A Study of Belimumab in Subjects With Systemic Lupus Eryt... | NCT00424476

ID	Type	Description	Link
BLISS-52	Other Identifier	Human Genome Sciences Inc.
110752	Other Identifier	GSK

Status Module

Name	Class
GlaxoSmithKline	INDUSTRY

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Placebo	Drug: Placebo
Belimumab 1 mg/kg	Experimental	Belimumab 1 mg/kg	Drug: Belimumab 1 mg/kg
Belimumab 10 mg/kg	Experimental	Belimumab 10 mg/kg	Drug: Belimumab 10 mg/kg

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through Week 48.	Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
SLE Responder Index (SRI) Response Rate at Week 52	Percentage of subjects with a ≥ 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. SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare. PGA is a visual analog scale scored from 0 to 3 (1=mild, 2=moderate, 3=severe). BILAG uses a single score for each of the 8 organ domains; range is from severe to no disease (A to E).	Baseline, 52 weeks

Secondary Outcomes

Measure	Description	Time Frame
Percent of Subjects With a ≥ 4 Point Reduction From Baseline in SELENA SLEDAI Score at Wk 52.		Baseline, 52 weeks
Mean Change in Physician's Global Assessment (PGA) at Wk 24.	The PGA is a visual analog scale scored from 0 to 3. A score of 1 corresponds to mild lupus disease activity. A score of 2 correlates with moderate disease activity and a score of 3 with severe disease activity.

Measure	Description	Time Frame
Adverse Events (AE) Overview	SEE ALSO ADVERSE EVENTS RESULTS SECTION	Up to 56 Weeks

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
GSK Clinical Trials	Human Genome Sciences Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
OMI, Organización Médica de Investigación		Buenos Aires		C1015ABO	Argentina
CIER, Centro de Investigaciones en Enfermedades Reumáticas

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40256631	Derived	Botto J, Cetrez N, Nikolopoulos D, Regardt M, Heintz E, Lindblom J, Parodis I. Predicting EQ-5D full health state in systemic lupus erythematosus using machine learning algorithms. Rheumatol Adv Pract. 2025 Apr 18;9(2):rkaf032. doi: 10.1093/rap/rkaf032. eCollection 2025.
39208825	Derived	Parodis I, Lindblom J, Levy RA, Zen M, Cetrez N, Gomez A, Oon S, Henning C, Khamashta M, Quasny HA, Chauhan D, Askanase A, van Vollenhoven R, Nikpour M. Attainment of remission and low disease activity after treatment with belimumab in patients with systemic lupus erythematosus: a post-hoc analysis of pooled data from five randomised clinical trials. Lancet Rheumatol. 2024 Nov;6(11):e751-e761. doi: 10.1016/S2665-9913(24)00162-0. Epub 2024 Aug 26.

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
HGS1006-C1057	Informed Consent Form	View IPD

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
FG001	Belimumab 1 mg/kg	Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Placebo	Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
BG001	Belimumab 1 mg/kg	Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
BG002	Belimumab 10 mg/kg	Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00036.2± 11.8 BG00135.0± 10.6 BG00235.4± 10.8 BG003

Age, Customized

Number

participants

Title

Denominators

Categories

≤ 45 years

Title	Measurements
	BG000225 BG001236 BG002

Gender

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000270 BG001271 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

Europe

Title	Measurements
	BG00033 BG00134 BG002

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

SLE Responder Index (SRI) Response Rate at Week 52

Percentage of subjects with a ≥ 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.

SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare. PGA is a visual analog scale scored from 0 to 3 (1=mild, 2=moderate, 3=severe). BILAG uses a single score for each of the 8 organ domains; range is from severe to no disease (A to E).

Analysis was performed on a modified intention-to-treat (MITT) population, defined as all subjects who were randomized and received at least 1 dose of study agent. Subjects who required rescue SLE medications were declared nonresponders, as were subjects who dropped out or were missing Week 52 data.

Posted

Number

Percentage of participants

Baseline, 52 weeks

ID	Title	Description
OG000	Placebo	Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
OG001	Belimumab 1 mg/kg	Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
OG002	Belimumab 10 mg/kg	Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.

Units	Counts
Participants	OG000287 OG001288 OG002290

Title

Denominators

Categories

Title	Measurements
	OG00043.6 OG00151.4 OG00257.6

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 OG002		Regression, Logistic	Adjusted for baseline stratification factors (SELENA SLEDAI Score: ≤9 vs ≥10; proteinuria: <2g vs ≥2g per 24hr; Race: African/indig-American vs Other)	0.0006	For the primary analysis of the primary efficacy endpoint, a step-down sequential testing procedure was used to control the type 1 error.	Odds Ratio (OR)	1.83				95	1.30	2.59				No	Superiority or Other

Secondary

Percent of Subjects With a ≥ 4 Point Reduction From Baseline in SELENA SLEDAI Score at Wk 52.

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

Posted

Number

Percentage of participants

Baseline, 52 weeks

ID	Title	Description
OG000	Placebo	Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
OG001	Belimumab 1 mg/kg	Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
OG002	Belimumab 10 mg/kg	Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.

Units	Counts
Participants

Secondary

Mean Change in Physician's Global Assessment (PGA) at Wk 24.

The PGA is a visual analog scale scored from 0 to 3. A score of 1 corresponds to mild lupus disease activity. A score of 2 correlates with moderate disease activity and a score of 3 with severe disease activity.

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

Posted

Mean

Standard Error

Scores on a 3-point scale

Baseline, 24 weeks

ID	Title	Description
OG000	Placebo	Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
OG001	Belimumab 1 mg/kg	Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
OG002	Belimumab 10 mg/kg	Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.

Secondary

Mean Change From Baseline in Medical Outcomes 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score (PCS) at Wk 24.

The SF-36 is a generic health related quality of life (HRQOL) measurement. The survey includes 36 questions grouped to 8 domains and 2 summary measures (physical and mental health component, PCS and MCS, respectively) assessing HRQOL. Responses are scored according to the SF-36v2™ manual. A score is calculated for each SF-36 domain based on the patient's response to each question within it. This is then transformed to a scale ranging from 0 (worst) to 100 (best) points. The PCS is norm-based where the mean=50 and standard deviation (SD)=10. Higher scores represent better physical health.

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

Posted

Mean

Standard Error

Scores on a scale

Baseline, 24 weeks

ID	Title	Description
OG000	Placebo	Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
OG001	Belimumab 1 mg/kg	Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
OG002	Belimumab 10 mg/kg

Secondary

Percent of Subjects Whose Average Prednisone Dose Has Been Reduced by ≥ 25% From Baseline to ≤ 7.5 mg/Day During Weeks 40 Through 52

Analysis was performed on a MITT population, defined as all subjects who were randomized and received at least 1 dose of study agent. Includes only subjects with baseline prednisone dose > 7.5 mg/day

Posted

Number

Percentage of participants

Baseline, Weeks 40 through 52

ID	Title	Description
OG000	Placebo	Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
OG001	Belimumab 1 mg/kg	Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
OG002	Belimumab 10 mg/kg	Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.

Units	Counts

Other Pre-specified

Adverse Events (AE) Overview

SEE ALSO ADVERSE EVENTS RESULTS SECTION

Posted

Number

Percentage of participants

Up to 56 Weeks

ID	Title	Description
OG000	Placebo	Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
OG001	Belimumab 1 mg/kg	Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
OG002	Belimumab 10 mg/kg	Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.	36	287	222	287
EG001	Belimumab 1 mg/kg	Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.	47	288	219	288
EG002	Belimumab 10 mg/kg	Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.	41	290	223	290

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0010 affected288 at risk EG0022 affected290 at risk
Anaemia haemolytic autoimmune	Blood and lymphatic system disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected287 at risk EG0010 affected288 at risk EG0020 affected290 at risk
Haemolytic anaemia	Blood and lymphatic system disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected287 at risk EG0010 affected288 at risk EG0022 affected290 at risk
Hypochromic anaemia	Blood and lymphatic system disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0010 affected288 at risk EG0021 affected290 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0010 affected288 at risk EG0021 affected290 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0010 affected288 at risk EG0021 affected290 at risk
Cardiac arrest	Cardiac disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected287 at risk EG0010 affected288 at risk EG0020 affected290 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0010 affected288 at risk EG0021 affected290 at risk
Myocardial infarction	Cardiac disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected287 at risk EG0010 affected288 at risk EG0020 affected290 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0010 affected288 at risk EG0021 affected290 at risk
Pericardial effusion	Cardiac disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected287 at risk EG0010 affected288 at risk EG0020 affected290 at risk
Pericarditis	Cardiac disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0011 affected288 at risk EG0020 affected290 at risk
Pericarditis lupus	Cardiac disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected287 at risk EG0010 affected288 at risk EG0021 affected290 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0011 affected288 at risk EG0020 affected290 at risk
Hypothyroidism	Endocrine disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0012 affected288 at risk EG0020 affected290 at risk
Blindness unilateral	Eye disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0011 affected288 at risk EG0020 affected290 at risk
Glaucoma	Eye disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0010 affected288 at risk EG0021 affected290 at risk
Ocular vasculitis	Eye disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0011 affected288 at risk EG0020 affected290 at risk
Retinal detachment	Eye disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0011 affected288 at risk EG0020 affected290 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected287 at risk EG0011 affected288 at risk EG0020 affected290 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected287 at risk EG0010 affected288 at risk EG0020 affected290 at risk
Gastritis	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0012 affected288 at risk EG0020 affected290 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected287 at risk EG0010 affected288 at risk EG0020 affected290 at risk
Ileus paralytic	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected287 at risk EG0010 affected288 at risk EG0020 affected290 at risk
Lupus enteritis	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0010 affected288 at risk EG0021 affected290 at risk
Melaena	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected287 at risk EG0010 affected288 at risk EG0020 affected290 at risk
Mesenteric vein thrombosis	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected287 at risk EG0010 affected288 at risk EG0020 affected290 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0010 affected288 at risk EG0021 affected290 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected287 at risk EG0010 affected288 at risk EG0020 affected290 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected287 at risk EG0010 affected288 at risk EG0020 affected290 at risk
Peptic ulcer	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected287 at risk EG0010 affected288 at risk EG0020 affected290 at risk
Peritonitis	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected287 at risk EG0010 affected288 at risk EG0021 affected290 at risk
Vasculitis gastrointestinal	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected287 at risk EG0010 affected288 at risk EG0020 affected290 at risk
Death	General disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected287 at risk EG0010 affected288 at risk EG0020 affected290 at risk
Infusion related reaction	General disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected287 at risk EG0011 affected288 at risk EG0021 affected290 at risk
Non-cardiac chest pain	General disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0010 affected288 at risk EG0021 affected290 at risk
Pyrexia	General disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected287 at risk EG0014 affected288 at risk EG0024 affected290 at risk
Biliary dilatation	Hepatobiliary disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0010 affected288 at risk EG0021 affected290 at risk
Cholangitis acute	Hepatobiliary disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0010 affected288 at risk EG0021 affected290 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0010 affected288 at risk EG0021 affected290 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected287 at risk EG0012 affected288 at risk EG0021 affected290 at risk
Portal vein thrombosis	Hepatobiliary disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected287 at risk EG0010 affected288 at risk EG0020 affected290 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0012 affected288 at risk EG0021 affected290 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0010 affected288 at risk EG0021 affected290 at risk
Food allergy	Immune system disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected287 at risk EG0010 affected288 at risk EG0020 affected290 at risk
Acinetobacter bacteraemia	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0010 affected288 at risk EG0021 affected290 at risk
Acute sinusitis	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0010 affected288 at risk EG0021 affected290 at risk
Appendiceal abscess	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0001 affected287 at risk EG0010 affected288 at risk EG0020 affected290 at risk
Appendicitis	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0010 affected288 at risk EG0022 affected290 at risk
Appendicitis perforated	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0001 affected287 at risk EG0010 affected288 at risk EG0020 affected290 at risk
Bacterial sepsis	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0010 affected288 at risk EG0021 affected290 at risk
Bronchitis	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0011 affected288 at risk EG0020 affected290 at risk
Cellulitis	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0001 affected287 at risk EG0014 affected288 at risk EG0021 affected290 at risk
Conjunctivitis bacterial	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0001 affected287 at risk EG0010 affected288 at risk EG0020 affected290 at risk
Cystitis	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0011 affected288 at risk EG0021 affected290 at risk
Dengue fever	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0011 affected288 at risk EG0020 affected290 at risk
Diarrhoea infectious	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0010 affected288 at risk EG0021 affected290 at risk
Ecthyma	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0011 affected288 at risk EG0020 affected290 at risk
Escherichia sepsis	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0010 affected288 at risk EG0021 affected290 at risk
Gastroenteritis	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0001 affected287 at risk EG0010 affected288 at risk EG0020 affected290 at risk
Gastroenteritis bacterial	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0002 affected287 at risk EG0010 affected288 at risk EG0020 affected290 at risk
Haematoma infection	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0011 affected288 at risk EG0020 affected290 at risk
Hepatitis A	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0011 affected288 at risk EG0020 affected290 at risk
Herpes zoster	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0002 affected287 at risk EG0012 affected288 at risk EG0021 affected290 at risk
Herpes zoster multi-dermatomal	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0012 affected288 at risk EG0020 affected290 at risk
Joint abscess	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0011 affected288 at risk EG0020 affected290 at risk
Kidney infection	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0010 affected288 at risk EG0022 affected290 at risk
Otitis media chronic	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0001 affected287 at risk EG0010 affected288 at risk EG0020 affected290 at risk
Phlebitis infective	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0001 affected287 at risk EG0010 affected288 at risk EG0020 affected290 at risk
Pneumonia	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0005 affected287 at risk EG0011 affected288 at risk EG0021 affected290 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0011 affected288 at risk EG0020 affected290 at risk
Pyelonephritis	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0002 affected287 at risk EG0011 affected288 at risk EG0020 affected290 at risk
Sepsis	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0011 affected288 at risk EG0020 affected290 at risk
Septic shock	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0011 affected288 at risk EG0020 affected290 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0001 affected287 at risk EG0010 affected288 at risk EG0020 affected290 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0001 affected287 at risk EG0010 affected288 at risk EG0020 affected290 at risk
Urinary tract infection	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0002 affected287 at risk EG0014 affected288 at risk EG0022 affected290 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0001 affected287 at risk EG0010 affected288 at risk EG0020 affected290 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0011 affected288 at risk EG0021 affected290 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0010 affected288 at risk EG0021 affected290 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0010 affected288 at risk EG0021 affected290 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0010 affected288 at risk EG0021 affected290 at risk
Weight decreased	Investigations	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0010 affected288 at risk EG0021 affected290 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected287 at risk EG0010 affected288 at risk EG0020 affected290 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected287 at risk EG0010 affected288 at risk EG0021 affected290 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected287 at risk EG0010 affected288 at risk EG0020 affected290 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0011 affected288 at risk EG0020 affected290 at risk
Myositis	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected287 at risk EG0010 affected288 at risk EG0020 affected290 at risk
Osteochondrosis	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected287 at risk EG0011 affected288 at risk EG0020 affected290 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0013 affected288 at risk EG0021 affected290 at risk
SLE arthritis	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected287 at risk EG0010 affected288 at risk EG0023 affected290 at risk
Benign breast neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0011 affected288 at risk EG0020 affected290 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected287 at risk EG0010 affected288 at risk EG0020 affected290 at risk
Cerebral infarction	Nervous system disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected287 at risk EG0010 affected288 at risk EG0020 affected290 at risk
Headache	Nervous system disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected287 at risk EG0011 affected288 at risk EG0021 affected290 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0011 affected288 at risk EG0020 affected290 at risk
Syncope	Nervous system disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected287 at risk EG0010 affected288 at risk EG0020 affected290 at risk
Tension headache	Nervous system disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0010 affected288 at risk EG0021 affected290 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA 12.0	Non-systematic Assessment	EG0001 affected287 at risk EG0011 affected288 at risk EG0023 affected290 at risk
Abortion spontaneous incomplete	Pregnancy, puerperium and perinatal conditions	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0010 affected288 at risk EG0021 affected290 at risk
Adjustment disorder	Psychiatric disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected287 at risk EG0010 affected288 at risk EG0020 affected290 at risk
Completed suicide	Psychiatric disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0010 affected288 at risk EG0021 affected290 at risk
Delirium	Psychiatric disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0010 affected288 at risk EG0021 affected290 at risk
Depression	Psychiatric disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected287 at risk EG0010 affected288 at risk EG0021 affected290 at risk
Intentional self-injury	Psychiatric disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected287 at risk EG0010 affected288 at risk EG0020 affected290 at risk
Mania	Psychiatric disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0010 affected288 at risk EG0021 affected290 at risk
Panic attack	Psychiatric disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected287 at risk EG0010 affected288 at risk EG0021 affected290 at risk
Personality disorder	Psychiatric disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected287 at risk EG0010 affected288 at risk EG0020 affected290 at risk
Cystitis haemorrhagic	Renal and urinary disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0011 affected288 at risk EG0020 affected290 at risk
Haematuria	Renal and urinary disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0011 affected288 at risk EG0020 affected290 at risk
Lupus nephritis	Renal and urinary disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0013 affected288 at risk EG0023 affected290 at risk
Nephrotic syndrome	Renal and urinary disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0011 affected288 at risk EG0020 affected290 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0011 affected288 at risk EG0020 affected290 at risk
Renal vein thrombosis	Renal and urinary disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected287 at risk EG0010 affected288 at risk EG0020 affected290 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0010 affected288 at risk EG0021 affected290 at risk
Uterine haemorrhage	Reproductive system and breast disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0011 affected288 at risk EG0020 affected290 at risk
Uterine polyp	Reproductive system and breast disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0010 affected288 at risk EG0021 affected290 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected287 at risk EG0010 affected288 at risk EG0020 affected290 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected287 at risk EG0010 affected288 at risk EG0020 affected290 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected287 at risk EG0010 affected288 at risk EG0020 affected290 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0010 affected288 at risk EG0021 affected290 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0011 affected288 at risk EG0021 affected290 at risk
Cutaneous vasculitis	Skin and subcutaneous tissue disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected287 at risk EG0010 affected288 at risk EG0021 affected290 at risk
Mucocutaneous rash	Skin and subcutaneous tissue disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0010 affected288 at risk EG0021 affected290 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0011 affected288 at risk EG0020 affected290 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0011 affected288 at risk EG0020 affected290 at risk
Systemic lupus erythematosus rash	Skin and subcutaneous tissue disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected287 at risk EG0010 affected288 at risk EG0020 affected290 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0011 affected288 at risk EG0020 affected290 at risk
Aortic dissection	Vascular disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0011 affected288 at risk EG0020 affected290 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected287 at risk EG0010 affected288 at risk EG0020 affected290 at risk
Hypertension	Vascular disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0011 affected288 at risk EG0021 affected290 at risk
Hypertensive crisis	Vascular disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0010 affected288 at risk EG0022 affected290 at risk
Hypotension	Vascular disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected287 at risk EG0011 affected288 at risk EG0021 affected290 at risk
Thrombophlebitis superficial	Vascular disorders	MedDRA 12.0	Non-systematic Assessment	EG0002 affected287 at risk EG0010 affected288 at risk EG0020 affected290 at risk
Vasculitis	Vascular disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected287 at risk EG0011 affected288 at risk EG0020 affected290 at risk
Vena cava thrombosis	Vascular disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected287 at risk EG0010 affected288 at risk EG0020 affected290 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 12.0	Non-systematic Assessment	EG00013 affected287 at risk EG00113 affected288 at risk EG00215 affected290 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG00018 affected287 at risk EG0018 affected288 at risk EG00213 affected290 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG00019 affected287 at risk EG00128 affected288 at risk EG00230 affected290 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG00015 affected287 at risk EG00111 affected288 at risk EG00211 affected290 at risk
Gastritis	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0007 affected287 at risk EG00110 affected288 at risk EG00215 affected290 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG00018 affected287 at risk EG0015 affected288 at risk EG00212 affected290 at risk
Nausea	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG00031 affected287 at risk EG00116 affected288 at risk EG00223 affected290 at risk
Vomiting	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG00013 affected287 at risk EG00116 affected288 at risk EG00214 affected290 at risk
Fatigue	General disorders	MedDRA 12.0	Non-systematic Assessment	EG00012 affected287 at risk EG00117 affected288 at risk EG00218 affected290 at risk
Oedema peripheral	General disorders	MedDRA 12.0	Non-systematic Assessment	EG00021 affected287 at risk EG00120 affected288 at risk EG00217 affected290 at risk
Pyrexia	General disorders	MedDRA 12.0	Non-systematic Assessment	EG00017 affected287 at risk EG00115 affected288 at risk EG00216 affected290 at risk
Bronchitis	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0007 affected287 at risk EG00121 affected288 at risk EG00216 affected290 at risk
Cystitis	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0009 affected287 at risk EG00112 affected288 at risk EG00222 affected290 at risk
Gastroenteritis	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG00016 affected287 at risk EG00120 affected288 at risk EG00212 affected290 at risk
Influenza	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG00025 affected287 at risk EG00122 affected288 at risk EG00233 affected290 at risk
Nasopharyngitis	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG00023 affected287 at risk EG00130 affected288 at risk EG00220 affected290 at risk
Pharyngitis	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0007 affected287 at risk EG00116 affected288 at risk EG00215 affected290 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG00047 affected287 at risk EG00141 affected288 at risk EG00236 affected290 at risk
Urinary tract infection	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG00024 affected287 at risk EG00127 affected288 at risk EG00226 affected290 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Non-systematic Assessment	EG00033 affected287 at risk EG00121 affected288 at risk EG00232 affected290 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Non-systematic Assessment	EG00018 affected287 at risk EG00113 affected288 at risk EG00215 affected290 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Non-systematic Assessment	EG00025 affected287 at risk EG00125 affected288 at risk EG00219 affected290 at risk
Dizziness	Nervous system disorders	MedDRA 12.0	Non-systematic Assessment	EG00023 affected287 at risk EG00116 affected288 at risk EG00215 affected290 at risk
Headache	Nervous system disorders	MedDRA 12.0	Non-systematic Assessment	EG00075 affected287 at risk EG00158 affected288 at risk EG00266 affected290 at risk
Insomnia	Psychiatric disorders	MedDRA 12.0	Non-systematic Assessment	EG00014 affected287 at risk EG0019 affected288 at risk EG00221 affected290 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Non-systematic Assessment	EG00025 affected287 at risk EG00123 affected288 at risk EG00216 affected290 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Non-systematic Assessment	EG00015 affected287 at risk EG0016 affected288 at risk EG0023 affected290 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 12.0	Non-systematic Assessment	EG00017 affected287 at risk EG00110 affected288 at risk EG00217 affected290 at risk
Hypertension	Vascular disorders	MedDRA 12.0	Non-systematic Assessment	EG00030 affected287 at risk EG00124 affected288 at risk EG00217 affected290 at risk

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