Efficacy and Safety of Belimumab in Patients With Active... | NCT01639339

NCT01639339

ID	Type	Description	Link
2011-004570-28	EudraCT Number

Status Module

Name	Class
GlaxoSmithKline	INDUSTRY

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo plus standard therapy	Placebo Comparator	Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and then every 28 days thereafter through Week 100, with a final evaluation at Week 104 in the double-blind period. In the open-label extension period, placebo patients who opt to participate will receive belimumab 10 mg/kg IV every 28 days for an additional 6 months.	Biological: Placebo plus standard therapy Drug: Standard therapy
Belimumab 10 mg/kg plus standard therapy	Experimental	Belimumab 10 mg/kg IV plus standard therapy; belimumab administered on Days 0, 14, 28, and then every 28 days thereafter through Week 100, with a final evaluation at Week 104 in the double-blind period. In the open-label extension period, patients who opt to participate will continue to receive belimumab 10 mg/kg IV every 28 days for an additional 6 months.	Biological: Belimumab 10 mg/kg plus standard therapy Drug: Standard therapy

Name	Type	Description	Arm Group Labels	Other Names
Placebo plus standard therapy	Biological	Placebo plus standard therapy	Placebo plus standard therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Double-blind Period: Percentage of Participants With Primary Efficacy Renal Response (PERR) at Week 104	PERR is defined as urinary protein creatinine ratio <=0.7, estimated glomerular filtration rate (eGRF) was not more than 20 percent (%) below the pre-flare value or >=60 milliliters per minute per 1.73 square meter (mL/min/1.73m^2) and was not a treatment failure. Analysis was performed using a logistic regression model for the comparison between Belimumab and Placebo with covariates treatment group, induction regimen (CYC vs. MMF), race (Black vs. Non-Black), Baseline urine protein-creatinine ratio (uPCR), and Baseline eGFR. Modified Intent-to-treat (mITT) Population consisted of all randomized participants who received at least one dose of study treatment and were not excluded due to Good Clinical Practice (GCP) non-compliance. Percentage of participants with PERR at Week 104 has been presented.	Week 104
Open-label Period: Number of Participants Reporting Adverse Events (AEs) and Serious AEs (SAEs)	An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is any untoward medical occurrence that, at any dose: resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinemia were categorized as SAE. Number of participants with AEs and SAEs have been reported.	From first open-label dose (Day 1) up to open-label Week 32 (8 weeks after last dose)
Open-label Period: Number of Participants Reporting Adverse Events of Special Interest (AESI)	An AESI is one of scientific and medical concern specific to the product, for which ongoing monitoring and rapid communication by investigator to sponsor can be appropriate. A summary of protocol defined AESIs include malignant neoplasms including and excluding non-melanoma skin cancer (NMSC), post-infusion systemic reactions (PISR), all infections of special interest (opportunistic infections [OI], Herpes Zoster [HZ], tuberculosis [TB], and sepsis), depression (including mood disorders and anxiety)/suicide/self-injury and deaths.

Secondary Outcomes

Measure	Description	Time Frame
Double-blind Period: Percentage of Participants With Complete Renal Response (CRR) at Week 104	CRR is defined as urinary protein creatinine ratio <0.5, eGRF was not more than 10% below the pre-flare value or >=90 mL/min/1.73m^2 and was not a treatment failure. Analysis was performed using a logistic regression model for the comparison between Belimumab and Placebo with covariates of induction regimen (CYC vs. MMF), race (Black vs. Non-Black), Baseline uPCR and Baseline eGFR. Percentage of participants with CRR at Week 104 has been presented.

Eligibility Module

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		La Palma	California	90623	United States
GSK Investigational Site

PubMed Identifier	Type	Citation	Retractions
42173278	Derived	Furie R, Anders HJ, Bertsias G, Delgado A, Levy RA, Curtis P, O'Shea C, Tomlinson R, Rovin B. A post hoc analysis of BLISS-LN found Belimumab plus mycophenolate mofetil improves kidney outcomes versus placebo plus mycophenolate mofetil in active lupus nephritis. Kidney Int. 2026 May 21:S0085-2538(26)00397-2. doi: 10.1016/j.kint.2026.03.030. Online ahead of print.
37463054

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo to Belimumab 10 mg/kg	Participants were randomized to receive matching placebo intravenous (IV) plus standard of care (SoC) on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (high dose cortiocsteroids [HDCS] plus Cyclophosphamide [CYC] versus [vs.] HDCS plus Mycophenolate Mofetil [MMF]) and race. After completing the double-blind period, eligible participants that were randomized to placebo IV plus SOC received Belimumab 10 milligram per kilogram (mg/kg) every 28 days until Week 24 with a final evaluation at Week 28 (4 weeks after the last dose) in open-label extension period.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 24, 2019	Jun 16, 2020

Arm/Group Information

ID	Title	Description
BG000	Placebo to Belimumab 10 mg/kg	Participants were randomized to receive matching placebo intravenous (IV) plus standard of care (SoC) on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (high dose cortiocsteroids [HDCS] plus Cyclophosphamide [CYC] versus [vs.] HDCS plus Mycophenolate Mofetil [MMF]) and race. After completing the double-blind period, eligible participants that were randomized to placebo IV plus SOC received Belimumab 10 milligram per kilogram (mg/kg) every 28 days until Week 24 with a final evaluation at Week 28 (4 weeks after the last dose) in open-label extension period.
BG001	Belimumab 10 mg/kg to Belimumab 10	Participants were randomized to receive Belimumab 10 mg/kg IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (HDCS plus CYC vs. HDCS plus MMF) and race. After completing the double-blind period, eligible participants that were randomized to belimumab 10 mg/kg IV plus SOC continued to receive Belimumab 10 mg/kg every 28 days until Week 24 with a final evaluation at Week 28 (4 weeks after the last dose) in open-label extension period.
BG002	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

Double-blind Period: Percentage of Participants With Primary Efficacy Renal Response (PERR) at Week 104

PERR is defined as urinary protein creatinine ratio <=0.7, estimated glomerular filtration rate (eGRF) was not more than 20 percent (%) below the pre-flare value or >=60 milliliters per minute per 1.73 square meter (mL/min/1.73m^2) and was not a treatment failure. Analysis was performed using a logistic regression model for the comparison between Belimumab and Placebo with covariates treatment group, induction regimen (CYC vs. MMF), race (Black vs. Non-Black), Baseline urine protein-creatinine ratio (uPCR), and Baseline eGFR. Modified Intent-to-treat (mITT) Population consisted of all randomized participants who received at least one dose of study treatment and were not excluded due to Good Clinical Practice (GCP) non-compliance. Percentage of participants with PERR at Week 104 has been presented.

mITT Population.

Posted

Number

Percentage of participants

Week 104

ID	Title	Description
OG000	Placebo	Participants were randomized to receive matching placebo IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (high dose cortiocsteroids [HDCS] plus Cyclophosphamide [CYC] versus [vs.] HDCS plus Mycophenolate Mofetil [MMF]) and race.
OG001	Belimumab 10 mg/kg	Participants were randomized to receive Belimumab 10 milligrams per kilogram (mg/kg) IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (HDCS plus CYC vs. HDCS plus MMF) and race.

Units	Counts
Participants	OG000223 OG001223

Title

Denominators

Categories

Title	Measurements
	OG00032.3 OG00143.0

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		0.0311	P-value was calculated using logistic regression model. Test 1 of 5 in a step-down sequential testing procedure.	Odds Ratio (OR)	1.55			2-Sided	95	1.04	2.32			Treatment comparison between Belimumab 10 mg/kg and placebo using odds ratio and its corresponding 95% confidence interval has been presented.		Other

Secondary

Double-blind Period: Percentage of Participants With Complete Renal Response (CRR) at Week 104

CRR is defined as urinary protein creatinine ratio <0.5, eGRF was not more than 10% below the pre-flare value or >=90 mL/min/1.73m^2 and was not a treatment failure. Analysis was performed using a logistic regression model for the comparison between Belimumab and Placebo with covariates of induction regimen (CYC vs. MMF), race (Black vs. Non-Black), Baseline uPCR and Baseline eGFR. Percentage of participants with CRR at Week 104 has been presented.

mITT Population.

Posted

Number

Percentage of participants

Week 104

ID	Title	Description
OG000	Placebo	Participants were randomized to receive matching placebo IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (high dose cortiocsteroids [HDCS] plus Cyclophosphamide [CYC] versus [vs.] HDCS plus Mycophenolate Mofetil [MMF]) and race.
OG001	Belimumab 10 mg/kg	Participants were randomized to receive Belimumab 10 milligrams per kilogram (mg/kg) IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (HDCS plus CYC vs. HDCS plus MMF) and race.

Secondary

Double-blind Period: Percentage of Participants With PERR at Week 52

PERR is defined as urinary protein creatinine ratio <=0.7, eGRF was not more than 20% below the pre-flare value or >=60 mL/min/1.73m^2 and was not a treatment failure. Analysis was performed using a logistic regression model for the comparison between Belimumab and Placebo with covariates of induction regimen (CYC vs. MMF), race (Black vs. Non-Black), uPCR, and Baseline eGFR. Percentage of participants with PERR at Week 52 has been presented.

mITT Population.

Posted

Number

Percentage of participants

Week 52

ID	Title	Description
OG000	Placebo	Participants were randomized to receive matching placebo IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (high dose cortiocsteroids [HDCS] plus Cyclophosphamide [CYC] versus [vs.] HDCS plus Mycophenolate Mofetil [MMF]) and race.
OG001	Belimumab 10 mg/kg	Participants were randomized to receive Belimumab 10 milligrams per kilogram (mg/kg) IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (HDCS plus CYC vs. HDCS plus MMF) and race.

Secondary

Double-blind Period: Number of Participants With Time to Death or Renal Related Event

Events are defined as the first event experienced among the following: death, progression to end stage renal disease, doubling of serum creatinine from Baseline, renal worsening or renal-related treatment failure. Participants who discontinued randomized treatment, withdrew from the study, were lost to follow-up, or had a non renal-related treatment failure were censored. Participants who completed the 104-week treatment period were censored at the Week 104 visit. Time to event is defined as event date minus treatment start date plus one. Analysis was performed using Cox proportional hazards model for the comparison between Belimumab and Placebo adjusting for induction regimen, race, Baseline uPCR and Baseline eGFR. Number of participants with time to death or renal related event up to Week 104 has been presented.

mITT Population.

Posted

Count of Participants

Participants

Up to Week 104

ID	Title	Description
OG000	Placebo	Participants were randomized to receive matching placebo IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (high dose cortiocsteroids [HDCS] plus Cyclophosphamide [CYC] versus [vs.] HDCS plus Mycophenolate Mofetil [MMF]) and race.
OG001	Belimumab 10 mg/kg

Secondary

Double-blind Period: Percentage of Participants With Ordinal Renal Response (ORR) at Week 104

ORR is defined with respect to reproducible responses that included CRR, partial RR (PRR) and non responder. CRR is reported when uPCR was <0.5, eGFR was not more than 10% below pre-flare GFR or within normal range and not a treatment failure. PRR is >=50% decrease from Baseline in uPCR and one of the following: value <1 if Baseline <=3, or value <3 if the Baseline was >3, eGFR not more than 10% below Baseline GFR or within normal range and not a treatment failure and not a CRR. Non responder is reported when neither CRR nor PRR criteria was met. Percentage of participants reporting CRR, PRR and non responders at Week 104 has been presented.

mITT Population.

Posted

Number

Percentage of participants

Week 104

ID	Title	Description
OG000	Placebo	Participants were randomized to receive matching placebo IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (high dose cortiocsteroids [HDCS] plus Cyclophosphamide [CYC] versus [vs.] HDCS plus Mycophenolate Mofetil [MMF]) and race.
OG001	Belimumab 10 mg/kg	Participants were randomized to receive Belimumab 10 milligrams per kilogram (mg/kg) IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (HDCS plus CYC vs. HDCS plus MMF) and race.

Secondary

Double-blind Period: Number of Participants Reporting On-treatment AEs and SAEs

An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is any untoward medical occurrence that, at any dose: resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinemia were categorized as SAE. Number of participants with on-treatment AEs and SAEs has been reported.

Safety Population comprised of all randomized participants who received at least one dose of study treatment.

Posted

Count of Participants

Participants

Up to Week 104

ID	Title	Description
OG000	Placebo	Participants were randomized to receive matching placebo IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (high dose cortiocsteroids [HDCS] plus Cyclophosphamide [CYC] versus [vs.] HDCS plus Mycophenolate Mofetil [MMF]) and race.
OG001	Belimumab 10 mg/kg	Participants were randomized to receive Belimumab 10 milligrams per kilogram (mg/kg) IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (HDCS plus CYC vs. HDCS plus MMF) and race.

Secondary

Double-blind Period: Number of Participants Reporting AESI

An AESI is one of scientific and medical concern specific to the product, for which ongoing monitoring and rapid communication by investigator to sponsor can be appropriate. A summary of protocol defined AESIs include malignant neoplasms including and excluding non-melanoma skin cancer (NMSC), post-infusion systemic reactions (PISR), all infections of special interest (opportunistic infections [OI], Herpes Zoster [HZ], tuberculosis [TB], and sepsis), depression (including mood disorders and anxiety)/suicide/self-injury and deaths. On-treatment data is displayed.

Safety Population.

Posted

Count of Participants

Participants

Up to Week 104

ID	Title	Description
OG000	Placebo	Participants were randomized to receive matching placebo IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (high dose cortiocsteroids [HDCS] plus Cyclophosphamide [CYC] versus [vs.] HDCS plus Mycophenolate Mofetil [MMF]) and race.
OG001	Belimumab 10 mg/kg	Participants were randomized to receive Belimumab 10 milligrams per kilogram (mg/kg) IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (HDCS plus CYC vs. HDCS plus MMF) and race.

Primary

Open-label Period: Number of Participants Reporting Adverse Events (AEs) and Serious AEs (SAEs)

Safety Open-Label Population comprised of all participants who received at least one dose of open-label treatment.

Posted

Count of Participants

Participants

From first open-label dose (Day 1) up to open-label Week 32 (8 weeks after last dose)

ID	Title	Description
OG000	Placebo to Belimumab 10 mg/kg	Participants were randomized to receive matching placebo intravenous (IV) plus standard of care (SoC) on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (high dose cortiocsteroids [HDCS] plus Cyclophosphamide [CYC] versus [vs.] HDCS plus Mycophenolate Mofetil [MMF]) and race. After completing the double-blind period, eligible participants that were randomized to placebo IV plus SOC received Belimumab 10 milligram per kilogram (mg/kg) every 28 days until Week 24 with a final evaluation at Week 28 (4 weeks after the last dose) in open-label extension period.

Primary

Open-label Period: Number of Participants Reporting Adverse Events of Special Interest (AESI)

Safety Open-Label Population.

Posted

Count of Participants

Participants

From first open-label dose (Day 1) up to open-label Week 32 (8 weeks after last dose)

ID	Title	Description
OG000	Placebo to Belimumab 10 mg/kg	Participants were randomized to receive matching placebo intravenous (IV) plus standard of care (SoC) on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (high dose cortiocsteroids [HDCS] plus Cyclophosphamide [CYC] versus [vs.] HDCS plus Mycophenolate Mofetil [MMF]) and race. After completing the double-blind period, eligible participants that were randomized to placebo IV plus SOC received Belimumab 10 milligram per kilogram (mg/kg) every 28 days until Week 24 with a final evaluation at Week 28 (4 weeks after the last dose) in open-label extension period.
OG001

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 were randomized to receive matching placebo IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (high dose cortiocsteroids [HDCS] plus Cyclophosphamide [CYC] versus [vs.] HDCS plus Mycophenolate Mofetil [MMF]) and race.	5	224	78	224	191	224
EG001	Belimumab 10 mg/kg	Participants were randomized to receive Belimumab 10 milligrams per kilogram (mg/kg) IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (HDCS plus CYC vs. HDCS plus MMF) and race.	6	224	65	224	186	224
EG002	Placebo to Belimumab 10 mg/kg	Participants were randomized to receive matching placebo intravenous (IV) plus standard of care (SoC) on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (high dose cortiocsteroids [HDCS] plus Cyclophosphamide [CYC] versus [vs.] HDCS plus Mycophenolate Mofetil [MMF]) and race. After completing the double-blind period, eligible participants that were randomized to placebo IV plus SOC received Belimumab 10 milligram per kilogram (mg/kg) every 28 days until Week 24 with a final evaluation at Week 28 (4 weeks after the last dose) in open-label extension period.	1	123	5	123	34	123
EG003	Belimumab 10 mg/kg to Belimumab 10 mg/kg	Participants were randomized to receive Belimumab 10 mg/kg IV plus SoC on Days 0 (Baseline), 14, 28 and then every 28 days thereafter through 100 Weeks with a final evaluation for the double-blind treatment period at Week 104. The randomization was stratified by their induction regimen (HDCS plus CYC vs. HDCS plus MMF) and race. After completing the double-blind period, eligible participants that were randomized to belimumab 10 mg/kg IV plus SOC continued to receive Belimumab 10 mg/kg every 28 days until Week 24 with a final evaluation at Week 28 (4 weeks after the last dose) in open-label extension period.	0	132	10	132	39	132

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pneumonia	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG00011 events10 affected224 at risk EG00111 events10 affected224 at risk EG0022 events2 affected123 at risk EG0031 events1 affected132 at risk
Herpes zoster	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected224 at risk EG0014 events4 affected224 at risk EG0020 events0 affected123 at risk EG003
Lung infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0004 events4 affected224 at risk EG0012 events2 affected224 at risk EG0020 events0 affected123 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected224 at risk EG0014 events4 affected224 at risk EG0020 events0 affected123 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0005 events5 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Cellulitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0003 events3 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Sepsis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Subcutaneous abscess	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0013 events2 affected224 at risk EG0020 events0 affected123 at risk EG003
Bronchitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Cytomegalovirus colitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Endocarditis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Influenza	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Pulmonary tuberculosis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0012 events2 affected224 at risk EG0020 events0 affected123 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Abscess limb	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Acute sinusitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Appendicitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Arthritis bacterial	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Bacteraemia	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Bone abscess	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Clostridium difficile colitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Cytomegalovirus infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Diverticulitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Enteritis infectious	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Enterocolitis bacterial	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Enterocolitis viral	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Escherichia urinary tract infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Furuncle	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Herpes oesophagitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Large intestine infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Periorbital cellulitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Peritonitis bacterial	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Pneumonia bacterial	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Pneumonia cytomegaloviral	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Pneumonia streptococcal	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Proteus infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Pulmonary nocardiosis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Respiratory syncytial virus bronchitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Rhodococcus infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Septic shock	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Sinusitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Staphylococcal abscess	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Staphylococcal infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Tuberculosis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Urosepsis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Varicella	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Varicella zoster viral infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Viral infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Wound infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Lupus nephritis	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG00010 events8 affected224 at risk EG0012 events2 affected224 at risk EG0020 events0 affected123 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0005 events5 affected224 at risk EG0012 events2 affected224 at risk EG0020 events0 affected123 at risk EG003
End stage renal disease	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Nephrotic syndrome	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0014 events2 affected224 at risk EG0020 events0 affected123 at risk EG003
Renal impairment	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0012 events2 affected224 at risk EG0020 events0 affected123 at risk EG003
Azotaemia	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected224 at risk EG0021 events1 affected123 at risk EG003
Systemic lupus erythematosus	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0004 events4 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Oligoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected224 at risk EG0012 events2 affected224 at risk EG0022 events1 affected123 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0013 events3 affected224 at risk EG0020 events0 affected123 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0012 events2 affected224 at risk EG0021 events1 affected123 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Chronic gastritis	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Enteritis	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Epiploic appendagitis	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Gastrointestinal inflammation	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Impaired gastric emptying	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Large intestine perforation	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Vasculitis gastrointestinal	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0006 events6 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0013 events3 affected224 at risk EG0020 events0 affected123 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Pancytopenia	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0012 events2 affected224 at risk EG0020 events0 affected123 at risk EG003
Bone marrow toxicity	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Hypoglobulinaemia	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Pyrexia	General disorders	MedDRA 22.0	Systematic Assessment	EG0003 events3 affected224 at risk EG0012 events2 affected224 at risk EG0020 events0 affected123 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected224 at risk EG0012 events2 affected224 at risk EG0020 events0 affected123 at risk EG003
Asthenia	General disorders	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Fatigue	General disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Generalised oedema	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0012 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Mucosal inflammation	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Pain	General disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Serositis	General disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Systemic inflammatory response syndrome	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Organizing pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Pneumomediastinum	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Pulmonary alveolar haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Pulmonary arterial hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Cerebral infarction	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Central nervous system lupus	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Encephalopathy	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Epilepsy	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Generalized tonic-clonic seizure	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Haemorrhage intracranial	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Headache	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected224 at risk EG0021 events1 affected123 at risk EG003
Hypertensive encephalopathy	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Metabolic encephalopathy	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Polyneuropathy	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Posterior reversible encephalopathy syndrome	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Seizure	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0002 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Hypertension	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0012 events2 affected224 at risk EG0020 events0 affected123 at risk EG003
Hypotension	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Hypertensive emergency	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Shock haemorrhagic	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Thrombosis	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Pericardial effusion	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0004 events3 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Aortic valve incompetence	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Cardiac failure acute	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Pericarditis	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Pericarditis uraemic	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Skin laceration	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0012 events2 affected224 at risk EG0020 events0 affected123 at risk EG003
Brain herniation	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Head injury	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Joint injury	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Ligament injury	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0012 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Blood creatinine increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Blood immunoglobulin G decreased	Investigations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Foetal biophysical profile score equivocal	Investigations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Hepatic enzyme increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Weight decreased	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Hypophagia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Abortion missed	Pregnancy, puerperium and perinatal conditions	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Foetal death	Pregnancy, puerperium and perinatal conditions	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Prolonged labour	Pregnancy, puerperium and perinatal conditions	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Erythema annulare	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Systemic lupus erythematosus rash	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Immunosuppression	Immune system disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Thymoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Mental status changes	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Suicide attempt	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Hyperparathyroidism	Endocrine disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003
Complicated appendicitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0010 events0 affected224 at risk EG0021 events1 affected123 at risk EG003
Disseminated tuberculosis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Genital infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0010 events0 affected224 at risk EG0021 events1 affected123 at risk EG003
Otitis media	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Pyelonephritis acute	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0010 events0 affected224 at risk EG0021 events1 affected123 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0010 events0 affected224 at risk EG0022 events1 affected123 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Cyclic vomiting syndrome	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0010 events0 affected224 at risk EG0021 events1 affected123 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0010 events0 affected224 at risk EG0021 events1 affected123 at risk EG003
Multiple organ dysfunction syndrome	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0010 events0 affected224 at risk EG0021 events1 affected123 at risk EG003
Unintended pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Cervical dysplasia	Reproductive system and breast disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected224 at risk EG0020 events0 affected123 at risk EG003
Endometriosis	Reproductive system and breast disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected224 at risk EG0020 events0 affected123 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Upper respiratory tract infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG000134 events74 affected224 at risk EG001159 events81 affected224 at risk EG00218 events14 affected123 at risk EG00324 events23 affected132 at risk
Urinary tract infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG00072 events37 affected224 at risk EG00173 events43 affected224 at risk EG00212 events10 affected123 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG00050 events31 affected224 at risk EG00160 events35 affected224 at risk EG0029 events8 affected123 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG00028 events23 affected224 at risk EG00124 events21 affected224 at risk EG0020 events0 affected123 at risk EG003
Bronchitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG00026 events19 affected224 at risk EG00124 events18 affected224 at risk EG0020 events0 affected123 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG00020 events19 affected224 at risk EG00117 events17 affected224 at risk EG0020 events0 affected123 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0005 events5 affected224 at risk EG00113 events13 affected224 at risk EG0020 events0 affected123 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG00056 events48 affected224 at risk EG00159 events45 affected224 at risk EG0020 events0 affected123 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG00033 events24 affected224 at risk EG00128 events21 affected224 at risk EG0020 events0 affected123 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG00021 events16 affected224 at risk EG00125 events16 affected224 at risk EG0020 events0 affected123 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG00013 events13 affected224 at risk EG00115 events12 affected224 at risk EG0020 events0 affected123 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG00018 events15 affected224 at risk EG00110 events9 affected224 at risk EG0020 events0 affected123 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0007 events6 affected224 at risk EG00116 events16 affected224 at risk EG0020 events0 affected123 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG00052 events32 affected224 at risk EG00144 events26 affected224 at risk EG0025 events5 affected123 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG00017 events17 affected224 at risk EG00124 events17 affected224 at risk EG0020 events0 affected123 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG00018 events15 affected224 at risk EG00125 events18 affected224 at risk EG0020 events0 affected123 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0009 events8 affected224 at risk EG00114 events12 affected224 at risk EG0020 events0 affected123 at risk EG003
Headache	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG00057 events35 affected224 at risk EG00151 events34 affected224 at risk EG0020 events0 affected123 at risk EG003
Dizziness	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG00021 events19 affected224 at risk EG00118 events13 affected224 at risk EG0020 events0 affected123 at risk EG003
Oedema peripheral	General disorders	MedDRA 22.0	Systematic Assessment	EG00017 events13 affected224 at risk EG00123 events16 affected224 at risk EG0020 events0 affected123 at risk EG003
Pyrexia	General disorders	MedDRA 22.0	Systematic Assessment	EG00020 events17 affected224 at risk EG00114 events11 affected224 at risk EG0020 events0 affected123 at risk EG003
Fatigue	General disorders	MedDRA 22.0	Systematic Assessment	EG00015 events14 affected224 at risk EG00112 events12 affected224 at risk EG0020 events0 affected123 at risk EG003
Oedema	General disorders	MedDRA 22.0	Systematic Assessment	EG00015 events12 affected224 at risk EG0019 events9 affected224 at risk EG0020 events0 affected123 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG00026 events23 affected224 at risk EG00116 events13 affected224 at risk EG0020 events0 affected123 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG00029 events19 affected224 at risk EG00128 events15 affected224 at risk EG0020 events0 affected123 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG00018 events17 affected224 at risk EG00131 events23 affected224 at risk EG0020 events0 affected123 at risk EG003
Acne	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG00011 events9 affected224 at risk EG00113 events12 affected224 at risk EG0020 events0 affected123 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG00023 events21 affected224 at risk EG00138 events30 affected224 at risk EG0020 events0 affected123 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG00023 events20 affected224 at risk EG00136 events24 affected224 at risk EG0020 events0 affected123 at risk EG003
Hypertension	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG00023 events20 affected224 at risk EG00114 events12 affected224 at risk EG0020 events0 affected123 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG00019 events18 affected224 at risk EG00110 events10 affected224 at risk EG0020 events0 affected123 at risk EG003

ID	Term
D008181	Lupus Nephritis
D008180	Lupus Erythematosus, Systemic
D001327	Autoimmune Diseases
D005921	Glomerulonephritis
D009393	Nephritis
D007674	Kidney Diseases

ID	Term
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
D007154	Immune System Diseases

ID	Term
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation