Study of Epratuzumab Versus Placebo in Subjects With Mode... | NCT01262365

NCT01262365

ID	Type	Description	Link
2010-018563-41	EudraCT Number

Status Module

Oversight 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 (Weekly infusion)	Placebo Comparator	Placebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles	Drug: Placebo
Epratuzumab 600 mg per week	Experimental	600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles	Drug: Epratuzumab
Epratuzumab 1200 mg every other week	Experimental	1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles and placebo infusions delivered every other week for a total of 4 weeks over four 12-week treatment cycles	Drug: Epratuzumab Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Epratuzumab	Drug	600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12- week treatment cycles	Epratuzumab 600 mg per week

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Percent of Subjects Meeting Treatment Response Criteria at Week 48 According to a Combined Response Index	Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set. The combined response index incorporated criteria for achievement of responder status from the: British Isles Lupus Assessment Group Index (BILAG-2004)- improvement from study entry or no worsening in other organ systems, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; Version 2000, also known as SLEDAI-2K) - no worsening compared to study entry, physician's global assessment of disease activity(PGA)- no worsening compared to study entry, and concomitant medications- no changes.	At Week 48

Secondary Outcomes

Measure	Description	Time Frame
The Percent of Subjects Meeting Treatment Response Criteria at Week 24 According to a Combined Response Index	Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set. The combined response index incorporated criteria for achievement of responder status from the: British Isles Lupus Assessment Group Index (BILAG-2004)- improvement from study entry or no worsening in other organ systems, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; Version 2000, also known as SLEDAI-2K) - no worsening compared to study entry, physician's global assessment of disease activity(PGA)- no worsening compared to study entry, and concomitant medications- no changes.

Eligibility Module

Name	Affiliation	Role
UCb Clinical Trial Call Center	+1 877 822 9493 (UCB)	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
069		Birmingham	Alabama		United States
063

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29381843	Derived	Gottenberg JE, Dorner T, Bootsma H, Devauchelle-Pensec V, Bowman SJ, Mariette X, Bartz H, Oortgiesen M, Shock A, Koetse W, Galateanu C, Bongardt S, Wegener WA, Goldenberg DM, Meno-Tetang G, Kosutic G, Gordon C. Efficacy of Epratuzumab, an Anti-CD22 Monoclonal IgG Antibody, in Systemic Lupus Erythematosus Patients With Associated Sjogren's Syndrome: Post Hoc Analyses From the EMBODY Trials. Arthritis Rheumatol. 2018 May;70(5):763-773. doi: 10.1002/art.40425. Epub 2018 Apr 12.
27598855

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo (RS)	Placebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles
FG001	Epratuzumab 1200 mg Every Other Week (RS)	1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles and placebo infusions delivered every other week for a total of 4 weeks over four 12-week treatment cycles

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Placebo (Weekly Infusion)	Placebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles
BG001	Epratuzumab 1200 mg Every Other Week	1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles and placebo infusions delivered every other week for a total of 4 weeks over four 12-week treatment cycles
BG002	Epratuzumab 600 mg Per Week	600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles
BG003	Total Title

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020 BG003

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00041.4± 12.6 BG00142.5± 11.8 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000250 BG001243 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

The Percent of Subjects Meeting Treatment Response Criteria at Week 48 According to a Combined Response Index

Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set. The combined response index incorporated criteria for achievement of responder status from the: British Isles Lupus Assessment Group Index (BILAG-2004)- improvement from study entry or no worsening in other organ systems, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; Version 2000, also known as SLEDAI-2K) - no worsening compared to study entry, physician's global assessment of disease activity(PGA)- no worsening compared to study entry, and concomitant medications- no changes.

The Full Analysis Set (FAS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug, with the exception of 45 subjects who were randomized at Site 071, located in the USA, who were excluded from the FAS.

Posted

Number

percentage of participants

At Week 48

ID	Title	Description
OG000	Placebo (Weekly Infusion) FAS	Placebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles
OG001	Epratuzumab 1200 mg Every Other Week (FAS)	1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles and placebo infusions delivered every other week for a total of 4 weeks over four 12-week treatment cycles
OG002	Epratuzumab 600 mg Per Week (FAS)	600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles

Units	Counts
Participants	OG000249 OG001244 OG002248

Title

Denominators

Categories

Title	Measurements
	OG00034.1 OG00139.8 OG00237.5

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Odds Ratio: Epratuzumab/Placebo calculated using logistic regression with factors for treatment, region, and baseline disease status.	Regression, Logistic	p-values have been calculated using logistic regression with factors for treatment, region, and baseline disease status.	=0.175		Odds Ratio (OR)	1.307			2-Sided	95	0.888	1.923					Superiority

Secondary

The Percent of Subjects Meeting Treatment Response Criteria at Week 24 According to a Combined Response Index

Posted

Number

percentage of participants

At Week 24

ID	Title	Description
OG000	Placebo (Weekly Infusion) FAS	Placebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles
OG001	Epratuzumab 1200 mg Every Other Week (FAS)	1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles and placebo infusions delivered every other week for a total of 4 weeks over four 12-week treatment cycles

Secondary

The Percent of Subjects Meeting Treatment Response Criteria at Week 12 According to a Combined Response Index

Posted

Number

percentage of participants

At Week 12

ID	Title	Description
OG000	Placebo (Weekly Infusion) FAS	Placebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles
OG001	Epratuzumab 1200 mg Every Other Week (FAS)	1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles and placebo infusions delivered every other week for a total of 4 weeks over four 12-week treatment cycles

Secondary

The Percent of Subjects Meeting Treatment Response Criteria at Week 36 According to a Combined Response Index

Posted

Number

percentage of participants

At Week 36

ID	Title	Description
OG000	Placebo (Weekly Infusion) FAS	Placebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles
OG001	Epratuzumab 1200 mg Every Other Week (FAS)	1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles and placebo infusions delivered every other week for a total of 4 weeks over four 12-week treatment cycles

Secondary

Change From Baseline in Daily Corticosteroid Dose at Week 24

Subjects with a missing corticosteroid dose at any visit for any reason are counted in the Dose Increased or Missing Data category for that visit.

Posted

Number

percentage of participants

At Week 24

ID	Title	Description
OG000	Placebo (Weekly Infusion) FAS	Placebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles
OG001	Epratuzumab 1200 mg Every Other Week (FAS)	1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles and placebo infusions delivered every other week for a total of 4 weeks over four 12-week treatment cycles
OG002	Epratuzumab 600 mg Per Week (FAS)	600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles

Secondary

Change From Baseline in Daily Corticosteroid Dose at Week 48

Subjects with a missing corticosteroid dose at any visit for any reason are counted in the Dose Increased or Missing Data category for that visit.

Posted

Number

percentage of participants

At Week 48

ID	Title	Description
OG000	Placebo (Weekly Infusion) FAS	Placebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles
OG001	Epratuzumab 1200 mg Every Other Week (FAS)	1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles and placebo infusions delivered every other week for a total of 4 weeks over four 12-week treatment cycles
OG002	Epratuzumab 600 mg Per Week (FAS)	600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo (Weekly Infusion)	Placebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles	1	263	48	263	144	263
EG001	Epratuzumab 1200 mg Every Other Week	1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles and placebo infusions delivered every other week for a total of 4 weeks over four 12-week treatment cycles	2	259	44	259	153	259
EG002	Epratuzumab 600 mg Per Week	600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles	2	264	45	264	141	264

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0012 events2 affected259 at risk EG0022 events2 affected264 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected259 at risk EG0020 events0 affected264 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected259 at risk EG0020 events0 affected264 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected259 at risk EG0021 events1 affected264 at risk
Splenomegaly	Blood and lymphatic system disorders	MedDRA17	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected259 at risk EG0020 events0 affected264 at risk
Cardiac failure	Cardiac disorders	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected259 at risk EG0020 events0 affected264 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected259 at risk EG0020 events0 affected264 at risk
Pericardial effusion	Cardiac disorders	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected259 at risk EG0020 events0 affected264 at risk
Pericarditis lupus	Cardiac disorders	MedDRA17	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0011 events1 affected259 at risk EG0020 events0 affected264 at risk
Pericarditis	Cardiac disorders	MedDRA17	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected259 at risk EG0020 events0 affected264 at risk
Arteriovenous malformation	Congenital, familial and genetic disorders	MedDRA17	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected259 at risk EG0020 events0 affected264 at risk
Cerebrovascular arteriovenous malformation	Congenital, familial and genetic disorders	MedDRA17	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected259 at risk EG0020 events0 affected264 at risk
Hyperparathyroidism	Endocrine disorders	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected259 at risk EG0021 events1 affected264 at risk
Retinal detachment	Eye disorders	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected259 at risk EG0020 events0 affected264 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected259 at risk EG0023 events3 affected264 at risk
Colitis	Gastrointestinal disorders	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected259 at risk EG0020 events0 affected264 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected259 at risk EG0020 events0 affected264 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected259 at risk EG0021 events1 affected264 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected259 at risk EG0020 events0 affected264 at risk
Mesenteric artery thrombosis	Gastrointestinal disorders	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected259 at risk EG0020 events0 affected264 at risk
Nausea	Gastrointestinal disorders	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected259 at risk EG0021 events1 affected264 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected259 at risk EG0020 events0 affected264 at risk
Vomiting	Gastrointestinal disorders	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected259 at risk EG0022 events1 affected264 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA17	Non-systematic Assessment	EG0002 events1 affected263 at risk EG0010 events0 affected259 at risk EG0020 events0 affected264 at risk
Bezoar	Gastrointestinal disorders	MedDRA17	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected259 at risk EG0020 events0 affected264 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA17	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected259 at risk EG0020 events0 affected264 at risk
Chest pain	General disorders	MedDRA17	Non-systematic Assessment	EG0002 events2 affected263 at risk EG0010 events0 affected259 at risk EG0022 events2 affected264 at risk
Inflammation	General disorders	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected259 at risk EG0020 events0 affected264 at risk
Pyrexia	General disorders	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected259 at risk EG0021 events1 affected264 at risk
Non-cardiac chest pain	General disorders	MedDRA17	Non-systematic Assessment	EG0002 events2 affected263 at risk EG0010 events0 affected259 at risk EG0020 events0 affected264 at risk
Serositis	General disorders	MedDRA17	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected259 at risk EG0020 events0 affected264 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA17	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0013 events2 affected259 at risk EG0021 events1 affected264 at risk
Lupus hepatitis	Hepatobiliary disorders	MedDRA17	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected259 at risk EG0020 events0 affected264 at risk
Drug hypersensitivity	Immune system disorders	MedDRA17	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0011 events1 affected259 at risk EG0021 events1 affected264 at risk
Serum sickness	Immune system disorders	MedDRA17	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected259 at risk EG0020 events0 affected264 at risk
Sepsis	Infections and infestations	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0013 events3 affected259 at risk EG0023 events3 affected264 at risk
Cellulitis	Infections and infestations	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0013 events3 affected259 at risk EG0022 events2 affected264 at risk
Urinary tract infection	Infections and infestations	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected259 at risk EG0024 events4 affected264 at risk
Pneumonia	Infections and infestations	MedDRA17	Non-systematic Assessment	EG0004 events4 affected263 at risk EG0011 events1 affected259 at risk EG0022 events2 affected264 at risk
Abscess limb	Infections and infestations	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected259 at risk EG0022 events1 affected264 at risk
Pyelonephritis	Infections and infestations	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected259 at risk EG0021 events1 affected264 at risk
Abscess neck	Infections and infestations	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected259 at risk EG0021 events1 affected264 at risk
Appendicitis	Infections and infestations	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected259 at risk EG0021 events1 affected264 at risk
Atypical pneumonia	Infections and infestations	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected259 at risk EG0020 events0 affected264 at risk
Bacterial pyelonephritis	Infections and infestations	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected259 at risk EG0020 events0 affected264 at risk
Bronchopneumonia	Infections and infestations	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected259 at risk EG0020 events0 affected264 at risk
Diverticulitis	Infections and infestations	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected259 at risk EG0020 events0 affected264 at risk
Erysipelas	Infections and infestations	MedDRA17	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected259 at risk EG0021 events1 affected264 at risk
Gastroenteritis viral	Infections and infestations	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected259 at risk EG0021 events1 affected264 at risk
Herpes zoster	Infections and infestations	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected259 at risk EG0021 events1 affected264 at risk
Herpes zoster meningitis	Infections and infestations	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected259 at risk EG0021 events1 affected264 at risk
Influenza	Infections and infestations	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected259 at risk EG0020 events0 affected264 at risk
Localised infection	Infections and infestations	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected259 at risk EG0020 events0 affected264 at risk
Lymphangitis	Infections and infestations	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected259 at risk EG0020 events0 affected264 at risk
Myringitis bullous	Infections and infestations	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected259 at risk EG0021 events1 affected264 at risk
Pelvic inflammatory disease	Infections and infestations	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected259 at risk EG0020 events0 affected264 at risk
Pyelonephritis acute	Infections and infestations	MedDRA17	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0011 events1 affected259 at risk EG0020 events0 affected264 at risk
Pyelonephritis chronic	Infections and infestations	MedDRA17	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0011 events1 affected259 at risk EG0020 events0 affected264 at risk
Pyomyositis	Infections and infestations	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected259 at risk EG0020 events0 affected264 at risk
Septic shock	Infections and infestations	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected259 at risk EG0021 events1 affected264 at risk
Urinary tract infection pseudomonal	Infections and infestations	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected259 at risk EG0021 events1 affected264 at risk
Bronchitis	Infections and infestations	MedDRA17	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected259 at risk EG0020 events0 affected264 at risk
Diarrhoea infectious	Infections and infestations	MedDRA17	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected259 at risk EG0020 events0 affected264 at risk
Pneumococcal sepsis	Infections and infestations	MedDRA17	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected259 at risk EG0020 events0 affected264 at risk
Viral infection	Infections and infestations	MedDRA17	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected259 at risk EG0020 events0 affected264 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA17	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected259 at risk EG0020 events0 affected264 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA17	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected259 at risk EG0020 events0 affected264 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA17	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected259 at risk EG0020 events0 affected264 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA17	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected259 at risk EG0020 events0 affected264 at risk
Hepatic enzyme increased	Investigations	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected259 at risk EG0021 events1 affected264 at risk
Weight decreased	Investigations	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected259 at risk EG0021 events1 affected264 at risk
Haemoglobin decreased	Investigations	MedDRA17	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected259 at risk EG0020 events0 affected264 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected259 at risk EG0021 events1 affected264 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected259 at risk EG0021 events1 affected264 at risk
Obesity	Metabolism and nutrition disorders	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected259 at risk EG0021 events1 affected264 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA17	Non-systematic Assessment	EG0002 events2 affected263 at risk EG0010 events0 affected259 at risk EG0020 events0 affected264 at risk
Systemic lupus erythematosus	Musculoskeletal and connective tissue disorders	MedDRA17	Non-systematic Assessment	EG0003 events3 affected263 at risk EG0015 events5 affected259 at risk EG0023 events3 affected264 at risk
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected259 at risk EG0020 events0 affected264 at risk
Haemarthrosis	Musculoskeletal and connective tissue disorders	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected259 at risk EG0021 events1 affected264 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected259 at risk EG0021 events1 affected264 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0012 events1 affected259 at risk EG0020 events0 affected264 at risk
Osteoporotic fracture	Musculoskeletal and connective tissue disorders	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected259 at risk EG0021 events1 affected264 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA17	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected259 at risk EG0020 events0 affected264 at risk
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA17	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected259 at risk EG0020 events0 affected264 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected259 at risk EG0021 events1 affected264 at risk
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected259 at risk EG0021 events1 affected264 at risk
Ovarian adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected259 at risk EG0021 events1 affected264 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected259 at risk EG0023 events1 affected264 at risk
Convulsion	Nervous system disorders	MedDRA17	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0011 events1 affected259 at risk EG0021 events1 affected264 at risk
Syncope	Nervous system disorders	MedDRA17	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0011 events1 affected259 at risk EG0021 events1 affected264 at risk
Carotid artery thrombosis	Nervous system disorders	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected259 at risk EG0021 events1 affected264 at risk
Ischaemic stroke	Nervous system disorders	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected259 at risk EG0021 events1 affected264 at risk
Lupus encephalitis	Nervous system disorders	MedDRA17	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0011 events1 affected259 at risk EG0020 events0 affected264 at risk
Partial seizures with secondary generalisation	Nervous system disorders	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected259 at risk EG0020 events0 affected264 at risk
Hemiparesis	Nervous system disorders	MedDRA17	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected259 at risk EG0020 events0 affected264 at risk
Hypoaesthesia	Nervous system disorders	MedDRA17	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected259 at risk EG0020 events0 affected264 at risk
Mononeuropathy multiplex	Nervous system disorders	MedDRA17	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected259 at risk EG0020 events0 affected264 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA17	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected259 at risk EG0020 events0 affected264 at risk
Delirium tremens	Psychiatric disorders	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected259 at risk EG0020 events0 affected264 at risk
Suicidal ideation	Psychiatric disorders	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected259 at risk EG0021 events1 affected264 at risk
Bipolar I disorder	Psychiatric disorders	MedDRA17	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected259 at risk EG0020 events0 affected264 at risk
Depression	Psychiatric disorders	MedDRA17	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected259 at risk EG0020 events0 affected264 at risk
Lupus nephritis	Renal and urinary disorders	MedDRA17	Non-systematic Assessment	EG0002 events2 affected263 at risk EG0012 events2 affected259 at risk EG0021 events1 affected264 at risk
Nephrotic syndrome	Renal and urinary disorders	MedDRA17	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0014 events2 affected259 at risk EG0020 events0 affected264 at risk
Renal failure	Renal and urinary disorders	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected259 at risk EG0021 events1 affected264 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected259 at risk EG0021 events1 affected264 at risk
Proteinuria	Renal and urinary disorders	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected259 at risk EG0021 events1 affected264 at risk
Renal failure acute	Renal and urinary disorders	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected259 at risk EG0021 events1 affected264 at risk
Renal impairment	Renal and urinary disorders	MedDRA17	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected259 at risk EG0020 events0 affected264 at risk
Urinary retention	Renal and urinary disorders	MedDRA17	Non-systematic Assessment	EG0002 events2 affected263 at risk EG0010 events0 affected259 at risk EG0020 events0 affected264 at risk
Breast ulceration	Reproductive system and breast disorders	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected259 at risk EG0021 events1 affected264 at risk
Endometriosis	Reproductive system and breast disorders	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected259 at risk EG0021 events1 affected264 at risk
Ovarian cyst ruptured	Reproductive system and breast disorders	MedDRA17	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0011 events1 affected259 at risk EG0020 events0 affected264 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected259 at risk EG0020 events0 affected264 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected259 at risk EG0022 events2 affected264 at risk
Pulmonary alveolar haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected259 at risk EG0021 events1 affected264 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0012 events2 affected259 at risk EG0020 events0 affected264 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected259 at risk EG0021 events1 affected264 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected259 at risk EG0022 events1 affected264 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected259 at risk EG0020 events0 affected264 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected259 at risk EG0020 events0 affected264 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected259 at risk EG0021 events1 affected264 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA17	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected259 at risk EG0020 events0 affected264 at risk
Cutaneous lupus erythematosus	Skin and subcutaneous tissue disorders	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected259 at risk EG0021 events1 affected264 at risk
Hidradenitis	Skin and subcutaneous tissue disorders	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected259 at risk EG0021 events1 affected264 at risk
Swelling face	Skin and subcutaneous tissue disorders	MedDRA17	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected259 at risk EG0020 events0 affected264 at risk
Abortion induced	Surgical and medical procedures	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected259 at risk EG0021 events1 affected264 at risk
Hypertension	Vascular disorders	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected259 at risk EG0022 events2 affected264 at risk
Thrombophlebitis superficial	Vascular disorders	MedDRA17	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected259 at risk EG0020 events0 affected264 at risk
Arteriosclerosis	Vascular disorders	MedDRA17	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected259 at risk EG0020 events0 affected264 at risk
Jugular vein thrombosis	Vascular disorders	MedDRA17	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected259 at risk EG0020 events0 affected264 at risk
Lupus vasculitis	Vascular disorders	MedDRA17	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected259 at risk EG0020 events0 affected264 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA17	Non-systematic Assessment	EG00028 events23 affected263 at risk EG00144 events30 affected259 at risk EG00249 events38 affected264 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA17	Non-systematic Assessment	EG00019 events17 affected263 at risk EG00124 events21 affected259 at risk EG00228 events19 affected264 at risk
Fatigue	General disorders	MedDRA17	Non-systematic Assessment	EG00010 events10 affected263 at risk EG00120 events17 affected259 at risk EG00217 events12 affected264 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA17	Non-systematic Assessment	EG00036 events30 affected263 at risk EG00138 events32 affected259 at risk EG00238 events32 affected264 at risk
Urinary tract infection	Infections and infestations	MedDRA17	Non-systematic Assessment	EG00041 events30 affected263 at risk EG00129 events25 affected259 at risk EG00241 events27 affected264 at risk
Nasopharyngitis	Infections and infestations	MedDRA17	Non-systematic Assessment	EG00026 events21 affected263 at risk EG00121 events20 affected259 at risk EG00229 events22 affected264 at risk
Sinusitis	Infections and infestations	MedDRA17	Non-systematic Assessment	EG00014 events13 affected263 at risk EG00124 events24 affected259 at risk EG00217 events15 affected264 at risk
Bronchitis	Infections and infestations	MedDRA17	Non-systematic Assessment	EG00023 events20 affected263 at risk EG00114 events12 affected259 at risk EG00218 events15 affected264 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA17	Non-systematic Assessment	EG00021 events14 affected263 at risk EG00128 events20 affected259 at risk EG00224 events14 affected264 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA17	Non-systematic Assessment	EG00014 events10 affected263 at risk EG00120 events19 affected259 at risk EG00217 events15 affected264 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA17	Non-systematic Assessment	EG00013 events11 affected263 at risk EG00118 events14 affected259 at risk EG0029 events9 affected264 at risk
Headache	Nervous system disorders	MedDRA17	Non-systematic Assessment	EG00038 events29 affected263 at risk EG00142 events34 affected259 at risk EG00258 events38 affected264 at risk
Dizziness	Nervous system disorders	MedDRA17	Non-systematic Assessment	EG00011 events11 affected263 at risk EG00110 events9 affected259 at risk EG00218 events16 affected264 at risk
Migraine	Nervous system disorders	MedDRA17	Non-systematic Assessment	EG0004 events3 affected263 at risk EG00119 events16 affected259 at risk EG0028 events7 affected264 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA17	Non-systematic Assessment	EG00016 events12 affected263 at risk EG00114 events13 affected259 at risk EG00212 events12 affected264 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA17	Non-systematic Assessment	EG0005 events5 affected263 at risk EG00116 events14 affected259 at risk EG0028 events8 affected264 at risk
Hypertension	Vascular disorders	MedDRA17	Non-systematic Assessment	EG00012 events11 affected263 at risk EG00121 events20 affected259 at risk EG00214 events13 affected264 at risk

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