Study of Epratuzumab Versus Placebo in Subjects With Mode... | NCT01261793

ID	Type	Description	Link
2010-018565-26	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: Placebo Drug: Epratuzumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	Placebo infusions delivered weekly for 4 weeks over four 12-week treatment cycles	Epratuzumab 1200 mg every other week Placebo (Weekly infusion)

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 (FAS). 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 (FAS). 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
539		Birmingham	Alabama		United States
557

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 Weekly (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 (SS)	Placebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles
BG001	Epratuzumab 1200 mg Every Other Week (SS)	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 Weekly (SS)	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
	BG00041.1± 11.8 BG00140.8± 11.5 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000245 BG001247 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 (FAS). 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 the study drug.

Posted

Number

Percentage of responders

At Week 48

ID	Title	Description
OG000	Placebo Weekly (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 Weekly (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	OG000263 OG001261 OG002264

Title

Denominators

Categories

Title	Measurements
	OG00033.5 OG00134.1 OG00235.2

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 OG001		Regression, Logistic		=0.899	p-values for the comparison of treatment groups have been calculated using logistic regression with factors for treatment, pooled region, and baseline disease status.	Odds Ratio (OR)	1.024			2-Sided	95	0.710	1.477			Odds ratio: Epratuzumab/Placebo calculated using logistic regression with factors for treatment, pooled region, and baseline disease status.		Superiority

Secondary

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

The Full Analysis Set (FAS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of the study drug.

Posted

Number

Percentage of responders

At Week 24

ID	Title	Description
OG000	Placebo Weekly (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

Secondary

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

The Full Analysis Set (FAS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of the study drug.

Posted

Number

Percentage of responders

At Week 12

ID	Title	Description
OG000	Placebo Weekly (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

Secondary

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

The Full Analysis Set (FAS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of the study drug.

Posted

Number

Percentage of responders

At Week 36

ID	Title	Description
OG000	Placebo Weekly (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

Secondary

Change From Baseline in Daily Corticosteroid Dose at Week 24

Participants were grouped into 4 categories: Dose decreased by >50%, Dose decreased >0% to ≤50%, No change in dose and Dose increased or missing data.

The Full Analysis Set (FAS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of the study drug.

Posted

Number

Percentage of subjects

At Week 24

ID	Title	Description
OG000	Placebo Weekly (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 Weekly (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

Participants were grouped into 4 categories: Dose decreased by >50%, Dose decreased >0% to ≤50%, No change in dose and Dose increased or missing data.

The Full Analysis Set (FAS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of the study drug.

Posted

Number

Percentage of participants

At Week 48

ID	Title	Description
OG000	Placebo Weekly (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 Weekly (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 (SS)	Placebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles	3	263	45	263	151	263
EG001	Epratuzumab 1200 mg Every Other Week (SS)	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	1	261	45	261	145	261
EG002	Epratuzumab 600 mg Weekly (SS)	600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12 week treatment cycles	0	264	50	264	158	264

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0012 events2 affected261 at risk EG0020 events0 affected264 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected261 at risk EG0022 events2 affected264 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected261 at risk EG0021 events1 affected264 at risk
Antiphospholipid syndrome	Blood and lymphatic system disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected261 at risk EG0021 events1 affected264 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected261 at risk EG0020 events0 affected264 at risk
Angina pectoris	Cardiac disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0012 events2 affected261 at risk EG0020 events0 affected264 at risk
Angina unstable	Cardiac disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected261 at risk EG0021 events1 affected264 at risk
Atrial fibrillation	Cardiac disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected261 at risk EG0020 events0 affected264 at risk
Coronary artery disease	Cardiac disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected261 at risk EG0021 events1 affected264 at risk
Palpitations	Cardiac disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected261 at risk EG0020 events0 affected264 at risk
Sinus tachycardia	Cardiac disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected261 at risk EG0021 events1 affected264 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected261 at risk EG0020 events0 affected264 at risk
Lupus myocarditis	Cardiac disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected261 at risk EG0020 events0 affected264 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected261 at risk EG0020 events0 affected264 at risk
Myocardial infarction	Cardiac disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected261 at risk EG0020 events0 affected264 at risk
Talipes	Congenital, familial and genetic disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected261 at risk EG0020 events0 affected264 at risk
Goitre	Endocrine disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected261 at risk EG0021 events1 affected264 at risk
Necrotising retinitis	Eye disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected261 at risk EG0020 events0 affected264 at risk
Visual impairment	Eye disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected261 at risk EG0021 events1 affected264 at risk
Cataract	Eye disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected261 at risk EG0020 events0 affected264 at risk
Retinal degeneration	Eye disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected261 at risk EG0020 events0 affected264 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected261 at risk EG0021 events1 affected264 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected261 at risk EG0020 events0 affected264 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA17.0	Non-systematic Assessment	EG0002 events2 affected263 at risk EG0010 events0 affected261 at risk EG0021 events1 affected264 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected261 at risk EG0021 events1 affected264 at risk
Mechanical ileus	Gastrointestinal disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0012 events1 affected261 at risk EG0020 events0 affected264 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected261 at risk EG0021 events1 affected264 at risk
Reflux gastritis	Gastrointestinal disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected261 at risk EG0021 events1 affected264 at risk
Vomiting	Gastrointestinal disorders	MedDRA17.0	Non-systematic Assessment	EG0002 events1 affected263 at risk EG0010 events0 affected261 at risk EG0021 events1 affected264 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected261 at risk EG0020 events0 affected264 at risk
Diverticulum intestinal	Gastrointestinal disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected261 at risk EG0020 events0 affected264 at risk
Enteritis	Gastrointestinal disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected261 at risk EG0020 events0 affected264 at risk
Gastrointestinal hypomotility	Gastrointestinal disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected261 at risk EG0020 events0 affected264 at risk
Nausea	Gastrointestinal disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected261 at risk EG0020 events0 affected264 at risk
Chest pain	General disorders	MedDRA17.0	Non-systematic Assessment	EG0002 events2 affected263 at risk EG0015 events4 affected261 at risk EG0024 events3 affected264 at risk
Asthenia	General disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected261 at risk EG0021 events1 affected264 at risk
Oedema peripheral	General disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected261 at risk EG0020 events0 affected264 at risk
Pyrexia	General disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected261 at risk EG0021 events1 affected264 at risk
Bile duct stenosis	Hepatobiliary disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected261 at risk EG0020 events0 affected264 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected261 at risk EG0020 events0 affected264 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA17.0	Non-systematic Assessment	EG0003 events3 affected263 at risk EG0010 events0 affected261 at risk EG0020 events0 affected264 at risk
Hepatic steatosis	Hepatobiliary disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected261 at risk EG0020 events0 affected264 at risk
Liver injury	Hepatobiliary disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected261 at risk EG0020 events0 affected264 at risk
Anaphylactic reaction	Immune system disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected261 at risk EG0021 events1 affected264 at risk
Drug hypersensitivity	Immune system disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected261 at risk EG0020 events0 affected264 at risk
Pneumonia	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0003 events3 affected263 at risk EG0012 events2 affected261 at risk EG0024 events4 affected264 at risk
Urinary tract infection	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0002 events2 affected263 at risk EG0010 events0 affected261 at risk EG0023 events3 affected264 at risk
Sepsis	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0012 events2 affected261 at risk EG0020 events0 affected264 at risk
Abdominal abscess	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected261 at risk EG0020 events0 affected264 at risk
Arthritis infective	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected261 at risk EG0020 events0 affected264 at risk
Cellulitis	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0011 events1 affected261 at risk EG0020 events0 affected264 at risk
Cytomegalovirus chorioretinitis	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected261 at risk EG0020 events0 affected264 at risk
Cytomegalovirus viraemia	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected261 at risk EG0020 events0 affected264 at risk
Dengue fever	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected261 at risk EG0021 events1 affected264 at risk
Dermatitis infected	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected261 at risk EG0020 events0 affected264 at risk
Gastroenteritis	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0003 events3 affected263 at risk EG0010 events0 affected261 at risk EG0021 events1 affected264 at risk
Gastroenteritis viral	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0011 events1 affected261 at risk EG0020 events0 affected264 at risk
Herpes zoster	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected261 at risk EG0021 events1 affected264 at risk
Infected skin ulcer	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected261 at risk EG0021 events1 affected264 at risk
Infection	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected261 at risk EG0020 events0 affected264 at risk
Meningitis aseptic	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected261 at risk EG0021 events1 affected264 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected261 at risk EG0021 events1 affected264 at risk
Sialoadenitis	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected261 at risk EG0021 events1 affected264 at risk
Skin bacterial infection	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected261 at risk EG0021 events1 affected264 at risk
Viral infection	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected261 at risk EG0020 events0 affected264 at risk
Appendicitis	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected261 at risk EG0020 events0 affected264 at risk
Eye infection toxoplasmal	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected261 at risk EG0020 events0 affected264 at risk
Lobar pneumonia	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected261 at risk EG0020 events0 affected264 at risk
Meningitis bacterial	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected261 at risk EG0020 events0 affected264 at risk
Pseudomonas infection	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected261 at risk EG0020 events0 affected264 at risk
Pyelonephritis	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected261 at risk EG0020 events0 affected264 at risk
Respiratory tract infection	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected261 at risk EG0020 events0 affected264 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected261 at risk EG0021 events1 affected264 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected261 at risk EG0020 events0 affected264 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected261 at risk EG0020 events0 affected264 at risk
Ulna fracture	Injury, poisoning and procedural complications	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected261 at risk EG0021 events1 affected264 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected261 at risk EG0020 events0 affected264 at risk
Post lumbar puncture syndrome	Injury, poisoning and procedural complications	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected261 at risk EG0020 events0 affected264 at risk
Blood creatinine decreased	Investigations	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected261 at risk EG0020 events0 affected264 at risk
Blood pressure increased	Investigations	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected261 at risk EG0021 events1 affected264 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected261 at risk EG0020 events0 affected264 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected261 at risk EG0021 events1 affected264 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected261 at risk EG0020 events0 affected264 at risk
Systemic lupus erythematosus	Musculoskeletal and connective tissue disorders	MedDRA17.0	Non-systematic Assessment	EG0007 events7 affected263 at risk EG0016 events6 affected261 at risk EG0026 events6 affected264 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected261 at risk EG0021 events1 affected264 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0011 events1 affected261 at risk EG0020 events0 affected264 at risk
Compartment syndrome	Musculoskeletal and connective tissue disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected261 at risk EG0020 events0 affected264 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected261 at risk EG0021 events1 affected264 at risk
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected261 at risk EG0020 events0 affected264 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected261 at risk EG0021 events1 affected264 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected261 at risk EG0021 events1 affected264 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected261 at risk EG0020 events0 affected264 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected261 at risk EG0020 events0 affected264 at risk
Myositis	Musculoskeletal and connective tissue disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected261 at risk EG0020 events0 affected264 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected261 at risk EG0020 events0 affected264 at risk
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected261 at risk EG0020 events0 affected264 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected261 at risk EG0020 events0 affected264 at risk
Synovitis	Musculoskeletal and connective tissue disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected261 at risk EG0021 events1 affected264 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected261 at risk EG0020 events0 affected264 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected261 at risk EG0020 events0 affected264 at risk
Patellofemoral pain syndrome	Musculoskeletal and connective tissue disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected261 at risk EG0020 events0 affected264 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected261 at risk EG0020 events0 affected264 at risk
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected261 at risk EG0021 events1 affected264 at risk
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected261 at risk EG0020 events0 affected264 at risk
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected261 at risk EG0021 events1 affected264 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected261 at risk EG0020 events0 affected264 at risk
Ovarian adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected261 at risk EG0020 events0 affected264 at risk
Aphasia	Nervous system disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected261 at risk EG0020 events0 affected264 at risk
Cerebral infarction	Nervous system disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected261 at risk EG0020 events0 affected264 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected261 at risk EG0022 events1 affected264 at risk
Convulsion	Nervous system disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0013 events1 affected261 at risk EG0020 events0 affected264 at risk
Dizziness	Nervous system disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected261 at risk EG0021 events1 affected264 at risk
Dysarthria	Nervous system disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected261 at risk EG0020 events0 affected264 at risk
Headache	Nervous system disorders	MedDRA17.0	Non-systematic Assessment	EG0003 events3 affected263 at risk EG0010 events0 affected261 at risk EG0021 events1 affected264 at risk
Lupus encephalitis	Nervous system disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected261 at risk EG0020 events0 affected264 at risk
Memory impairment	Nervous system disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected261 at risk EG0021 events1 affected264 at risk
Migraine	Nervous system disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected261 at risk EG0020 events0 affected264 at risk
Myoclonus	Nervous system disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected261 at risk EG0021 events1 affected264 at risk
Nerve compression	Nervous system disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected261 at risk EG0021 events1 affected264 at risk
Syncope	Nervous system disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected261 at risk EG0020 events0 affected264 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected261 at risk EG0020 events0 affected264 at risk
VIIth nerve paralysis	Nervous system disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected261 at risk EG0020 events0 affected264 at risk
Vasculitis cerebral	Nervous system disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected261 at risk EG0021 events1 affected264 at risk
Hemiparesis	Nervous system disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected261 at risk EG0020 events0 affected264 at risk
Noninfectious myelitis	Nervous system disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected261 at risk EG0020 events0 affected264 at risk
Optic neuritis	Nervous system disorders	MedDRA17.0	Non-systematic Assessment	EG0002 events1 affected263 at risk EG0010 events0 affected261 at risk EG0020 events0 affected264 at risk
Paraesthesia	Nervous system disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected261 at risk EG0020 events0 affected264 at risk
Pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0011 events1 affected261 at risk EG0020 events0 affected264 at risk
Pregnancy on contraceptive	Pregnancy, puerperium and perinatal conditions	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected261 at risk EG0020 events0 affected264 at risk
Anxiety	Psychiatric disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected261 at risk EG0021 events1 affected264 at risk
Confusional state	Psychiatric disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected261 at risk EG0020 events0 affected264 at risk
Depression	Psychiatric disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected261 at risk EG0022 events1 affected264 at risk
Generalised anxiety disorder	Psychiatric disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected261 at risk EG0021 events1 affected264 at risk
Suicide attempt	Psychiatric disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected261 at risk EG0020 events0 affected264 at risk
Lupus nephritis	Renal and urinary disorders	MedDRA17.0	Non-systematic Assessment	EG0002 events2 affected263 at risk EG0011 events1 affected261 at risk EG0020 events0 affected264 at risk
Nephrotic syndrome	Renal and urinary disorders	MedDRA17.0	Non-systematic Assessment	EG0002 events2 affected263 at risk EG0011 events1 affected261 at risk EG0020 events0 affected264 at risk
Proteinuria	Renal and urinary disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected261 at risk EG0020 events0 affected264 at risk
Renal impairment	Renal and urinary disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected261 at risk EG0020 events0 affected264 at risk
Cervical dysplasia	Reproductive system and breast disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected261 at risk EG0021 events1 affected264 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected261 at risk EG0024 events4 affected264 at risk
Bronchiectasis	Respiratory, thoracic and mediastinal disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected261 at risk EG0021 events1 affected264 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected261 at risk EG0021 events1 affected264 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected261 at risk EG0021 events1 affected264 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected261 at risk EG0022 events1 affected264 at risk
Lupus pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected261 at risk EG0020 events0 affected264 at risk
Lupus pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected261 at risk EG0020 events0 affected264 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected261 at risk EG0020 events0 affected264 at risk
Pulmonary alveolar haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected261 at risk EG0020 events0 affected264 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected261 at risk EG0021 events1 affected264 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected261 at risk EG0021 events1 affected264 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected261 at risk EG0020 events0 affected264 at risk
Cutaneous lupus erythematosus	Skin and subcutaneous tissue disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected261 at risk EG0021 events1 affected264 at risk
Purpura	Skin and subcutaneous tissue disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected261 at risk EG0021 events1 affected264 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected261 at risk EG0021 events1 affected264 at risk
Stevens-Johnson syndrome	Skin and subcutaneous tissue disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected261 at risk EG0020 events0 affected264 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected261 at risk EG0020 events0 affected264 at risk
Cutaneous vasculitis	Skin and subcutaneous tissue disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected261 at risk EG0020 events0 affected264 at risk
Abortion induced	Surgical and medical procedures	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected261 at risk EG0020 events0 affected264 at risk
Hypertensive crisis	Vascular disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0012 events2 affected261 at risk EG0021 events1 affected264 at risk
Hypertension	Vascular disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0012 events2 affected261 at risk EG0020 events0 affected264 at risk
Lymphoedema	Vascular disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected261 at risk EG0021 events1 affected264 at risk
Raynaud's phenomenon	Vascular disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected261 at risk EG0021 events1 affected264 at risk
Temporal arteritis	Vascular disorders	MedDRA17.0	Non-systematic Assessment	EG0000 events0 affected263 at risk EG0010 events0 affected261 at risk EG0021 events1 affected264 at risk
Deep vein thrombosis	Vascular disorders	MedDRA17.0	Non-systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected261 at risk EG0020 events0 affected264 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA17.0	Non-systematic Assessment	EG00051 events36 affected263 at risk EG00141 events32 affected261 at risk EG00238 events25 affected264 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA17.0	Non-systematic Assessment	EG00024 events19 affected263 at risk EG00115 events15 affected261 at risk EG00241 events25 affected264 at risk
Vomiting	Gastrointestinal disorders	MedDRA17.0	Non-systematic Assessment	EG00018 events16 affected263 at risk EG00114 events12 affected261 at risk EG00223 events16 affected264 at risk
Fatigue	General disorders	MedDRA17.0	Non-systematic Assessment	EG00017 events14 affected263 at risk EG00131 events15 affected261 at risk EG00218 events15 affected264 at risk
Pyrexia	General disorders	MedDRA17.0	Non-systematic Assessment	EG00019 events17 affected263 at risk EG0019 events8 affected261 at risk EG00218 events13 affected264 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG00046 events37 affected263 at risk EG00149 events38 affected261 at risk EG00247 events37 affected264 at risk
Urinary tract infection	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG00066 events44 affected263 at risk EG00145 events37 affected261 at risk EG00254 events38 affected264 at risk
Nasopharyngitis	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG00023 events21 affected263 at risk EG00123 events15 affected261 at risk EG00231 events24 affected264 at risk
Sinusitis	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG00023 events19 affected263 at risk EG00117 events12 affected261 at risk EG00223 events20 affected264 at risk
Bronchitis	Infections and infestations	MedDRA17.0	Non-systematic Assessment	EG00024 events23 affected263 at risk EG00113 events13 affected261 at risk EG00213 events11 affected264 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA17.0	Non-systematic Assessment	EG00020 events19 affected263 at risk EG00116 events14 affected261 at risk EG00214 events14 affected264 at risk
Headache	Nervous system disorders	MedDRA17.0	Non-systematic Assessment	EG00068 events42 affected263 at risk EG00139 events29 affected261 at risk EG00250 events33 affected264 at risk
Dizziness	Nervous system disorders	MedDRA17.0	Non-systematic Assessment	EG00020 events13 affected263 at risk EG00115 events10 affected261 at risk EG00216 events14 affected264 at risk
Depression	Psychiatric disorders	MedDRA17.0	Non-systematic Assessment	EG00016 events15 affected263 at risk EG00111 events10 affected261 at risk EG00210 events9 affected264 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA17.0	Non-systematic Assessment	EG00012 events12 affected263 at risk EG00112 events12 affected261 at risk EG00219 events16 affected264 at risk
Hypertension	Vascular disorders	MedDRA17.0	Non-systematic Assessment	EG00012 events12 affected263 at risk EG00115 events13 affected261 at risk EG00217 events17 affected264 at risk

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