A Study of Laquinimod in Participants With Systemic Lupus... | NCT01085097

NCT01085097

ID	Type	Description	Link
2010-018329-20	EudraCT Number

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Participants will receive 2 capsules of placebo matching to laquinimod orally once daily (QD) for 24 weeks, MMF 500 mg tablet orally twice daily (BID) for the first week then 1 gram (g) BID from Week 2 to Week 28, and MP 500 mg/day intravenously (IV) from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which is tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.	Drug: Mycophenolate Mofetil Drug: Prednisolone/Prednisone Drug: Placebo Drug: Methylprednisolone
Laquinimod 0.5 mg	Experimental	Participants will receive 1 capsule of laquinimod 0.5 mg and 1 capsule of placebo matching to laquinimod orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which is tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.	Drug: Laquinimod Drug: Mycophenolate Mofetil Drug: Prednisolone/Prednisone Drug: Placebo Drug: Methylprednisolone
Laquinimod 1 mg	Experimental	Participants will receive 2 capsules of laquinimod 0.5 mg orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which is tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.	Drug: Laquinimod

Name	Type	Description	Arm Group Labels	Other Names
Laquinimod	Drug	Laquinimod will be administered per dose and schedule specified in the arm description.	Laquinimod 0.5 mg Laquinimod 1 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Adverse Events (AEs)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.	Baseline up to Week 28
Percent Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 24	Estimated Glomerular Filtration Rate (eGFR) was calculated using the Modification of Diet in Renal Disease (MDRD) formula.	Baseline, Week 24

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Teva Medical Expert, M.D.	Teva Branded Pharmaceutical Products R&D, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Teva Investigational Site 1032		Phoenix	Arizona	85012	United States
Teva Investigational Site 1024

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	Participants received 2 capsules of placebo matched to laquinimod orally once daily (QD) for 24 weeks, mycophenolate mofetil (MMF) 500 milligrams (mg) tablet orally twice daily (BID) for the first week then 1 gram (g) BID from Week 2 to Week 28, and methylprednisolone (MP) 500 mg/day intravenously(IV) from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which was tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Drug: Mycophenolate Mofetil

Drug: Prednisolone/Prednisone

Drug: Methylprednisolone

Intent-to-treat (ITT) analysis set included all participants randomly assigned to treatment. In this population, treatment was assigned based on the treatment to which participants were randomly assigned, regardless of which treatment they actually received.

Arm/Group Information

ID	Title	Description
BG000	Placebo	Participants received 2 capsules of placebo matched to laquinimod orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which was tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.
BG001	Laquinimod 0.5 mg	Participants received 1 capsule of laquinimod 0.5 mg and 1 capsule of placebo matched to laquinimod orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which was tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.
BG002	Laquinimod 1 mg	Participants received 2 capsules of laquinimod 0.5 mg orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which was tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00033.4± 10.9 BG00135.3± 11.5 BG00232.7± 9.7 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00011 BG00110 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Asian	BG0002 BG0010 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

Number of Participants With Adverse Events (AEs)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.

Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.

Posted

Number

participants

Baseline up to Week 28

ID	Title	Description
OG000	Placebo	Participants received 2 capsules of placebo matched to laquinimod orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which was tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.
OG001	Laquinimod 0.5 mg	Participants received 1 capsule of laquinimod 0.5 mg and 1 capsule of placebo matched to laquinimod orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which was tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.
OG002	Laquinimod 1 mg	Participants received 2 capsules of laquinimod 0.5 mg orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which was tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.

Units	Counts
Participants	OG00015 OG00116 OG00215

Title

Denominators

Categories

Title	Measurements
	OG00014 OG00115 OG00215

Primary

Percent Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 24

Estimated Glomerular Filtration Rate (eGFR) was calculated using the Modification of Diet in Renal Disease (MDRD) formula.

Modified intent-to-treat (mITT) analysis set included all randomized participants, excluding observations after treatment failure.

Posted

Mean

Standard Deviation

percent change

Baseline, Week 24

ID	Title	Description
OG000	Placebo	Participants received 2 capsules of placebo matched to laquinimod orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which was tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.
OG001	Laquinimod 0.5 mg	Participants received 1 capsule of laquinimod 0.5 mg and 1 capsule of placebo matched to laquinimod orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which was tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.
OG002

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	Participants received 2 capsules of placebo matched to laquinimod orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which was tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.	0	15	4	15	14	15
EG001	Laquinimod 0.5 mg	Participants received 1 capsule of laquinimod 0.5 mg and 1 capsule of placebo matched to laquinimod orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which was tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.	0	16	4	16	13	16
EG002	Laquinimod 1 mg	Participants received 2 capsules of laquinimod 0.5 mg orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which was tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.	1	15	4	15	15	15

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected16 at risk EG0021 events1 affected15 at risk
Disseminated Intravascular Coagulation	Blood and lymphatic system disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected16 at risk EG0021 events1 affected15 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected16 at risk EG0021 events1 affected15 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected16 at risk EG0021 events1 affected15 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected16 at risk EG0021 events1 affected15 at risk
Cardio-Respiratory Arrest	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected16 at risk EG0021 events1 affected15 at risk
Gastroduodenitis	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected16 at risk EG0021 events1 affected15 at risk
Generalised Oedema	General disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected16 at risk EG0020 events0 affected15 at risk
Cellulitis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected16 at risk EG0020 events0 affected15 at risk
Herpes Zoster	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected16 at risk EG0020 events0 affected15 at risk
Pneumonia	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected16 at risk EG0021 events1 affected15 at risk
Sepsis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected16 at risk EG0021 events1 affected15 at risk
Tracheobronchitis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected16 at risk EG0021 events1 affected15 at risk
Fluid Overload	Metabolism and nutrition disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected16 at risk EG0020 events0 affected15 at risk
Systemic Lupus Erythematosus	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0011 events1 affected16 at risk EG0020 events0 affected15 at risk
Abortion Spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected16 at risk EG0021 events1 affected15 at risk
Renal Failure Acute	Renal and urinary disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected16 at risk EG0021 events1 affected15 at risk
Pleuritic Pain	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected16 at risk EG0021 events1 affected15 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected16 at risk EG0020 events0 affected15 at risk
Skin Necrosis	Skin and subcutaneous tissue disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected16 at risk EG0020 events0 affected15 at risk
Deep Vein Thrombosis	Vascular disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0011 events1 affected16 at risk EG0020 events0 affected15 at risk
Thrombophlebitis Superficial	Vascular disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected16 at risk EG0020 events0 affected15 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected16 at risk EG0022 events2 affected15 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected16 at risk EG0020 events0 affected15 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected16 at risk EG0021 events1 affected15 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected16 at risk EG0020 events0 affected15 at risk
Sinus Tachycardia	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected16 at risk EG0022 events2 affected15 at risk
Ear Pain	Ear and labyrinth disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected16 at risk EG0020 events0 affected15 at risk
Middle Ear Effusion	Ear and labyrinth disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected16 at risk EG0021 events1 affected15 at risk
Cushing's Syndrome	Endocrine disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected16 at risk EG0021 events1 affected15 at risk
Conjunctivitis	Eye disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0013 events2 affected16 at risk EG0021 events1 affected15 at risk
Dry Eye	Eye disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected16 at risk EG0020 events0 affected15 at risk
Visual Impairment	Eye disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected16 at risk EG0020 events0 affected15 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected16 at risk EG0020 events0 affected15 at risk
Abdominal Pain Lower	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected16 at risk EG0021 events1 affected15 at risk
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0013 events2 affected16 at risk EG0020 events0 affected15 at risk
Constipation	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected16 at risk EG0022 events2 affected15 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0012 events2 affected16 at risk EG0023 events3 affected15 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected16 at risk EG0021 events1 affected15 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected16 at risk EG0020 events0 affected15 at risk
Flatulence	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected16 at risk EG0021 events1 affected15 at risk
Gastritis	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0011 events1 affected16 at risk EG0020 events0 affected15 at risk
Gastrooesophageal Reflux Disease	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected16 at risk EG0021 events1 affected15 at risk
Gingival Recession	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected16 at risk EG0020 events0 affected15 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected16 at risk EG0021 events1 affected15 at risk
Inguinal Hernia	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected16 at risk EG0020 events0 affected15 at risk
Irritable Bowel Syndrome	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected16 at risk EG0021 events1 affected15 at risk
Nausea	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0003 events3 affected15 at risk EG0012 events2 affected16 at risk EG0022 events2 affected15 at risk
Vomiting	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0002 events2 affected15 at risk EG0012 events2 affected16 at risk EG0020 events0 affected15 at risk
Asthenia	General disorders	MedDRA 15.0	Systematic Assessment	EG0003 events2 affected15 at risk EG0010 events0 affected16 at risk EG0020 events0 affected15 at risk
Chills	General disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected16 at risk EG0020 events0 affected15 at risk
Fatigue	General disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected16 at risk EG0020 events0 affected15 at risk
Generalised Oedema	General disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected16 at risk EG0020 events0 affected15 at risk
Non-Cardiac Chest Pain	General disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected16 at risk EG0021 events1 affected15 at risk
Oedema	General disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0012 events1 affected16 at risk EG0020 events0 affected15 at risk
Oedema Peripheral	General disorders	MedDRA 15.0	Systematic Assessment	EG0006 events4 affected15 at risk EG0012 events2 affected16 at risk EG0022 events2 affected15 at risk
Pyrexia	General disorders	MedDRA 15.0	Systematic Assessment	EG0002 events2 affected15 at risk EG0010 events0 affected16 at risk EG0020 events0 affected15 at risk
Bronchitis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0012 events2 affected16 at risk EG0021 events1 affected15 at risk
Cystitis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected16 at risk EG0020 events0 affected15 at risk
Escherichia Urinary Tract Infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected16 at risk EG0025 events2 affected15 at risk
Folliculitis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected16 at risk EG0020 events0 affected15 at risk
Herpes Zoster	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0003 events2 affected15 at risk EG0010 events0 affected16 at risk EG0023 events3 affected15 at risk
Nasopharyngitis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0011 events1 affected16 at risk EG0021 events1 affected15 at risk
Oral Candidiasis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0002 events1 affected15 at risk EG0010 events0 affected16 at risk EG0020 events0 affected15 at risk
Oral Fungal Infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected16 at risk EG0021 events1 affected15 at risk
Sinusitis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0002 events2 affected15 at risk EG0013 events2 affected16 at risk EG0020 events0 affected15 at risk
Subcutaneous Abscess	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected16 at risk EG0020 events0 affected15 at risk
Tinea Pedis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected16 at risk EG0020 events0 affected15 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0003 events3 affected15 at risk EG0011 events1 affected16 at risk EG0020 events0 affected15 at risk
Urinary Tract Infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0015 events4 affected16 at risk EG0022 events2 affected15 at risk
Urinary Tract Infection Bacterial	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0002 events1 affected15 at risk EG0010 events0 affected16 at risk EG0021 events1 affected15 at risk
Varicella	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected16 at risk EG0021 events1 affected15 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected16 at risk EG0020 events0 affected15 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected16 at risk EG0020 events0 affected15 at risk
Excoriation	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected16 at risk EG0020 events0 affected15 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected16 at risk EG0020 events0 affected15 at risk
Muscle Strain	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected16 at risk EG0021 events1 affected15 at risk
Procedural Pain	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected16 at risk EG0020 events0 affected15 at risk
Bacterial Test Positive	Investigations	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0011 events1 affected16 at risk EG0020 events0 affected15 at risk
Blood Albumin Increased	Investigations	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected16 at risk EG0020 events0 affected15 at risk
Blood Glucose Increased	Investigations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected16 at risk EG0021 events1 affected15 at risk
Blood Urea Increased	Investigations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected16 at risk EG0020 events0 affected15 at risk
C-Reactive Protein Increased	Investigations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected16 at risk EG0021 events1 affected15 at risk
Haemoglobin Decreased	Investigations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected16 at risk EG0021 events1 affected15 at risk
Weight Decreased	Investigations	MedDRA 15.0	Systematic Assessment	EG0002 events2 affected15 at risk EG0013 events3 affected16 at risk EG0020 events0 affected15 at risk
Weight Increased	Investigations	MedDRA 15.0	Systematic Assessment	EG0003 events3 affected15 at risk EG0013 events3 affected16 at risk EG0020 events0 affected15 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected16 at risk EG0021 events1 affected15 at risk
Macroamylasaemia	Metabolism and nutrition disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected16 at risk EG0021 events1 affected15 at risk
Vitamin B12 Deficiency	Metabolism and nutrition disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected16 at risk EG0021 events1 affected15 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0003 events2 affected15 at risk EG0013 events2 affected16 at risk EG0021 events1 affected15 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected16 at risk EG0020 events0 affected15 at risk
Bone Pain	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected16 at risk EG0020 events0 affected15 at risk
Joint Lock	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected16 at risk EG0020 events0 affected15 at risk
Joint Swelling	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected16 at risk EG0021 events1 affected15 at risk
Muscle Spasms	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0004 events3 affected15 at risk EG0015 events3 affected16 at risk EG0021 events1 affected15 at risk
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected16 at risk EG0021 events1 affected15 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0002 events1 affected15 at risk EG0010 events0 affected16 at risk EG0020 events0 affected15 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected16 at risk EG0020 events0 affected15 at risk
Neck Pain	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected16 at risk EG0021 events1 affected15 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected16 at risk EG0020 events0 affected15 at risk
Pain In Extremity	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0013 events2 affected16 at risk EG0020 events0 affected15 at risk
Pain In Jaw	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected16 at risk EG0020 events0 affected15 at risk
Synovial Cyst	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected16 at risk EG0020 events0 affected15 at risk
Systemic Lupus Erythematosus	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected16 at risk EG0020 events0 affected15 at risk
Melanocytic Naevus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Systematic Assessment	EG0002 events1 affected15 at risk EG0010 events0 affected16 at risk EG0020 events0 affected15 at risk
Skin Papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected16 at risk EG0020 events0 affected15 at risk
Ageusia	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected16 at risk EG0020 events0 affected15 at risk
Burning Sensation	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected16 at risk EG0020 events0 affected15 at risk
Dizziness	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0012 events1 affected16 at risk EG0020 events0 affected15 at risk
Headache	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0016 events4 affected16 at risk EG0020 events0 affected15 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected16 at risk EG0021 events1 affected15 at risk
Migraine	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0014 events1 affected16 at risk EG0020 events0 affected15 at risk
Paraesthesia	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected16 at risk EG0020 events0 affected15 at risk
Sinus Headache	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected16 at risk EG0020 events0 affected15 at risk
Tremor	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0011 events1 affected16 at risk EG0020 events0 affected15 at risk
Affect Lability	Psychiatric disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected16 at risk EG0020 events0 affected15 at risk
Anxiety	Psychiatric disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected16 at risk EG0020 events0 affected15 at risk
Depressed Mood	Psychiatric disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected16 at risk EG0020 events0 affected15 at risk
Insomnia	Psychiatric disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0013 events3 affected16 at risk EG0022 events2 affected15 at risk
Dysuria	Renal and urinary disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0013 events1 affected16 at risk EG0020 events0 affected15 at risk
Haematospermia	Reproductive system and breast disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected16 at risk EG0021 events1 affected15 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected16 at risk EG0021 events1 affected15 at risk
Polymenorrhoea	Reproductive system and breast disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected16 at risk EG0020 events0 affected15 at risk
Uterine Haemorrhage	Reproductive system and breast disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected16 at risk EG0020 events0 affected15 at risk
Vaginal Discharge	Reproductive system and breast disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected16 at risk EG0020 events0 affected15 at risk
Vaginal Haemorrhage	Reproductive system and breast disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected16 at risk EG0021 events1 affected15 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0011 events1 affected16 at risk EG0023 events2 affected15 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected16 at risk EG0020 events0 affected15 at risk
Dyspnoea Exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected16 at risk EG0020 events0 affected15 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected16 at risk EG0020 events0 affected15 at risk
Increased Upper Airway Secretion	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected16 at risk EG0021 events1 affected15 at risk
Oropharyngeal Pain	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0002 events2 affected15 at risk EG0010 events0 affected16 at risk EG0020 events0 affected15 at risk
Productive Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected16 at risk EG0020 events0 affected15 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected16 at risk EG0021 events1 affected15 at risk
Rhonchi	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected16 at risk EG0021 events1 affected15 at risk
Sinus Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected16 at risk EG0020 events0 affected15 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 15.0	Systematic Assessment	EG0002 events2 affected15 at risk EG0010 events0 affected16 at risk EG0022 events2 affected15 at risk
Dry Skin	Skin and subcutaneous tissue disorders	MedDRA 15.0	Systematic Assessment	EG0002 events2 affected15 at risk EG0010 events0 affected16 at risk EG0020 events0 affected15 at risk
Intertrigo	Skin and subcutaneous tissue disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected16 at risk EG0021 events1 affected15 at risk
Papule	Skin and subcutaneous tissue disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected16 at risk EG0020 events0 affected15 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 15.0	Systematic Assessment	EG0002 events1 affected15 at risk EG0011 events1 affected16 at risk EG0020 events0 affected15 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 15.0	Systematic Assessment	EG0002 events2 affected15 at risk EG0010 events0 affected16 at risk EG0020 events0 affected15 at risk
Rash Erythematous	Skin and subcutaneous tissue disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected16 at risk EG0020 events0 affected15 at risk
Rash Papular	Skin and subcutaneous tissue disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected16 at risk EG0020 events0 affected15 at risk
Skin Exfoliation	Skin and subcutaneous tissue disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected16 at risk EG0020 events0 affected15 at risk
Skin Ulcer	Skin and subcutaneous tissue disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected16 at risk EG0021 events1 affected15 at risk
Vasectomy	Surgical and medical procedures	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected16 at risk EG0020 events0 affected15 at risk
Flushing	Vascular disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected16 at risk EG0020 events0 affected15 at risk
Hot Flush	Vascular disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected16 at risk EG0020 events0 affected15 at risk
Hypertension	Vascular disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected16 at risk EG0021 events1 affected15 at risk
Hypotension	Vascular disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected16 at risk EG0021 events1 affected15 at risk

ID	Term
D008181	Lupus Nephritis
D008180	Lupus Erythematosus, Systemic

Ancestor Terms

ID	Term
D005921	Glomerulonephritis
D009393	Nephritis
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

ID	Term
C476223	laquinimod
D009173	Mycophenolic Acid
D011239	Prednisolone
D011241	Prednisone
D008775	Methylprednisolone

Ancestor Terms

ID	Term
D002208	Caproates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals
D005227	Fatty Acids
D008055	Lipids
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D011244	Pregnadienediols