Calcium, Year 10, Week 8, n=151 -0.0114  (0.1050)
Calcium, Year 10, Week 16, n=143 0.0026  (0.1015)
Calcium, Year 10, Week 24, n=145 -0.0067  (0.1115)
Calcium, Year 10, Week 32, n=140 -0.0066  (0.1109)
Calcium, Year 10, Week 40, n=137 -0.0067  (0.1157)
Calcium, Year 10, Week 48, n=135 -0.0033  (0.1268)
Calcium, Year 11, Week 8, n=138 -0.0043  (0.1185)
Calcium, Year 11, Week 16, n=128 -0.0033  (0.1078)
Calcium, Year 11, Week 24, n=129 -0.0116  (0.1304)
Calcium, Year 11, Week 32, n=124 -0.0131  (0.1131)
Calcium, Year 11, Week 40, n=124 -0.0093  (0.1157)
Calcium, Year 11, Week 48, n=107 -0.0061  (0.1238)
Calcium, Year 12, Week 8, n=109 -0.0153  (0.1214)
Calcium, Year 12, Week 16, n=97 -0.0005  (0.1189)
Calcium, Year 12, Week 24, n=85 0.0220  (0.1251)
Calcium, Year 12, Week 32, n=84 0.0009  (0.1265)
Calcium, Year 12, Week 40, n=82 -0.0103  (0.1247)
Calcium, Year 12, Week 48, n=72 -0.0028  (0.1206)
Calcium, Year 13, Week 8, n=53 -0.0151  (0.1402)
Calcium, Year 13, Week 16, n=42 -0.0154  (0.1595)
Calcium, Year 13, Week 24, n=20 0.0037  (0.1435)
Calcium, Year 13, Week 32, n=7 -0.0784  (0.1234)
Calcium, Year 13, Week 40, n=1 0.0000 [1]   (NA)
Calcium, Exit, n=248 0.0141  (0.1239)
Calcium, 8-Week Follow-up, n=220 0.0082  (0.1152)
Calcium, 24-Week Follow-up , n=200 0.0181  (0.1211)
Carbon dioxide, Year 1, Week 8, n=281 0.2  (2.54)
Carbon dioxide, Year 1, Week 16, n=283 0.7  (2.73)
Carbon dioxide, Year 1, Week 24, n=287 0.9  (2.78)
Carbon dioxide, Year 1, Week 32, n=283 1.0  (2.51)
Carbon dioxide, Year 1, Week 40, n=282 1.0  (2.75)
Carbon dioxide, Year 1, Week 48, n=284 1.3  (2.71)
Carbon dioxide, Year 2, Week 8, n=288 1.0  (2.74)
Carbon dioxide, Year 2, Week 16, n=275 1.2  (2.74)
Carbon dioxide, Year 2, Week 24, n=269 1.2  (2.96)
Carbon dioxide, Year 2, Week 32, n=284 1.3  (2.77)
Carbon dioxide, Year 2, Week 40, n=261 1.1  (2.72)
Carbon dioxide, Year 2, Week 48, n=267 1.7  (3.02)
Carbon dioxide, Year 3, Week 8, n=262 1.3  (2.83)
Carbon dioxide, Year 3, Week 16, n=258 1.5  (2.95)
Carbon dioxide, Year 3, Week 24, n=241 1.0  (2.81)
Carbon dioxide, Year 3, Week 32, n=245 1.1  (2.96)
Carbon dioxide, Year 3, Week 40, n=242 1.0  (2.94)
Carbon dioxide, Year 3, Week 48, n=239 1.3  (3.29)
Carbon dioxide, Year 4, Week 8, n=237 1.1  (2.81)
Carbon dioxide, Year 4, Week 16, n=235 1.3  (3.04)
Carbon dioxide, Year 4, Week 24, n=225 1.0  (2.84)
Carbon dioxide, Year 4, Week 32, n=230 1.1  (2.90)
Carbon dioxide, Year 4, Week 40, n=218 1.2  (3.11)
Carbon dioxide, Year 4, Week 48, n=214 1.6  (3.17)
Carbon dioxide, Year 5, Week 8, n=217 1.4  (2.93)
Carbon dioxide, Year 5, Week 16, n=213 1.7  (2.93)
Carbon dioxide, Year 5, Week 24, n=206 1.4  (2.82)
Carbon dioxide, Year 5, Week 32, n=211 1.5  (2.98)
Carbon dioxide, Year 5, Week 40, n=196 1.5  (2.91)
Carbon dioxide, Year 5, Week 48, n=207 1.7  (2.82)
Carbon dioxide, Year 6, Week 8, n=205 1.8  (3.10)
Carbon dioxide, Year 6, Week 16, n=198 1.8  (2.94)
Carbon dioxide, Year 6, Week 24, n=189 1.7  (2.77)
Carbon dioxide, Year 6, Week 32, n=192 1.7  (2.82)
Carbon dioxide, Year 6, Week 40, n=181 1.8  (3.07)
Carbon dioxide, Year 6, Week 48, n=186 1.9  (2.97)
Carbon dioxide, Year 7, Week 8, n=177 1.8  (3.12)
Carbon dioxide, Year 7, Week 16, n=178 1.6  (3.11)
Carbon dioxide, Year 7, Week 24, n=171 1.6  (3.08)
Carbon dioxide, Year 7, Week 32, n=179 1.6  (3.10)
Carbon dioxide, Year 7, Week 40, n=172 1.6  (2.83)
Carbon dioxide, Year 7, Week 48, n=175 1.6  (2.97)
Carbon dioxide, Year 8, Week 8, n=170 1.5  (3.00)
Carbon dioxide, Year 8, Week 16, n=169 1.5  (3.17)
Carbon dioxide, Year 8, Week 24, n=167 1.5  (3.08)
Carbon dioxide, Year 8, Week 32, n=166 1.5  (3.27)
Carbon dioxide, Year 8, Week 40, n=161 1.6  (3.32)
Carbon dioxide, Year 8, Week 48, n=159 1.5  (3.25)
Carbon dioxide, Year 9, Week 8, n=163 1.1  (3.26)
Carbon dioxide, Year 9, Week 16, n=160 1.4  (3.08)
Carbon dioxide, Year 9, Week 24, n=160 1.1  (2.93)
Carbon dioxide, Year 9, Week 32, n=162 1.4  (3.13)
Carbon dioxide, Year 9, Week 40, n=156 1.0  (3.30)
Carbon dioxide, Year 9, Week 48, n=150 1.0  (3.16)
Carbon dioxide, Year 10, Week 8, n=151 1.1  (2.95)
Carbon dioxide, Year 10, Week 16, n=143 1.2  (3.14)
Carbon dioxide, Year 10, Week 24, n=145 1.0  (3.14)
Carbon dioxide, Year 10, Week 32, n=140 1.5  (3.12)
Carbon dioxide, Year 10, Week 40, n=137 1.5  (3.21)
Carbon dioxide, Year 10, Week 48, n=135 1.3  (3.03)
Carbon dioxide, Year 11, Week 8, n=138 1.0  (3.13)
Carbon dioxide, Year 11, Week 16, n=128 1.5  (3.04)
Carbon dioxide, Year 11, Week 24, n=129 1.5  (3.13)
Carbon dioxide, Year 11, Week 32, n=124 1.6  (2.99)
Carbon dioxide, Year 11, Week 40, n=124 1.7  (3.03)
Carbon dioxide, Year 11, Week 48, n=107 1.7  (3.10)
Carbon dioxide, Year 12, Week 8, n=109 1.1  (3.12)
Carbon dioxide, Year 12, Week 16, n=97 2.1  (3.05)
Carbon dioxide, Year 12, Week 24, n=85 2.0  (3.12)
Carbon dioxide, Year 12, Week 32, n=84 2.3  (3.58)
Carbon dioxide, Year 12, Week 40, n=82 2.0  (3.26)
Carbon dioxide, Year 12, Week 48, n=72 1.7  (3.39)
Carbon dioxide, Year 13, Week 8, n=53 1.6  (2.90)
Carbon dioxide, Year 13, Week 16, n=42 2.0  (2.76)
Carbon dioxide, Year 13, Week 24, n=20 2.5  (3.19)
Carbon dioxide, Year 13, Week 32, n=7 1.3  (3.59)
Carbon dioxide, Year 13, Week 40, n=1 4.0 [1]   (NA)
Carbon dioxide, Exit, n=248 1.8  (2.93)
Carbon dioxide, 8-Week Follow-up, n=220 1.8  (3.26)
Carbon dioxide, 24-Week Follow-up , n=200 1.8  (3.25)
Chloride, Year 1, Week 8, n=284 0.1  (2.52)
Chloride, Year 1, Week 16, n=286 0.4  (2.76)
Chloride, Year 1, Week 24, n=292 0.0  (2.64)
Chloride, Year 1, Week 32, n=287 0.0  (2.66)
Chloride, Year 1, Week 40, n=284 0.0  (2.74)
Chloride, Year 1, Week 48, n=287 0.4  (2.90)
Chloride, Year 2, Week 8, n=288 0.2  (2.77)
Chloride, Year 2, Week 16, n=278 0.4  (2.95)
Chloride, Year 2, Week 24, n=273 0.6  (2.82)
Chloride, Year 2, Week 32, n=284 0.4  (2.80)
Chloride, Year 2, Week 40, n=264 0.3  (3.05)
Chloride, Year 2, Week 48, n=269 0.2  (2.94)
Chloride, Year 3, Week 8, n=265 0.3  (3.07)
Chloride, Year 3, Week 16, n=260 0.0  (2.91)
Chloride, Year 3, Week 24, n=244 0.1  (2.93)
Chloride, Year 3, Week 32, n=249 -0.1  (2.99)
Chloride, Year 3, Week 40, n=245 -0.2  (2.87)
Chloride, Year 3, Week 48, n=244 -0.3  (3.29)
Chloride, Year 4, Week 8, n=239 -0.2  (2.93)
Chloride, Year 4, Week 16, n=238 -0.2  (3.16)
Chloride, Year 4, Week 24, n=227 0.1  (2.85)
Chloride, Year 4, Week 32, n=233 -0.3  (3.12)
Chloride, Year 4, Week 40, n=220 -0.4  (2.94)
Chloride, Year 4, Week 48, n=218 -0.3  (3.15)
Chloride, Year 5, Week 8, n=218 -0.1  (3.20)
Chloride, Year 5, Week 16, n=214 0.1  (2.80)
Chloride, Year 5, Week 24, n=211 0.2  (3.05)
Chloride, Year 5, Week 32, n=211 -0.2  (3.08)
Chloride, Year 5, Week 40, n=198 0.1  (2.97)
Chloride, Year 5, Week 48, n=207 -0.3  (3.00)
Chloride, Year 6, Week 8, n=206 -0.2  (3.11)
Chloride, Year 6, Week 16, n=198 -0.2  (3.23)
Chloride, Year 6, Week 24, n=190 -0.2  (3.11)
Chloride, Year 6, Week 32, n=193 -0.4  (3.31)
Chloride, Year 6, Week 40, n=185 -0.3  (3.25)
Chloride, Year 6, Week 48, n=186 -0.4  (3.07)
Chloride, Year 7, Week 8, n=179 -0.3  (2.95)
Chloride, Year 7, Week 16, n=179 -0.3  (3.10)
Chloride, Year 7, Week 24, n=173 -0.2  (3.18)
Chloride, Year 7, Week 32, n=180 -0.3  (4.06)
Chloride, Year 7, Week 40, n=175 -0.4  (3.32)
Chloride, Year 7, Week 48, n=175 -0.4  (3.24)
Chloride, Year 8, Week 8, n=171 -0.3  (3.46)
Chloride, Year 8, Week 16, n=170 -0.5  (3.75)
Chloride, Year 8, Week 24, n=168 -0.5  (3.37)
Chloride, Year 8, Week 32, n=168 -0.6  (3.30)
Chloride, Year 8, Week 40, n=162 -0.4  (3.26)
Chloride, Year 8, Week 48, n=159 -0.4  (3.49)
Chloride, Year 9, Week 8, n=164 -0.7  (3.36)
Chloride, Year 9, Week 16, n=162 -0.7  (3.26)
Chloride, Year 9, Week 24, n=161 -0.3  (3.21)
Chloride, Year 9, Week 32, n=163 -0.6  (3.43)
Chloride, Year 9, Week 40, n=156 -0.3  (3.72)
Chloride, Year 9, Week 48, n=151 -0.6  (3.76)
Chloride, Year 10, Week 8, n=152 -0.6  (3.61)
Chloride, Year 10, Week 16, n=143 -0.7  (3.59)
Chloride, Year 10, Week 24, n=145 -0.3  (3.87)
Chloride, Year 10, Week 32, n=142 -0.3  (3.72)
Chloride, Year 10, Week 40, n=138 -0.2  (3.18)
Chloride, Year 10, Week 48, n=135 -0.2  (3.48)
Chloride, Year 11, Week 8, n=138 -0.1  (3.28)
Chloride, Year 11, Week 16, n=128 -0.4  (3.41)
Chloride, Year 11, Week 24, n=130 -0.5  (3.39)
Chloride, Year 11, Week 32, n=125 -0.7  (3.69)
Chloride, Year 11, Week 40, n=124 -0.4  (3.22)
Chloride, Year 11, Week 48, n=108 -0.4  (3.33)
Chloride, Year 12, Week 8, n=110 -0.3  (3.51)
Chloride, Year 12, Week 16, n=97 -0.6  (3.23)
Chloride, Year 12, Week 24, n=87 -0.3  (3.18)
Chloride, Year 12, Week 32, n=84 -0.4  (3.01)
Chloride, Year 12, Week 40, n=82 -0.4  (3.32)
Chloride, Year 12, Week 48, n=72 -1.3  (3.09)
Chloride, Year 13, Week 8, n=53 -0.8  (3.31)
Chloride, Year 13, Week 16, n=42 -0.8  (3.00)
Chloride, Year 13, Week 24, n=20 0.0  (3.03)
Chloride, Year 13, Week 32, n=7 1.1  (3.13)
Chloride, Year 13, Week 40, n=1 0.0 [1]   (NA)
Chloride, Exit, n=248 -0.8  (3.38)
Chloride, 8-Week Follow-up, n=220 -0.8  (3.33)
Chloride, 24-Week Follow-up, n=200 -0.8  (3.52)
Magnesium, Year 1, Week 8, n=284 -0.003  (0.0646)
Magnesium, Year 1, Week 16, n=286 -0.006  (0.0707)
Magnesium, Year 1, Week 24, n=292 -0.002  (0.0660)
Magnesium, Year 1, Week 32, n=287 -0.007  (0.0680)
Magnesium, Year 1, Week 40, n=284 -0.007  (0.0657)
Magnesium, Year 1, Week 48, n=287 -0.017  (0.0724)
Magnesium, Year 2, Week 8, n=288 -0.016  (0.0694)
Magnesium, Year 2, Week 16, n=278 -0.015  (0.0723)
Magnesium, Year 2, Week 24, n=273 -0.020  (0.0704)
Magnesium, Year 2, Week 32, n=284 -0.018  (0.0642)
Magnesium, Year 2, Week 40, n=264 -0.018  (0.0699)
Magnesium, Year 2, Week 48, n=269 -0.021  (0.0720)
Magnesium, Year 3, Week 8, n=265 -0.029  (0.0709)
Magnesium, Year 3, Week 16, n=260 -0.027  (0.0672)
Magnesium, Year 3, Week 24, n=244 -0.040  (0.0646)
Magnesium, Year 3, Week 32, n=249 -0.042  (0.0742)
Magnesium, Year 3, Week 40, n=245 -0.054  (0.0712)
Magnesium, Year 3, Week 48, n=244 -0.051  (0.0724)
Magnesium, Year 4, Week 8, n=239 -0.052  (0.0692)
Magnesium, Year 4, Week 16, n=238 -0.049  (0.0764)
Magnesium, Year 4, Week 24, n=227 -0.046  (0.0720)
Magnesium, Year 4, Week 32, n=233 -0.049  (0.0709)
Magnesium, Year 4, Week 40, n=220 -0.053  (0.0702)
Magnesium, Year 4, Week 48, n=218 -0.050  (0.0757)
Magnesium, Year 5, Week 8, n=218 -0.052  (0.0676)
Magnesium, Year 5, Week 16, n=214 -0.054  (0.0633)
Magnesium, Year 5, Week 24, n=211 -0.062  (0.0648)
Magnesium, Year 5, Week 32, n=211 -0.068  (0.0700)
Magnesium, Year 5, Week 40, n=198 -0.063  (0.0709)
Magnesium, Year 5, Week 48, n=207 -0.067  (0.0754)
Magnesium, Year 6, Week 8, n=206 -0.059  (0.0724)
Magnesium, Year 6, Week 16, n=198 -0.067  (0.0786)
Magnesium, Year 6, Week 24, n=190 -0.065  (0.0724)
Magnesium, Year 6, Week 32, n=193 -0.063  (0.0712)
Magnesium, Year 6, Week 40, n=185 -0.060  (0.0750)
Magnesium, Year 6, Week 48, n=186 -0.068  (0.0721)
Magnesium, Year 7, Week 8, n=179 -0.052  (0.0746)
Magnesium, Year 7, Week 16, n=179 -0.058  (0.0711)
Magnesium, Year 7, Week 24, n=173 -0.056  (0.0712)
Magnesium, Year 7, Week 32, n=180 -0.054  (0.0747)
Magnesium, Year 7, Week 40, n=175 -0.050  (0.0826)
Magnesium, Year 7, Week 48, n=175 -0.057  (0.0772)
Magnesium, Year 8, Week 8, n=171 -0.052  (0.0761)
Magnesium, Year 8, Week 16, n=170 -0.060  (0.0748)
Magnesium, Year 8, Week 24, n=168 -0.051  (0.0739)
Magnesium, Year 8, Week 32, n=168 -0.055  (0.0777)
Magnesium, Year 8, Week 40, n=162 -0.050  (0.0737)
Magnesium, Year 8, Week 48, n=159 -0.047  (0.0788)
Magnesium, Year 9, Week 8, n=164 -0.049  (0.0793)
Magnesium, Year 9, Week 16, n=162 -0.047  (0.0776)
Magnesium, Year 9, Week 24, n=161 -0.052  (0.0825)
Magnesium, Year 9, Week 32, n=163 -0.052  (0.0771)
Magnesium, Year 9, Week 40, n=156 -0.048  (0.0840)
Magnesium, Year 9, Week 48, n=151 -0.056  (0.0771)
Magnesium, Year 10, Week 8, n=152 -0.050  (0.0795)
Magnesium, Year 10, Week 16, n=143 -0.054  (0.0772)
Magnesium, Year 10, Week 24, n=145 -0.055  (0.0770)
Magnesium, Year 10, Week 32, n=142 -0.050  (0.0750)
Magnesium, Year 10, Week 40, n=138 -0.055  (0.0798)
Magnesium, Year 10, Week 48, n=135 -0.055  (0.0825)
Magnesium, Year 11, Week 8, n=138 -0.057  (0.0823)
Magnesium, Year 11, Week 16, n=128 -0.055  (0.0809)
Magnesium, Year 11, Week 24, n=130 -0.055  (0.0810)
Magnesium, Year 11, Week 32, n=125 -0.055  (0.0889)
Magnesium, Year 11, Week 40, n=124 -0.044  (0.0842)
Magnesium, Year 11, Week 48, n=108 -0.057  (0.0800)
Magnesium, Year 12, Week 8, n=110 -0.041  (0.0855)
Magnesium, Year 12, Week 16, n=97 -0.047  (0.0797)
Magnesium, Year 12, Week 24, n=87 -0.040  (0.0846)
Magnesium, Year 12, Week 32, n=84 -0.056  (0.0808)
Magnesium, Year 12, Week 40, n=82 -0.049  (0.0909)
Magnesium, Year 12, Week 48, n=72 -0.047  (0.0809)
Magnesium, Year 13, Week 8, n=53 -0.045  (0.0834)
Magnesium, Year 13, Week 16, n=42 -0.046  (0.0752)
Magnesium, Year 13, Week 24, n=20 -0.055  (0.0776)
Magnesium, Year 13, Week 32, n=7 -0.050  (0.0500)
Magnesium, Year 13, Week 40, n=1 0.050 [1]   (NA)
Magnesium, Exit, n=248 -0.037  (0.0793)
Magnesium, 8-Week Follow-up, n=220 -0.037  (0.0794)
Magnesium, 24-Week Follow-up , n=200 -0.040  (0.0790)
Phosphate, Year 1, Week 8, n=284 -0.0259  (0.1980)
Phosphate, Year 1, Week 16, n=286 -0.0215  (0.1849)
Phosphate, Year 1, Week 24, n=292 -0.0001  (0.2023)
Phosphate, Year 1, Week 32, n=287 -0.0154  (0.1983)
Phosphate, Year 1, Week 40, n=284 -0.0024  (0.1913)
Phosphate, Year 1, Week 48, n=287 -0.0234  (0.1926)
Phosphate, Year 2, Week 8, n=288 -0.0185  (0.1959)
Phosphate, Year 2, Week 16, n=278 -0.0194  (0.2003)
Phosphate, Year 2, Week 24, n=273 -0.0209  (0.1991)
Phosphate, Year 2, Week 32, n=284 -0.0318  (0.2122)
Phosphate, Year 2, Week 40, n=264 -0.0297  (0.2103)
Phosphate, Year 2, Week 48, n=269 -0.0116  (0.2050)
Phosphate, Year 3, Week 8, n=265 -0.04112  (0.2073)
Phosphate, Year 3, Week 16, n=260 -0.0451  (0.2059)
Phosphate, Year 3, Week 24, n=244 -0.0639  (0.2068)
Phosphate, Year 3, Week 32, n=249 -0.0484  (0.2139)
Phosphate, Year 3, Week 40, n=245 -0.0583  (0.2190)
Phosphate, Year 3, Week 48, n=244 -0.0658  (0.2179)
Phosphate, Year 4, Week 8, n=239 -0.0621  (0.2103)
Phosphate, Year 4, Week 16, n=238 -0.0532  (0.2217)
Phosphate, Year 4, Week 24, n=227 -0.0700  (0.2106)
Phosphate, Year 4, Week 32, n=233 -0.0601  (0.2034)
Phosphate, Year 4, Week 40, n=220 -0.0710  (0.2098)
Phosphate, Year 4, Week 48, n=218 -0.0400  (0.2213)
Phosphate, Year 5, Week 8, n=218 -0.0529  (0.2222)
Phosphate, Year 5, Week 16, n=214 -0.0429  (0.2240)
Phosphate, Year 5, Week 24, n=211 -0.0502  (0.1996)
Phosphate, Year 5, Week 32, n=211 -0.0435  (0.2313)
Phosphate, Year 5, Week 40, n=198 -0.0452  (0.2147)
Phosphate, Year 5, Week 48, n=207 -0.0323  (0.2167)
Phosphate, Year 6, Week 8, n=206 -0.0417  (0.2246)
Phosphate, Year 6, Week 16, n=198 -0.0354  (0.2253)
Phosphate, Year 6, Week 24, n=190 -0.0262  (0.2326)
Phosphate, Year 6, Week 32, n=193 -0.0341  (0.2154)
Phosphate, Year 6, Week 40, n=185 -0.0086  (0.2179)
Phosphate, Year 6, Week 48, n=186 -0.0085  (0.2256)
Phosphate, Year 7, Week 8, n=179 -0.0316  (0.2254)
Phosphate, Year 7, Week 16, n=179 -0.0372  (0.1999)
Phosphate, Year 7, Week 24, n=173 -0.0390  (0.2099)
Phosphate, Year 7, Week 32, n=180 -0.0321  (0.2099)
Phosphate, Year 7, Week 40, n=175 -0.0138  (0.2146)
Phosphate, Year 7, Week 48, n=175 -0.0400  (0.2031)
Phosphate, Year 8, Week 8, n=171 -0.0453  (0.2135)
Phosphate, Year 8, Week 16, n=170 -0.0319  (0.2088)
Phosphate, Year 8, Week 24, n=168 -0.0450  (0.2136)
Phosphate, Year 8, Week 32, n=168 -0.0530  (0.2073)
Phosphate, Year 8, Week 40, n=162 -0.0429  (0.2341)
Phosphate, Year 8, Week 48, n=159 -0.0266  (0.2158)
Phosphate, Year 9, Week 8, n=164 -0.0329  (0.2133)
Phosphate, Year 9, Week 16, n=162 -0.0255  (0.2140)
Phosphate, Year 9, Week 24, n=161 -0.0327  (0.2372)
Phosphate, Year 9, Week 32, n=163 -0.0487  (0.2039)
Phosphate, Year 9, Week 40, n=156 -0.0230  (0.2123)
Phosphate, Year 9, Week 48, n=151 -0.0385  (0.2170)
Phosphate, Year 10, Week 8, n=152 -0.0310  (0.2136)
Phosphate, Year 10, Week 16, n=143 -0.0458  (0.2087)
Phosphate, Year 10, Week 24, n=145 -0.0307  (0.2130)
Phosphate, Year 10, Week 32, n=142 -0.0241  (0.2227)
Phosphate, Year 10, Week 40, n=138 -0.0459  (0.2184)
Phosphate, Year 10, Week 48, n=135 -0.0335  (0.2158)
Phosphate, Year 11, Week 8, n=138 -0.0314  (0.2311)
Phosphate, Year 11, Week 16, n=128 -0.0560  (0.2327)
Phosphate, Year 11, Week 24, n=130 -0.0365  (0.2371)
Phosphate, Year 11, Week 32, n=125 -0.0302  (0.2140)
Phosphate, Year 11, Week 40, n=124 -0.0370  (0.2215)
Phosphate, Year 11, Week 48, n=108 -0.0287  (0.2361)
Phosphate, Year 12, Week 8, n=110 -0.0470  (0.2230)
Phosphate, Year 12, Week 16, n=97 -0.0333  (0.2264)
Phosphate, Year 12, Week 24, n=87 -0.0238  (0.2169)
Phosphate, Year 12, Week 32, n=84 -0.0488  (0.2235)
Phosphate, Year 12, Week 40, n=82 -0.0555  (0.2188)
Phosphate, Year 12, Week 48, n=72 -0.0341  (0.2213)
Phosphate, Year 13, Week 8, n=53 -0.0804  (0.2002)
Phosphate, Year 13, Week 16, n=42 -0.0461  (0.2669)
Phosphate, Year 13, Week 24, n=20 0.0533  (0.1881)
Phosphate, Year 13, Week 32, n=7 0.0784  (0.2075)
Phosphate, Year 13, Week 40, n=1 -0.1615 [1]   (NA)
Phosphate, Exit, n=248 -0.0328  (0.2385)
Phosphate, 8-Week Follow-up, n=220 -0.0631  (0.2221)
Phosphate, 24-Week Follow-up , n=200 -0.0375  (0.2183)
Potassium, Year 1, Week 8, n=281 -0.01  (0.354)
Potassium, Year 1, Week 16, n=283 0.04  (0.394)
Potassium, Year 1, Week 24, n=287 0.04  (0.406)
Potassium, Year 1, Week 32, n=283 0.01  (0.381)
Potassium, Year 1, Week 40, n=282 0.03  (0.378)
Potassium, Year 1, Week 48, n=284 0.00  (0.406)
Potassium, Year 2, Week 8, n=288 0.00  (0.370)
Potassium, Year 2, Week 16, n=275 0.03  (0.385)
Potassium, Year 2, Week 24, n=269 0.02  (0.398)
Potassium, Year 2, Week 32, n=284 0.00  (0.397)
Potassium, Year 2, Week 40, n=261 0.04  (0.378)
Potassium, Year 2, Week 48, n=267 0.01  (0.386)
Potassium, Year 3, Week 8, n=262 0.00  (0.415)
Potassium, Year 3, Week 16, n=258 0.02  (0.413)
Potassium, Year 3, Week 24, n=241 0.02  (0.407)
Potassium, Year 3, Week 32, n=245 -0.02  (0.406)
Potassium, Year 3, Week 40, n=242 0.02  (0.428)
Potassium, Year 3, Week 48, n=239 0.00  (0.400)
Potassium, Year 4, Week 8, n=237 0.03  (0.414)
Potassium, Year 4, Week 16, n=236 0.00  (0.423)
Potassium, Year 4, Week 24, n=225 0.03  (0.400)
Potassium, Year 4, Week 32, n=230 0.02  (0.383)
Potassium, Year 4, Week 40, n=218 -0.02  (0.396)
Potassium, Year 4, Week 48, n=214 0.02  (0.391)
Potassium, Year 5, Week 8, n=217 0.01  (0.413)
Potassium, Year 5, Week 16, n=213 0.00  (0.390)
Potassium, Year 5, Week 24, n=206 0.03  (0.420)
Potassium, Year 5, Week 32, n=211 -0.01  (0.393)
Potassium, Year 5, Week 40, n=196 0.03  (0.416)
Potassium, Year 5, Week 48, n=207 -0.01  (0.375)
Potassium, Year 6, Week 8, n=205 -0.02  (0.424)
Potassium, Year 6, Week 16, n=198 -0.04  (0.429)
Potassium, Year 6, Week 24, n=189 0.00  (0.411)
Potassium, Year 6, Week 32, n=192 -0.02  (0.395)
Potassium, Year 6, Week 40, n=181 0.03  (0.435)
Potassium, Year 6, Week 48, n=186 -0.01  (0.388)
Potassium,Year 7, Week 8, n=177 0.00  (0.424)
Potassium, Year 7, Week 16, n=178 -0.02  (0.412)
Potassium, Year 7, Week 24, n=171 0.03  (0.388)
Potassium, Year 7, Week 32, n=179 0.02  (0.406)
Potassium, Year 7, Week 40, n=172 0.03  (0.453)
Potassium, Year 7, Week 48, n=175 -0.03  (0.403)
Potassium, Year 8, Week 8, n=170 -0.05  (0.426)
Potassium, Year 8, Week 16, n=169 -0.05  (0.455)
Potassium, Year 8, Week 24, n=167 0.00  (0.386)
Potassium, Year 8, Week 32, n=166 -0.06  (0.382)
Potassium, Year 8, Week 40, n=161 0.00  (0.401)
Potassium, Year 8, Week 48, n=159 -0.07  (0.377)
Potassium, Year 9, Week 8, n=163 -0.02  (0.448)
Potassium, Year 9, Week 16, n=160 -0.02  (0.385)
Potassium, Year 9, Week 24, n=160 -0.03  (0.391)
Potassium, Year 9, Week 32, n=162 -0.05  (0.391)
Potassium, Year 9, Week 40, n=156 -0.04  (0.447)
Potassium, Year 9, Week 48, n=150 -0.04  (0.432)
Potassium, Year 10, Week 8, n=151 -0.03  (0.417)
Potassium, Year 10, Week 16, n=143 -0.05  (0.415)
Potassium, Year 10, Week 24, n=145 0.00  (0.428)
Potassium, Year 10, Week 32, n=140 -0.03  (0.452)
Potassium, Year 10, Week 40, n=137 -0.02  (0.433)
Potassium, Year 10, Week 48, n=135 -0.02  (0.442)
Potassium, Year 11, Week 8, n=138 -0.03  (0.438)
Potassium, Year 11, Week 16, n=128 -0.04  (0.395)
Potassium, Year 11, Week 24, n=129 0.02  (0.433)
Potassium, Year 11, Week 32, n=124 -0.08  (0.399)
Potassium, Year 11, Week 40, n=124 -0.01  (0.383)
Potassium, Year 11, Week 48, n=107 0.01  (0.413)
Potassium, Year 12, Week 8, n=109 0.01  (0.422)
Potassium, Year 12, Week 16, n=97 -0.02  (0.433)
Potassium, Year 12, Week 24, n=85 0.00  (0.447)
Potassium, Year 12, Week 32, n=84 -0.06  (0.443)
Potassium, Year 12, Week 40, n=82 -0.02  (0.411)
Potassium, Year 12, Week 48, n=72 -0.06  (0.527)
Potassium, Year 13, Week 8, n=53 -0.14  (0.401)
Potassium, Year 13, Week 16, n=42 -0.09  (0.416)
Potassium, Year 13, Week 24, n=20 0.01  (0.525)
Potassium, Year 13, Week 32, n=7 -0.19  (0.389)
Potassium, Year 13, Week 40, n=1 0.60 [1]   (NA)
Potassium, Exit, n=248 0.03  (0.409)
Potassium, 8-Week Follow-up, n=220 0.01  (0.415)
Potassium, 24-Week Follow-up , n=200 0.02  (0.411)
Sodium, Year 1, Week 8, n=284 0.1  (2.76)
Sodium, Year 1, Week 16, n=286 0.2  (2.91)
Sodium, ,Year 1, Week 24, n=292 0.0  (2.78)
Sodium, Year 1, Week 32, n=287 0.0  (2.83)
Sodium, Year 1, Week 40, n=284 -0.2  (2.64)
Sodium, Year 1, Week 48, n=287 -0.1  (2.75)
Sodium, Year 2, Week 8, n=288 0.0  (2.64)
Sodium, Year 2, Week 16, n=278 0.1  (2.74)
Sodium, Year 2, Week 24, n=273 0.1  (2.72)
Sodium, Year 2, Week 32, n=284 -0.3  (2.79)
Sodium, Year 2, Week 40, n=264 -0.2  (2.67)
Sodium, Year 2, Week 48, n=269 -0.1  (2.86)
Sodium, Year 3, Week 8, n=265 -0.3  (2.81)
Sodium, Year 3, Week 16, n=260 -0.3  (2.90)
Sodium, Year 3, Week 24, n=244 -0.2  (2.76)
Sodium, Year 3, Week 32, n=249 -0.2  (2.74)
Sodium, Year 3, Week 40, n=245 -0.2  (2.77)
Sodium, Year 3, Week 48, n=244 -0.3  (2.91)
Sodium, Year 4, Week 8, n=239 -0.2  (2.72)
Sodium, Year 4, Week 16, n=238 -0.2  (2.71)
Sodium, Year 4, Week 24, n=227 -0.1  (2.64)
Sodium, Year 4, Week 32, n=233 -0.2  (2.57)
Sodium, Year 4, Week 40, n=220 -0.1  (2.55)
Sodium, Year 4, Week 48, n=218 -0.1  (2.64)
Sodium, Year 5, Week 8, n=218 -0.1  (2.85)
Sodium, Year 5, Week 16, n=214 -0.1  (2.60)
Sodium, Year 5, Week 24, n=211 0.0  (2.92)
Sodium, Year 5, Week 32, n=211 -0.1  (2.74)
Sodium, Year 5, Week 40, n=198 0.1  (3.04)
Sodium, Year 5, Week 48, n=207 -0.3  (2.90)
Sodium, Year 6, Week 8, n=206 -0.1  (2.96)
Sodium, Year 6, Week 16, n=198 -0.3  (2.85)
Sodium, Year 6, Week 24, n=190 -0.3  (2.90)
Sodium, Year 6, Week 32, n=193 -0.3  (2.90)
Sodium, Year 6, Week 40, n=185 -0.3  (2.91)
Sodium, Year 6, Week 48, n=186 -0.4  (2.77)
Sodium,Year 7, Week 8, n=179 -0.4  (2.90)
Sodium, Year 7, Week 16, n=179 -0.5  (2.86)
Sodium, Year 7, Week 24, n=173 -0.5  (2.86)
Sodium, Year 7, Week 32, n=180 -0.4  (4.24)
Sodium, Year 7, Week 40, n=175 -0.2  (2.98)
Sodium, Year 7, Week 48, n=175 -0.5  (3.01)
Sodium, Year 8, Week 8, n=171 -0.2  (2.96)
Sodium, Year 8, Week 16, n=170 -0.3  (3.22)
Sodium, Year 8, Week 24, n=168 -0.3  (2.79)
Sodium, Year 8, Week 32, n=168 -0.5  (3.01)
Sodium, Year 8, Week 40, n=162 -0.3  (2.94)
Sodium, Year 8, Week 48, n=159 -0.3  (2.88)
Sodium, Year 9, Week 8, n=164 -0.4  (2.94)
Sodium, Year 9, Week 16, n=162 -0.4  (3.14)
Sodium, Year 9, Week 24, n=161 -0.3  (3.05)
Sodium, Year 9, Week 32, n=163 -0.7  (2.94)
Sodium, Year 9, Week 40, n=156 -0.4  (3.13)
Sodium, Year 9, Week 48, n=151 -0.6  (3.22)
Sodium, Year 10, Week 8, n=152 -0.5  (3.25)
Sodium, Year 10, Week 16, n=143 -0.3  (3.31)
Sodium, Year 10, Week 24, n=145 -0.4  (3.56)
Sodium, Year 10, Week 32, n=142 -0.2  (3.15)
Sodium, Year 10, Week 40, n=138 -0.1  (2.80)
Sodium, Year 10, Week 48, n=135 -0.4  (3.26)
Sodium, Year 11, Week 8, n=138 -0.2  (3.21)
Sodium, Year 11, Week 16, n=128 -0.5  (3.30)
Sodium, Year 11, Week 24, n=130 -0.4  (3.27)
Sodium, Year 11, Week 32, n=125 -0.6  (3.19)
Sodium, Year 11, Week 40, n=124 -0.5  (3.25)
Sodium, Year 11, Week 48, n=108 -0.7  (3.16)
Sodium, Year 12, Week 8, n=110 -0.9  (3.07)
Sodium, Year 12, Week 16, n=97 -0.7  (3.12)
Sodium, Year 12, Week 24, n=87 -0.1  (3.26)
Sodium, Year 12, Week 32, n=84 -0.3  (2.91)
Sodium, Year 12, Week 40, n=82 -0.5  (3.18)
Sodium, Year 12, Week 48, n=72 -1.1  (2.98)
Sodium, Year 13, Week 8, n=53 -0.3  (3.04)
Sodium, Year 13, Week 16, n=42 -0.3  (2.68)
Sodium, Year 13, Week 24, n=20 0.2  (3.47)
Sodium, Year 13, Week 32, n=7 0.0  (3.21)
Sodium, Year 13, Week 40, n=1 2.0 [1]   (NA)
Sodium, Exit, n=248 -0.7  (2.96)
Sodium, 8-Week Follow-up, n=220 -0.5  (3.06)
Sodium, 24-Week Follow-up , n=200 -0.3  (3.16)
[1]
No value as only one participant was analyzed.
11.Primary Outcome
Title Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Hide Description Clinical chemistry parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in creatinine, urate, and bilirubin is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants 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.
Time Frame Baseline and approximately up to 13 years
Hide Outcome Measure Data
Hide Analysis Population Description
MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Arm/Group Title Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
Overall Number of Participants Analyzed 296
Mean (Standard Deviation)
Unit of Measure: micromoles per liter
Creatinine, Year 1, Week 8, n=284 0.436  (11.3838)
Creatinine, Year 1, Week 16, n=286 0.464  (12.4820)
Creatinine, Year 1, Week 24, n=292 1.211  (12.9503)
Creatinine, Year 1, Week 32, n=287 1.047  (12.5885)
Creatinine, Year 1, Week 40, n=284 0.965  (12.0245)
Creatinine, Year 1, Week 48, n=287 0.955  (12.4760)
Creatinine, Year 2, Week 8, n=288 0.583  (11.9874)
Creatinine, Year 2, Week 16, n=278 1.558  (11.7857)
Creatinine, Year 2, Week 24, n=273 1.036  (13.7310)
Creatinine, Year 2, Week 32, n=284 0.716  (14.1894)
Creatinine, Year 2, Week 40, n=264 1.976  (15.7590)
Creatinine, Year 2, Week 48, n=269 1.413  (13.7896)
Creatinine, Year 3, Week 8, n=265 -1.268  (14.8256)
Creatinine, Year 3, Week 16, n=260 -2.006  (14.6735)
Creatinine, Year 3, Week 24, n=244 -2.464  (15.3328)
Creatinine, Year 3, Week 32, n=249 -3.089  (14.8793)
Creatinine, Year 3, Week 40, n=245 -3.320  (18.5589)
Creatinine, Year 3, Week 48, n=244 -3.297  (17.3222)
Creatinine, Year 4, Week 8, n=239 -3.440  (14.6181)
Creatinine, Year 4, Week 16, n=238 -3.417  (17.3832)
Creatinine, Year 4, Week 24, n=227 -3.271  (15.7446)
Creatinine, Year 4, Week 32, n=233 -2.238  (15.9372)
Creatinine, Year 4, Week 40, n=220 -2.331  (15.0967)
Creatinine, Year 4, Week 48, n=218 -1.987  (18.0028)
Creatinine, Year 5, Week 8, n=218 -2.514  (16.1511)
Creatinine, Year 5, Week 16, n=214 -2.602  (16.0764)
Creatinine, Year 5, Week 24, n=211 -1.843  (16.8703)
Creatinine, Year 5, Week 32, n=211 -1.634  (17.1000)
Creatinine, Year 5, Week 40, n=198 -2.456  (17.8333)
Creatinine, Year 5, Week 48, n=207 -3.203  (17.3533)
Creatinine, Year 6, Week 8, n=206 -3.562  (16.8131)
Creatinine, Year 6, Week 16, n=198 -2.634  (26.0097)
Creatinine, Year 6, Week 24, n=190 -4.373  (15.1824)
Creatinine, Year 6, Week 32, n=193 -3.527  (18.6685)
Creatinine, Year 6, Week 40, n=185 -3.488  (19.8547)
Creatinine, Year 6, Week 48, n=186 -3.565  (18.7328)
Creatinine, Year 7, Week 8, n=179 -4.198  (19.0041)
Creatinine, Year 7, Week 16, n=179 -5.185  (20.4159)
Creatinine, Year 7, Week 24, n=173 -6.438  (20.9087)
Creatinine, Year 7, Week 32, n=180 -7.907  (19.4999)
Creatinine, Year 7, Week 40, n=175 -8.486  (15.0558)
Creatinine, Year 7, Week 48, n=175 -8.789  (17.9447)
Creatinine, Year 8, Week 8, n=171 -9.202  (17.7671)
Creatinine, Year 8, Week 16, n=170 -8.008  (19.5492)
Creatinine, Year 8, Week 24, n=168 -8.630  (19.0791)
Creatinine, Year 8, Week 32, n=168 -8.682  (19.2383)
Creatinine, Year 8, Week 40, n=162 -8.349  (21.3658)
Creatinine, Year 8, Week 48, n=159 -8.228  (18.9524)
Creatinine, Year 9, Week 8, n=164 -8.517  (14.5862)
Creatinine, Year 9, Week 16, n=162 -7.585  (20.0682)
Creatinine, Year 9, Week 24, n=161 -8.291  (21.4197)
Creatinine, Year 9, Week 32, n=163 -7.593  (18.2143)
Creatinine, Year 9, Week 40, n=156 -7.763  (18.4432)
Creatinine, Year 9, Week 48, n=151 -8.430  (15.7255)
Creatinine, Year 10, Week 8, n=152 -8.258  (19.3747)
Creatinine, Year 10, Week 16, n=143 -9.273  (14.3973)
Creatinine, Year 10, Week 24, n=145 -7.986  (17.3492)
Creatinine, Year 10, Week 32, n=142 -8.217  (17.1597)
Creatinine, Year 10, Week 40, n=138 -9.417  (16.4848)
Creatinine, Year 10, Week 48, n=135 -8.120  (15.7637)
Creatinine, Year 11, Week 8, n=138 -8.584  (16.5792)
Creatinine, Year 11, Week 16, n=128 -9.254  (16.0322)
Creatinine, Year 11, Week 24, n=130 -8.500  (16.4151)
Creatinine, Year 11, Week 32, n=125 -8.699  (15.1035)
Creatinine, Year 11, Week 40, n=124 -7.058  (19.1292)
Creatinine, Year 11, Week 48, n=108 -7.858  (15.6339)
Creatinine, Year 12, Week 8, n=110 -7.715  (14.5236)
Creatinine, Year 12, Week 16, n=97 -6.744  (13.1845)
Creatinine, Year 12, Week 24, n=87 -7.316  (13.4273)
Creatinine, Year 12, Week 32, n=84 -7.998  (14.5624)
Creatinine, Year 12, Week 40, n=82 -7.331  (14.9482)
Creatinine, Year 12, Week 48, n=72 -8.103  (14.0558)
Creatinine, Year 13, Week 8, n=53 -7.672  (12.1403)
Creatinine, Year 13, Week 16, n=42 -6.104  (9.8570)
Creatinine, Year 13, Week 24, n=20 -9.282  (9.7155)
Creatinine, Year 13, Week 32, n=7 -3.789  (15.1893)
Creatinine, Year 13, Week 40, n=1 -8.840 [1]   (NA)
Creatinine, Exit, n=248 -3.707  (21.7147)
Creatinine, 8-Week Follow-up, n=220 -4.058  (21.6587)
Creatinine, 24-Week Follow-up , n=200 -5.216  (19.0936)
Urate, Year 1, Week 8, n=284 1.8849  (44.3384)
Urate, Year 1, Week 16, n=286 -2.8076  (47.4812)
Urate, Year 1, Week 24, n=292 -2.6888  (47.8723)
Urate, Year 1, Week 32, n=287 -4.9739  (51.9503)
Urate, Year 1, Week 40, n=284 -10.2415  (52.6846)
Urate, Year 1, Week 48, n=287 -9.6785  (52.9454)
Urate, Year 2, Week 8, n=288 -5.8034  (54.3409)
Urate, Year 2, Week 16, n=278 -2.2679  (55.1544)
Urate, Year 2, Week 24, n=273 -2.5709  (59.5925)
Urate, Year 2, Week 32, n=284 -2.1153  (62.2559)
Urate, Year 2, Week 40, n=264 0.8111  (59.7227)
Urate, Year 2, Week 48, n=269 2.1448  (60.1246)
Urate, Year 3, Week 8, n=265 2.1772  (66.2923)
Urate, Year 3, Week 16, n=260 8.6246  (60.1972)
Urate, Year 3, Week 24, n=244 17.1614  (64.9072)
Urate, Year 3, Week 32, n=249 20.6627  (69.7507)
Urate, Year 3, Week 40, n=245 15.5862  (64.9204)
Urate, Year 3, Week 48, n=244 17.2346  (69.9632)
Urate, Year 4, Week 8, n=239 18.8644  (69.2770)
Urate, Year 4, Week 16, n=238 17.0443  (65.9764)
Urate, Year 4, Week 24, n=227 22.1150  (73.0409)
Urate, Year 4, Week 32, n=233 27.1872  (67.0773)
Urate, Year 4, Week 40, n=220 20.6017  (77.3509)
Urate, Year 4, Week 48, n=218 27.3663  (74.9898)
Urate, Year 5, Week 8, n=218 26.3294  (73.0884)
Urate, Year 5, Week 16, n=214 26.4325  (75.1583)
Urate, Year 5, Week 24, n=211 25.6525  (73.5651)
Urate, Year 5, Week 32, n=211 32.0515  (75.9635)
Urate, Year 5, Week 40, n=198 26.8862  (77.2803)
Urate, Year 5, Week 48, n=207 24.9126  (79.1890)
Urate, Year 6, Week 8, n=206 26.3329  (80.0258)
Urate, Year 6, Week 16, n=198 27.2166  (79.2525)
Urate, Year 6, Week 24, n=190 32.5888  (81.4485)
Urate, Year 6, Week 32, n=193 32.3904  (81.4550)
Urate, Year 6, Week 40, n=185 34.4019  (75.0211)
Urate, Year 6, Week 48, n=186 39.1737  (75.6743)
Urate, Year 7, Week 8, n=179 34.0930  (75.0241)
Urate, Year 7, Week 16, n=179 35.0566  (77.2918)
Urate, Year 7, Week 24, n=173 34.7941  (80.7184)
Urate, Year 7, Week 32, n=180 32.8792  (75.6337)
Urate, Year 7, Week 40, n=175 31.7453  (81.9889)
Urate, Year 7, Week 48, n=175 31.9832  (78.3131)
Urate, Year 8, Week 8, n=171 26.6790  (79.7678)
Urate, Year 8, Week 16, n=170 30.7197  (83.1681)
Urate, Year 8, Week 24, n=168 25.4560  (83.0349)
Urate, Year 8, Week 32, n=168 30.0940  (81.9997)
Urate, Year 8, Week 40, n=162 29.4096  (76.1203)
Urate, Year 8, Week 48, n=159 29.9270  (82.9390)
Urate, Year 9, Week 8, n=164 37.6828  (78.7998)
Urate, Year 9, Week 16, n=162 27.2066  (79.3972)
Urate, Year 9, Week 24, n=161 25.9717  (78.7793)
Urate, Year 9, Week 32, n=163 26.1639  (78.0704)
Urate, Year 9, Week 40, n=156 24.7833  (81.4956)
Urate, Year 9, Week 48, n=151 21.9012  (82.0174)
Urate, Year 10, Week 8, n=152 24.8486  (75.5325)
Urate, Year 10, Week 16, n=143 17.5528  (82.4129)
Urate, Year 10, Week 24, n=145 17.6389  (88.8154)
Urate, Year 10, Week 32, n=142 16.9644  (84.0128)
Urate, Year 10, Week 40, n=138 16.0768  (88.6943)
Urate, Year 10, Week 48, n=135 20.9722  (92.2400)
Urate, Year 11, Week 8, n=138 16.3354  (88.7370)
Urate, Year 11, Week 16, n=128 19.0057  (80.9138)
Urate, Year 11, Week 24, n=129 13.8326  (91.9844)
Urate, Year 11, Week 32, n=125 14.4180  (81.6362)
Urate, Year 11, Week 40, n=124 17.8920  (97.1467)
Urate, Year 11, Week 48, n=108 15.9164  (86.7371)
Urate, Year 12, Week 8, n=110 18.3307  (92.3013)
Urate, Year 12, Week 16, n=97 15.3912  (85.1873)
Urate, Year 12, Week 24, n=87 15.3828  (87.1985)
Urate, Year 12, Week 32, n=84 16.7817  (89.8376)
Urate, Year 12, Week 40, n=82 12.2587  (83.5304)
Urate, Year 12, Week 48, n=72 9.9133  (85.1185)
Urate, Year 13, Week 8, n=53 32.4334  (79.1035)
Urate, Year 13, Week 16, n=42 42.6273  (74.2314)
Urate, Year 13, Week 24, n=20 25.5764  (56.8583)
Urate, Year 13, Week 32, n=7 64.5783  (59.0251)
Urate, Year 13, Week 40, n=1 53.5320 [1]   (NA)
Urate, Exit, n=248 18.5635  (89.4280)
Urate, 8-Week Follow-up, n=220 19.6014  (89.9097)
Urate, 24-Week Follow-up , n=200 17.5763  (82.1420)
Bilirubin, Year 1, Week 8, n=283 0.145  (2.2995)
Bilirubin, Year 1, Week 16, n=285 0.168  (2.3476)
Bilirubin, Year 1, Week 24, n=292 0.287  (2.4529)
Bilirubin, Year 1, Week 32, n=287 0.346  (2.6100)
Bilirubin, Year 1, Week 40, n=283 0.236  (2.3829)
Bilirubin, Year 1, Week 48, n=286 0.293  (2.5315)
Bilirubin, Year 2, Week 8, n=288 0.243  (2.6498)
Bilirubin, Year 2, Week 16, n=277 0.019  (2.5896)
Bilirubin, Year 2, Week 24, n=272 0.176  (2.5041)
Bilirubin, Year 2, Week 32, n=284 0.331  (2.6475)
Bilirubin, Year 2, Week 40, n=262 0.398  (2.9233)
Bilirubin, Year 2, Week 48, n=269 0.464  (2.5138)
Bilirubin, Year 3, Week 8, n=264 0.343  (2.6599)
Bilirubin, Year 3, Week 16, n=258 0.252  (2.8788)
Bilirubin, Year 3, Week 24, n=243 0.274  (3.0754)
Bilirubin, Year 3, Week 32, n=249 0.494  (2.5860)
Bilirubin, Year 3, Week 40, n=244 0.182  (2.8589)
Bilirubin, Year 3, Week 48, n=243 0.267  (3.0780)
Bilirubin, Year 4, Week 8, n=239 0.336  (2.7639)
Bilirubin, Year 4, Week 16, n=238 0.481  (2.8625)
Bilirubin, Year 4, Week 24, n=227 0.309  (2.8038)
Bilirubin, Year 4, Week 32, n=231 0.326  (2.9524)
Bilirubin, Year 4, Week 40, n=220 -0.023  (2.5236)
Bilirubin, Year 4, Week 48, n=218 0.157  (2.8815)
Bilirubin, Year 5, Week 8, n=218 0.329  (2.4013)
Bilirubin, Year 5, Week 16, n=214 0.304  (2.6180)
Bilirubin, Year 5, Week 24, n=211 0.259  (2.5450)
Bilirubin, Year 5, Week 32, n=211 0.575  (2.6520)
Bilirubin, Year 5, Week 40, n=198 0.544  (2.6496)
Bilirubin, Year 5, Week 48, n=207 0.322  (2.5320)
Bilirubin, Year 6, Week 8, n=206 0.282  (2.5233)
Bilirubin, Year 6, Week 16, n=198 0.138  (2.6093)
Bilirubin, Year 6, Week 24, n=190 0.099  (2.7600)
Bilirubin, Year 6, Week 32, n=193 0.284  (2.6431)
Bilirubin, Year 6, Week 40, n=185 0.296  (2.8314)
Bilirubin, Year 6, Week 48, n=186 0.248  (3.0097)
Bilirubin, Year 7, Week 8, n=179 0.258  (2.6974)
Bilirubin, Year 7, Week 16, n=179 0.143  (2.6134)
Bilirubin, Year 7, Week 24, n=173 0.287  (2.6082)
Bilirubin, Year 7, Week 32, n=180 0.313  (2.9727)
Bilirubin, Year 7, Week 40, n=175 0.137  (2.7527)
Bilirubin, Year 7, Week 48, n=175 0.156  (2.9747)
Bilirubin, Year 8, Week 8, n=171 0.020  (2.9559)
Bilirubin, Year 8, Week 16, n=170 -0.050  (2.6856)
Bilirubin, Year 8, Week 24, n=168 0.010  (2.4720)
Bilirubin, Year 8, Week 32, n=168 -0.336  (2.5471)
Bilirubin, Year 8, Week 40, n=162 -0.032  (2.8934)
Bilirubin, Year 8, Week 48, n=159 -0.097  (3.2550)
Bilirubin, Year 9, Week 8, n=164 -0.125  (2.7616)
Bilirubin, Year 9, Week 16, n=162 -0.095  (2.9603)
Bilirubin, Year 9, Week 24, n=161 -0.234  (3.1385)
Bilirubin, Year 9, Week 32, n=163 -0.126  (2.7175)
Bilirubin, Year 9, Week 40, n=156 -0.296  (3.3709)
Bilirubin, Year 9, Week 48, n=151 0.057  (2.8231)
Bilirubin, Year 10, Week 8, n=152 -0.158  (3.0763)
Bilirubin, Year 10, Week 16, n=143 -0.179  (3.1616)
Bilirubin, Year 10, Week 24, n=145 -0.024  (2.8853)
Bilirubin, Year 10, Week 32, n=142 0.120  (3.3068)
Bilirubin, Year 10, Week 40, n=138 -0.248  (3.0684)
Bilirubin, Year 10, Week 48, n=135 0.190  (3.0751)
Bilirubin, Year 11, Week 8, n=138 0.050  (2.9936)
Bilirubin, Year 11, Week 16, n=128 0.281  (2.9640)
Bilirubin, Year 11, Week 24, n=130 0.026  (2.8004)
Bilirubin, Year 11, Week 32, n=125 0.192  (2.5160)
Bilirubin, Year 11, Week 40, n=124 0.193  (3.2650)
Bilirubin, Year 11, Week 48, n=108 0.538  (2.9261)
Bilirubin, Year 12, Week 8, n=110 0.311  (2.8762)
Bilirubin, Year 12, Week 16, n=97 0.776  (3.0231)
Bilirubin, Year 12, Week 24, n=87 0.511  (3.4508)
Bilirubin, Year 12, Week 32, n=84 1.282  (3.3563)
Bilirubin, Year 12, Week 40, n=82 0.542  (3.2454)
Bilirubin, Year 12, Week 48, n=72 0.570  (3.8398)
Bilirubin, Year 13, Week 8, n=53 0.129  (2.8623)
Bilirubin, Year 13, Week 16, n=42 -0.244  (3.1046)
Bilirubin, Year 13, Week 24, n=20 -0.513  (2.0080)
Bilirubin, Year 13, Week 32, n=7 -0.244  (2.5032)
Bilirubin, Year 13, Week 40, n=1 0.000 [1]   (NA)
Bilirubin, Exit, n=248 0.510  (3.0619)
Bilirubin, 8-Week Follow-up, n=220 0.389  (2.7311)
Bilirubin, 24-Week Follow-up , n=200 0.650  (3.3222)
[1]
No value as only one participant was analyzed.
12.Primary Outcome
Title Change From Baseline in BUN/Creatinine at the Indicated Time Points
Hide Description Clinical chemistry parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in BUN/creatinine is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants 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.
Time Frame Baseline and approximately up to 13 years
Hide Outcome Measure Data
Hide Analysis Population Description
MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Arm/Group Title Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
Overall Number of Participants Analyzed 296
Mean (Standard Deviation)
Unit of Measure: Ratio
BUN/Creatinine, Year 1, Week 8, n=284 -0.1  (4.13)
BUN/Creatinine, Year 1, Week 16, n=286 -0.4  (4.31)
BUN/Creatinine, Year 1, Week 24, n=292 -0.4  (4.67)
BUN/Creatinine, Year 1, Week 32, n=287 -0.4  (4.07)
BUN/Creatinine, Year 1, Week 40, n=284 -0.8  (4.26)
BUN/Creatinine, Year 1, Week 48, n=287 -0.3  (4.80)
BUN/Creatinine, Year 2, Week 8, n=288 -0.4  (4.91)
BUN/Creatinine, Year 2, Week 16, n=278 -0.6  (4.95)
BUN/Creatinine, Year 2, Week 24, n=273 -0.6  (5.00)
BUN/Creatinine, Year 2, Week 32, n=284 -0.4  (4.82)
BUN/Creatinine, Year 2, Week 40, n=264 -0.8  (4.80)
BUN/Creatinine, Year 2, Week 48, n=269 -0.5  (4.90)
BUN/Creatinine, Year 3, Week 8, n=265 0.2  (4.81)
BUN/Creatinine, Year 3, Week 16, n=260 0.2  (4.95)
BUN/Creatinine, Year 3, Week 24, n=244 0.6  (4.93)
BUN/Creatinine, Year 3, Week 32, n=249 0.5  (5.16)
BUN/Creatinine, Year 3, Week 40, n=245 0.9  (4.83)
BUN/Creatinine, Year 3, Week 48, n=244 0.8  (4.99)
BUN/Creatinine, Year 4, Week 8, n=239 1.1  (4.99)
BUN/Creatinine, Year 4, Week 16, n=238 0.8  (4.86)
BUN/Creatinine, Year 4, Week 24, n=227 0.9  (5.15)
BUN/Creatinine, Year 4, Week 32, n=233 0.5  (4.93)
BUN/Creatinine, Year 4, Week 40, n=220 0.3  (4.81)
BUN/Creatinine, Year 4, Week 48, n=218 1.1  (5.35)
BUN/Creatinine, Year 5, Week 8, n=218 0.8  (5.34)
BUN/Creatinine, Year 5, Week 16, n=214 1.2  (5.03)
BUN/Creatinine, Year 5, Week 24, n=211 0.8  (5.01)
BUN/Creatinine, Year 5, Week 32, n=211 0.3  (4.93)
BUN/Creatinine, Year 5, Week 40, n=198 1.2  (5.04)
BUN/Creatinine, Year 5, Week 48, n=207 0.9  (5.11)
BUN/Creatinine, Year 6, Week 8, n=206 1.4  (5.04)
BUN/Creatinine, Year 6, Week 16, n=198 1.3  (5.03)
BUN/Creatinine, Year 6, Week 24, n=190 1.2  (5.37)
BUN/Creatinine, Year 6, Week 32, n=193 1.6  (5.76)
BUN/Creatinine, Year 6, Week 40, n=185 1.5  (4.73)
BUN/Creatinine, Year 6, Week 48, n=186 1.8  (5.08)
BUN/Creatinine, Year 7, Week 8, n=179 1.6  (5.07)
BUN/Creatinine, Year 7, Week 16, n=179 2.1  (5.04)
BUN/Creatinine, Year 7, Week 24, n=173 2.1  (5.55)
BUN/Creatinine, Year 7, Week 32, n=180 2.3  (5.39)
BUN/Creatinine, Year 7, Week 40, n=175 2.6  (5.19)
BUN/Creatinine, Year 7, Week 48, n=175 2.6  (5.31)
BUN/Creatinine, Year 8, Week 8, n=171 2.7  (5.65)
BUN/Creatinine, Year 8, Week 16, n=170 2.5  (5.54)
BUN/Creatinine, Year 8, Week 24, n=168 2.6  (5.37)
BUN/Creatinine, Year 8, Week 32, n=168 2.2  (5.11)
BUN/Creatinine, Year 8, Week 40, n=162 2.3  (5.36)
BUN/Creatinine, Year 8, Week 48, n=159 2.9  (5.20)
BUN/Creatinine, Year 9, Week 8, n=164 2.4  (5.26)
BUN/Creatinine, Year 9, Week 16, n=162 2.5  (6.15)
BUN/Creatinine, Year 9, Week 24, n=161 2.4  (5.89)
BUN/Creatinine, Year 9, Week 32, n=163 2.7  (5.54)
BUN/Creatinine, Year 9, Week 40, n=156 2.4  (5.90)
BUN/Creatinine, Year 9, Week 48, n=151 2.2  (6.01)
BUN/Creatinine, Year 10, Week 8, n=152 2.6  (5.98)
BUN/Creatinine, Year 10, Week 16, n=143 2.6  (6.13)
BUN/Creatinine, Year 10, Week 24, n=145 2.5  (5.72)
BUN/Creatinine, Year 10, Week 32, n=142 2.8  (6.03)
BUN/Creatinine, Year 10, Week 40, n=138 2.0  (5.87)
BUN/Creatinine, Year 10, Week 48, n=135 2.4  (6.07)
BUN/Creatinine, Year 11, Week 8, n=138 2.7  (6.13)
BUN/Creatinine, Year 11, Week 16, n=128 2.6  (6.28)
BUN/Creatinine, Year 11, Week 24, n=130 2.8  (6.12)
BUN/Creatinine, Year 11, Week 32, n=125 2.2  (6.10)
BUN/Creatinine, Year 11, Week 40, n=124 2.3  (6.68)
BUN/Creatinine, Year 11, Week 48, n=108 1.7  (5.65)
BUN/Creatinine, Year 12, Week 8, n=110 2.4  (6.36)
BUN/Creatinine, Year 12, Week 16, n=97 2.4  (6.38)
BUN/Creatinine, Year 12, Week 24, n=87 2.2  (6.62)
BUN/Creatinine, Year 12, Week 32, n=84 1.5  (5.75)
BUN/Creatinine, Year 12, Week 40, n=82 1.4  (6.50)
BUN/Creatinine, Year 12, Week 48, n=72 1.6  (6.42)
BUN/Creatinine, Year 13, Week 8, n=53 2.1  (5.44)
BUN/Creatinine, Year 13, Week 16, n=42 3.5  (6.22)
BUN/Creatinine, Year 13, Week 24, n=20 3.6  (4.36)
BUN/Creatinine, Year 13, Week 32, n=7 0.3  (2.93)
BUN/Creatinine, Year 13, Week 40, n=1 -6.0 [1]   (NA)
BUN/Creatinine, Exit, n=248 1.6  (5.66)
BUN/Creatinine, 8-Week Follow-up, n=220 1.1  (5.88)
BUN/Creatinine, 24-Week Follow-up , n=200 1.3  (5.53)
[1]
No value as only one participant was analyzed.
13.Primary Outcome
Title Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
Hide Description Clinical chemistry parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in ALT, AP, AST, GGT and LD are summarized. Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants 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.
Time Frame Baseline and approximately up to 13 years
Hide Outcome Measure Data
Hide Analysis Population Description
MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Arm/Group Title Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
Overall Number of Participants Analyzed 296
Mean (Standard Deviation)
Unit of Measure: International units per liter
ALT, Year 1, Week 8, n=284 -0.7  (12.05)
ALT, Year 1, Week 16, n=286 0.2  (17.32)
ALT, Year 1, Week 24, n=292 0.9  (17.04)
ALT, Year 1, Week 32, n=287 -0.6  (12.36)
ALT, Year 1, Week 40, n=284 -0.6  (14.15)
ALT, Year 1, Week 48, n=287 -1.3  (11.56)
ALT, Year 2, Week 8, n=288 -0.7  (13.36)
ALT, Year 2, Week 16, n=278 -1.2  (11.44)
ALT, Year 2, Week 24, n=273 0.3  (13.35)
ALT, Year 2, Week 32, n=284 0.1  (15.85)
ALT, Year 2, Week 40, n=264 0.0  (14.02)
ALT, Year 2, Week 48, n=269 0.9  (15.65)
ALT, Year 3, Week 8, n=265 0.5  (14.46)
ALT, Year 3, Week 16, n=260 1.3  (21.94)
ALT, Year 3, Week 24, n=244 -0.1  (13.95)
ALT, Year 3, Week 32, n=249 0.0  (12.55)
ALT, Year 3, Week 40, n=245 -0.3  (13.08)
ALT, Year 3, Week 48, n=244 -0.4  (13.62)
ALT, Year 4, Week 8, n=239 -0.5  (10.97)
ALT, Year 4, Week 16, n=238 -1.3  (14.28)
ALT, Year 4, Week 24, n=227 -1.3  (13.29)
ALT, Year 4, Week 32, n=233 -0.4  (13.60)
ALT, Year 4, Week 40, n=220 -1.6  (12.83)
ALT, Year 4, Week 48, n=218 -1.3  (12.45)
ALT, Year 5, Week 8, n=218 0.1  (12.76)
ALT, Year 5, Week 16, n=214 -0.5  (12.67)
ALT, Year 5, Week 24, n=211 -0.9  (14.68)
ALT, Year 5, Week 32, n=211 -1.5  (13.23)
ALT, Year 5, Week 40, n=198 -1.3  (13.90)
ALT, Year 5, Week 48, n=207 -0.1  (17.16)
ALT, Year 6, Week 8, n=206 -1.4  (12.09)
ALT, Year 6, Week 16, n=198 -1.4  (13.55)
ALT, Year 6, Week 24, n=190 -1.6  (13.87)
ALT, Year 6, Week 32, n=193 -1.4  (13.58)
ALT, Year 6, Week 40, n=185 -1.4  (14.78)
ALT, Year 6, Week 48, n=186 -0.9  (14.98)
ALT, Year 7, Week 8, n=179 -0.4  (14.50)
ALT, Year 7, Week 16, n=179 0.5  (15.78)
ALT, Year 7, Week 24, n=173 0.1  (16.09)
ALT, Year 7, Week 32, n=180 -0.2  (14.71)
ALT, Year 7, Week 40, n=175 -0.1  (16.43)
ALT, Year 7, Week 48, n=175 -0.4  (16.15)
ALT, Year 8, Week 8, n=171 0.9  (16.58)
ALT, Year 8, Week 16, n=170 -0.2  (17.74)
ALT, Year 8, Week 24, n=168 -0.2  (15.62)
ALT, Year 8, Week 32, n=168 -0.4  (14.82)
ALT, Year 8, Week 40, n=162 -0.7  (14.79)
ALT, Year 8, Week 48, n=159 -0.7  (15.14)
ALT, Year 9, Week 8, n=164 1.5  (21.38)
ALT, Year 9, Week 16, n=162 -0.8  (14.31)
ALT, Year 9, Week 24, n=161 -1.5  (14.35)
ALT, Year 9, Week 32, n=163 0.0  (15.62)
ALT, Year 9, Week 40, n=156 -0.5  (14.61)
ALT, Year 9, Week 48, n=151 -0.2  (15.69)
ALT, Year 10, Week 8, n=152 -0.6  (14.25)
ALT, Year 10, Week 16, n=143 -0.3  (13.88)
ALT, Year 10, Week 24, n=145 -1.1  (15.71)
ALT, Year 10, Week 32, n=142 -0.8  (15.97)
ALT, Year 10, Week 40, n=138 -1.9  (15.56)
ALT, Year 10, Week 48, n=135 -0.7  (19.61)
ALT, Year 11, Week 8, n=138 -1.9  (15.75)
ALT, Year 11, Week 16, n=128 -1.3  (16.74)
ALT, Year 11, Week 24, n=130 -2.5  (15.11)
ALT, Year 11, Week 32, n=125 -3.2  (14.71)
ALT, Year 11, Week 40, n=124 -2.8  (15.31)
ALT, Year 11, Week 48, n=108 -1.7  (18.29)
ALT, Year 12, Week 8, n=110 -1.9  (16.30)
ALT, Year 12, Week 16, n=97 -2.9  (12.74)
ALT, Year 12, Week 24, n=87 -2.0  (13.47)
ALT, Year 12, Week 32, n=84 -2.4  (13.39)
ALT, Year 12, Week 40, n=82 -2.3  (14.74)
ALT, Year 12, Week 48, n=72 -3.6  (14.92)
ALT, Year 13, Week 8, n=53 -5.3  (16.58)
LT, Year 13, Week 16, n=42 -5.7  (20.42)
ALT, Year 13, Week 24, n=20 -1.0  (6.55)
ALT, Year 13, Week 32, n=7 -0.6  (9.14)
ALT, Year 13, Week 40, n=1 3.0 [1]   (NA)
ALT, Exit, n=248 -1.2  (13.39)
ALT, 8-Week Follow-up, n=220 -0.6  (15.74)
ALT, 24-Week Follow-up , n=200 1.5  (36.52)
AP, Year 1, Week 8, n=284 -0.1  (11.43)
AP, Year 1, Week 16, n=286 0.9  (14.08)
AP, Year 1, Week 24, n=292 0.7  (13.87)
AP, Year 1, Week 32, n=287 0.6  (14.03)
AP, Year 1, Week 40, n=284 1.1  (14.61)
AP, Year 1, Week 48, n=287 0.5  (16.94)
AP, Year 2, Week 8, n=288 1.2  (17.67)
AP, Year 2, Week 16, n=278 0.2  (15.87)
AP, Year 2, Week 24, n=273 1.3  (16.91)
AP, Year 2, Week 32, n=284 2.5  (17.17)
AP, Year 2, Week 40, n=264 3.5  (19.55)
AP, Year 2, Week 48, n=269 5.6  (23.81)
AP, Year 3, Week 8, n=265 4.0  (18.04)
AP, Year 3, Week 16, n=260 3.2  (19.53)
AP, Year 3, Week 24, n=244 2.0  (19.26)
AP, Year 3, Week 32, n=249 3.7  (21.48)
AP, Year 3, Week 40, n=245 3.4  (18.62)
AP, Year 3, Week 48, n=244 3.4  (19.32)
AP, Year 4, Week 8, n=239 2.5  (19.33)
AP, Year 4, Week 16, n=238 2.8  (17.37)
AP, Year 4, Week 24, n=227 2.5  (21.94)
AP, Year 4, Week 32, n=233 3.7  (21.17)
AP, Year 4, Week 40, n=220 2.9  (20.93)
AP, Year 4, Week 48, n=218 3.7  (22.97)
AP, Year 5, Week 8, n=218 4.9  (24.65)
AP, Year 5, Week 16, n=214 4.1  (23.87)
AP, Year 5, Week 24, n=211 4.0  (20.17)
AP, Year 5, Week 32, n=211 5.7  (20.68)
AP, Year 5, Week 40, n=198 5.5  (21.34)
AP, Year 5, Week 48, n=207 6.6  (21.74)
AP, Year 6, Week 8, n=206 7.1  (23.65)
AP, Year 6, Week 16, n=198 7.5  (21.41)
AP, Year 6, Week 24, n=190 7.5  (22.41)
AP, Year 6, Week 32, n=193 14.0  (67.61)
AP, Year 6, Week 40, n=185 10.2  (24.43)
AP, Year 6, Week 48, n=186 9.1  (22.93)
AP, Year 7, Week 8, n=179 9.0  (24.52)
AP, Year 7, Week 16, n=179 9.6  (25.70)
AP, Year 7, Week 24, n=173 9.9  (25.38)
AP, Year 7, Week 32, n=180 11.5  (27.02)
AP, Year 7, Week 40, n=175 9.6  (25.13)
AP, Year 7, Week 48, n=175 11.1  (24.96)
AP, Year 8, Week 8, n=171 10.0  (23.29)
AP, Year 8, Week 16, n=170 10.1  (27.16)
AP, Year 8, Week 24, n=168 10.4  (26.44)
AP, Year 8, Week 32, n=168 12.9  (27.45)
AP, Year 8, Week 40, n=162 11.1  (25.66)
AP, Year 8, Week 48, n=159 11.5  (30.97)
AP, Year 9, Week 8, n=164 12.0  (25.38)
AP, Year 9, Week 16, n=162 10.9  (25.48)
AP, Year 9, Week 24, n=161 10.5  (22.81)
AP, Year 9, Week 32, n=163 10.4  (24.05)
AP, Year 9, Week 40, n=156 9.5  (24.43)
AP, Year 9, Week 48, n=151 10.2  (22.77)
AP, Year 10, Week 8, n=152 10.6  (24.51)
AP, Year 10, Week 16, n=143 11.9  (29.31)
AP, Year 10, Week 24, n=145 13.0  (22.92)
AP, Year 10, Week 32, n=142 14.4  (24.55)
AP, Year 10, Week 40, n=138 13.7  (23.20)
AP, Year 10, Week 48, n=135 12.5  (23.89)
AP, Year 11, Week 8, n=138 13.3  (26.11)
AP, Year 11, Week 16, n=128 14.2  (26.05)
AP, Year 11, Week 24, n=130 12.9  (23.22)
AP, Year 11, Week 32, n=125 13.3  (23.74)
AP, Year 11, Week 40, n=124 13.3  (23.05)
AP, Year 11, Week 48, n=108 11.9  (25.59)
AP, Year 12, Week 8, n=110 12.3  (25.69)
AP, Year 12, Week 16, n=97 10.2  (22.48)
AP, Year 12, Week 24, n=87 11.5  (20.69)
AP, Year 12, Week 32, n=84 10.7  (19.91)
AP, Year 12, Week 40, n=82 10.8  (21.35)
AP, Year 12, Week 48, n=72 11.6  (21.77)
AP, Year 13, Week 8, n=53 12.2  (19.25)
AP, Year 13, Week 16, n=42 16.9  (37.69)
AP, Year 13, Week 24, n=20 20.7  (23.57)
AP, Year 13, Week 32, n=7 18.1  (21.47)
AP, Year 13, Week 40, n=1 15.0 [1]   (NA)
AP, Exit, n=248 8.3  (26.49)
AP, 8-Week Follow-up, n=220 10.3  (42.15)
AP, 24-Week Follow-up , n=200 10.7  (32.86)
AST, Year 1, Week 8, n=281 -0.3  (8.68)
AST, Year 1, Week 16, n=283 2.0  (22.78)
AST, Year 1, Week 24, n=287 2.3  (26.94)
AST, Year 1, Week 32, n=283 0.5  (12.19)
AST, Year 1, Week 40, n=282 -0.1  (9.63)
AST, Year 1, Week 48, n=284 -1.2  (6.98)
AST, Year 2, Week 8, n=288 -0.8  (9.15)
AST, Year 2, Week 16, n=275 -1.2  (8.51)
AST, Year 2, Week 24, n=269 -0.3  (9.04)
AST, Year 2, Week 32, n=284 0.2  (13.80)
AST, Year 2, Week 40, n=261 -0.2  (10.44)
AST, Year 2, Week 48, n=267 0.7  (10.95)
AST, Year 3, Week 8, n=262 0.3  (10.81)
AST, Year 3, Week 16, n=258 1.0  (11.84)
AST, Year 3, Week 24, n=241 0.4  (10.36)
AST, Year 3, Week 32, n=245 1.3  (11.19)
AST, Year 3, Week 40, n=242 0.2  (10.99)
AST, Year 3, Week 48, n=239 0.6  (10.60)
AST, Year 4, Week 8, n=237 0.5  (7.73)
AST, Year 4, Week 16, n=235 -0.2  (12.78)
AST, Year 4, Week 24, n=226 0.4  (11.45)
AST, Year 4, Week 32, n=230 0.8  (9.26)
AST, Year 4, Week 40, n=218 -0.3  (9.44)
AST, Year 4, Week 48, n=214 -0.2  (9.48)
AST, Year 5, Week 8, n=217 0.3  (12.79)
AST, Year 5, Week 16, n=213 0.8  (15.76)
AST, Year 5, Week 24, n=206 -0.5  (11.36)
AST, Year 5, Week 32, n=211 -0.8  (10.64)
AST, Year 5, Week 40, n=197 0.3  (14.39)
AST, Year 5, Week 48, n=207 0.0  (11.58)
AST, Year 6, Week 8, n=205 -0.4  (9.04)
AST, Year 6, Week 16, n=198 -0.7  (9.83)
AST, Year 6, Week 24, n=189 -0.9  (11.35)
AST, Year 6, Week 32, n=192 -0.6  (11.04)
AST, Year 6, Week 40, n=181 -0.7  (10.56)
AST, Year 6, Week 48, n=186 0.1  (12.21)
AST, Year 7, Week 8, n=177 -0.2  (10.76)
AST, Year 7, Week 16, n=178 1.0  (12.91)
AST, Year 7, Week 24, n=171 1.5  (14.44)
AST, Year 7, Week 32, n=179 0.5  (10.56)
AST, Year 7, Week 40, n=172 0.4  (14.51)
AST, Year 7, Week 48, n=175 0.2  (11.15)
AST, Year 8, Week 8, n=170 1.0  (16.78)
AST, Year 8, Week 16, n=169 1.0  (21.12)
AST, Year 8, Week 24, n=167 0.5  (13.61)
AST, Year 8, Week 32, n=166 0.7  (14.74)
AST, Year 8, Week 40, n=161 1.4  (16.28)
AST, Year 8, Week 48, n=159 0.2  (11.00)
AST, Year 9, Week 8, n=163 1.6  (16.09)
AST, Year 9, Week 16, n=160 0.8  (13.55)
AST, Year 9, Week 24, n=160 0.3  (12.60)
AST, Year 9, Week 32, n=162 1.3  (17.39)
AST, Year 9, Week 40, n=156 1.0  (14.17)
AST, Year 9, Week 48, n=150 1.5  (15.79)