Safety and Efficacy Study of LymphoStat-B (Belimumab) in... | NCT00071487

Label	Type	Intervention Names
Placebo plus SOC	Placebo Comparator	Drug: Placebo
Belimumab 1 mg/kg plus SOC	Experimental	Drug: Belimumab 1 mg/kg
Belimumab 4 mg/kg plus SOC	Experimental	Drug: Belimumab 4 mg/kg
Belimumab 10 mg/kg plus SOC	Experimental	Drug: Belimumab 10 mg/kg

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	Placebo IV plus standard therapy (SOC) for SLE; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 52 weeks in the double-blind period. In the open-label extension period, placebo patients who opted to participate received belimumab 10 mg/kg IV plus SOC every 28 days for an additional 24 weeks.

Measure	Description	Time Frame
Percentage Change From Baseline in Safety of Estrogens in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA SLEDAI) Score at Week 24.	SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare.	Baseline, 24 weeks
Time to First Mild/Moderate or Severe SLE Flare (SLE Flare Index)	The SLE Flare Index categorized SLE flare as "mild or moderate" or "severe" based on 5 variables: 1) change in SELENA SLEDAI score from the most recent assessment to current, 2) change in signs or symptoms of disease activity, 3) change in prednisone dosage, 4) use of new medications for disease activity or hospitalization, and 5) change in Physician's Global Assessment score, a visual analog scale scored from 0 to 3 (1=mild, 2=moderate, 3=severe).	0 to 52 weeks

Measure	Description	Time Frame
Percentage Change From Baseline in SELENA SLEDAI Score at Week 52	SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare	Baseline, 52 weeks
Area Under the Curve (AUC) of SELENA SLEDAI Score at Week 52

Measure	Description	Time Frame
Adverse Events (AE) Overview	Includes AEs reported in patients from the first dose of study agent throughout the study up to the Week 76/exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (LBSL99/NCT00583362).	Up to 84 weeks

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35294-0006	United States
Arizona Arthritis Research

PubMed Identifier	Type	Citation	Retractions
19714604	Result	Wallace DJ, Stohl W, Furie RA, Lisse JR, McKay JD, Merrill JT, Petri MA, Ginzler EM, Chatham WW, McCune WJ, Fernandez V, Chevrier MR, Zhong ZJ, Freimuth WW. A phase II, randomized, double-blind, placebo-controlled, dose-ranging study of belimumab in patients with active systemic lupus erythematosus. Arthritis Rheum. 2009 Sep 15;61(9):1168-78. doi: 10.1002/art.24699.
19714615

ID	Title	Description
FG000	Placebo Plus SOC	Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
FG001	Belimumab 1 mg/kg Plus SOC	Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study. The 24-week open-label extension period of the study included patients who completed the 52-week double-blind period and opted to continue to receive the same dose in the 24-week open-label extension period of the study.

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 Change From Baseline in Safety of Estrogens in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA SLEDAI) Score at Week 24.

SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare.

Analysis was performed on a modified intention-to-treat (MITT) population, defined as all patients who were randomized and received at least 1 dose of study agent.

Posted

Mean

Standard Error

percent change

Baseline, 24 weeks

ID	Title	Description
OG000	Placebo Plus SOC	Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
OG001	Belimumab 1 mg/kg Plus SOC	Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
OG002	Belimumab 4 mg/kg Plus SOC	Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
OG003	Belimumab 10 mg/kg Plus SOC	Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.

Units	Counts
Participants	OG000113 OG001114 OG002111 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-17.2± 5.1 OG001-23.3± 4.4 OG002-11.3± 5.4 OG003

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	Missing data was handled by using a last observation carried forward (LOCF) imputation. If patient required a protocol-prohibited medication, the SELENA SLEDAI score of the last visit prior to the use of the prohibited medication was used.	t-test, 2 sided		0.3677	P-value was not adjusted for multiple testing.	Mean Difference (Final Values)	-6.1			2-Sided	95	-19.4	7.2				No	Superiority or Other

Primary

Time to First Mild/Moderate or Severe SLE Flare (SLE Flare Index)

The SLE Flare Index categorized SLE flare as "mild or moderate" or "severe" based on 5 variables: 1) change in SELENA SLEDAI score from the most recent assessment to current, 2) change in signs or symptoms of disease activity, 3) change in prednisone dosage, 4) use of new medications for disease activity or hospitalization, and 5) change in Physician's Global Assessment score, a visual analog scale scored from 0 to 3 (1=mild, 2=moderate, 3=severe).

Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent.

Posted

Median

Inter-Quartile Range

days

0 to 52 weeks

ID	Title	Description
OG000	Placebo Plus SOC	Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
OG001	Belimumab 1 mg/kg Plus SOC	Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
OG002	Belimumab 4 mg/kg Plus SOC	Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.

Secondary

Percentage Change From Baseline in SELENA SLEDAI Score at Week 52

SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare

Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent.

Posted

Mean

Standard Error

percent change

Baseline, 52 weeks

ID	Title	Description
OG000	Placebo Plus SOC	Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
OG001	Belimumab 1 mg/kg Plus SOC	Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
OG002	Belimumab 4 mg/kg Plus SOC	Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
OG003	Belimumab 10 mg/kg Plus SOC	Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.

Secondary

Area Under the Curve (AUC) of SELENA SLEDAI Score at Week 52

SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare. The normalized AUC was created as the ratio of the area under the SELENA SLEDAI score curve divided by baseline score.

Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent.

Posted

Mean

Standard Error

ratio score*days

Baseline and every 4 to 8 weeks through Week 52

ID	Title	Description
OG000	Placebo Plus SOC	Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
OG001	Belimumab 1 mg/kg Plus SOC	Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
OG002	Belimumab 4 mg/kg Plus SOC	Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
OG003	Belimumab 10 mg/kg Plus SOC

Secondary

Percentage Change From Baseline in British Isles Lupus Activity Group (BILAG) Score at Week 52

The BILAG index is a clinical measure of lupus disease activity. BILAG uses a single score for each of the 8 organ domains; range is from severe to no disease (A to E). The global BILAG score is the sum of the numerical scores in the 8 domains assigning A=9, B=3, C=1, D=0, E=0.

Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent.

Posted

Mean

Standard Error

percent change

Baseline, 52 weeks

ID	Title	Description
OG000	Placebo Plus SOC	Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
OG001	Belimumab 1 mg/kg Plus SOC	Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
OG002	Belimumab 4 mg/kg Plus SOC	Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
OG003	Belimumab 10 mg/kg Plus SOC

Secondary

Area Under the Curve (AUC) of BILAG Score at Week 52

Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent.

Posted

Mean

Standard Error

ratio score*days

Baseline and every 4 to 8 weeks through Week 52

ID	Title	Description
OG000	Placebo Plus SOC	Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
OG001	Belimumab 1 mg/kg Plus SOC	Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
OG002	Belimumab 4 mg/kg Plus SOC	Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
OG003

Secondary

Time to First Type A/B SLE Flare (as Defined Using BILAG) Over 52 Weeks

SLE flare indicates an increase in SLE disease activity. An SLE flare was a type A or B SLE flare (as defined using BILAG) compared with the previous visit.

Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent.

Posted

Median

Inter-Quartile Range

days

0 to 52 weeks

ID	Title	Description
OG000	Placebo Plus SOC	Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
OG001	Belimumab 1 mg/kg Plus SOC	Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
OG002	Belimumab 4 mg/kg Plus SOC	Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
OG003	Belimumab 10 mg/kg Plus SOC	Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.

Secondary

Percentage of Patients With a Reduction in Prednisone Dose

Percentage of patients whose average prednisone dose has been reduced by ≥ 50% and/or has been reduced to ≤ 7.5 mg/day during Weeks 40 through 52 in patients receiving greater than 7.5 mg/day at baseline.

Analysis was performed on a subgroup of the MITT population, which included only patients with baseline prednisone dose > 7.5 mg/day.

Posted

Number

percentatge of particpants

Baseline, weeks 40 to 52

ID	Title	Description
OG000	Placebo Plus SOC	Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
OG001	Belimumab 1 mg/kg Plus SOC	Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
OG002	Belimumab 4 mg/kg Plus SOC	Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
OG003	Belimumab 10 mg/kg Plus SOC	Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.

Other Pre-specified

Adverse Events (AE) Overview

Includes AEs reported in patients from the first dose of study agent throughout the study up to the Week 76/exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (LBSL99/NCT00583362).

Posted

Number

percentage of participants

Up to 84 weeks

ID	Title	Description
OG000	Placebo Plus SOC	Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
OG001	Belimumab 1 mg/kg Plus SOC	Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
OG002	Belimumab 4 mg/kg Plus SOC	Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
OG003	Belimumab 10 mg/kg Plus SOC	Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Aplastic anaemia	Blood and lymphatic system disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG0030 affected111 at risk EG0041 affected345 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Haemolysis	Blood and lymphatic system disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Acute coronary syndrome	Cardiac disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected114 at risk EG0020 affected111 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected114 at risk EG0021 affected111 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0010 affected114 at risk EG0021 affected111 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected114 at risk EG0020 affected111 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected113 at risk EG0011 affected114 at risk EG0020 affected111 at risk EG003
Pericarditis lupus	Cardiac disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Pleuropericarditis	Cardiac disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Adrenal insufficiency	Endocrine disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Appendicitis noninfective	Gastrointestinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Gastroduodenitis	Gastrointestinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Gastroenteritis noninfectious	Gastrointestinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0010 affected114 at risk EG0021 affected111 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0010 affected114 at risk EG0022 affected111 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Rectocele	Gastrointestinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Adhesion	General disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 7.1	Non-systematic Assessment	EG0002 affected113 at risk EG0011 affected114 at risk EG0020 affected111 at risk EG003
Pyrexia	General disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected114 at risk EG0022 affected111 at risk EG003
Hepatotoxicity	Hepatobiliary disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected114 at risk EG0020 affected111 at risk EG003
Anal infection	Infections and infestations	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Bronchitis acute	Infections and infestations	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected114 at risk EG0021 affected111 at risk EG003
Cellulitis	Infections and infestations	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0012 affected114 at risk EG0021 affected111 at risk EG003
Clostridium colitis	Infections and infestations	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Furuncle	Infections and infestations	MedDRA 7.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected114 at risk EG0020 affected111 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Lobar pneumonia	Infections and infestations	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected114 at risk EG0020 affected111 at risk EG003
Pneumonia	Infections and infestations	MedDRA 7.1	Non-systematic Assessment	EG0001 affected113 at risk EG0012 affected114 at risk EG0021 affected111 at risk EG003
Pneumonia bacterial	Infections and infestations	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected114 at risk EG0021 affected111 at risk EG003
Pyelonephritis acute	Infections and infestations	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0010 affected114 at risk EG0021 affected111 at risk EG003
Sepsis	Infections and infestations	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Septic arthritis streptobacillus	Infections and infestations	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected114 at risk EG0020 affected111 at risk EG003
Streptococcal bacteraemia	Infections and infestations	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0010 affected114 at risk EG0021 affected111 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0010 affected114 at risk EG0021 affected111 at risk EG003
Viral infection	Infections and infestations	MedDRA 7.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected114 at risk EG0021 affected111 at risk EG003
West Nile viral infection	Infections and infestations	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0010 affected114 at risk EG0021 affected111 at risk EG003
Wound infection	Infections and infestations	MedDRA 7.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0010 affected114 at risk EG0021 affected111 at risk EG003
Patella fracture	Injury, poisoning and procedural complications	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected114 at risk EG0020 affected111 at risk EG003
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA 7.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0010 affected114 at risk EG0021 affected111 at risk EG003
Seroma	Injury, poisoning and procedural complications	MedDRA 7.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Therapeutic agent toxicity	Injury, poisoning and procedural complications	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0010 affected114 at risk EG0021 affected111 at risk EG003
Haematocrit decreased	Investigations	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Haemoglobin decreased	Investigations	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Pulmonary function test decreased	Investigations	MedDRA 7.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Weight decreased	Investigations	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0010 affected114 at risk EG0021 affected111 at risk EG003
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected114 at risk EG0020 affected111 at risk EG003
Spondylosis	Musculoskeletal and connective tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Tenosynovitis	Musculoskeletal and connective tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected114 at risk EG0020 affected111 at risk EG003
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Metastases to bone marrow	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Cauda equina syndrome	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Convulsion	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Encephalopathy	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Grand mal convulsion	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Headache	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Neuralgia	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected114 at risk EG0020 affected111 at risk EG003
Simple partial seizures	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected114 at risk EG0020 affected111 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0012 affected114 at risk EG0021 affected111 at risk EG003
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected114 at risk EG0020 affected111 at risk EG003
Completed suicide	Psychiatric disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected114 at risk EG0020 affected111 at risk EG003
Depression	Psychiatric disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected114 at risk EG0020 affected111 at risk EG003
Calculus ureteric	Renal and urinary disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Cystocele	Renal and urinary disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Glomerulonephritis	Renal and urinary disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Lupus nephritis	Renal and urinary disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Proteinuria	Renal and urinary disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Cervical dysplasia	Reproductive system and breast disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Menometrorrhagia	Reproductive system and breast disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Ovarian cyst	Reproductive system and breast disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Vulvar dysplasia	Reproductive system and breast disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected114 at risk EG0020 affected111 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected114 at risk EG0021 affected111 at risk EG003
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected114 at risk EG0020 affected111 at risk EG003
Chronic obstructive airways disease exacerbated	Respiratory, thoracic and mediastinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0010 affected114 at risk EG0021 affected111 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Dyspnoea exacerbated	Respiratory, thoracic and mediastinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0002 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Angioneurotic oedema	Skin and subcutaneous tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected114 at risk EG0020 affected111 at risk EG003
Systemic lupus erythematosus rash	Skin and subcutaneous tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Post procedural drainage	Surgical and medical procedures	MedDRA 7.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Arteriosclerosis	Vascular disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected114 at risk EG0021 affected111 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Hypertensive crisis	Vascular disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0010 affected114 at risk EG0020 affected111 at risk EG003
Vasculitis	Vascular disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0010 affected114 at risk EG0021 affected111 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 7.1	Non-systematic Assessment	EG0003 affected113 at risk EG0015 affected114 at risk EG0027 affected111 at risk EG0032 affected111 at risk EG00419 affected345 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 7.1	Non-systematic Assessment	EG0005 affected113 at risk EG0014 affected114 at risk EG0026 affected111 at risk EG003
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 7.1	Non-systematic Assessment	EG0005 affected113 at risk EG0012 affected114 at risk EG0025 affected111 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0009 affected113 at risk EG0016 affected114 at risk EG0024 affected111 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0006 affected113 at risk EG0013 affected114 at risk EG0024 affected111 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 7.1	Non-systematic Assessment	EG00019 affected113 at risk EG00119 affected114 at risk EG00223 affected111 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0008 affected113 at risk EG0013 affected114 at risk EG0025 affected111 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0005 affected113 at risk EG00111 affected114 at risk EG0025 affected111 at risk EG003
Mouth ulceration	Gastrointestinal disorders	MedDRA 7.1	Non-systematic Assessment	EG00011 affected113 at risk EG0019 affected114 at risk EG00212 affected111 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 7.1	Non-systematic Assessment	EG00027 affected113 at risk EG00131 affected114 at risk EG00222 affected111 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 7.1	Non-systematic Assessment	EG00013 affected113 at risk EG00114 affected114 at risk EG00215 affected111 at risk EG003
Fatigue	General disorders	MedDRA 7.1	Non-systematic Assessment	EG00034 affected113 at risk EG00127 affected114 at risk EG00233 affected111 at risk EG003
Infusion site reaction	General disorders	MedDRA 7.1	Non-systematic Assessment	EG0006 affected113 at risk EG0013 affected114 at risk EG00212 affected111 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 7.1	Non-systematic Assessment	EG0009 affected113 at risk EG0016 affected114 at risk EG0026 affected111 at risk EG003
Oedema peripheral	General disorders	MedDRA 7.1	Non-systematic Assessment	EG00013 affected113 at risk EG00115 affected114 at risk EG00218 affected111 at risk EG003
Pain	General disorders	MedDRA 7.1	Non-systematic Assessment	EG0003 affected113 at risk EG0011 affected114 at risk EG0026 affected111 at risk EG003
Pyrexia	General disorders	MedDRA 7.1	Non-systematic Assessment	EG00014 affected113 at risk EG00113 affected114 at risk EG00217 affected111 at risk EG003
Bronchitis	Infections and infestations	MedDRA 7.1	Non-systematic Assessment	EG0007 affected113 at risk EG0015 affected114 at risk EG00211 affected111 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA 7.1	Non-systematic Assessment	EG0004 affected113 at risk EG0016 affected114 at risk EG0025 affected111 at risk EG003
Influenza	Infections and infestations	MedDRA 7.1	Non-systematic Assessment	EG0008 affected113 at risk EG0016 affected114 at risk EG00211 affected111 at risk EG003
Sinusitis	Infections and infestations	MedDRA 7.1	Non-systematic Assessment	EG00021 affected113 at risk EG00111 affected114 at risk EG00215 affected111 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 7.1	Non-systematic Assessment	EG00033 affected113 at risk EG00136 affected114 at risk EG00236 affected111 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 7.1	Non-systematic Assessment	EG00018 affected113 at risk EG00116 affected114 at risk EG00218 affected111 at risk EG003
Vaginal mycosis	Infections and infestations	MedDRA 7.1	Non-systematic Assessment	EG0008 affected113 at risk EG0013 affected114 at risk EG0028 affected111 at risk EG003
Viral infection	Infections and infestations	MedDRA 7.1	Non-systematic Assessment	EG0005 affected113 at risk EG0013 affected114 at risk EG0028 affected111 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	MedDRA 7.1	Non-systematic Assessment	EG0005 affected113 at risk EG0015 affected114 at risk EG0026 affected111 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 7.1	Non-systematic Assessment	EG0007 affected113 at risk EG00110 affected114 at risk EG0027 affected111 at risk EG003
Creatinine renal clearance decreased	Investigations	MedDRA 7.1	Non-systematic Assessment	EG0004 affected113 at risk EG0015 affected114 at risk EG0028 affected111 at risk EG003
Weight decreased	Investigations	MedDRA 7.1	Non-systematic Assessment	EG0006 affected113 at risk EG0016 affected114 at risk EG0025 affected111 at risk EG003
Weight increased	Investigations	MedDRA 7.1	Non-systematic Assessment	EG0008 affected113 at risk EG0016 affected114 at risk EG0028 affected111 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 7.1	Non-systematic Assessment	EG0002 affected113 at risk EG0016 affected114 at risk EG0020 affected111 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG00042 affected113 at risk EG00141 affected114 at risk EG00237 affected111 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG00018 affected113 at risk EG00116 affected114 at risk EG00221 affected111 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG00016 affected113 at risk EG00115 affected114 at risk EG00215 affected111 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG0002 affected113 at risk EG0016 affected114 at risk EG0026 affected111 at risk EG003
Fibromyalgia	Musculoskeletal and connective tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG0004 affected113 at risk EG0012 affected114 at risk EG0025 affected111 at risk EG003
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG00010 affected113 at risk EG0019 affected114 at risk EG00211 affected111 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG00014 affected113 at risk EG00115 affected114 at risk EG00210 affected111 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG0008 affected113 at risk EG00114 affected114 at risk EG00213 affected111 at risk EG003
SLE arthritis	Musculoskeletal and connective tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG0006 affected113 at risk EG0015 affected114 at risk EG0022 affected111 at risk EG003
Synovitis	Musculoskeletal and connective tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG0004 affected113 at risk EG0014 affected114 at risk EG0026 affected111 at risk EG003
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG0003 affected113 at risk EG0012 affected114 at risk EG0024 affected111 at risk EG003
Dizziness	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0008 affected113 at risk EG0018 affected114 at risk EG00212 affected111 at risk EG003
Headache	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG00027 affected113 at risk EG00129 affected114 at risk EG00231 affected111 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0003 affected113 at risk EG0014 affected114 at risk EG0025 affected111 at risk EG003
Migraine	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG00011 affected113 at risk EG00111 affected114 at risk EG0026 affected111 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected113 at risk EG0017 affected114 at risk EG0023 affected111 at risk EG003
Sinus headache	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0006 affected113 at risk EG0011 affected114 at risk EG0020 affected111 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 7.1	Non-systematic Assessment	EG0006 affected113 at risk EG0016 affected114 at risk EG0028 affected111 at risk EG003
Depression	Psychiatric disorders	MedDRA 7.1	Non-systematic Assessment	EG0009 affected113 at risk EG00116 affected114 at risk EG00212 affected111 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 7.1	Non-systematic Assessment	EG00010 affected113 at risk EG0015 affected114 at risk EG0025 affected111 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 7.1	Non-systematic Assessment	EG0003 affected113 at risk EG0013 affected114 at risk EG0024 affected111 at risk EG003
Proteinuria	Renal and urinary disorders	MedDRA 7.1	Non-systematic Assessment	EG0006 affected113 at risk EG0016 affected114 at risk EG0027 affected111 at risk EG003
Pyuria	Renal and urinary disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected113 at risk EG0016 affected114 at risk EG0024 affected111 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 7.1	Non-systematic Assessment	EG00012 affected113 at risk EG00113 affected114 at risk EG0028 affected111 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0007 affected113 at risk EG0013 affected114 at risk EG0028 affected111 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0003 affected113 at risk EG0013 affected114 at risk EG0020 affected111 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0009 affected113 at risk EG0016 affected114 at risk EG0023 affected111 at risk EG003
Nasal ulcer	Respiratory, thoracic and mediastinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0002 affected113 at risk EG0016 affected114 at risk EG0022 affected111 at risk EG003
Pharyngolaryngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0002 affected113 at risk EG0017 affected114 at risk EG0025 affected111 at risk EG003
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0009 affected113 at risk EG0015 affected114 at risk EG0024 affected111 at risk EG003
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0007 affected113 at risk EG0016 affected114 at risk EG0026 affected111 at risk EG003
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0008 affected113 at risk EG0014 affected114 at risk EG0021 affected111 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG00013 affected113 at risk EG00110 affected114 at risk EG0029 affected111 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG0004 affected113 at risk EG0016 affected114 at risk EG00210 affected111 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG0008 affected113 at risk EG0015 affected114 at risk EG0025 affected111 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG00012 affected113 at risk EG00116 affected114 at risk EG00217 affected111 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG0009 affected113 at risk EG0013 affected114 at risk EG0027 affected111 at risk EG003
Systemic lupus erythematosus rash	Skin and subcutaneous tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG0005 affected113 at risk EG0012 affected114 at risk EG0024 affected111 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected113 at risk EG0015 affected114 at risk EG0026 affected111 at risk EG003
Hypertension	Vascular disorders	MedDRA 7.1	Non-systematic Assessment	EG0005 affected113 at risk EG0016 affected114 at risk EG0025 affected111 at risk EG003
Raynaud's phenomenon	Vascular disorders	MedDRA 7.1	Non-systematic Assessment	EG0004 affected113 at risk EG0016 affected114 at risk EG0024 affected111 at risk EG003

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

ID	Title	Description
BG000	Placebo Plus SOC	Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
BG001	Belimumab 1 mg/kg Plus SOC	Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
BG002	Belimumab 4 mg/kg Plus SOC	Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
BG003	Belimumab 10 mg/kg Plus SOC	Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
BG004	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo Plus SOC	Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study	22	113	103	113
EG001	Belimumab 1 mg/kg Plus SOC	Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study	21	114	107	114
EG002	Belimumab 4 mg/kg Plus SOC	Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study	15	111	100	111
EG003	Belimumab 10 mg/kg Plus SOC	Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study	18	111	105	111
EG004	Open-label Extension Period: All Active	Includes all patients who completed the 52-week double-blind period and opted to continue in a 24-week open-label extension period. Belimumab patients received the same dose or were switched to 10 mg/kg at investigator discretion and former placebo patients received belimumab 10 mg/kg. AE onset may be during the extension phase or continuing from the double-blind period.	33	345	312	345