GSK1550188 A 52 Week Study of Belimumab Versus Placebo in... | NCT01345253

Name	Class
Human Genome Sciences Inc.	INDUSTRY

Label	Type	Description	Intervention Names
Belimumab	Experimental	10mg/kg	Drug: Belimumab
Placebo	Placebo Comparator	placebo	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Belimumab	Drug	10mg/kg administered intravenously. Dosing at Weeks 0, 2, and 4, then every 4 weeks through Week 48, with a final evaluation at Week 52. All study subjects will receive standard SLE therapies during the study.

Measure	Description	Time Frame
Percent of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response Rate at Week 52 for Double-blind Phase.	SRI response is a composite index, defined as the percent of participants with >=4 point reduction from Baseline in safety of estrogen in lupus national assessment (SELENA) systemic lupus erythematosus disease activity index (SLEDAI) score and no worsening (increase of < 0.30 points from Baseline) in physicians global assessment (PGA) and no new British isles lupus assessment group (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with Baseline at the time of assessment (at Week 52 of the blinded period). A SELENA SLEDAI score of 0 would suggest no lupus activity; while a score of 105 is the maximum calculable if all items were scored as being present from active lupus. PGA ranges from 0 (no activity) to 3 (severe activity). BILAG has no range. The higher thresholds of SELENA SLEDAI improvement (i.e., SRI5, SRI6, and SRI7) indicates a higher response (SRI5 is a 5 point SELENA SLEDAI reduction, SRI6 is a 6 point reduction, and SRI7 is a 7 point reduction).	Week 52

Measure	Description	Time Frame
Percent of Participants With >=4 Point Reduction From Baseline in SELENA SLEDAI Score at Week 52 for Double-blind Phase.	The SELENA SLEDAI score is a weighted index for assessing SLE disease activity in which signs and symptoms, laboratory tests and physician's assessment for each of 9 organ system were given a weighted score and summed if present at the time of the visit or in the preceding 10 days. A SELENA SLEDAI score of 0 would suggest no lupus activity; while a score of 105 is the maximum calculable if all items were scored as being present from active lupus. A decrease of 4 points or more equates to a clinically meaningful improvement. The Baseline value of a variable is defined as the value of the variable measured at Day 0 prior to dosing. In case of multiple results on Day 0 prior to dosing, the latest result was used. If a Day 0 value was not available, the last available value prior to Day 0 was used.

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Hefei	Anhui	230001	China
GSK Investigational Site

PubMed Identifier	Type	Citation	Retractions
29295825	Background	Zhang F, Bae SC, Bass D, Chu M, Egginton S, Gordon D, Roth DA, Zheng J, Tanaka Y. A pivotal phase III, randomised, placebo-controlled study of belimumab in patients with systemic lupus erythematosus located in China, Japan and South Korea. Ann Rheum Dis. 2018 Mar;77(3):355-363. doi: 10.1136/annrheumdis-2017-211631. Epub 2018 Jan 2.
39208825

ID	Title	Description
FG000	Placebo	Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 milligrams (mg)/kilogram (kg) up to Year 5 Week 28.
FG001

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percent of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response Rate at Week 52 for Double-blind Phase.

SRI response is a composite index, defined as the percent of participants with >=4 point reduction from Baseline in safety of estrogen in lupus national assessment (SELENA) systemic lupus erythematosus disease activity index (SLEDAI) score and no worsening (increase of < 0.30 points from Baseline) in physicians global assessment (PGA) and no new British isles lupus assessment group (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with Baseline at the time of assessment (at Week 52 of the blinded period). A SELENA SLEDAI score of 0 would suggest no lupus activity; while a score of 105 is the maximum calculable if all items were scored as being present from active lupus. PGA ranges from 0 (no activity) to 3 (severe activity). BILAG has no range. The higher thresholds of SELENA SLEDAI improvement (i.e., SRI5, SRI6, and SRI7) indicates a higher response (SRI5 is a 5 point SELENA SLEDAI reduction, SRI6 is a 6 point reduction, and SRI7 is a 7 point reduction).

Modified Intention-to-Treat (MITT) Population: all participants who were randomized and treated with at least one dose of study treatment, with exclusion of participants from the site 086485.

Posted

Number

Percentage of participants

Week 52

ID	Title	Description
OG000	Placebo	Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 milligrams (mg)/kilogram (kg) up to Year 5 Week 28.
OG001	Belimumab 10 mg/kg	Participants received belimumab 10 mg/kg IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 mg/kg up to Year 5 Week 28.

Units	Counts
Participants	OG000217 OG001446

Title

Denominators

Categories

Title	Measurements
	OG00040.1 OG00153.8

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Regression, Logistic		0.0001		Odds Ratio (OR)	1.99			2-Sided	95	1.40	2.82			Odds Ratio (95% CI) and p-value were estimated by a logistic regression model with independent variables treatment group, country, Baseline SELENA SLEDAI score (<=9 vs. >=10) and complement (C) levels (low C3 and/or C4 vs. no low C3 or C4).		Superiority or Other (legacy)

Secondary

Percent of Participants With >=4 Point Reduction From Baseline in SELENA SLEDAI Score at Week 52 for Double-blind Phase.

The SELENA SLEDAI score is a weighted index for assessing SLE disease activity in which signs and symptoms, laboratory tests and physician's assessment for each of 9 organ system were given a weighted score and summed if present at the time of the visit or in the preceding 10 days. A SELENA SLEDAI score of 0 would suggest no lupus activity; while a score of 105 is the maximum calculable if all items were scored as being present from active lupus. A decrease of 4 points or more equates to a clinically meaningful improvement. The Baseline value of a variable is defined as the value of the variable measured at Day 0 prior to dosing. In case of multiple results on Day 0 prior to dosing, the latest result was used. If a Day 0 value was not available, the last available value prior to Day 0 was used.

MITT Population. Only those participants available at the specified time points were analyzed.

Posted

Number

Percentage of participants

Baseline (Day 0) and Week 52

ID	Title	Description
OG000	Placebo	Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 milligrams (mg)/kilogram (kg) up to Year 5 Week 28.
OG001	Belimumab 10 mg/kg

Secondary

Percent of Participants With SRI7 Response at Week 52 for Double-blind Phase.

SRI7 response is defined as the percent of participants with >=7 point reduction from Baseline in SELENA SLEDAI score and no worsening (increase of < 0.30 points from Baseline) in PGA and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with Baseline at the time of assessment (at Week 52 of the blinded period). A SELENA SLEDAI score of 0 would suggest no lupus activity; while a score of 105 is the maximum calculable if all items were scored as being present from active lupus. PGA ranges from 0 (no activity) to 3 (severe activity). BILAG has no range. The higher thresholds of SELENA SLEDAI improvement (i.e., SRI5, SRI6, and SRI7) indicates a higher response (SRI5 is a 5 point SELENA SLEDAI reduction, SRI6 is a 6 point reduction, and SRI7 is a 7 point reduction).

MITT Population. Only those participants available at the specified time point were analyzed.

Posted

Number

Percentage of participants

Baseline (Day 0) and Week 52

ID	Title	Description
OG000	Placebo	Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 milligrams (mg)/kilogram (kg) up to Year 5 Week 28.
OG001	Belimumab 10 mg/kg	Participants received belimumab 10 mg/kg IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 mg/kg up to Year 5 Week 28.

Secondary

Number of Days of Daily Prednisone Dose <=7.5 mg/Day and/or Reduced by 50 Percent From Baseline Over 52 Weeks for Double-blind Phase.

Number of days of daily prednisone dose <=7.5 mg/day and/or reduced by 50 percent over time through each scheduled visit during the blinded period were compared between belimumab and placebo using Rank ANCOVA model which was used for comparing belimumab and placebo. The independent variables in the model included treatment group, Baseline prednisone dose level, country, Baseline SELENA SLEDAI score (<=9 vs. >=10) and complement levels (low C3 and/or C4 vs. no low C3 or C4). This analysis was perfomed on the participants who used prednisone >7.5 mg/day at Baseline.

MITT Population

Posted

Median

Inter-Quartile Range

Days

Week 52

ID	Title	Description
OG000	Placebo	Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 milligrams (mg)/kilogram (kg) up to Year 5 Week 28.
OG001	Belimumab 10 mg/kg	Participants received belimumab 10 mg/kg IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 mg/kg up to Year 5 Week 28.

Secondary

Time to First Severe SLE Flare Index (SFI) Flare Over 52 Weeks for Double-blind Phase.

Time to first severe SLE flare is defined as the number of days from first treatment until the participant had an event (event date-treatement start date +1). If a participant had a severe SFI flare and received protocol restricted medication then the event date was the earliest of the first severe SFI flare date, and the treatment failure date. Analysis of severe SFI flare was performed on the modified SELENA SLEDAI SLE flare index in which the modification excluded severe flares that were triggered only by an increase in SELENA SLEDAI score to >12. Analysis was from Cox proportional hazards model for the comparison between belimumab and placebo adjusting for country, Baseline SELENA SLEDAI score (<=9 vs. >=10) and complement levels (low C3 and/or C4 vs. no low C3 or C4).

MITT Population

Posted

Median

Inter-Quartile Range

Days

52 weeks

ID	Title	Description
OG000	Placebo	Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 milligrams (mg)/kilogram (kg) up to Year 5 Week 28.
OG001	Belimumab 10 mg/kg	Participants received belimumab 10 mg/kg IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 mg/kg up to Year 5 Week 28.

Secondary

Percent of Participants Achieving SLE SRI Response Rate for Open-label (OL) Phase

SRI response is a composite index, defined as the percent of participants with >=4 point reduction from Baseline in SELENA SLEDAI score and no worsening (increase of < 0.30 points from Baseline) in PGA and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with Baseline at time of assessment. Excludes participants with a SELENA SLEDAI score <4 at baseline. Participants randomized to belimumab in double-blinded (DB) phase, Baseline is last available value before first belimumab dose received in DB phase. Participants randomized to placebo in DB phase, Baseline is last available value before receiving first belimumab dose in OL phase. Observed case data are presented.Year 6 Week 48 is the Exit Visit obtained by slotting the Exit Visit to Week 48. A SELENA SLEDAI score of 0 (no lupus activity) and a score of 105 (maximum). PGA ranges from 0 (no activity) to 3 (severe activity). BILAG has no range.

Efficacy Population: all participants in China who received at least 1 dose of belimumab during open-label phase, exclusive of site 086485. Only those participants available at the specified time points were analyzed (represented by n=x).

Posted

Number

Percentage of participants

Weeks 24 and 48 for Years 2, 3, 4, 5 and 6

ID	Title	Description
OG000	Belimumab 10mg/kg (Open-label Phase)	All eligible China participants who had received placebo and belimumab in DB period and entered open-label phase to receive belimumab 10 mg/kg over 1 hour every 28 days from first belimumab date through end of open-label phase.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Herpes zoster	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0002 affected235 at risk EG0016 affected470 at risk EG0026 affected424 at risk
Pneumonia	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 affected235 at risk EG0012 affected470 at risk EG0024 affected424 at risk
Appendicitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 affected235 at risk EG0012 affected470 at risk EG0022 affected424 at risk
Lung infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0002 affected235 at risk EG0010 affected470 at risk EG0022 affected424 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 affected235 at risk EG0012 affected470 at risk EG0020 affected424 at risk
Salmonella sepsis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0002 affected235 at risk EG0010 affected470 at risk EG0020 affected424 at risk
Skin infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 affected235 at risk EG0011 affected470 at risk EG0020 affected424 at risk
Arthritis salmonella	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 affected235 at risk EG0011 affected470 at risk EG0020 affected424 at risk
Bacterial pyelonephritis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 affected235 at risk EG0011 affected470 at risk EG0020 affected424 at risk
Cellulitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 affected235 at risk EG0011 affected470 at risk EG0020 affected424 at risk
Cellulitis streptococcal	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 affected235 at risk EG0010 affected470 at risk EG0020 affected424 at risk
Cystitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 affected235 at risk EG0010 affected470 at risk EG0020 affected424 at risk
Cytomegalovirus infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 affected235 at risk EG0011 affected470 at risk EG0020 affected424 at risk
Disseminated tuberculosis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 affected235 at risk EG0011 affected470 at risk EG0020 affected424 at risk
Enteritis infectious	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 affected235 at risk EG0010 affected470 at risk EG0020 affected424 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 affected235 at risk EG0011 affected470 at risk EG0020 affected424 at risk
Gastroenteritis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 affected235 at risk EG0011 affected470 at risk EG0020 affected424 at risk
Gastrointestinal fungal infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 affected235 at risk EG0010 affected470 at risk EG0020 affected424 at risk
Infectious colitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 affected235 at risk EG0011 affected470 at risk EG0020 affected424 at risk
Lymph node tuberculosis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 affected235 at risk EG0010 affected470 at risk EG0020 affected424 at risk
Meningitis tuberculous	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 affected235 at risk EG0011 affected470 at risk EG0020 affected424 at risk
Otitis media acute	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 affected235 at risk EG0011 affected470 at risk EG0020 affected424 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 affected235 at risk EG0010 affected470 at risk EG0020 affected424 at risk
Pneumonia mycoplasmal	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 affected235 at risk EG0011 affected470 at risk EG0020 affected424 at risk
Pneumonia streptococcal	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 affected235 at risk EG0011 affected470 at risk EG0020 affected424 at risk
Sepsis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 affected235 at risk EG0011 affected470 at risk EG0020 affected424 at risk
Spleen tuberculosis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 affected235 at risk EG0010 affected470 at risk EG0020 affected424 at risk
Tuberculosis liver	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 affected235 at risk EG0010 affected470 at risk EG0020 affected424 at risk
Tuberculous pleurisy	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 affected235 at risk EG0011 affected470 at risk EG0020 affected424 at risk
Upper respiratory tract infection bacterial	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 affected235 at risk EG0010 affected470 at risk EG0020 affected424 at risk
Urinary tract infection enterococcal	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 affected235 at risk EG0010 affected470 at risk EG0020 affected424 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 affected235 at risk EG0011 affected470 at risk EG0020 affected424 at risk
Lupus nephritis	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0005 affected235 at risk EG0015 affected470 at risk EG00212 affected424 at risk
Proteinuria	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0002 affected235 at risk EG0010 affected470 at risk EG0020 affected424 at risk
Renal failure	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0000 affected235 at risk EG0012 affected470 at risk EG0020 affected424 at risk
Haematuria	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0000 affected235 at risk EG0011 affected470 at risk EG0020 affected424 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0001 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Lupus cystitis	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0000 affected235 at risk EG0011 affected470 at risk EG0020 affected424 at risk
Ureteric stenosis	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0001 affected235 at risk EG0010 affected470 at risk EG0020 affected424 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0000 affected235 at risk EG0011 affected470 at risk EG0020 affected424 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0001 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Fractured sacrum	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0000 affected235 at risk EG0011 affected470 at risk EG0020 affected424 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0000 affected235 at risk EG0011 affected470 at risk EG0021 affected424 at risk
Jaw fracture	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0000 affected235 at risk EG0011 affected470 at risk EG0021 affected424 at risk
Ligament rupture	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0000 affected235 at risk EG0011 affected470 at risk EG0021 affected424 at risk
Patella fracture	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0001 affected235 at risk EG0010 affected470 at risk EG0020 affected424 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0000 affected235 at risk EG0011 affected470 at risk EG0020 affected424 at risk
Scapula fracture	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0000 affected235 at risk EG0011 affected470 at risk EG0021 affected424 at risk
Pyrexia	General disorders	MedDRA 18.1	Systematic Assessment	EG0004 affected235 at risk EG0012 affected470 at risk EG0021 affected424 at risk
Generalised oedema	General disorders	MedDRA 18.1	Systematic Assessment	EG0001 affected235 at risk EG0010 affected470 at risk EG0020 affected424 at risk
Polyserositis	General disorders	MedDRA 18.1	Systematic Assessment	EG0001 affected235 at risk EG0010 affected470 at risk EG0020 affected424 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 affected235 at risk EG0012 affected470 at risk EG0021 affected424 at risk
Allergic colitis	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 affected235 at risk EG0010 affected470 at risk EG0020 affected424 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 affected235 at risk EG0011 affected470 at risk EG0020 affected424 at risk
Lupus pancreatitis	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 affected235 at risk EG0011 affected470 at risk EG0020 affected424 at risk
Oesophageal varices haemorrhage	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 affected235 at risk EG0010 affected470 at risk EG0020 affected424 at risk
Pancreatitis chronic	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 affected235 at risk EG0011 affected470 at risk EG0020 affected424 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment	EG0000 affected235 at risk EG0012 affected470 at risk EG0022 affected424 at risk
Anogenital warts	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment	EG0001 affected235 at risk EG0010 affected470 at risk EG0020 affected424 at risk
Benign breast neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment	EG0001 affected235 at risk EG0010 affected470 at risk EG0020 affected424 at risk
Cervix carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment	EG0000 affected235 at risk EG0011 affected470 at risk EG0020 affected424 at risk
Ovarian adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment	EG0001 affected235 at risk EG0010 affected470 at risk EG0020 affected424 at risk
Thyroid adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment	EG0000 affected235 at risk EG0011 affected470 at risk EG0021 affected424 at risk
Lupus encephalitis	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0001 affected235 at risk EG0011 affected470 at risk EG0021 affected424 at risk
Brain stem infarction	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 affected235 at risk EG0011 affected470 at risk EG0020 affected424 at risk
Cerebral infarction	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 affected235 at risk EG0011 affected470 at risk EG0021 affected424 at risk
Dysarthria	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0001 affected235 at risk EG0010 affected470 at risk EG0020 affected424 at risk
Epilepsy	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0001 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Arterial rupture	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0001 affected235 at risk EG0010 affected470 at risk EG0020 affected424 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0000 affected235 at risk EG0011 affected470 at risk EG0020 affected424 at risk
Lupus vasculitis	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0000 affected235 at risk EG0011 affected470 at risk EG0020 affected424 at risk
Necrosis ischaemic	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0000 affected235 at risk EG0011 affected470 at risk EG0022 affected424 at risk
Phlebitis	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0001 affected235 at risk EG0010 affected470 at risk EG0020 affected424 at risk
Varicose vein	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0001 affected235 at risk EG0010 affected470 at risk EG0020 affected424 at risk
Vasculitis	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0001 affected235 at risk EG0010 affected470 at risk EG0020 affected424 at risk
SLE arthritis	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0002 affected235 at risk EG0010 affected470 at risk EG0020 affected424 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0001 affected235 at risk EG0010 affected470 at risk EG0020 affected424 at risk
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 affected235 at risk EG0011 affected470 at risk EG0020 affected424 at risk
Tenosynovitis	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0001 affected235 at risk EG0010 affected470 at risk EG0020 affected424 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 affected235 at risk EG0010 affected470 at risk EG0020 affected424 at risk
Lupus pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 affected235 at risk EG0010 affected470 at risk EG0020 affected424 at risk
Lupus pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 affected235 at risk EG0011 affected470 at risk EG0020 affected424 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 affected235 at risk EG0011 affected470 at risk EG0021 affected424 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 affected235 at risk EG0010 affected470 at risk EG0020 affected424 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 18.1	Systematic Assessment	EG0001 affected235 at risk EG0011 affected470 at risk EG0020 affected424 at risk
Histiocytosis haematophagic	Blood and lymphatic system disorders	MedDRA 18.1	Systematic Assessment	EG0001 affected235 at risk EG0010 affected470 at risk EG0020 affected424 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 18.1	Systematic Assessment	EG0001 affected235 at risk EG0010 affected470 at risk EG0020 affected424 at risk
Cataract	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0000 affected235 at risk EG0011 affected470 at risk EG0020 affected424 at risk
Glaucoma	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0000 affected235 at risk EG0011 affected470 at risk EG0020 affected424 at risk
Retinal detachment	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0000 affected235 at risk EG0011 affected470 at risk EG0020 affected424 at risk
Acute psychosis	Psychiatric disorders	MedDRA 18.1	Systematic Assessment	EG0000 affected235 at risk EG0011 affected470 at risk EG0020 affected424 at risk
Suicidal ideation	Psychiatric disorders	MedDRA 18.1	Systematic Assessment	EG0000 affected235 at risk EG0011 affected470 at risk EG0020 affected424 at risk
Suicide attempt	Psychiatric disorders	MedDRA 18.1	Systematic Assessment	EG0001 affected235 at risk EG0010 affected470 at risk EG0020 affected424 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 affected235 at risk EG0011 affected470 at risk EG0020 affected424 at risk
Erythema multiforme	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0001 affected235 at risk EG0010 affected470 at risk EG0020 affected424 at risk
Systemic lupus erythematosus rash	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0001 affected235 at risk EG0010 affected470 at risk EG0020 affected424 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 18.1	Systematic Assessment	EG0000 affected235 at risk EG0012 affected470 at risk EG0022 affected424 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0000 affected235 at risk EG0011 affected470 at risk EG0020 affected424 at risk
Hypoproteinaemia	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0001 affected235 at risk EG0010 affected470 at risk EG0020 affected424 at risk
Cardiomyopathy	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 affected235 at risk EG0011 affected470 at risk EG0020 affected424 at risk
Blood creatinine increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0001 affected235 at risk EG0010 affected470 at risk EG0020 affected424 at risk
Ectopic pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA 18.1	Systematic Assessment	EG0000 affected235 at risk EG0011 affected470 at risk EG0020 affected424 at risk
Metrorrhagia	Reproductive system and breast disorders	MedDRA 18.1	Systematic Assessment	EG0000 affected235 at risk EG0011 affected470 at risk EG0020 affected424 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Soft tissue infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Pneumonia viral	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Periorbital infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Periodontitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Ludwig angina	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Gingivitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Cutaneous tuberculosis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Breast abscess	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Bartholin's abscess	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0022 affected424 at risk
Ureterolithiasis	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0022 affected424 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0022 affected424 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0022 affected424 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Lip injury	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Multiple fractures	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Loose body in joint	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0022 affected424 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0026 affected424 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0022 affected424 at risk
Systemic lupus erythematosus	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Fibroadenoma of breast	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0022 affected424 at risk
Benign ear neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Benign renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Haemangioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Haemangioma of liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Vaginal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Syncope	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Cerebrovascular insufficiency	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Neuropsychiatric lupus	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Noninfectious myelitis	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Ascites	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Chronic gastritis	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Gastric varices haemorrhage	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Intestinal pseudo-obstruction	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Granulocytopenia	Blood and lymphatic system disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0022 affected424 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Haemolytic anaemia	Blood and lymphatic system disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Chest discomfort	General disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Granuloma	General disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Peripheral swelling	General disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Bartholin's cyst	Reproductive system and breast disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Dysfunctional uterine bleeding	Reproductive system and breast disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Endometrial thickening	Reproductive system and breast disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Menstruation irregular	Reproductive system and breast disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Cardiac failure	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Wolff-Parkinson-White syndrome	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0022 affected424 at risk
Foetal growth restriction	Pregnancy, puerperium and perinatal conditions	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Thrombophlebitis superficial	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Platelet count decreased	Investigations	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Protein urine present	Investigations	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Dermoid cyst	Congenital, familial and genetic disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk
Post-traumatic stress disorder	Psychiatric disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected235 at risk EG0010 affected470 at risk EG0021 affected424 at risk

ID	Term
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

ID	Title	Description
BG000	Placebo	Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 milligrams (mg)/kilogram (kg) up to Year 5 Week 28.
BG001	Belimumab 10 mg/kg	Participants received belimumab 10 mg/kg IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 mg/kg up to Year 5 Week 28.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo (Double-blind Phase)	Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.	1	235	43	235	108	235
EG001	Belimumab 10 mg/kg (Double-blind Phase)	Participants received belimumab 10 miligrams (mg)/kilogram (kg) IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.	0	470	58	470	207	470
EG002	Belimumab 10 mg/kg (Open-label Phase)	All eligible China participants who had received placebo and belimumab in DB period and entered open-label phase to receive belimumab 10 mg/kg over 1 hour every 28 days from first belimumab date through end of open-label phase.	1	424	96	424	263	424