A Study of Belimumab in Subjects With Systemic Lupus Eryt... | NCT00410384

NCT00410384

ID	Type	Description	Link
BLISS-76
110751	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 72 weeks.	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
SRI Response Rate at Week 76	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).

Measure	Description	Time Frame
Adverse Event (AE) Overview	SEE ALSO ADVERSE EVENT RESULTS SECTION	Up to 80 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
University of Alabama at Birmingham		Birmingham	Alabama	35249	United States
Arizona Arthritis and Rheumatology Research, PPLC

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-C1056	Statistical Analysis Plan	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 72 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 72 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 72 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 72 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 72 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
	BG00040.0± 11.9 BG00140.0± 11.4 BG00240.5± 11.1 BG003

Age, Customized

Number

participants

Title

Denominators

Categories

≤ 45 years

Title	Measurements
	BG000189 BG001184 BG002

Gender

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000252 BG001253 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

North America

Title	Measurements
	BG000145 BG001155 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 72 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 72 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 72 weeks.

Units	Counts
Participants	OG000275 OG001271 OG002273

Title

Denominators

Categories

Title	Measurements
	OG00033.5 OG00140.6 OG00243.2

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)	0.0167	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)	1.54			2-Sided	95	1.08	2.19				No	Superiority or Other

Secondary

SRI Response Rate at Week 76

Analysis was performed on a 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 76 data.

Posted

Number

Percentage of participants

Baseline, 76 Weeks

ID	Title	Description
OG000	Placebo	Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 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 72 weeks.
OG002	Belimumab 10 mg/kg

Secondary

Percent of Subjects With a ≥ 4 Point Reduction From Baseline in SELENA SLEDAI Score at Week 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 72 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 72 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 72 weeks.

Units	Counts
Participants

Secondary

Mean Change in Physician's Global Assessment (PGA) at Week 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 72 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 72 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 72 weeks.

Secondary

Mean Change From Baseline in Medical Outcomes 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score (PCS) at Week 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 72 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 72 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 40-52

ID	Title	Description
OG000	Placebo	Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 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 72 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 72 weeks.

Units	Counts
Participants

Other Pre-specified

Adverse Event (AE) Overview

SEE ALSO ADVERSE EVENT RESULTS SECTION

Posted

Number

Percentage of participants

Up to 80 Weeks

ID	Title	Description
OG000	Placebo	Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 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 72 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 72 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 72 weeks.	54	275	213	275
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 72 weeks.	63	271	217	271
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 72 weeks.	61	273	219	273

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 12.0	Non-systematic Assessment	EG0002 affected275 at risk EG0012 affected271 at risk EG0024 affected273 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0011 affected271 at risk EG0021 affected273 at risk
Haemolytic anaemia	Blood and lymphatic system disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0010 affected271 at risk EG0020 affected273 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0011 affected271 at risk EG0020 affected273 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected271 at risk EG0021 affected273 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0011 affected271 at risk EG0021 affected273 at risk
Spontaneous haematoma	Blood and lymphatic system disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0010 affected271 at risk EG0020 affected273 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 12.0	Non-systematic Assessment	EG0002 affected275 at risk EG0011 affected271 at risk EG0021 affected273 at risk
Thymus enlargement	Blood and lymphatic system disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected271 at risk EG0021 affected273 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0010 affected271 at risk EG0021 affected273 at risk
Angina pectoris	Cardiac disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected271 at risk EG0022 affected273 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 12.0	Non-systematic Assessment	EG0002 affected275 at risk EG0010 affected271 at risk EG0020 affected273 at risk
Bradyarrhythmia	Cardiac disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0011 affected271 at risk EG0020 affected273 at risk
Bradycardia	Cardiac disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0011 affected271 at risk EG0020 affected273 at risk
Cardiac arrest	Cardiac disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected271 at risk EG0021 affected273 at risk
Cardiac failure	Cardiac disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0011 affected271 at risk EG0020 affected273 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected271 at risk EG0021 affected273 at risk
Myocardial infarction	Cardiac disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0010 affected271 at risk EG0021 affected273 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected271 at risk EG0021 affected273 at risk
Pericardial effusion	Cardiac disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0010 affected271 at risk EG0020 affected273 at risk
Pericarditis	Cardiac disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected271 at risk EG0021 affected273 at risk
Pericarditis lupus	Cardiac disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0011 affected271 at risk EG0020 affected273 at risk
Prinzmetal angina	Cardiac disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0010 affected271 at risk EG0020 affected273 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0010 affected271 at risk EG0020 affected273 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected271 at risk EG0021 affected273 at risk
Chorioretinopathy	Eye disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected271 at risk EG0021 affected273 at risk
Diplopia	Eye disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0011 affected271 at risk EG0020 affected273 at risk
Abdominal adhesions	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected271 at risk EG0021 affected273 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0013 affected271 at risk EG0020 affected273 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0011 affected271 at risk EG0020 affected273 at risk
Erosive oesophagitis	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0011 affected271 at risk EG0020 affected273 at risk
Food poisoning	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected271 at risk EG0021 affected273 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0011 affected271 at risk EG0020 affected273 at risk
Gastritis	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0002 affected275 at risk EG0010 affected271 at risk EG0020 affected273 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0010 affected271 at risk EG0020 affected273 at risk
Gastrointestinal inflammation	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0011 affected271 at risk EG0020 affected273 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0011 affected271 at risk EG0020 affected273 at risk
Ileus	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0010 affected271 at risk EG0020 affected273 at risk
Intestinal haemorrhage	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0011 affected271 at risk EG0020 affected273 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0010 affected271 at risk EG0020 affected273 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0011 affected271 at risk EG0020 affected273 at risk
Nausea	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0011 affected271 at risk EG0021 affected273 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0010 affected271 at risk EG0020 affected273 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0002 affected275 at risk EG0010 affected271 at risk EG0021 affected273 at risk
Proctitis	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected271 at risk EG0021 affected273 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0011 affected271 at risk EG0020 affected273 at risk
Varices oesophageal	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0010 affected271 at risk EG0020 affected273 at risk
Vomiting	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0011 affected271 at risk EG0020 affected273 at risk
Chest discomfort	General disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0010 affected271 at risk EG0021 affected273 at risk
Chills	General disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0011 affected271 at risk EG0020 affected273 at risk
Death	General disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0011 affected271 at risk EG0020 affected273 at risk
Fatigue	General disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0011 affected271 at risk EG0020 affected273 at risk
Infusion related reaction	General disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0011 affected271 at risk EG0023 affected273 at risk
Non-cardiac chest pain	General disorders	MedDRA 12.0	Non-systematic Assessment	EG0004 affected275 at risk EG0010 affected271 at risk EG0020 affected273 at risk
Oedema peripheral	General disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected271 at risk EG0022 affected273 at risk
Pyrexia	General disorders	MedDRA 12.0	Non-systematic Assessment	EG0002 affected275 at risk EG0011 affected271 at risk EG0024 affected273 at risk
Autoimmune hepatitis	Hepatobiliary disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0010 affected271 at risk EG0020 affected273 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0012 affected271 at risk EG0020 affected273 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected271 at risk EG0021 affected273 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 12.0	Non-systematic Assessment	EG0003 affected275 at risk EG0012 affected271 at risk EG0021 affected273 at risk
Gallbladder non-functioning	Hepatobiliary disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0011 affected271 at risk EG0020 affected273 at risk
Hepatitis toxic	Hepatobiliary disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected271 at risk EG0021 affected273 at risk
Appendicitis	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0010 affected271 at risk EG0020 affected273 at risk
Arthritis bacterial	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0010 affected271 at risk EG0020 affected273 at risk
Bronchitis	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0010 affected271 at risk EG0023 affected273 at risk
Bronchitis bacterial	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0011 affected271 at risk EG0020 affected273 at risk
Bursitis infective staphylococcal	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0011 affected271 at risk EG0020 affected273 at risk
Cellulitis	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0011 affected271 at risk EG0020 affected273 at risk
Cellulitis staphylococcal	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0010 affected271 at risk EG0020 affected273 at risk
Disseminated cytomegaloviral infection	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected271 at risk EG0021 affected273 at risk
Enterocolitis infectious	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected271 at risk EG0021 affected273 at risk
Erysipelas	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0012 affected271 at risk EG0020 affected273 at risk
Escherichia bacteraemia	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0011 affected271 at risk EG0020 affected273 at risk
Escherichia sepsis	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0011 affected271 at risk EG0020 affected273 at risk
Fungal skin infection	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0011 affected271 at risk EG0020 affected273 at risk
Furuncle	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected271 at risk EG0021 affected273 at risk
Gastroenteritis	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0011 affected271 at risk EG0021 affected273 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0011 affected271 at risk EG0020 affected273 at risk
Gastrointestinal infection	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0011 affected271 at risk EG0020 affected273 at risk
Gastrointestinal viral infection	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0012 affected271 at risk EG0020 affected273 at risk
Genital herpes	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected271 at risk EG0021 affected273 at risk
Helicobacter gastritis	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0010 affected271 at risk EG0020 affected273 at risk
Hepatitis B	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0010 affected271 at risk EG0020 affected273 at risk
Herpes zoster	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0011 affected271 at risk EG0021 affected273 at risk
Herpes zoster multi-dermatomal	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0010 affected271 at risk EG0020 affected273 at risk
HIV infection	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0010 affected271 at risk EG0020 affected273 at risk
Infected bites	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0011 affected271 at risk EG0020 affected273 at risk
Infected sebaceous cyst	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected271 at risk EG0021 affected273 at risk
Influenza	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected271 at risk EG0021 affected273 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0011 affected271 at risk EG0020 affected273 at risk
Meningitis aseptic	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected271 at risk EG0021 affected273 at risk
Oral candidiasis	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0011 affected271 at risk EG0020 affected273 at risk
Pneumococcal sepsis	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0010 affected271 at risk EG0020 affected273 at risk
Pneumonia	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0004 affected275 at risk EG0013 affected271 at risk EG0025 affected273 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected271 at risk EG0021 affected273 at risk
Pyelonephritis	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0012 affected271 at risk EG0020 affected273 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0010 affected271 at risk EG0020 affected273 at risk
Skin candida	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected271 at risk EG0021 affected273 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected271 at risk EG0021 affected273 at risk
Staphylococcal skin infection	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected271 at risk EG0021 affected273 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0010 affected271 at risk EG0020 affected273 at risk
Urinary tract infection	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0003 affected275 at risk EG0013 affected271 at risk EG0023 affected273 at risk
Urosepsis	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected271 at risk EG0021 affected273 at risk
Anaemia postoperative	Injury, poisoning and procedural complications	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0010 affected271 at risk EG0020 affected273 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0011 affected271 at risk EG0020 affected273 at risk
Deep vein thrombosis postoperative	Injury, poisoning and procedural complications	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0010 affected271 at risk EG0020 affected273 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0010 affected271 at risk EG0020 affected273 at risk
Meniscus lesion	Injury, poisoning and procedural complications	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0010 affected271 at risk EG0020 affected273 at risk
Narcotic intoxication	Injury, poisoning and procedural complications	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected271 at risk EG0021 affected273 at risk
Operative haemorrhage	Injury, poisoning and procedural complications	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0011 affected271 at risk EG0020 affected273 at risk
Perirenal haematoma	Injury, poisoning and procedural complications	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0011 affected271 at risk EG0020 affected273 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected271 at risk EG0022 affected273 at risk
Procedural complication	Injury, poisoning and procedural complications	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0010 affected271 at risk EG0020 affected273 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0011 affected271 at risk EG0020 affected273 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0011 affected271 at risk EG0020 affected273 at risk
Ulna fracture	Injury, poisoning and procedural complications	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0011 affected271 at risk EG0020 affected273 at risk
Bacteria blood identified	Investigations	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected271 at risk EG0021 affected273 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0011 affected271 at risk EG0021 affected273 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0011 affected271 at risk EG0020 affected273 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0010 affected271 at risk EG0020 affected273 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0011 affected271 at risk EG0020 affected273 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0012 affected271 at risk EG0020 affected273 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0011 affected271 at risk EG0020 affected273 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0010 affected271 at risk EG0020 affected273 at risk
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0010 affected271 at risk EG0020 affected273 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected271 at risk EG0021 affected273 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0011 affected271 at risk EG0020 affected273 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Non-systematic Assessment	EG0002 affected275 at risk EG0010 affected271 at risk EG0020 affected273 at risk
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0010 affected271 at risk EG0020 affected273 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0010 affected271 at risk EG0020 affected273 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0011 affected271 at risk EG0020 affected273 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0011 affected271 at risk EG0020 affected273 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0010 affected271 at risk EG0020 affected273 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0011 affected271 at risk EG0020 affected273 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected271 at risk EG0021 affected273 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected271 at risk EG0021 affected273 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0012 affected271 at risk EG0020 affected273 at risk
Polymyositis	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0011 affected271 at risk EG0020 affected273 at risk
SLE arthritis	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0011 affected271 at risk EG0021 affected273 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected271 at risk EG0021 affected273 at risk
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected271 at risk EG0021 affected273 at risk
Synovitis	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected271 at risk EG0021 affected273 at risk
Temporomandibular joint syndrome	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0011 affected271 at risk EG0020 affected273 at risk
Benign soft tissue neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0011 affected271 at risk EG0020 affected273 at risk
Bladder papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0010 affected271 at risk EG0020 affected273 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0011 affected271 at risk EG0020 affected273 at risk
Carcinoid tumour of the stomach	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0010 affected271 at risk EG0020 affected273 at risk
Cervix carcinoma stage 0	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0011 affected271 at risk EG0020 affected273 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0010 affected271 at risk EG0020 affected273 at risk
Ovarian cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0011 affected271 at risk EG0020 affected273 at risk
Amnesia	Nervous system disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected271 at risk EG0021 affected273 at risk
Brain stem ischaemia	Nervous system disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected271 at risk EG0021 affected273 at risk
Convulsion	Nervous system disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0011 affected271 at risk EG0021 affected273 at risk
Dizziness	Nervous system disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected271 at risk EG0021 affected273 at risk
Headache	Nervous system disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected271 at risk EG0021 affected273 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected271 at risk EG0021 affected273 at risk
Intracranial hypotension	Nervous system disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected271 at risk EG0021 affected273 at risk
Lupus encephalitis	Nervous system disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0010 affected271 at risk EG0021 affected273 at risk
Mononeuropathy multiplex	Nervous system disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0011 affected271 at risk EG0020 affected273 at risk
Myasthenia gravis	Nervous system disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected271 at risk EG0021 affected273 at risk
Myelitis transverse	Nervous system disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0011 affected271 at risk EG0020 affected273 at risk
Neuritis	Nervous system disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0011 affected271 at risk EG0020 affected273 at risk
Neuropsychiatric lupus	Nervous system disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected271 at risk EG0022 affected273 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0011 affected271 at risk EG0020 affected273 at risk
Reversible posterior leukoencephalopathy syndrome	Nervous system disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0010 affected271 at risk EG0020 affected273 at risk
Ruptured cerebral aneurysm	Nervous system disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0010 affected271 at risk EG0020 affected273 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0010 affected271 at risk EG0020 affected273 at risk
Syncope	Nervous system disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected271 at risk EG0021 affected273 at risk
Thalamic infarction	Nervous system disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected271 at risk EG0021 affected273 at risk
Vasculitis cerebral	Nervous system disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0010 affected271 at risk EG0020 affected273 at risk
Depression	Psychiatric disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0012 affected271 at risk EG0022 affected273 at risk
Drug abuse	Psychiatric disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected271 at risk EG0021 affected273 at risk
Insomnia	Psychiatric disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0011 affected271 at risk EG0020 affected273 at risk
Mania	Psychiatric disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0011 affected271 at risk EG0020 affected273 at risk
Cystitis noninfective	Renal and urinary disorders	MedDRA 12.0	Non-systematic Assessment	EG0002 affected275 at risk EG0010 affected271 at risk EG0020 affected273 at risk
Diabetic nephropathy	Renal and urinary disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected271 at risk EG0021 affected273 at risk
Glomerulonephritis membranous	Renal and urinary disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected271 at risk EG0021 affected273 at risk
Lupus nephritis	Renal and urinary disorders	MedDRA 12.0	Non-systematic Assessment	EG0005 affected275 at risk EG0012 affected271 at risk EG0023 affected273 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0011 affected271 at risk EG0020 affected273 at risk
Nephrotic syndrome	Renal and urinary disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected271 at risk EG0022 affected273 at risk
Proteinuria	Renal and urinary disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0010 affected271 at risk EG0022 affected273 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 12.0	Non-systematic Assessment	EG0003 affected275 at risk EG0010 affected271 at risk EG0020 affected273 at risk
Cervical dysplasia	Reproductive system and breast disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0012 affected271 at risk EG0020 affected273 at risk
Cervix disorder	Reproductive system and breast disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected271 at risk EG0021 affected273 at risk
Cystocele	Reproductive system and breast disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected271 at risk EG0021 affected273 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0010 affected271 at risk EG0020 affected273 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected271 at risk EG0021 affected273 at risk
Postmenopausal haemorrhage	Reproductive system and breast disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0010 affected271 at risk EG0020 affected273 at risk
Uterovaginal prolapse	Reproductive system and breast disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected271 at risk EG0021 affected273 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0010 affected271 at risk EG0020 affected273 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected271 at risk EG0021 affected273 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0010 affected271 at risk EG0021 affected273 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0002 affected275 at risk EG0011 affected271 at risk EG0020 affected273 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0011 affected271 at risk EG0020 affected273 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected271 at risk EG0021 affected273 at risk
Organising pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0010 affected271 at risk EG0020 affected273 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0011 affected271 at risk EG0021 affected273 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected271 at risk EG0023 affected273 at risk
Pulmonary arterial hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected271 at risk EG0021 affected273 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0011 affected271 at risk EG0021 affected273 at risk
Dermatitis bullous	Skin and subcutaneous tissue disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected271 at risk EG0021 affected273 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected271 at risk EG0021 affected273 at risk
Skin necrosis	Skin and subcutaneous tissue disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0010 affected271 at risk EG0020 affected273 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0010 affected271 at risk EG0020 affected273 at risk
Systemic lupus erythematosus rash	Skin and subcutaneous tissue disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0011 affected271 at risk EG0021 affected273 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0010 affected271 at risk EG0022 affected273 at risk
Femoral artery embolism	Vascular disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected271 at risk EG0021 affected273 at risk
Hypertension	Vascular disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0010 affected271 at risk EG0020 affected273 at risk
Jugular vein thrombosis	Vascular disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected271 at risk EG0021 affected273 at risk
Raynaud's phenomenon	Vascular disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected275 at risk EG0011 affected271 at risk EG0021 affected273 at risk
Subclavian vein thrombosis	Vascular disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0010 affected271 at risk EG0020 affected273 at risk
Vasculitis	Vascular disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected275 at risk EG0010 affected271 at risk EG0020 affected273 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	EG00017 affected275 at risk EG0017 affected271 at risk EG0027 affected273 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG00015 affected275 at risk EG00117 affected271 at risk EG00218 affected273 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0009 affected275 at risk EG00119 affected271 at risk EG00211 affected273 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG00028 affected275 at risk EG00134 affected271 at risk EG00233 affected273 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0006 affected275 at risk EG00116 affected271 at risk EG0026 affected273 at risk
Nausea	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG00027 affected275 at risk EG00142 affected271 at risk EG00245 affected273 at risk
Vomiting	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG00018 affected275 at risk EG00118 affected271 at risk EG00224 affected273 at risk
Fatigue	General disorders	MedDRA 12.0	Non-systematic Assessment	EG00024 affected275 at risk EG00126 affected271 at risk EG00221 affected273 at risk
Oedema peripheral	General disorders	MedDRA 12.0	Non-systematic Assessment	EG00021 affected275 at risk EG00126 affected271 at risk EG00225 affected273 at risk
Pyrexia	General disorders	MedDRA 12.0	Non-systematic Assessment	EG00019 affected275 at risk EG00122 affected271 at risk EG00227 affected273 at risk
Bronchitis	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG00020 affected275 at risk EG00119 affected271 at risk EG00230 affected273 at risk
Gastroenteritis	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG00011 affected275 at risk EG00115 affected271 at risk EG00214 affected273 at risk
Influenza	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG00012 affected275 at risk EG00119 affected271 at risk EG0028 affected273 at risk
Nasopharyngitis	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG00024 affected275 at risk EG00129 affected271 at risk EG00243 affected273 at risk
Oral herpes	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0008 affected275 at risk EG00115 affected271 at risk EG00211 affected273 at risk
Pharyngitis	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG00014 affected275 at risk EG00116 affected271 at risk EG00216 affected273 at risk
Sinusitis	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG00028 affected275 at risk EG00121 affected271 at risk EG00231 affected273 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG00058 affected275 at risk EG00153 affected271 at risk EG00254 affected273 at risk
Urinary tract infection	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG00041 affected275 at risk EG00150 affected271 at risk EG00241 affected273 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG00012 affected275 at risk EG00117 affected271 at risk EG00213 affected273 at risk
Vulvovaginal mycotic infection	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG00015 affected275 at risk EG00118 affected271 at risk EG00215 affected273 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Non-systematic Assessment	EG00042 affected275 at risk EG00142 affected271 at risk EG00241 affected273 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Non-systematic Assessment	EG00020 affected275 at risk EG00125 affected271 at risk EG00227 affected273 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Non-systematic Assessment	EG00021 affected275 at risk EG00124 affected271 at risk EG00219 affected273 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Non-systematic Assessment	EG00013 affected275 at risk EG00112 affected271 at risk EG00224 affected273 at risk
SLE arthritis	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Non-systematic Assessment	EG00014 affected275 at risk EG0017 affected271 at risk EG0029 affected273 at risk
Dizziness	Nervous system disorders	MedDRA 12.0	Non-systematic Assessment	EG00011 affected275 at risk EG00114 affected271 at risk EG00216 affected273 at risk
Headache	Nervous system disorders	MedDRA 12.0	Non-systematic Assessment	EG00038 affected275 at risk EG00156 affected271 at risk EG00243 affected273 at risk
Anxiety	Psychiatric disorders	MedDRA 12.0	Non-systematic Assessment	EG00010 affected275 at risk EG00116 affected271 at risk EG0026 affected273 at risk
Depression	Psychiatric disorders	MedDRA 12.0	Non-systematic Assessment	EG00010 affected275 at risk EG00114 affected271 at risk EG00219 affected273 at risk
Insomnia	Psychiatric disorders	MedDRA 12.0	Non-systematic Assessment	EG00013 affected275 at risk EG00126 affected271 at risk EG00217 affected273 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Non-systematic Assessment	EG00015 affected275 at risk EG00121 affected271 at risk EG00226 affected273 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 12.0	Non-systematic Assessment	EG00012 affected275 at risk EG00117 affected271 at risk EG00220 affected273 at risk
Hypertension	Vascular disorders	MedDRA 12.0	Non-systematic Assessment	EG00020 affected275 at risk EG00113 affected271 at risk EG00215 affected273 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