Trial Outcomes & Findings for A Study of Belimumab in Idiopathic Membranous Glomerulonephropathy (NCT NCT01610492)

Last Updated: 2017-10-13

Results Overview

Proteinuria based on urinary protein creatinine ratio (PCR) was measured from 2 consecutive 24 hour (h) urine collection pre and post dosing at Baseline and Week 28 and the mean PCR was determined at each time point. Baseline is defined as the mean of the pre and post dosing Day 0 values. The ratio is defined as the Week 28 value divided by the Baseline value. Ratio to Baseline: Estimated value = 0.76, 2-sided 95% confidence interval (CI)=0.57 to 1.01. The geometric mean method was used to calculate the CI. The analysis was performed on Intent-to-treat (ITT) Population which comprised of all eligible participants who received at least one dose of investigational drug. Only those participants available at the indicated time point (Week 28) were analyzed.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

14 participants

Primary outcome timeframe

Baseline and Week 28

Results posted on

2017-10-13

Participant Flow

Eligible participants were recruited from July 2012 until March 2014, into this 2 part study of a initial treatment phase, a long term treatment phase, and then followed up for a further 6 months. Results have previously been presented for the initial treatment phase, up to the Week 28 and are now presented for the completed study.

Screening occurred within 35 days and no less than 14 days before the first scheduled study treatment dose. Total 21 participants were screened; 14 were randomized and entered the initial treatment phase while 11 participants entered the long-term treatment phase. Common reasons for screen failures were insufficient, or improvements in proteinuria.

Participant milestones

Participant milestones
Measure	Belimumab 10 mg/kg IV Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Overall Study STARTED	14
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Belimumab 10 mg/kg IV Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Overall Study Adverse Event	1
Overall Study Lack of Efficacy	3
Overall Study Other: Reached stopping criteria	1
Overall Study Other:Treatment stopped due to remission	1

Baseline Characteristics

A Study of Belimumab in Idiopathic Membranous Glomerulonephropathy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Belimumab 10 mg/kg IV n=14 Participants Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Age, Continuous	46.1 Years STANDARD_DEVIATION 13.30 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Race/Ethnicity, Customized Asian - Central/South Asian Heritage	4 Participants n=5 Participants
Race/Ethnicity, Customized White- White/Caucasian/European Heritage	9 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 28

Population: Intent-to-Treat (ITT) Population

Outcome measures

Outcome measures
Measure	Belimumab 10 mg/kg IV n=11 Participants Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Change From Baseline in Proteinuria Levels at Week 28	0.7552 Ratio Geometric Coefficient of Variation 45.0

PRIMARY outcome

Timeframe: Baseline and Week 28

Population: ITT Population. Only those participants available at the indicated time point (Week 28) were analyzed.

PLA2R autoantibody titers in serum were analyzed at Baseline and Week 28 by means of a validated anti- PLA2R enzyme linked immunosorbent assay (ELISA) from EuroImmun. Baseline is defined as the Day 0 value and change from Baseline was calculated as ratio to Baseline by dividing the Week 28 values with the Baseline values. Ratio to Baseline: Estimated value = 0.27, 2-sided 95% CI=0.12 to 0.58. The geometric mean method was used to calculate the CI.

Outcome measures

Outcome measures
Measure	Belimumab 10 mg/kg IV n=11 Participants Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Change From Baseline in Anti-phospholipase A2 Receptor (PLA2R) Autoantibody Titers at Week 28	0.2666 Ratio Geometric Coefficient of Variation 171.0

SECONDARY outcome

Timeframe: Baseline and Week 12, 28, 52, 76, 104 and 128/6 month follow-up

Population: ITT Population

Proteinuria based on urinary protein creatinine ratio (PCR) measured from 2 consecutive 24h urine collections at Baseline and Week 28, from a pre-intervention spot urine sample and 24 hour urine collection after visit at Weeks 12, 52, 76 and 104, and from a spot urine sample at week 128. Mean PCR was calculated at each time point where there were 2 samples. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	Belimumab 10 mg/kg IV n=14 Participants Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Proteinuria Levels at the Indicated Time Points Baseline, n=14	724.3157 milligrams per millimole (mg/mmol) Geometric Coefficient of Variation 40.2
Proteinuria Levels at the Indicated Time Points Week 12, n=13	670.8655 milligrams per millimole (mg/mmol) Geometric Coefficient of Variation 46.9
Proteinuria Levels at the Indicated Time Points Week 28, n=11	498.1255 milligrams per millimole (mg/mmol) Geometric Coefficient of Variation 40.9
Proteinuria Levels at the Indicated Time Points Week 52, n=9	356.4209 milligrams per millimole (mg/mmol) Geometric Coefficient of Variation 174.8
Proteinuria Levels at the Indicated Time Points Week 76, n=8	274.9714 milligrams per millimole (mg/mmol) Geometric Coefficient of Variation 70.4
Proteinuria Levels at the Indicated Time Points Week 104, n=10	129.9761 milligrams per millimole (mg/mmol) Geometric Coefficient of Variation 186.0
Proteinuria Levels at the Indicated Time Points Week 128, n=9	75.2359 milligrams per millimole (mg/mmol) Geometric Coefficient of Variation 136.4

SECONDARY outcome

Timeframe: Baseline and Week 12, 28, 52, 76, 104 and Week 128/6 month follow up

Population: ITT Population.

Proteinuria based on urinary protein creatinine ratio (PCR) measured from 2 consecutive 24h urine collections at Baseline and Week 28, from a pre-intervention spot urine sample and 24 hour urine collection after visit at Weeks 12, 52, 76 and 104, and from a spot urine sample at week 128. Mean PCR was calculated at each time point where there were 2 samples. Baseline is defined as Day 0 value and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	Belimumab 10 mg/kg IV n=14 Participants Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Change From Baseline in Proteinuria Levels at the Indicated Time Points Week 12; n= 13	0.9437 Ratio Geometric Coefficient of Variation 39.3
Change From Baseline in Proteinuria Levels at the Indicated Time Points Week 28; n= 11	0.7552 Ratio Geometric Coefficient of Variation 45.0
Change From Baseline in Proteinuria Levels at the Indicated Time Points Week 52; n= 9	0.5297 Ratio Geometric Coefficient of Variation 206.7
Change From Baseline in Proteinuria Levels at the Indicated Time Points Week 76; n= 8	0.4177 Ratio Geometric Coefficient of Variation 54.3
Change From Baseline in Proteinuria Levels at the Indicated Time Points Week 104; n= 10	0.1874 Ratio Geometric Coefficient of Variation 189.3
Change From Baseline in Proteinuria Levels at the Indicated Time Points Week 128; n= 9	0.1118 Ratio Geometric Coefficient of Variation 139.1

SECONDARY outcome

Timeframe: Baseline and Week 12, 28, 52, 76, 104 and 128/6 month follow-up

Population: ITT Population.

Anti-PLA2R autoantibody titers in serum were analyzed by means of a validated anti-PLA2R enzyme linked immunosorbent assay (ELISA) assay from Euroimmun. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	Belimumab 10 mg/kg IV n=14 Participants Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Anti-phospholipase A2 Receptor (PLA2R) Autoantibody Levels at Indicated Time Points Baseline, n=14	168.3 relative units per milliliter (RU/mL) Geometric Coefficient of Variation 138.9
Anti-phospholipase A2 Receptor (PLA2R) Autoantibody Levels at Indicated Time Points Week 28, n=11	46.4 relative units per milliliter (RU/mL) Geometric Coefficient of Variation 319.6
Anti-phospholipase A2 Receptor (PLA2R) Autoantibody Levels at Indicated Time Points Week 52, n=9	12.9 relative units per milliliter (RU/mL) Geometric Coefficient of Variation 358.4
Anti-phospholipase A2 Receptor (PLA2R) Autoantibody Levels at Indicated Time Points Week 76, n=8	7.5 relative units per milliliter (RU/mL) Geometric Coefficient of Variation 140.4
Anti-phospholipase A2 Receptor (PLA2R) Autoantibody Levels at Indicated Time Points Week 104, n=10	3.7 relative units per milliliter (RU/mL) Geometric Coefficient of Variation 72.7
Anti-phospholipase A2 Receptor (PLA2R) Autoantibody Levels at Indicated Time Points Week 128, n=8	4.4 relative units per milliliter (RU/mL) Geometric Coefficient of Variation 112.0
Anti-phospholipase A2 Receptor (PLA2R) Autoantibody Levels at Indicated Time Points Week 12, n=13	91.0 relative units per milliliter (RU/mL) Geometric Coefficient of Variation 200.4

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 28, 52, 76, 104 and 128.

Population: ITT Population

Anti-PLA2R autoantibody titers in serum were analyzed by means of a validated anti- PLA2R enzyme linked immunosorbent assay (ELISA) from Euroimmun. Baseline is defined as the Day 0 value and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	Belimumab 10 mg/kg IV n=14 Participants Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Change From Baseline in Anti-PLA2R Autoantibody Titers at the Indicated Time Points Week 12; n= 13	0.5362 Ratio Geometric Coefficient of Variation 58.1
Change From Baseline in Anti-PLA2R Autoantibody Titers at the Indicated Time Points Week 28; n= 11	0.2666 Ratio Geometric Coefficient of Variation 171.0
Change From Baseline in Anti-PLA2R Autoantibody Titers at the Indicated Time Points Week 52; n= 9	0.0737 Ratio Geometric Coefficient of Variation 130.3
Change From Baseline in Anti-PLA2R Autoantibody Titers at the Indicated Time Points Week 76; n= 8	0.0436 Ratio Geometric Coefficient of Variation 102.8
Change From Baseline in Anti-PLA2R Autoantibody Titers at the Indicated Time Points Week 104; n= 10	0.0212 Ratio Geometric Coefficient of Variation 169.1
Change From Baseline in Anti-PLA2R Autoantibody Titers at the Indicated Time Points Week 128; n= 8	0.0284 Ratio Geometric Coefficient of Variation 243.7

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 28, 52, 76, 104 and 128

Population: ITT Population

Complete remission is defined as PCR \<30 mg/mmol (proteinuria \<0.3grams \[g\]/24 h) with no worsening in renal function (estimated glomerular filtration rate \[eGFR\] reduction from Baseline \<15 percent). Partial remission is defined as PCR \<350 mg/mmol (proteinuria \<3.5 g/24 h) but \>= 30 mg/mmol (proteinuria \>= 0.3g/24h) and decrease of \>50 percent from Day 0 Baseline, together with no consistent worsening in renal function (eGFR reduction from Baseline \<15percent). Only those participants available at the specified time points were analyzed (represented by n=X in category titles).

Outcome measures

Outcome measures
Measure	Belimumab 10 mg/kg IV n=14 Participants Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Number of Participants With Complete or Partial Remission Week 12; Partial remission; n= 13	0 Participants
Number of Participants With Complete or Partial Remission Week 12; Complete remission; n= 13	0 Participants
Number of Participants With Complete or Partial Remission Week 28; Partial remission; n= 11	1 Participants
Number of Participants With Complete or Partial Remission Week 28; Complete remission; n= 11	0 Participants
Number of Participants With Complete or Partial Remission Week 52; Partial remission; n= 9	2 Participants
Number of Participants With Complete or Partial Remission Week 52; Complete remission; n= 9	1 Participants
Number of Participants With Complete or Partial Remission Week 76; Partial remission; n= 8	3 Participants
Number of Participants With Complete or Partial Remission Week 76; Complete remission; n= 8	0 Participants
Number of Participants With Complete or Partial Remission Week 104; Partial remission; n= 10	6 Participants
Number of Participants With Complete or Partial Remission Week 104; Complete remission; n= 10	1 Participants
Number of Participants With Complete or Partial Remission Week 128; Partial remission; n= 9	6 Participants
Number of Participants With Complete or Partial Remission Week 128; Complete remission; n= 9	1 Participants

SECONDARY outcome

Timeframe: Baseline and up to Week 128/6 month follow up

Population: ITT Population

Time to complete or partial remission was estimated using the Kaplan-Meier method. Complete remission is defined as PCR \<30 mg/mmol (proteinuria \<0.3g/24 h) with no worsening in renal function (eGFR reduction from Baseline \<15 percent ). Partial remission is defined as PCR \<350 mg/mmol (proteinuria \<3.5 g/24 h) but \>= 30 mg/mmol (proteinuria \>= 0.3g/24h) and decrease of \>50 percent from Day 0 Baseline, together with no consistent worsening in renal function (eGFR reduction from Baseline \<15 percent). Only 1 participant reached complete remission. Hence, statistical analysis for complete remission was not performed.

Outcome measures

Outcome measures
Measure	Belimumab 10 mg/kg IV n=14 Participants Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Time to Complete or Partial Remission	68.20 Weeks Interval 28.0 to 93.6

SECONDARY outcome

Timeframe: Baseline and up to Week 128/6 month follow up

Population: ITT Population

Complete remission is defined as PCR \<30 mg/mmol (proteinuria \<0.3g/24 h) with no worsening in renal function (eGFR reduction from Baseline \<15percent). Partial remission is defined as PCR \<350 mg/mmol (proteinuria \<3.5 g/24 h) but \>= 30 mg/mmol (proteinuria \>= 0.3g/24h) and decrease of \>50% from Day 0 Baseline, together with no consistent worsening in renal function (eGFR reduction from Baseline \<15percent). Only those participants available at the specified time points were analyzed (represented by n=X in category titles). NA indicates that data was not available as only 1 participant reached complete remission. Hence, standard deviation for complete remission was not calculated.

Outcome measures

Outcome measures
Measure	Belimumab 10 mg/kg IV n=14 Participants Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Duration of Complete or Partial Remission Complete remission; n= 1	365.0 Days Standard Deviation NA NA indicates that data was not available as only 1 participant reached complete remission. Hence, standard deviation for complete remission was not calculated.
Duration of Complete or Partial Remission Partial remission; n= 9	378.6 Days Standard Deviation 186.15

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 28, 52, 76, 104 and 128

Population: ITT Population

Incidence of anti-PLA2R autoantibody remission were evaluated by full response and partial response. Full response is defined as antibody undetectable, partial response is defined as reduction in titers by 50 percent. For anti PLA2R autoantibody data, log transformation was applied before the formal analyses. Anti-PLA2R autoantibody blood samples were evaluated at Week 12, 28, 52, 76, 104 and 128/6 week post last-dose. Only those participants available at the specified time points were analyzed (represented by n=X in category titles).

Outcome measures

Outcome measures
Measure	Belimumab 10 mg/kg IV n=14 Participants Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Number of Participants With PLA2R Autoantibody Remission Week 12; full response; n= 13	1 Participants
Number of Participants With PLA2R Autoantibody Remission Week 12; partial response; n= 13	3 Participants
Number of Participants With PLA2R Autoantibody Remission Week 28; full response; n= 11	3 Participants
Number of Participants With PLA2R Autoantibody Remission Week 28; partial response; n= 11	6 Participants
Number of Participants With PLA2R Autoantibody Remission Week 52; full response; n= 9	4 Participants
Number of Participants With PLA2R Autoantibody Remission Week 52; partial response; n= 9	5 Participants
Number of Participants With PLA2R Autoantibody Remission Week 76; full response; n= 8	4 Participants
Number of Participants With PLA2R Autoantibody Remission Week 76; partial response; n= 8	4 Participants
Number of Participants With PLA2R Autoantibody Remission Week 104; full response; n= 10	10 Participants
Number of Participants With PLA2R Autoantibody Remission Week 104; partial response; n= 10	0 Participants
Number of Participants With PLA2R Autoantibody Remission Week 128; Full response; n= 8	8 Participants
Number of Participants With PLA2R Autoantibody Remission Week 128; partial response; n= 8	0 Participants

SECONDARY outcome

Timeframe: Baseline and up to Week 128/6 month follow up

Population: ITT Population

Time to anti-PLA2R autoantibody remission was estimated using Kaplan-Meier method for full response and partial response full response with antibody undetectable and partial response with reduction in titers by 50 percent.

Outcome measures

Outcome measures
Measure	Belimumab 10 mg/kg IV n=14 Participants Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Time to Anti-PLA2R Autoantibody Remission Partial response	16.20 Weeks Interval 8.0 to 24.0
Time to Anti-PLA2R Autoantibody Remission Complete response	82.00 Weeks Interval 16.0 to 92.0

SECONDARY outcome

Timeframe: Baseline and up to Week 128/6 month follow up

Population: ITT Population

Incidence of anti-PLA2R autoantibody relapse defined as antibody detectable after previously undetectable. Anti-PLA2R autoantibody blood samples were evaluated at Week 12, 28, 52, 76, 104/4 week post last dose, Only those participants available at the specified time points were analyzed (represented by n=X in category titles).

Outcome measures

Outcome measures
Measure	Belimumab 10 mg/kg IV n=14 Participants Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Number of Participants With Anti-PLA2R Autoantibody Relapse Week 12; n= 13	0 Participants
Number of Participants With Anti-PLA2R Autoantibody Relapse Week 28; n= 11	0 Participants
Number of Participants With Anti-PLA2R Autoantibody Relapse Week 52; n= 9	0 Participants
Number of Participants With Anti-PLA2R Autoantibody Relapse Week 76; n= 8	0 Participants
Number of Participants With Anti-PLA2R Autoantibody Relapse Week 104; n= 10	0 Participants
Number of Participants With Anti-PLA2R Autoantibody Relapse Week 128; n= 8	0 Participants

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up.

Population: ITT Population

eGFR was assessed from levels of creatinine using the 4 variable version of the modification of diet in renal disease (MDRD) equation as recommended by National Kidney Foundation-Chronic Kidney Disease (NKF-CKD) guidelines. Baseline for eGFR is defined as the mean of the screening and Day 0 values. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	Belimumab 10 mg/kg IV n=14 Participants Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
eGFR Levels at the Indicated Time Points Baseline; n= 14	69.8170 milliliter/minute (mL/min/1.73meter^2) Geometric Coefficient of Variation 32.9
eGFR Levels at the Indicated Time Points Week 12; n= 13	66.2639 milliliter/minute (mL/min/1.73meter^2) Geometric Coefficient of Variation 35.4
eGFR Levels at the Indicated Time Points Week 28; n= 11	65.0866 milliliter/minute (mL/min/1.73meter^2) Geometric Coefficient of Variation 36.1
eGFR Levels at the Indicated Time Points Week 52; n= 7	65.1308 milliliter/minute (mL/min/1.73meter^2) Geometric Coefficient of Variation 45.0
eGFR Levels at the Indicated Time Points Week 76; n= 8	61.6732 milliliter/minute (mL/min/1.73meter^2) Geometric Coefficient of Variation 47.1
eGFR Levels at the Indicated Time Points Week 104; n= 10	69.7692 milliliter/minute (mL/min/1.73meter^2) Geometric Coefficient of Variation 39.1
eGFR Levels at the Indicated Time Points Week 128; n= 9	64.7984 milliliter/minute (mL/min/1.73meter^2) Geometric Coefficient of Variation 39.2

SECONDARY outcome

Timeframe: Baseline and up to Week 128/6 month follow up

Population: ITT Population

eGFR was assessed from levels of creatinine using the 4 variable version of the modification of diet in renal disease (MDRD) equation as recommended by national kidney foundation-chronic kidney disease (NKF-CKD) guidelines. Baseline for eGFR is defined as the mean of the Screening and Day 0 values and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	Belimumab 10 mg/kg IV n=14 Participants Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Change From Baseline in eGFR Levels at the Indicated Time Points Week 2, n=14	0.9954 Ratio Geometric Coefficient of Variation 10.8
Change From Baseline in eGFR Levels at the Indicated Time Points Week 4, n= 13	0.9190 Ratio Geometric Coefficient of Variation 16.4
Change From Baseline in eGFR Levels at the Indicated Time Points Week 8, n= 13	0.9035 Ratio Geometric Coefficient of Variation 16.2
Change From Baseline in eGFR Levels at the Indicated Time Points Week 12, n= 13	0.9339 Ratio Geometric Coefficient of Variation 17.1
Change From Baseline in eGFR Levels at the Indicated Time Points Week 16, n= 12	0.9521 Ratio Geometric Coefficient of Variation 12.5
Change From Baseline in eGFR Levels at the Indicated Time Points Week 20, n= 8	0.9819 Ratio Geometric Coefficient of Variation 11.8
Change From Baseline in eGFR Levels at the Indicated Time Points Week 24, n= 11	0.9274 Ratio Geometric Coefficient of Variation 17.1
Change From Baseline in eGFR Levels at the Indicated Time Points Week 28, n= 11	0.9694 Ratio Geometric Coefficient of Variation 21.1
Change From Baseline in eGFR Levels at the Indicated Time Points Week 32, n= 9	1.0099 Ratio Geometric Coefficient of Variation 19.5
Change From Baseline in eGFR Levels at the Indicated Time Points Week 36, n= 11	0.9692 Ratio Geometric Coefficient of Variation 17.4
Change From Baseline in eGFR Levels at the Indicated Time Points Week 40, n= 11	0.9425 Ratio Geometric Coefficient of Variation 20.8
Change From Baseline in eGFR Levels at the Indicated Time Points Week 44, n= 10	0.9531 Ratio Geometric Coefficient of Variation 22.6
Change From Baseline in eGFR Levels at the Indicated Time Points Week 48, n= 8	0.9929 Ratio Geometric Coefficient of Variation 23.8
Change From Baseline in eGFR Levels at the Indicated Time Points Week 52, n= 7	0.9290 Ratio Geometric Coefficient of Variation 27.7
Change From Baseline in eGFR Levels at the Indicated Time Points Week 56, n= 9	1.0181 Ratio Geometric Coefficient of Variation 21.9
Change From Baseline in eGFR Levels at the Indicated Time Points Week 60, n= 9	0.9805 Ratio Geometric Coefficient of Variation 26.8
Change From Baseline in eGFR Levels at the Indicated Time Points Week 64, n=9	1.0217 Ratio Geometric Coefficient of Variation 23.5
Change From Baseline in eGFR Levels at the Indicated Time Points Week 68, n=8	1.0233 Ratio Geometric Coefficient of Variation 24.6
Change From Baseline in eGFR Levels at the Indicated Time Points Week 72, n=8	1.0168 Ratio Geometric Coefficient of Variation 28.3
Change From Baseline in eGFR Levels at the Indicated Time Points Week 76, n=8	1.0055 Ratio Geometric Coefficient of Variation 33.3
Change From Baseline in eGFR Levels at the Indicated Time Points Week 80, n=8	1.0431 Ratio Geometric Coefficient of Variation 21.6
Change From Baseline in eGFR Levels at the Indicated Time Points Week 84, n=8	0.9959 Ratio Geometric Coefficient of Variation 25.3
Change From Baseline in eGFR Levels at the Indicated Time Points Week 88, n=8	1.0529 Ratio Geometric Coefficient of Variation 16.3
Change From Baseline in eGFR Levels at the Indicated Time Points Week 92, n=8	1.0052 Ratio Geometric Coefficient of Variation 26.3
Change From Baseline in eGFR Levels at the Indicated Time Points Week 96, n=8	1.1204 Ratio Geometric Coefficient of Variation 22.1
Change From Baseline in eGFR Levels at the Indicated Time Points Week 100, n=8	1.1122 Ratio Geometric Coefficient of Variation 24.7
Change From Baseline in eGFR Levels at the Indicated Time Points Week 104, n=10	1.0480 Ratio Geometric Coefficient of Variation 23.3
Change From Baseline in eGFR Levels at the Indicated Time Points Week 116; n= 8	1.0373 Ratio Geometric Coefficient of Variation 19.8
Change From Baseline in eGFR Levels at the Indicated Time Points Week 128, n=9	0.9971 Ratio Geometric Coefficient of Variation 35.2

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up

Population: ITT Population

Serum creatinine was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum creatinine is defined as the mean of the Screening and Day 0 values. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	Belimumab 10 mg/kg IV n=14 Participants Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Serum Creatinine Levels at the Indicated Time Points Baseline; n= 14	97.1658 micromoles/liter (µmol/L) Geometric Coefficient of Variation 22.8
Serum Creatinine Levels at the Indicated Time Points Week 12; n= 13	100.6421 micromoles/liter (µmol/L) Geometric Coefficient of Variation 26.8
Serum Creatinine Levels at the Indicated Time Points Week 28; n= 11	99.9535 micromoles/liter (µmol/L) Geometric Coefficient of Variation 24.8
Serum Creatinine Levels at the Indicated Time Points Week 52; n= 7	96.6583 micromoles/liter (µmol/L) Geometric Coefficient of Variation 30.2
Serum Creatinine Levels at the Indicated Time Points Week 76; n= 8	103.0265 micromoles/liter (µmol/L) Geometric Coefficient of Variation 32.8
Serum Creatinine Levels at the Indicated Time Points Week 104; n= 10	92.4547 micromoles/liter (µmol/L) Geometric Coefficient of Variation 29.6
Serum Creatinine Levels at the Indicated Time Points Week 128; n= 9	97.7260 micromoles/liter (µmol/L) Geometric Coefficient of Variation 29.7

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up

Population: ITT Population

Serum creatinine was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum creatinine is defined as the mean of the Screening and Day 0 values and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	Belimumab 10 mg/kg IV n=14 Participants Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Change From Baseline in Serum Creatinine Levels at the Indicated Time Points Week 12; n= 13	1.0530 Ratio Geometric Coefficient of Variation 14.8
Change From Baseline in Serum Creatinine Levels at the Indicated Time Points Week 28; n= 11	1.0202 Ratio Geometric Coefficient of Variation 18.6
Change From Baseline in Serum Creatinine Levels at the Indicated Time Points Week 52; n= 7	1.0581 Ratio Geometric Coefficient of Variation 23.7
Change From Baseline in Serum Creatinine Levels at the Indicated Time Points Week 76; n= 8	0.9818 Ratio Geometric Coefficient of Variation 28.7
Change From Baseline in Serum Creatinine Levels at the Indicated Time Points Week 104; n= 10	0.9467 Ratio Geometric Coefficient of Variation 20.1
Change From Baseline in Serum Creatinine Levels at the Indicated Time Points Week 128; n= 9	0.9874 Ratio Geometric Coefficient of Variation 30.4

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up.

Population: ITT Population

Serum albumin was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum albumin is defined as the mean of the Screening and Day 0 values. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	Belimumab 10 mg/kg IV n=14 Participants Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Serum Albumin Levels at Indicated Time Points Baseline; n= 14	23.3306 grams per liter (g/L) Geometric Coefficient of Variation 22.7
Serum Albumin Levels at Indicated Time Points Week 12; n= 13	24.4204 grams per liter (g/L) Geometric Coefficient of Variation 27.5
Serum Albumin Levels at Indicated Time Points Week 28; n= 11	27.8397 grams per liter (g/L) Geometric Coefficient of Variation 23.4
Serum Albumin Levels at Indicated Time Points Week 52; n= 7	31.9927 grams per liter (g/L) Geometric Coefficient of Variation 18.3
Serum Albumin Levels at Indicated Time Points Week 76; n= 8	33.9484 grams per liter (g/L) Geometric Coefficient of Variation 10.9
Serum Albumin Levels at Indicated Time Points Week 104; n= 10	39.1015 grams per liter (g/L) Geometric Coefficient of Variation 7.5
Serum Albumin Levels at Indicated Time Points Week 128; n= 9	39.2009 grams per liter (g/L) Geometric Coefficient of Variation 8.8

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up

Population: ITT Population

Serum albumin was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum albumin is defined as the mean of the Screening and Day 0 values and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	Belimumab 10 mg/kg IV n=14 Participants Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Change From Baseline in Levels of Serum Albumin at the Indicated Time Points Week 28; n= 11	1.1211 ratio Geometric Coefficient of Variation 16.9
Change From Baseline in Levels of Serum Albumin at the Indicated Time Points Week 12; n= 13	1.0324 ratio Geometric Coefficient of Variation 15.0
Change From Baseline in Levels of Serum Albumin at the Indicated Time Points Week 52; n= 7	1.2828 ratio Geometric Coefficient of Variation 28.1
Change From Baseline in Levels of Serum Albumin at the Indicated Time Points Week 76; n= 8	1.3695 ratio Geometric Coefficient of Variation 23.8
Change From Baseline in Levels of Serum Albumin at the Indicated Time Points Week 104; n= 10	1.5879 ratio Geometric Coefficient of Variation 19.6
Change From Baseline in Levels of Serum Albumin at the Indicated Time Points Week 128; n= 9	1.5799 ratio Geometric Coefficient of Variation 24.7

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up

Population: ITT Population

Serum cholesterol was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum cholesterol is defined as the mean of the Screening and Day 0 values. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	Belimumab 10 mg/kg IV n=14 Participants Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Serum Cholesterol Levels at Indicated Time Points Baseline; n= 14	7.6423 millimoles per liter (mmol/L) Geometric Coefficient of Variation 36.0
Serum Cholesterol Levels at Indicated Time Points Week 12; n= 13	7.2336 millimoles per liter (mmol/L) Geometric Coefficient of Variation 31.5
Serum Cholesterol Levels at Indicated Time Points Week 28; n= 11	6.2740 millimoles per liter (mmol/L) Geometric Coefficient of Variation 23.1
Serum Cholesterol Levels at Indicated Time Points Week 52; n= 7	5.8724 millimoles per liter (mmol/L) Geometric Coefficient of Variation 18.6
Serum Cholesterol Levels at Indicated Time Points Week 76; n= 8	5.0211 millimoles per liter (mmol/L) Geometric Coefficient of Variation 18.4
Serum Cholesterol Levels at Indicated Time Points Week 104; n= 10	4.8001 millimoles per liter (mmol/L) Geometric Coefficient of Variation 24.5
Serum Cholesterol Levels at Indicated Time Points Week 128; n= 9	4.2407 millimoles per liter (mmol/L) Geometric Coefficient of Variation 12.7

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up

Population: ITT Population

Serum cholesterol was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum cholesterol is defined as the mean of the Screening and Day 0 values and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	Belimumab 10 mg/kg IV n=14 Participants Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Change From Baseline in Serum Cholesterol at the Indicated Time Points Week 12; n= 13	0.9238 mmol/L Geometric Coefficient of Variation 16.8
Change From Baseline in Serum Cholesterol at the Indicated Time Points Week 28; n= 11	0.8896 mmol/L Geometric Coefficient of Variation 14.3
Change From Baseline in Serum Cholesterol at the Indicated Time Points Week 52; n= 7	0.8571 mmol/L Geometric Coefficient of Variation 16.7
Change From Baseline in Serum Cholesterol at the Indicated Time Points Week 76; n= 8	0.7111 mmol/L Geometric Coefficient of Variation 15.0
Change From Baseline in Serum Cholesterol at the Indicated Time Points Week 104; n= 10	0.6851 mmol/L Geometric Coefficient of Variation 17.3
Change From Baseline in Serum Cholesterol at the Indicated Time Points Week 128; n= 9	0.6140 mmol/L Geometric Coefficient of Variation 15.7

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up

Population: ITT Population

Serum IgG was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum IgG is defined as the pre-dose Day 0 value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	Belimumab 10 mg/kg IV n=14 Participants Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Serum Immunoglobulin G (IgG) Levels at Indicated Time Points Baseline; n= 14	4.026 g/L Standard Deviation 1.6810
Serum Immunoglobulin G (IgG) Levels at Indicated Time Points Week 12; n= 13	3.871 g/L Standard Deviation 1.5266
Serum Immunoglobulin G (IgG) Levels at Indicated Time Points Week 28; n= 11	4.405 g/L Standard Deviation 1.7833
Serum Immunoglobulin G (IgG) Levels at Indicated Time Points Week 52; n= 8	5.823 g/L Standard Deviation 2.2572
Serum Immunoglobulin G (IgG) Levels at Indicated Time Points Week 76; n= 8	6.050 g/L Standard Deviation 2.1103
Serum Immunoglobulin G (IgG) Levels at Indicated Time Points Week 104; n= 10	7.611 g/L Standard Deviation 2.8301
Serum Immunoglobulin G (IgG) Levels at Indicated Time Points Week 128; n= 9	8.609 g/L Standard Deviation 2.2597

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow up

Population: ITT Population

Serum IgG was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum IgG is defined as the pre-dose Day 0 value and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	Belimumab 10 mg/kg IV n=14 Participants Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Change From Baseline in Serum IgG at the Indicated Time Points Week 12; n= 13	0.055 Ratio Standard Deviation 0.6625
Change From Baseline in Serum IgG at the Indicated Time Points Week 28; n= 11	0.469 Ratio Standard Deviation 1.4287
Change From Baseline in Serum IgG at the Indicated Time Points Week 52; n= 8	1.525 Ratio Standard Deviation 2.4411
Change From Baseline in Serum IgG at the Indicated Time Points Week 76; n= 8	1.619 Ratio Standard Deviation 1.6681
Change From Baseline in Serum IgG at the Indicated Time Points Week 104; n= 10	3.613 Ratio Standard Deviation 2.5488
Change From Baseline in Serum IgG at the Indicated Time Points Week 128; n= 9	4.334 Ratio Standard Deviation 2.0289

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 28, 52, 76, and 104

Population: ITT Population

Reduction of proteinuria lessens the risk of thromboembolic and cardiovascular effects and reduces the edema in participants. Investigators physically reviewed participants for clinical manifestations of idiopathic membranous glomerulonephropathy (IMGN) (e.g. edema extending beyond calf) during study and analysis was performed at Week 12, 28, 52, 76 Week 104. Only those participants available at the specified time points were analyzed (represented by n=X in category titles).

Outcome measures

Outcome measures
Measure	Belimumab 10 mg/kg IV n=14 Participants Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Number of Participants With Edema and Edema Extending Beyond Calf 4 Week PFD; Oedema extending beyond calf; n= 10	1 Participants
Number of Participants With Edema and Edema Extending Beyond Calf Week 0; oedema; n= 14	13 Participants
Number of Participants With Edema and Edema Extending Beyond Calf Week 0; oedema extending beyond calf; n= 14	5 Participants
Number of Participants With Edema and Edema Extending Beyond Calf Week 12; oedema; n= 12	9 Participants
Number of Participants With Edema and Edema Extending Beyond Calf Week 12; Oedema extending beyond calf; n= 12	1 Participants
Number of Participants With Edema and Edema Extending Beyond Calf Week 28;Oedema; n= 11	7 Participants
Number of Participants With Edema and Edema Extending Beyond Calf Week 28; Oedema extending beyond calf; n= 11	1 Participants
Number of Participants With Edema and Edema Extending Beyond Calf Week 52; oedema; n= 9	4 Participants
Number of Participants With Edema and Edema Extending Beyond Calf Week 52;Oedema extending beyond calf; n= 9	1 Participants
Number of Participants With Edema and Edema Extending Beyond Calf Week 76;Oedema; n=8	4 Participants
Number of Participants With Edema and Edema Extending Beyond Calf Week 76;Oedema extending beyond calf; n= 8	0 Participants
Number of Participants With Edema and Edema Extending Beyond Calf 4 Week post final dose (PFD); Oedema; n=10	6 Participants
Number of Participants With Edema and Edema Extending Beyond Calf Week 104 withdrawn (WD); Oedema; n= 1	0 Participants
Number of Participants With Edema and Edema Extending Beyond Calf Week 104 WD;Oedema extending beyond calf; n= 1	0 Participants

SECONDARY outcome

Timeframe: Baseline and up to 4 week post last dose

Population: PK Population: all participants in the ITT Population for whom a PK sample was obtained and analyzed.

The first occurrence of Cmax was determined directly from the serum concentration-time data. The pharmacokinetic (PK) parameters were calculated by standard non-compartmental analysis and all calculations of non-compartmental parameters are being based on actual sampling times.

Outcome measures

Outcome measures
Measure	Belimumab 10 mg/kg IV n=14 Participants Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Summary of Maximum Observed Serum Concentration (Cmax) of Belimumab at the Indicated Time Points Day 0, 5 minutes; n= 13	267996.0 nanograms per milliliter (ng/mL) Standard Deviation 70598.02
Summary of Maximum Observed Serum Concentration (Cmax) of Belimumab at the Indicated Time Points Week 28, 5 minutes; n= 11	312462.2 nanograms per milliliter (ng/mL) Standard Deviation 95171.16

SECONDARY outcome

Timeframe: Baseline and up to 4 week post last dose

Population: PK Population

Trough concentration (Cmin) samples collected on the specified days are being used to assess attainment whether there was sufficient belimumab despite it being lost in the urine from the proteinuria and to check if it improved as proteinuria resolved. Analysis was performed on pre-infusion samples at weeks 2,4,8,12,28,40,52,76 and the 4 week post last-dose.

Outcome measures

Outcome measures
Measure	Belimumab 10 mg/kg IV n=14 Participants Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Summary of Minimum Observed Concentration (Cmin) of Belimumab at the Indicated Time Points Pre-infusion; Week 2; n= 14	29940.8 ng/mL Standard Deviation 20918.28
Summary of Minimum Observed Concentration (Cmin) of Belimumab at the Indicated Time Points Pre-infusion; Week 4; n= 12	41220.9 ng/mL Standard Deviation 35720.14
Summary of Minimum Observed Concentration (Cmin) of Belimumab at the Indicated Time Points Pre-infusion; Week 8; n= 13	30350.9 ng/mL Standard Deviation 25505.70
Summary of Minimum Observed Concentration (Cmin) of Belimumab at the Indicated Time Points Pre-infusion; Week 12; n= 11	30913.7 ng/mL Standard Deviation 30681.42
Summary of Minimum Observed Concentration (Cmin) of Belimumab at the Indicated Time Points Pre-infusion; Week 28; n= 11	34904.7 ng/mL Standard Deviation 26388.60
Summary of Minimum Observed Concentration (Cmin) of Belimumab at the Indicated Time Points Pre-infusion; Week 40; n= 10	40800.6 ng/mL Standard Deviation 28847.86
Summary of Minimum Observed Concentration (Cmin) of Belimumab at the Indicated Time Points Pre-infusion; Week 52; n= 9	38375.9 ng/mL Standard Deviation 14136.23
Summary of Minimum Observed Concentration (Cmin) of Belimumab at the Indicated Time Points Pre-infusion; Week 76; n= 8	65655.8 ng/mL Standard Deviation 32873.33
Summary of Minimum Observed Concentration (Cmin) of Belimumab at the Indicated Time Points 4 Weeks post last-dose; n= 9	60497.3 ng/mL Standard Deviation 28074.37

Adverse Events

Belimumab 10 mg/kg IV

Serious events: 3 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Belimumab 10 mg/kg IV n=14 participants at risk Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Infections and infestations Cellulitis	7.1% 1/14 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Investigations Weight decreased	7.1% 1/14 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Vascular disorders Embolism	7.1% 1/14 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.

Other adverse events

Other adverse events
Measure	Belimumab 10 mg/kg IV n=14 participants at risk Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Infections and infestations Upper respiratory tract infection	42.9% 6/14 • Number of events 10 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Infections and infestations Cellulitis	7.1% 1/14 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Infections and infestations Lower respiratory tract infection	14.3% 2/14 • Number of events 2 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Infections and infestations Oral candidiasis	7.1% 1/14 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Infections and infestations Respiratory tract infection	7.1% 1/14 • Number of events 4 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Infections and infestations Rhinitis	14.3% 2/14 • Number of events 2 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Infections and infestations Urinary tract infection	7.1% 1/14 • Number of events 2 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Infections and infestations Viral upper respiratory tract infection	35.7% 5/14 • Number of events 5 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Gastrointestinal disorders Diarrhoea	14.3% 2/14 • Number of events 3 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Gastrointestinal disorders Abdominal pain	7.1% 1/14 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Gastrointestinal disorders Abdominal pain upper	7.1% 1/14 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Gastrointestinal disorders Ascites	7.1% 1/14 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Gastrointestinal disorders Dyspepsia	14.3% 2/14 • Number of events 3 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Gastrointestinal disorders Irritable bowel syndrome	7.1% 1/14 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Gastrointestinal disorders Nausea	7.1% 1/14 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Musculoskeletal and connective tissue disorders Muscle spasms	28.6% 4/14 • Number of events 12 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Musculoskeletal and connective tissue disorders Arthralgia	14.3% 2/14 • Number of events 2 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Musculoskeletal and connective tissue disorders Flank pain	7.1% 1/14 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Musculoskeletal and connective tissue disorders Joint swelling	7.1% 1/14 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Musculoskeletal and connective tissue disorders Myalgia	7.1% 1/14 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Musculoskeletal and connective tissue disorders Pain in extremity	14.3% 2/14 • Number of events 2 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Nervous system disorders Headache	14.3% 2/14 • Number of events 7 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Nervous system disorders Dizziness	14.3% 2/14 • Number of events 3 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Nervous system disorders Migraine	7.1% 1/14 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Nervous system disorders Presyncope	7.1% 1/14 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Skin and subcutaneous tissue disorders Rash	14.3% 2/14 • Number of events 2 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Skin and subcutaneous tissue disorders Rash pruritic	7.1% 1/14 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Skin and subcutaneous tissue disorders Skin lesion	14.3% 2/14 • Number of events 2 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Skin and subcutaneous tissue disorders Swelling face	7.1% 1/14 • Number of events 3 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
General disorders Chest pain	14.3% 2/14 • Number of events 2 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
General disorders Malaise	7.1% 1/14 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
General disorders Pyrexia	7.1% 1/14 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Respiratory, thoracic and mediastinal disorders Cough	14.3% 2/14 • Number of events 2 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	14.3% 2/14 • Number of events 3 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Ear and labyrinth disorders Tinnitus	7.1% 1/14 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Eye disorders Periorbital oedema	7.1% 1/14 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Investigations Eosinophil count increased	7.1% 1/14 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Metabolism and nutrition disorders Decreased appetite	7.1% 1/14 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Psychiatric disorders Depression	7.1% 1/14 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Renal and urinary disorders Tubulointerstitial nephritis	7.1% 1/14 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Infections and infestations Viral infection	14.3% 2/14 • Number of events 2 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Infections and infestations Influenza	7.1% 1/14 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Infections and infestations Labyrinthitis	7.1% 1/14 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Infections and infestations Lower respiratory tract infection viral	7.1% 1/14 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Gastrointestinal disorders Rectal haemorrhage	14.3% 2/14 • Number of events 2 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Gastrointestinal disorders Vomiting	14.3% 2/14 • Number of events 2 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Gastrointestinal disorders Gingival bleeding	7.1% 1/14 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Gastrointestinal disorders Haemorrhoids	7.1% 1/14 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Gastrointestinal disorders Melaena	7.1% 1/14 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Gastrointestinal disorders Toothache	7.1% 1/14 • Number of events 2 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Nervous system disorders Hypoaesthesia	7.1% 1/14 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Nervous system disorders Peripheral sensory neuropathy	7.1% 1/14 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Nervous system disorders Sciatica	7.1% 1/14 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Musculoskeletal and connective tissue disorders Back pain	14.3% 2/14 • Number of events 4 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	7.1% 1/14 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Musculoskeletal and connective tissue disorders Neck pain	7.1% 1/14 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Musculoskeletal and connective tissue disorders Tendonitis	7.1% 1/14 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Skin and subcutaneous tissue disorders Angioedema	7.1% 1/14 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
General disorders Chest discomfort	7.1% 1/14 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Respiratory, thoracic and mediastinal disorders Epistaxis	7.1% 1/14 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Respiratory, thoracic and mediastinal disorders Productive cough	7.1% 1/14 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Psychiatric disorders Insomnia	14.3% 2/14 • Number of events 2 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Cardiac disorders Angina pectoris	7.1% 1/14 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Cardiac disorders Palpitations	7.1% 1/14 • Number of events 2 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Investigations Blood parathyroid hormone increased	7.1% 1/14 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Renal and urinary disorders Costovertebral angle tenderness	7.1% 1/14 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Immune system disorders Seasonal allergy	7.1% 1/14 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Injury, poisoning and procedural complications Limb injury	7.1% 1/14 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	7.1% 1/14 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	7.1% 1/14 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
Vascular disorders Hypertension	7.1% 1/14 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study. On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.

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