A Study of Belimumab Administered Subcutaneously in Subje... | NCT01484496

NCT01484496

Name	Class
GlaxoSmithKline	INDUSTRY

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo plus standard therapy	Placebo Comparator	Placebo SC plus standard therapy; placebo administered on Day 0 and then weekly (ie, every 7 days) through Week 51, with final evaluation at Week 52 in the double-blind period. In the open-label extension period, placebo subjects who opt to participate will receive belimumab 200 mg SC weekly for an additional 6-months.	Biological: Placebo Drug: Standard therapy
Belimumab 200 mg SC plus standard therapy	Experimental	Belimumab 200 mg SC plus standard therapy; belimumab administered on Day 0 and then weekly (ie, every 7 days) through Week 51, with a final evaluation at Week 52 in the double-blind period. In the open-label extension period, subjects who opt to participate will continue on the same dose of belimumab for an additional 6-months.	Biological: Belimumab 200 mg SC Drug: Standard therapy

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Biological	Placebo	Placebo plus standard therapy
Belimumab 200 mg SC

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Par. Achieving a SLE Responder Index (SRI) Response Rate at Week 52	SRI response is defined as >=4 point reduction, from Baseline in safety of estrogen in lupus national assessment (SELENA) systemic lupus erythematosus disease activity index (SLEDAI) score, no worsening (increase of <0.30 points from Baseline) in physician's global assessment (PGA) and no new British Isles Lupus Assessment Group of SLE clinics (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with Baseline. Analysis was performed using a logistic regression model for the comparison between belimumab and placebo with covariates treatment group, Baseline SELENA SLEDAI score (<=9 vs. >=10), Baseline complement levels (low C3 and/or C4 vs. no low C3 or C4) and race (black vs. other).	Week 52

Secondary Outcomes

Measure	Description	Time Frame
Time to First Severe Flare (as Measured by the Modified SLE Flare Index)	Time to first severe SLE flare is defined as the number of days from treatment start date until the participant met an event (event date - treatment start date +1). Analyses of severe SLE flare was performed on modified SELENA SLEDAI SLE flare index that excludes severe flares that were triggered only by an increase in SELENA SLEDAI score to >12 (since this may only represent a modest increase in disease activity). Only post-baseline severe flares were considered.

Eligibility Module

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Birmingham	Alabama	35294	United States
GSK Investigational Site

PubMed Identifier	Type	Citation	Retractions
40244828	Derived	Depascale R, Da Mutten R, Lindblom J, Cetrez N, Palazzo L, Iaccarino L, Doria A, Nikolopoulos D, Gatto M, Parodis I. Unsupervised machine learning identifies distinct SLE patient endotypes with differential response to belimumab. Rheumatology (Oxford). 2025 Aug 1;64(8):4650-4658. doi: 10.1093/rheumatology/keaf215.
39208825	Derived

Label	URL
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.	View source

ID	Type	URL	Comment
112341	Informed Consent Form	View IPD

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo SC	Par. received placebo administered subcutaneously (SC) once weekly through 51 weeks of thetreatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.
FG001	Belimumab 200 mg SC

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

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

Percentage of Par. Achieving a SLE Responder Index (SRI) Response Rate at Week 52

SRI response is defined as >=4 point reduction, from Baseline in safety of estrogen in lupus national assessment (SELENA) systemic lupus erythematosus disease activity index (SLEDAI) score, no worsening (increase of <0.30 points from Baseline) in physician's global assessment (PGA) and no new British Isles Lupus Assessment Group of SLE clinics (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with Baseline. Analysis was performed using a logistic regression model for the comparison between belimumab and placebo with covariates treatment group, Baseline SELENA SLEDAI score (<=9 vs. >=10), Baseline complement levels (low C3 and/or C4 vs. no low C3 or C4) and race (black vs. other).

Intention-To-Treat (ITT) Population: comprised of all par. who were randomized and treated with at least one dose of study treatment. Three par. did not have a Baseline PGA assessment; therefore, were not included.

Posted

Number

Percentage of par.

Week 52

ID	Title	Description
OG000	Placebo SC	Par. received placebo administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.
OG001	Belimumab 200 mg SC	Par. received belimumab 200 mg administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.

Units	Counts
Participants	OG000279 OG001554

Title

Denominators

Categories

Title	Measurements
	OG00048.4 OG00161.4

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		0.0006		Odds Ratio (OR)	1.68			2-Sided	95	1.25	2.25					Superiority or Other

Secondary

Time to First Severe Flare (as Measured by the Modified SLE Flare Index)

Time to first severe SLE flare is defined as the number of days from treatment start date until the participant met an event (event date - treatment start date +1). Analyses of severe SLE flare was performed on modified SELENA SLEDAI SLE flare index that excludes severe flares that were triggered only by an increase in SELENA SLEDAI score to >12 (since this may only represent a modest increase in disease activity). Only post-baseline severe flares were considered.

ITT population. Only those participants available at that particular timepoints were analyzed.

Posted

Median

Full Range

Days

Baseline (Day 0, prior to dosing) to Week 52

ID	Title	Description
OG000	Placebo SC	Par. received placebo administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.
OG001	Belimumab 200 mg SC	Par. received belimumab 200 mg administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.

Units	Counts

Secondary

Percentage of Par. Whose Average Prednisone Dose Had Been Reduced by >=25% From Baseline to <=7.5 mg/Day During Weeks 40 Through 52 in Par. Receiving Greater Than 7.5 mg/Day at Baseline

For the analysis of steroid use, all steroid dosages were converted to a prednisone equivalent in mg. The average daily prednisone dose was calculated taking into account all steroids taken intravenously, intramuscularly, SC, intradermally and orally for both SLE and non-SLE reasons. A responder was defined as having a prednisone reduction by >=25% from Baseline to <=7.5 mg/day during Weeks 40 through 52. At Baseline, the average daily prednisone dose was the sum of all prednisone doses over 7 consecutive days up to, but not including Day 0, divided by 7. For this analysis, the average prednisone dose was the total prednisone dose during weeks 40 through 52 divided by the number of days during Weeks 40 through 52. Analysis was performed using a logistic regression model with covariates treatment group, Baseline prednisone dose, Baseline SELENA SLEDAI score, (<=9 vs >=10), Baseline complement levels (low C3 and/or C4 vs. no low C3 or C4) and race (black vs. other).

ITT population. Only par. with Baseline prednisone dose >7.5 mg/day were included.

Posted

Number

Percentage of par.

Baseline (Day 0, prior to dosing), Weeks 40 through Week 52

ID	Title	Description
OG000	Placebo SC	Par. received placebo administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.
OG001

Arm/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 SC	Par. received placebo administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.	2	280	44	280	218	280
EG001	Belimumab 200 mg SC	Par. received belimumab 200 mg administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.	3	556	60	556	403	556
EG002	Open-Label - Placebo SC to Belimumab 200 mg SC	Par. received placebo administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period. Par. who completed the Double-Blind phase with active SLE were assessed for eligibility to participate in a 6-month extension phase during which they received open label belimumab 200 mg SC weekly.	0	206	14	206	42	206
EG003	Open-Label - Belimumab 200 SC to Belimumab 200 mg SC	Par. received belimumab 200 mg administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period. Par. who completed the Double-Blind phase with active SLE were assessed for eligibility to participate in a 6-month extension phase during which they received open label belimumab 200 mg SC weekly.	0	456	25	456	78	456

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cellulitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0002 affected280 at risk EG0013 affected556 at risk EG0020 affected206 at risk EG0031 affected456 at risk
Pneumonia	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected280 at risk EG0014 affected556 at risk EG0021 affected206 at risk EG003
Pneumonia bacterial	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0002 affected280 at risk EG0013 affected556 at risk EG0020 affected206 at risk EG003
Urosepsis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0013 affected556 at risk EG0020 affected206 at risk EG003
Bacterial sepsis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0012 affected556 at risk EG0020 affected206 at risk EG003
Urinary tract infection bacterial	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0012 affected556 at risk EG0020 affected206 at risk EG003
Amoebic dysentery	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0011 affected556 at risk EG0020 affected206 at risk EG003
Bronchitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003
Corynebacterium sepsis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003
Dengue fever	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0011 affected556 at risk EG0020 affected206 at risk EG003
Diarrhoea infectious	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0011 affected556 at risk EG0020 affected206 at risk EG003
Escherichia urinary tract infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0011 affected556 at risk EG0020 affected206 at risk EG003
External ear cellulitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0011 affected556 at risk EG0020 affected206 at risk EG003
Herpes virus infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0011 affected556 at risk EG0020 affected206 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0011 affected556 at risk EG0022 affected206 at risk EG003
Meningitis bacterial	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0011 affected556 at risk EG0020 affected206 at risk EG003
Osteomyelitis bacterial	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003
Perirectal abscess	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003
Pulmonary tuberculosis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003
Pyelonephritis acute	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0011 affected556 at risk EG0020 affected206 at risk EG003
Respiratory syncytial virus bronchitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0011 affected556 at risk EG0020 affected206 at risk EG003
Salmonellosis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0011 affected556 at risk EG0020 affected206 at risk EG003
Septic shock	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003
Subcutaneous abscess	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected280 at risk EG0010 affected556 at risk EG0021 affected206 at risk EG003
Tuberculosis of central nervous system	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0011 affected556 at risk EG0020 affected206 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0011 affected556 at risk EG0020 affected206 at risk EG003
Renal failure acute	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0014 affected556 at risk EG0020 affected206 at risk EG003
Lupus nephritis	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected280 at risk EG0012 affected556 at risk EG0020 affected206 at risk EG003
Nephritis	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected280 at risk EG0012 affected556 at risk EG0020 affected206 at risk EG003
Nephrotic syndrome	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected280 at risk EG0010 affected556 at risk EG0021 affected206 at risk EG003
Nephritic syndrome	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003
Proteinuria	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003
Renal tubular necrosis	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0011 affected556 at risk EG0020 affected206 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected280 at risk EG0012 affected556 at risk EG0020 affected206 at risk EG003
Headache	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003
Neuropsychiatric lupus	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0012 affected556 at risk EG0020 affected206 at risk EG003
Syncope	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected280 at risk EG0011 affected556 at risk EG0020 affected206 at risk EG003
Generalised tonic-clonic seizure	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0011 affected556 at risk EG0020 affected206 at risk EG003
Haemorrhage intracranial	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003
Intracranial venous sinus thrombosis	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0011 affected556 at risk EG0020 affected206 at risk EG003
Lupus encephalitis	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected280 at risk EG0010 affected556 at risk EG0021 affected206 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0011 affected556 at risk EG0021 affected206 at risk EG003
Vocal cord paralysis	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected280 at risk EG0011 affected556 at risk EG0020 affected206 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0012 affected556 at risk EG0020 affected206 at risk EG003
Abdominal hernia	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0011 affected556 at risk EG0020 affected206 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0011 affected556 at risk EG0020 affected206 at risk EG003
Haemorrhoids thrombosed	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0011 affected556 at risk EG0020 affected206 at risk EG003
Mouth ulceration	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0011 affected556 at risk EG0020 affected206 at risk EG003
Pancreatitis chronic	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0011 affected556 at risk EG0020 affected206 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003
SLE arthritis	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected280 at risk EG0011 affected556 at risk EG0020 affected206 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0011 affected556 at risk EG0021 affected206 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0011 affected556 at risk EG0020 affected206 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0011 affected556 at risk EG0020 affected206 at risk EG003
Polyarthritis	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0011 affected556 at risk EG0020 affected206 at risk EG003
Synovitis	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0011 affected556 at risk EG0020 affected206 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 17.0	Systematic Assessment	EG0003 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected280 at risk EG0011 affected556 at risk EG0020 affected206 at risk EG003
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0011 affected556 at risk EG0020 affected206 at risk EG003
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003
Hypochromic anaemia	Blood and lymphatic system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0011 affected556 at risk EG0020 affected206 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected280 at risk EG0012 affected556 at risk EG0020 affected206 at risk EG003
Pyrexia	General disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0013 affected556 at risk EG0020 affected206 at risk EG003
Peripheral swelling	General disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0011 affected556 at risk EG0020 affected206 at risk EG003
Systemic inflammatory response syndrome	General disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0011 affected556 at risk EG0020 affected206 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0012 affected556 at risk EG0020 affected206 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0011 affected556 at risk EG0020 affected206 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003
Mitral valve incompetence	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003
Pericarditis	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0011 affected556 at risk EG0020 affected206 at risk EG003
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected280 at risk EG0011 affected556 at risk EG0020 affected206 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0011 affected556 at risk EG0020 affected206 at risk EG003
Alveolitis	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0011 affected556 at risk EG0020 affected206 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected280 at risk EG0010 affected556 at risk EG0021 affected206 at risk EG003
Pulmonary arterial hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0011 affected556 at risk EG0020 affected206 at risk EG003
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0011 affected556 at risk EG0020 affected206 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected280 at risk EG0011 affected556 at risk EG0021 affected206 at risk EG003
Lupus vasculitis	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003
Hypertension	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0011 affected556 at risk EG0020 affected206 at risk EG003
Orthostatic hypotension	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0011 affected556 at risk EG0020 affected206 at risk EG003
Thrombosis	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0011 affected556 at risk EG0020 affected206 at risk EG003
Systemic lupus erythematosus rash	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected280 at risk EG0012 affected556 at risk EG0020 affected206 at risk EG003
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0011 affected556 at risk EG0020 affected206 at risk EG003
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0011 affected556 at risk EG0020 affected206 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0011 affected556 at risk EG0020 affected206 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0001 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0011 affected556 at risk EG0020 affected206 at risk EG003
Intraductal proliferative breast lesion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0011 affected556 at risk EG0020 affected206 at risk EG003
Lipoma of breast	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0001 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003
Thyroid neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0011 affected556 at risk EG0020 affected206 at risk EG003
Cervical dysplasia	Reproductive system and breast disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003
Cystocele	Reproductive system and breast disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003
Ovarian cyst	Reproductive system and breast disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0011 affected556 at risk EG0020 affected206 at risk EG003
Uterine polyp	Reproductive system and breast disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003
Uterine prolapse	Reproductive system and breast disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0011 affected556 at risk EG0020 affected206 at risk EG003
Hepatic enzyme increased	Investigations	MedDRA 17.0	Systematic Assessment	EG0001 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003
International normalised ratio increased	Investigations	MedDRA 17.0	Systematic Assessment	EG0001 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003
Liver function test abnormal	Investigations	MedDRA 17.0	Systematic Assessment	EG0001 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003
Troponin increased	Investigations	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0011 affected556 at risk EG0020 affected206 at risk EG003
Cataract	Eye disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003
Exfoliation syndrome	Eye disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0011 affected556 at risk EG0020 affected206 at risk EG003
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0011 affected556 at risk EG0020 affected206 at risk EG003
Hypernatraemia	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0011 affected556 at risk EG0020 affected206 at risk EG003
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0012 affected556 at risk EG0020 affected206 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003
Cholecystitis chronic	Hepatobiliary disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0011 affected556 at risk EG0021 affected206 at risk EG003
Procedural vomiting	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003
Suicidal ideation	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0011 affected556 at risk EG0020 affected206 at risk EG003
Antiphospholipid syndrome	Blood and lymphatic system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0010 affected556 at risk EG0021 affected206 at risk EG003
Lupus pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0010 affected556 at risk EG0021 affected206 at risk EG003
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0010 affected556 at risk EG0021 affected206 at risk EG003
Central nervous system lupus	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0010 affected556 at risk EG0021 affected206 at risk EG003
Large intestine perforation	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0010 affected556 at risk EG0021 affected206 at risk EG003
Gastric ulcer	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003
Lip swelling	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0010 affected556 at risk EG0021 affected206 at risk EG003
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0010 affected556 at risk EG0021 affected206 at risk EG003
Abdominal abscess	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0010 affected556 at risk EG0022 affected206 at risk EG003
Appendicitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0010 affected556 at risk EG0021 affected206 at risk EG003
Bronchitis viral	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0010 affected556 at risk EG0021 affected206 at risk EG003
Mycobacterial infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0010 affected556 at risk EG0021 affected206 at risk EG003
Paraspinal abscess	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0010 affected556 at risk EG0021 affected206 at risk EG003
Depression	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003
Suicide attempt	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003
Polycystic ovaries	Reproductive system and breast disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003
Eyelid oedema	Eye disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003
Arthritis infective	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003
Cystitis bacterial	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003
Staphylococcal sepsis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003
Tuberculosis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003
Urinary tract infection staphylococcal	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected280 at risk EG0010 affected556 at risk EG0020 affected206 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Viral upper respiratory tract infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG00024 affected280 at risk EG00148 affected556 at risk EG0029 affected206 at risk EG00317 affected456 at risk
Nasopharyngitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG00022 affected280 at risk EG00138 affected556 at risk EG0029 affected206 at risk EG003
Urinary tract infection bacterial	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG00018 affected280 at risk EG00141 affected556 at risk EG0022 affected206 at risk EG003
Upper respiratory tract infection bacterial	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG00014 affected280 at risk EG00130 affected556 at risk EG0023 affected206 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG00022 affected280 at risk EG00138 affected556 at risk EG0021 affected206 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG00014 affected280 at risk EG00127 affected556 at risk EG0023 affected206 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG00015 affected280 at risk EG00128 affected556 at risk EG0024 affected206 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG00011 affected280 at risk EG00131 affected556 at risk EG0026 affected206 at risk EG003
Headache	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG00025 affected280 at risk EG00157 affected556 at risk EG0024 affected206 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG00019 affected280 at risk EG00122 affected556 at risk EG0021 affected206 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG00020 affected280 at risk EG00118 affected556 at risk EG0020 affected206 at risk EG003
Hypertension	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG00014 affected280 at risk EG00125 affected556 at risk EG0024 affected206 at risk EG003

ID	Term
D008180	Lupus Erythematosus, Systemic
D001327	Autoimmune Diseases

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

ID	Term
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation

ID	Title	Description
BG000	Placebo SC	Par. received placebo administered SC, once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.
BG001	Belimumab 200 mg SC	Par. received belimumab 200 mg administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.
BG002	Total	Total of all reporting groups

ID	Type	Description	Link
2011-003814-18
HGS1006-C1115