Atacicept Phase 2/3 in Generalized Systemic Lupus Erythem... | NCT00624338

NCT00624338

Status Module

Name	Class
Merck KGaA, Darmstadt, Germany	INDUSTRY

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Intervention Names
Atacicept 75 mg	Experimental	Drug: Atacicept 75 mg
Atacicept 150 mg	Experimental	Drug: Atacicept 150 mg
Placebo	Placebo Comparator	Other: Placebo Comparator

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Atacicept 75 mg	Drug	75 milligram (mg) atacicept injection will be administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants Experiencing a New Flare as Defined by British Isles Lupus Assessment Group (BILAG) Score A or B	A flare was defined as having an adjudicated BILAG A or B score in any of the 8 organ systems during treatment, or imputed for participants who had premature treatment discontinuation. Discontinuations due to sponsor termination of the atacicept 150 mg group were not imputed as flares in this analysis. The BILAG disease activity index evaluates systemic lupus erythematosus (SLE) activity in 8 organ systems, using a separate alphabetic score (A to E) assigned to each organ system defined as follows. BILAG A: Disease sufficiently active requiring disease-modifying treatment (prednisone greater than 20 mg daily or immunosuppressants); BILAG B: Disease less active than in "A", mild reversible problems requiring only symptomatic therapy such as antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), or prednisone less than 20 mg day; BILAG C: Stable mild disease; BILAG D: System previously affected but now inactive; BILAG E: System never involved.	From screening up to Week 52

Secondary Outcomes

Measure	Description	Time Frame
Time to First New Flare as Defined by BILAG Score A or B	A flare was defined as having an adjudicated BILAG A or B score in any of the 8 organ systems during treatment. Analysis was right-censored at Week 52. The hazard ratios and 95% confidence intervals were obtained from the Cox proportional hazards model. The 25th Percentile of time to new flare was reported using Kaplan-Meier estimates (Median was not reached). The BILAG disease activity index evaluates SLE activity in 8 organ systems, using a separate alphabetic score (A to E) assigned to each organ system defined as follows. BILAG A: Disease sufficiently active requiring disease-modifying treatment (prednisone greater than 20 mg daily or immunosuppressants); BILAG B: Disease less active than in "A", mild reversible problems requiring only symptomatic therapy such as antimalarials, NSAIDs, or prednisone less than 20 mg day; BILAG C: Stable mild disease; BILAG D: System previously affected but now inactive; BILAG E: System never involved.

Eligibility Module

Name	Affiliation	Role
Medical Responsible	Merck KGaA, Darmstadt, Germany	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Division of Clinical Immunology and Rheumatology - UAB		Birmingham	Alabama	35249-7201	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37332136	Derived	Pitsiu M, Yalkinoglu O, Farrell C, Girard P, Vazquez-Mateo C, Papasouliotis O. Population pharmacokinetics of atacicept in systemic lupus erythematosus: An analysis of three clinical trials. CPT Pharmacometrics Syst Pharmacol. 2023 Aug;12(8):1157-1169. doi: 10.1002/psp4.12982. Epub 2023 Jun 18.
36532058	Derived

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Atacicept 75 mg	75 milligram (mg) atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
FG001	Atacicept 150 mg

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Atacicept 75 mg	75 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
BG001	Atacicept 150 mg	150 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
BG002	Placebo	Placebo matched to atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
BG003	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants Experiencing a New Flare as Defined by British Isles Lupus Assessment Group (BILAG) Score A or B

A flare was defined as having an adjudicated BILAG A or B score in any of the 8 organ systems during treatment, or imputed for participants who had premature treatment discontinuation. Discontinuations due to sponsor termination of the atacicept 150 mg group were not imputed as flares in this analysis. The BILAG disease activity index evaluates systemic lupus erythematosus (SLE) activity in 8 organ systems, using a separate alphabetic score (A to E) assigned to each organ system defined as follows. BILAG A: Disease sufficiently active requiring disease-modifying treatment (prednisone greater than 20 mg daily or immunosuppressants); BILAG B: Disease less active than in "A", mild reversible problems requiring only symptomatic therapy such as antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), or prednisone less than 20 mg day; BILAG C: Stable mild disease; BILAG D: System previously affected but now inactive; BILAG E: System never involved.

Modified intent-to-treat (MITT) population included all the randomized participants who received study treatment.

Posted

Number

percentage of participants

From screening up to Week 52

ID	Title	Description
OG000	Atacicept 75 mg	75 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
OG001	Atacicept 150 mg	150 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
OG002	Placebo	Placebo matched to atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.

Units	Counts
Participants	OG000157 OG001144 OG002154

Title

Denominators

Categories

Title	Measurements
	OG00057.32 OG00136.11 OG00253.25

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		0.518	Odds ratios were calculated from a logistic regression model adjusted for race and disease severity reported at screening.	Odds Ratio (OR)	1.160			2-Sided	95	0.74	1.82				No	Superiority or Other
OG001 OG002		Regression, Logistic

Secondary

Time to First New Flare as Defined by BILAG Score A or B

A flare was defined as having an adjudicated BILAG A or B score in any of the 8 organ systems during treatment. Analysis was right-censored at Week 52. The hazard ratios and 95% confidence intervals were obtained from the Cox proportional hazards model. The 25th Percentile of time to new flare was reported using Kaplan-Meier estimates (Median was not reached). The BILAG disease activity index evaluates SLE activity in 8 organ systems, using a separate alphabetic score (A to E) assigned to each organ system defined as follows. BILAG A: Disease sufficiently active requiring disease-modifying treatment (prednisone greater than 20 mg daily or immunosuppressants); BILAG B: Disease less active than in "A", mild reversible problems requiring only symptomatic therapy such as antimalarials, NSAIDs, or prednisone less than 20 mg day; BILAG C: Stable mild disease; BILAG D: System previously affected but now inactive; BILAG E: System never involved.

MITT population included all the randomized participants who received study treatment

Posted

Number

95% Confidence Interval

days

From screening up to Week 52

ID	Title	Description
OG000	Atacicept 75 mg	75 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
OG001	Atacicept 150 mg	150 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.

Secondary

Percentage of Participants Experiencing a New Flare as Defined by BILAG Score A or B During Initial 24 Weeks

A flare was defined as having an adjudicated BILAG A or B score in any of the 8 organ systems during treatment, or imputed for participants who had premature treatment discontinuation. The BILAG disease activity index evaluates SLE activity in 8 organ systems, using a separate alphabetic score (A to E) assigned to each organ system defined as follows. BILAG A: Disease sufficiently active requiring disease-modifying treatment (prednisone greater than 20 mg daily or immunosuppressants); BILAG B: Disease less active than in "A", mild reversible problems requiring only symptomatic therapy such as antimalarials, NSAIDs, or prednisone less than 20 mg day; BILAG C: Stable mild disease; BILAG D: System previously affected but now inactive; BILAG E: System never involved.

MITT population included all the randomized participants who received study treatment.

Posted

Number

percentage of participants

From screening up to Week 24

ID	Title	Description
OG000	Atacicept 75 mg	75 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
OG001	Atacicept 150 mg	150 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.

Secondary

Percentage of Participants Within Ordinal Response Categories for British Isles Lupus Assessment Group (BILAG) Flares

Ordinal response categories have been defined as: 1) No BILAG A, no BILAG B, and completed treatment, 2) No BILAG A, at least 1 BILAG B during treatment period, and 3) At least 1 BILAG A during treatment period. The BILAG disease activity index evaluates SLE activity in 8 organ systems, using a separate alphabetic score (A to E) assigned to each organ system defined as follows. BILAG A: Disease sufficiently active requiring disease-modifying treatment (prednisone greater than 20 mg daily or immunosuppressants); BILAG B: Disease less active than in "A", mild reversible problems requiring only symptomatic therapy such as antimalarials, NSAIDs, or prednisone less than 20 mg day; BILAG C: Stable mild disease; BILAG D: System previously affected but now inactive; BILAG E: System never involved.

MITT population included all the randomized participants who received study treatment. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.

Posted

Number

percentage of participants

Week 52

ID	Title	Description
OG000	Atacicept 75 mg	75 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
OG001	Atacicept 150 mg	150 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.

Secondary

Mean Cumulative Corticosteroid Dose

MITT population included all the randomized participants who received study treatment.

Posted

Mean

Standard Deviation

Randomization up to Week 52

ID	Title	Description
OG000	Atacicept 75 mg	75 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
OG001	Atacicept 150 mg	150 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
OG002	Placebo	Placebo matched to atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Atacicept 75 mg	75 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.	30	157	129	157
EG001	Atacicept 150 mg	150 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.	23	144	120	144
EG002	Placebo	Placebo matched to atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.	27	154	118	154

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pneumonia	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0005 affected157 at risk EG0013 affected144 at risk EG0022 affected154 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0002 affected157 at risk EG0012 affected144 at risk EG0020 affected154 at risk
Urinary tract infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected157 at risk EG0010 affected144 at risk EG0022 affected154 at risk
Bronchitis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0002 affected157 at risk EG0010 affected144 at risk EG0020 affected154 at risk
Oral candidiasis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0011 affected144 at risk EG0021 affected154 at risk
Septic shock	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0010 affected144 at risk EG0022 affected154 at risk
Abscess limb	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0011 affected144 at risk EG0020 affected154 at risk
Appendicitis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected157 at risk EG0010 affected144 at risk EG0020 affected154 at risk
Arthritis bacterial	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected157 at risk EG0010 affected144 at risk EG0020 affected154 at risk
Bronchopneumonia	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0010 affected144 at risk EG0021 affected154 at risk
Cellulitis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0010 affected144 at risk EG0021 affected154 at risk
Diarrhoea infectious	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0011 affected144 at risk EG0020 affected154 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected157 at risk EG0010 affected144 at risk EG0020 affected154 at risk
Gastroenteritis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0011 affected144 at risk EG0020 affected154 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0010 affected144 at risk EG0021 affected154 at risk
Herpes zoster	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0010 affected144 at risk EG0021 affected154 at risk
Influenza	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0011 affected144 at risk EG0020 affected154 at risk
Kidney infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected157 at risk EG0010 affected144 at risk EG0020 affected154 at risk
Leptospirosis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0011 affected144 at risk EG0020 affected154 at risk
Lobar pneumonia	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0010 affected144 at risk EG0021 affected154 at risk
Meningitis tuberculous	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0011 affected144 at risk EG0020 affected154 at risk
Mycetoma mycotic	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0011 affected144 at risk EG0020 affected154 at risk
Otitis media acute	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0011 affected144 at risk EG0020 affected154 at risk
Pelvic inflammatory disease	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected157 at risk EG0010 affected144 at risk EG0020 affected154 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected157 at risk EG0010 affected144 at risk EG0020 affected154 at risk
Salpingitis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0011 affected144 at risk EG0020 affected154 at risk
Sepsis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected157 at risk EG0010 affected144 at risk EG0020 affected154 at risk
Urosepsis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0010 affected144 at risk EG0021 affected154 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0010 affected144 at risk EG0021 affected154 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected157 at risk EG0010 affected144 at risk EG0020 affected154 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected157 at risk EG0011 affected144 at risk EG0020 affected154 at risk
Vomiting	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected157 at risk EG0010 affected144 at risk EG0021 affected154 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0010 affected144 at risk EG0021 affected154 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected157 at risk EG0010 affected144 at risk EG0020 affected154 at risk
Nausea	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0010 affected144 at risk EG0021 affected154 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected157 at risk EG0010 affected144 at risk EG0020 affected154 at risk
Periproctitis	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected157 at risk EG0010 affected144 at risk EG0020 affected154 at risk
Peritonitis	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected157 at risk EG0010 affected144 at risk EG0020 affected154 at risk
Vasculitis gastrointestinal	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected157 at risk EG0010 affected144 at risk EG0020 affected154 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0010 affected144 at risk EG0021 affected154 at risk
Chillblains	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0001 affected157 at risk EG0010 affected144 at risk EG0020 affected154 at risk
Fractured sacrum	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0011 affected144 at risk EG0020 affected154 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0010 affected144 at risk EG0021 affected154 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0010 affected144 at risk EG0021 affected154 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0001 affected157 at risk EG0010 affected144 at risk EG0020 affected154 at risk
Ligament rupture	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0011 affected144 at risk EG0020 affected154 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0011 affected144 at risk EG0020 affected154 at risk
Multiple fractures	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0011 affected144 at risk EG0020 affected154 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0011 affected144 at risk EG0020 affected154 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0011 affected144 at risk EG0020 affected154 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0011 affected144 at risk EG0020 affected154 at risk
Myocardial infarction	Cardiac disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected157 at risk EG0010 affected144 at risk EG0022 affected154 at risk
Angina pectoris	Cardiac disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected157 at risk EG0010 affected144 at risk EG0021 affected154 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0010 affected144 at risk EG0021 affected154 at risk
Atrial flutter	Cardiac disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected157 at risk EG0010 affected144 at risk EG0020 affected154 at risk
Coronary artery disease	Cardiac disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected157 at risk EG0010 affected144 at risk EG0020 affected154 at risk
Pericardial effusion	Cardiac disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0010 affected144 at risk EG0021 affected154 at risk
Systemic lupus erythematosus	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0010 affected144 at risk EG0022 affected154 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0010 affected144 at risk EG0021 affected154 at risk
Muscle tightness	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0010 affected144 at risk EG0021 affected154 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected157 at risk EG0010 affected144 at risk EG0020 affected154 at risk
Osteochondrosis	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0010 affected144 at risk EG0021 affected154 at risk
Polymyositis	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0010 affected144 at risk EG0021 affected154 at risk
Headache	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0010 affected144 at risk EG0022 affected154 at risk
Cerebral infarction	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0011 affected144 at risk EG0020 affected154 at risk
Dizziness	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0010 affected144 at risk EG0021 affected154 at risk
Epilepsy	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0011 affected144 at risk EG0020 affected154 at risk
Hemiparesis	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0010 affected144 at risk EG0021 affected154 at risk
Neuropsychiatric lupus	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0010 affected144 at risk EG0021 affected154 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected157 at risk EG0010 affected144 at risk EG0020 affected154 at risk
Autoimmune hepatitis	Hepatobiliary disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0011 affected144 at risk EG0020 affected154 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0011 affected144 at risk EG0020 affected154 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0011 affected144 at risk EG0020 affected154 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected157 at risk EG0010 affected144 at risk EG0020 affected154 at risk
Hepatitis	Hepatobiliary disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0011 affected144 at risk EG0020 affected154 at risk
Benign neoplasm of thyroid gland	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0011 affected144 at risk EG0020 affected154 at risk
Cervix carcinoma stage 0	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Non-systematic Assessment	EG0001 affected157 at risk EG0010 affected144 at risk EG0020 affected154 at risk
Fibroadenoma of breast	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0011 affected144 at risk EG0020 affected154 at risk
Glioblastoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0011 affected144 at risk EG0020 affected154 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0010 affected144 at risk EG0021 affected154 at risk
Pulmonary alveolar haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0012 affected144 at risk EG0020 affected154 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0011 affected144 at risk EG0020 affected154 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected157 at risk EG0010 affected144 at risk EG0020 affected154 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0011 affected144 at risk EG0020 affected154 at risk
Laryngeal oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0010 affected144 at risk EG0021 affected154 at risk
Cervical dysplasia	Reproductive system and breast disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0010 affected144 at risk EG0022 affected154 at risk
Endometrial hyperplasia	Reproductive system and breast disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0010 affected144 at risk EG0021 affected154 at risk
Uterine haemorrhage	Reproductive system and breast disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0010 affected144 at risk EG0021 affected154 at risk
Uterine polyp	Reproductive system and breast disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected157 at risk EG0010 affected144 at risk EG0020 affected154 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0010 affected144 at risk EG0021 affected154 at risk
Hypertension	Vascular disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0010 affected144 at risk EG0021 affected154 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0010 affected144 at risk EG0021 affected154 at risk
Vasculitis	Vascular disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected157 at risk EG0010 affected144 at risk EG0020 affected154 at risk
Asthenia	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0010 affected144 at risk EG0021 affected154 at risk
Injection site reaction	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected157 at risk EG0010 affected144 at risk EG0020 affected154 at risk
Malaise	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected157 at risk EG0010 affected144 at risk EG0020 affected154 at risk
Anaphylactic shock	Immune system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected157 at risk EG0010 affected144 at risk EG0020 affected154 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0010 affected144 at risk EG0021 affected154 at risk
Serum sickness	Immune system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected157 at risk EG0010 affected144 at risk EG0020 affected154 at risk
Biopsy cervix	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected157 at risk EG0010 affected144 at risk EG0020 affected154 at risk
Hepatic enzyme increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0011 affected144 at risk EG0020 affected154 at risk
International normalised ratio increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected157 at risk EG0010 affected144 at risk EG0020 affected154 at risk
Abortion missed	Pregnancy, puerperium and perinatal conditions	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0010 affected144 at risk EG0021 affected154 at risk
Intra-uterine death	Pregnancy, puerperium and perinatal conditions	MedDRA 14.0	Non-systematic Assessment	EG0001 affected157 at risk EG0010 affected144 at risk EG0020 affected154 at risk
Affect lability	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected157 at risk EG0010 affected144 at risk EG0020 affected154 at risk
Anxiety	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0010 affected144 at risk EG0021 affected154 at risk
Lupus nephritis	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0011 affected144 at risk EG0020 affected154 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0011 affected144 at risk EG0020 affected154 at risk
Social stay hospitalisation	Social circumstances	MedDRA 14.0	Non-systematic Assessment	EG0001 affected157 at risk EG0010 affected144 at risk EG0021 affected154 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0011 affected144 at risk EG0020 affected154 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0011 affected144 at risk EG0020 affected154 at risk
Vision blurred	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0010 affected144 at risk EG0021 affected154 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0011 affected144 at risk EG0020 affected154 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0011 affected144 at risk EG0020 affected154 at risk
Skin disorder	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected157 at risk EG0010 affected144 at risk EG0021 affected154 at risk
Hip arthroplasty	Surgical and medical procedures	MedDRA 14.0	Non-systematic Assessment	EG0001 affected157 at risk EG0010 affected144 at risk EG0020 affected154 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Upper respiratory tract infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG00024 affected157 at risk EG00127 affected144 at risk EG00224 affected154 at risk
Urinary tract infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG00022 affected157 at risk EG00123 affected144 at risk EG00217 affected154 at risk
Nasopharyngitis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG00021 affected157 at risk EG00116 affected144 at risk EG00211 affected154 at risk
Bronchitis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG00012 affected157 at risk EG00112 affected144 at risk EG0026 affected154 at risk
Sinusitis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0008 affected157 at risk EG0014 affected144 at risk EG00210 affected154 at risk
Influenza	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0004 affected157 at risk EG0016 affected144 at risk EG0029 affected154 at risk
Injection site reaction	General disorders	MedDRA 14.0	Non-systematic Assessment	EG00016 affected157 at risk EG00122 affected144 at risk EG0023 affected154 at risk
Injection site erythema	General disorders	MedDRA 14.0	Non-systematic Assessment	EG00010 affected157 at risk EG00116 affected144 at risk EG0020 affected154 at risk
Pyrexia	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0008 affected157 at risk EG0015 affected144 at risk EG0024 affected154 at risk
Injection site pruritus	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0004 affected157 at risk EG00110 affected144 at risk EG0020 affected154 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0009 affected157 at risk EG0015 affected144 at risk EG00213 affected154 at risk
Nausea	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG00011 affected157 at risk EG0017 affected144 at risk EG0026 affected154 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0008 affected157 at risk EG0013 affected144 at risk EG0023 affected154 at risk
Headache	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG00031 affected157 at risk EG00117 affected144 at risk EG00223 affected154 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG00014 affected157 at risk EG0015 affected144 at risk EG0028 affected154 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG00010 affected157 at risk EG0017 affected144 at risk EG0028 affected154 at risk
Hypertension	Vascular disorders	MedDRA 14.0	Non-systematic Assessment	EG0008 affected157 at risk EG0015 affected144 at risk EG0028 affected154 at risk
Hypotension	Vascular disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected157 at risk EG0011 affected144 at risk EG0028 affected154 at risk

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