A Study of LY3471851 in Adults With Systemic Lupus Erythe... | NCT04433585

ID	Type	Description	Link
J1P-MC-KFAJ	Other Identifier	Eli Lilly and Company
2019-003323-38	EudraCT Number

Status Module

Name	Class
Eli Lilly and Company	INDUSTRY

Oversight Module

Description 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
LY3471851 High Dose	Experimental	LY3471851 administered subcutaneously (SC).	Drug: LY3471851
LY3471851 Mid Dose	Experimental	LY3471851 administered SC.	Drug: LY3471851
LY3471851 Low Dose	Experimental	LY3471851 administered SC	Drug: LY3471851
Placebo	Placebo Comparator	Placebo administered SC.	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
LY3471851	Drug	Administered SC	LY3471851 High Dose LY3471851 Low Dose LY3471851 Mid Dose

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants Who Achieved a ≥4 Point Reduction in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) 2000 (2K) Score at Week 24	Percentage of Participants who Achieved a ≥4 Point Reduction in SLEDAI-2K Score at Week 24. A SLEDAI-4 response is defined as a ≥4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score from baseline. The SLEDAI-2K score range is from a minimum of 0 to a maximum of 105 (higher scores represent higher disease activity).	Week 24

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants Who Achieved British Isles Lupus Assessment Group (BILAG) Based Composite Lupus Assessment (BICLA) Response at Week 24.	Percentage of Participants who Achieve BICLA Response at Week 24. The BILAG-based Composite Lupus Assessment (BICLA) is a composite index used to assess disease activity in SLE. A BICLA response is defined as: Reduction of all baseline BILAG-2004 A to B or C or D; and baseline BILAG-2004 B to C or D; and no BILAG-2004 worsening in other organ systems, as defined by ≥1 new BILAG-2004 A or ≥2 new BILAG-2004 B. No worsening from baseline in SLEDAI-2K, where worsening is defined as any increase from baseline in SLEDAI-2K. No worsening from baseline in participants' lupus disease activity, where worsening is defined by an increase ≥0.30 points on a 3-point PGA visual analogue scale (VAS).

Eligibility Module

Name	Affiliation	Role
Study Director	Nektar Therapeutics	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of California - San Diego		La Jolla	California	92037	United States
Desert Medical Advances

Label	URL
A Study of LY3471851 in Adults With Systemic Lupus Erythematosus (SLE) (ISLAND-SLE)	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	LY3471851 High Dose	Participants received a subcutaneous injection of high dose LY3471851 every 2 weeks from weeks 0 to 24.
FG001	LY3471851 Mid Dose	Participants received a subcutaneous injection of mid dose LY3471851 every 2 weeks from weeks 0 to 24.

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	Aug 19, 2020	Mar 27, 2024

Arm/Group Information

ID	Title	Description
BG000	LY3471851 High Dose	Participants received a subcutaneous injection of high dose LY3471851 every 2 weeks from weeks 0 to 24.
BG001	LY3471851 Mid Dose	Participants received a subcutaneous injection of mid dose LY3471851 every 2 weeks from weeks 0 to 24.
BG002	LY3471851 Low Dose	Participants received a subcutaneous injection of low dose LY3471851 every 2 weeks from weeks 0 to 24.
BG003	Placebo	Participants received a subcutaneous injection of placebo dose every 2 weeks from weeks 0 to 24.
BG004	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, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020 BG003

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00040.0± 11.4 BG00141.3± 13.0 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00068 BG00164 BG002

Ethnicity (NIH/OMB)

Ethnicity is based on responses from US sites only.

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0009 BG00111 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0005 BG0017 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

Argentina

Title	Measurements
	BG00013 BG00111 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

Percentage of Participants Who Achieved a ≥4 Point Reduction in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) 2000 (2K) Score at Week 24

Percentage of Participants who Achieved a ≥4 Point Reduction in SLEDAI-2K Score at Week 24. A SLEDAI-4 response is defined as a ≥4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score from baseline. The SLEDAI-2K score range is from a minimum of 0 to a maximum of 105 (higher scores represent higher disease activity).

Modified Intent to Treat (mITT) patient population: All randomized patients with at least one dose of study intervention.

Posted

Count of Participants

Participants

Week 24

ID	Title	Description
OG000	LY3471851 High Dose	Participants received a subcutaneous injection of high dose LY3471851 every 2 weeks from weeks 0 to 24.
OG001	LY3471851 Mid Dose	Participants received a subcutaneous injection of mid dose LY3471851 every 2 weeks from weeks 0 to 24.
OG002	LY3471851 Low Dose	Participants received a subcutaneous injection of low dose LY3471851 every 2 weeks from weeks 0 to 24.
OG003	Placebo	Participants received a subcutaneous injection of placebo every 2 weeks from weeks 0 to 24.

Units	Counts
Participants	OG00073 OG00170 OG00274 OG003

Title

Denominators

Categories

Title	Measurements
	OG00020 OG00127 OG00222 OG003

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
OG001 OG003		Regression, Logistic		0.309		Odds Ratio (OR)	1.46			2-Sided	95	0.70	3.04					Superiority
OG002 OG003		Regression, Logistic		0.944

Secondary

Percentage of Participants Who Achieved British Isles Lupus Assessment Group (BILAG) Based Composite Lupus Assessment (BICLA) Response at Week 24.

Percentage of Participants who Achieve BICLA Response at Week 24. The BILAG-based Composite Lupus Assessment (BICLA) is a composite index used to assess disease activity in SLE. A BICLA response is defined as:

Reduction of all baseline BILAG-2004 A to B or C or D; and baseline BILAG-2004 B to C or D; and no BILAG-2004 worsening in other organ systems, as defined by ≥1 new BILAG-2004 A or ≥2 new BILAG-2004 B.
No worsening from baseline in SLEDAI-2K, where worsening is defined as any increase from baseline in SLEDAI-2K.
No worsening from baseline in participants' lupus disease activity, where worsening is defined by an increase ≥0.30 points on a 3-point PGA visual analogue scale (VAS).

A subset of modified intent-to-treat (mITT) patients with at least 1 BILAG A score or 2 BILAG B scores at Baseline.

Posted

Count of Participants

Participants

Week 24

ID	Title	Description
OG000	LY3471851 High Dose	Participants received a subcutaneous injection of high dose LY3471851 every 2 weeks from weeks 0 to 24.
OG001	LY3471851 Mid Dose	Participants received a subcutaneous injection of mid dose LY3471851 every 2 weeks from weeks 0 to 24.
OG002

Secondary

Percentage of Participants Who Achieved Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response at Week 24

Percentage of Participants who Achieved a SRI-4 Response at Week 24. A SRI-4 response is defined as a decrease in SLEDAI-2K >= 4 from baseline. No new BILAG A and no more than 1 new BILAG B disease activity score / organ domain (both compared with baseline), and no worsening in PGA (defined as an increase of 0.3 points [10 mm] from baseline.

Modified Intent to Treat (mITT) patient population: All randomized patients with at least one dose of study intervention.

Posted

Count of Participants

Participants

Week 24

ID	Title	Description
OG000	LY3471851 High Dose	Participants received a subcutaneous injection of high dose LY3471851 every 2 weeks from weeks 0 to 24.
OG001	LY3471851 Mid Dose	Participants received a subcutaneous injection of mid dose LY3471851 every 2 weeks from weeks 0 to 24.
OG002	LY3471851 Low Dose	Participants received a subcutaneous injection of low dose LY3471851 every 2 weeks from weeks 0 to 24.
OG003

Secondary

Percentage of Participants Who Achieved Lupus Low Disease Activity State (LLDAS) at Week 24

Percentage of Participants who Achieved LLDAS at Week 24. A LLDAS response is defined as a low level of disease activity attained without use of low-dose steroids and/or standard-of-care immunosuppressant medications.

Modified Intent to Treat (mITT) patient population: All randomized patients with at least one dose of study intervention.

Posted

Count of Participants

Participants

Week 24

ID	Title	Description
OG000	LY3471851 High Dose	Participants received a subcutaneous injection of high dose LY3471851 every 2 weeks from weeks 0 to 24.
OG001	LY3471851 Mid Dose	Participants received a subcutaneous injection of mid dose LY3471851 every 2 weeks from weeks 0 to 24.
OG002	LY3471851 Low Dose	Participants received a subcutaneous injection of low dose LY3471851 every 2 weeks from weeks 0 to 24.
OG003	Placebo	Participants received a subcutaneous injection of placebo every 2 weeks from weeks 0 to 24.

Secondary

Pharmacokinetics (PK): Trough Concentrations (Ctrough) of LY3471851

LY3471851 plasma trough concentrations are the concentrations of drug in plasma immediately before the next dose is administered.

PK population at Week 24 is a subset of the mITT population with PK samples collected and available at Week 24.

Posted

Mean

Standard Deviation

ng/mL

Week 24

ID	Title	Description
OG000	LY3471851 High Dose	Participants received a subcutaneous injection of high dose LY3471851 every 2 weeks from weeks 0 to 24.
OG001	LY3471851 Mid Dose	Participants received a subcutaneous injection of mid dose LY3471851 every 2 weeks from weeks 0 to 24.
OG002	LY3471851 Low Dose	Participants received a subcutaneous injection of low dose LY3471851 every 2 weeks from weeks 0 to 24.

Units	Counts
Participants

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	LY3471851 High Dose	LY3471851 administered subcutaneously (SC).	0	73	3	73	54	73
EG001	LY3471851 Mid Dose	LY3471851 administered subcutaneously (SC).	1	70	7	70	48	70
EG002	LY3471851 Low Dose	LY3471851 administered subcutaneously (SC).	0	74	1	74	42	74
EG003	Placebo	Placebo administered subcutaneously (SC).	0	74	5	74	40	74

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
COVID-19	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG0030 affected74 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Gastroenteritis salmonella	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Pneumonia	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Gastric disorder	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Chest pain	General disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Injection site reaction	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Pyrexia	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Systemic lupus erythematosus	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Headache	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Polyneuropathy	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0021 affected74 at risk EG003
Haemoglobin decreased	Investigations	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Cutaneous lupus erythematosus	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
COVID-19	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0003 affected73 at risk EG0018 affected70 at risk EG0024 affected74 at risk EG0035 affected74 at risk
Urinary tract infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0004 affected73 at risk EG0012 affected70 at risk EG0024 affected74 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0014 affected70 at risk EG0023 affected74 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0005 affected73 at risk EG0010 affected70 at risk EG0021 affected74 at risk EG003
Bronchitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0003 affected73 at risk EG0012 affected70 at risk EG0020 affected74 at risk EG003
Influenza	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0002 affected73 at risk EG0010 affected70 at risk EG0021 affected74 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Pharyngitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0002 affected73 at risk EG0010 affected70 at risk EG0021 affected74 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0012 affected70 at risk EG0020 affected74 at risk EG003
Cystitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected70 at risk EG0021 affected74 at risk EG003
Furuncle	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Respiratory tract infection viral	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0012 affected70 at risk EG0020 affected74 at risk EG003
Rhinitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Sinusitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Vaginal infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0022 affected74 at risk EG003
Asymptomatic bacteriuria	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0021 affected74 at risk EG003
Body tinea	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Bronchitis viral	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0021 affected74 at risk EG003
Cellulitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Dengue fever	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0021 affected74 at risk EG003
Escherichia urinary tract infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Fungal infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0021 affected74 at risk EG003
Gingivitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0021 affected74 at risk EG003
Herpes zoster cutaneous disseminated	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0021 affected74 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Otitis externa	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Parasitic gastroenteritis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0021 affected74 at risk EG003
Paronychia	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Pharyngitis bacterial	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Pharyngitis streptococcal	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0021 affected74 at risk EG003
Pharyngotonsillitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Sinusitis bacterial	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0021 affected74 at risk EG003
Skin infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Tonsillitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Tooth infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0021 affected74 at risk EG003
Viral infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Vulvovaginal mycotic infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Pyrexia	General disorders	MedDRA 26.0	Systematic Assessment	EG00011 affected73 at risk EG0017 affected70 at risk EG0023 affected74 at risk EG003
Injection site reaction	General disorders	MedDRA 26.0	Systematic Assessment	EG00012 affected73 at risk EG0015 affected70 at risk EG0022 affected74 at risk EG003
Fatigue	General disorders	MedDRA 26.0	Systematic Assessment	EG0006 affected73 at risk EG0011 affected70 at risk EG0023 affected74 at risk EG003
Pain	General disorders	MedDRA 26.0	Systematic Assessment	EG0002 affected73 at risk EG0014 affected70 at risk EG0021 affected74 at risk EG003
Injection site pruritus	General disorders	MedDRA 26.0	Systematic Assessment	EG0003 affected73 at risk EG0012 affected70 at risk EG0022 affected74 at risk EG003
Asthenia	General disorders	MedDRA 26.0	Systematic Assessment	EG0003 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Injection site erythema	General disorders	MedDRA 26.0	Systematic Assessment	EG0004 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Injection site pain	General disorders	MedDRA 26.0	Systematic Assessment	EG0004 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Injection site rash	General disorders	MedDRA 26.0	Systematic Assessment	EG0002 affected73 at risk EG0013 affected70 at risk EG0020 affected74 at risk EG003
Injection site swelling	General disorders	MedDRA 26.0	Systematic Assessment	EG0002 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Application site erythema	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0012 affected70 at risk EG0020 affected74 at risk EG003
Application site pruritus	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0012 affected70 at risk EG0020 affected74 at risk EG003
Application site reaction	General disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Chest pain	General disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Oedema peripheral	General disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Administration site pain	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Application site inflammation	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Chills	General disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Feeling abnormal	General disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Inflammation	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Influenza like illness	General disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Injection site discolouration	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Injection site erosion	General disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Injection site exfoliation	General disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Injection site hypersensitivity	General disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Injection site oedema	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Localised oedema	General disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Malaise	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Mucosal ulceration	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Sensation of foreign body	General disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Swelling face	General disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0012 affected70 at risk EG0025 affected74 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0002 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0002 affected73 at risk EG0010 affected70 at risk EG0022 affected74 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0011 affected70 at risk EG0021 affected74 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0022 affected74 at risk EG003
Dental caries	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Food poisoning	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0021 affected74 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Oesophagitis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0021 affected74 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Faeces discoloured	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Mouth ulceration	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Oesophageal motility disorder	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0005 affected73 at risk EG0011 affected70 at risk EG0025 affected74 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0002 affected73 at risk EG0011 affected70 at risk EG0021 affected74 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0003 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0021 affected74 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0002 affected73 at risk EG0010 affected70 at risk EG0021 affected74 at risk EG003
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0021 affected74 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0021 affected74 at risk EG003
Systemic lupus erythematosus	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0003 affected73 at risk EG0012 affected70 at risk EG0020 affected74 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0003 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0002 affected73 at risk EG0012 affected70 at risk EG0020 affected74 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0002 affected73 at risk EG0012 affected70 at risk EG0020 affected74 at risk EG003
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0002 affected73 at risk EG0010 affected70 at risk EG0021 affected74 at risk EG003
Pityriasis rosea	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0002 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Dermatosis	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Ingrowing nail	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Miliaria	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Pain of skin	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Skin atrophy	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0021 affected74 at risk EG003
Skin reaction	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0004 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0002 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Heart rate increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected70 at risk EG0021 affected74 at risk EG003
Urine protein/creatinine ratio increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0011 affected70 at risk EG0021 affected74 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0003 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Amylase increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected70 at risk EG0021 affected74 at risk EG003
Blood creatine phosphokinase increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Blood triglycerides increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Eosinophil count increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected70 at risk EG0021 affected74 at risk EG003
Blood iron decreased	Investigations	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Blood uric acid increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Cardiac murmur	Investigations	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Haemoglobin decreased	Investigations	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Neutrophil count decreased	Investigations	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0021 affected74 at risk EG003
SARS-CoV-2 test positive	Investigations	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0021 affected74 at risk EG003
Transaminases increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0021 affected74 at risk EG003
Urinary sediment	Investigations	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
White blood cell count increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Headache	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0002 affected73 at risk EG0011 affected70 at risk EG0023 affected74 at risk EG003
Dizziness	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected70 at risk EG0024 affected74 at risk EG003
Migraine	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0021 affected74 at risk EG003
Cluster headache	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Dysaesthesia	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Hypersomnia	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Memory impairment	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Neuralgia	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Ophthalmic migraine	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Tension headache	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected70 at risk EG0021 affected74 at risk EG003
Limb injury	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Vaccination complication	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0021 affected74 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Muscle strain	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Overdose	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Post procedural complication	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Post procedural oedema	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Soft tissue injury	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Thermal burn	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0004 affected73 at risk EG0012 affected70 at risk EG0020 affected74 at risk EG003
Eosinophilia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected70 at risk EG0021 affected74 at risk EG003
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0021 affected74 at risk EG003
Lymphadenitis	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected70 at risk EG0021 affected74 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected70 at risk EG0021 affected74 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected70 at risk EG0021 affected74 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0021 affected74 at risk EG003
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Nasal dryness	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Nasal obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Throat tightness	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0021 affected74 at risk EG003
Hypertension	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Hypotension	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Hot flush	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Peripheral ischaemia	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0021 affected74 at risk EG003
Raynaud's phenomenon	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Superficial vein thrombosis	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected70 at risk EG0021 affected74 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0021 affected74 at risk EG003
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Iron deficiency	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Depression	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Delusion	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA 26.0	Systematic Assessment	EG0002 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Seasonal allergy	Immune system disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Heavy menstrual bleeding	Reproductive system and breast disorders	MedDRA 26.0	Systematic Assessment	EG0002 affected73 at risk EG0011 affected70 at risk EG0021 affected74 at risk EG003
Intermenstrual bleeding	Reproductive system and breast disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Myopia	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Dry eye	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Erythema of eyelid	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Vision blurred	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Bradycardia	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Bundle branch block right	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Palpitations	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Autoimmune thyroiditis	Endocrine disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected70 at risk EG0020 affected74 at risk EG003
Device dislocation	Product Issues	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0021 affected74 at risk EG003
Tooth extraction	Surgical and medical procedures	MedDRA 26.0	Systematic Assessment	EG0000 affected73 at risk EG0010 affected70 at risk EG0020 affected74 at risk EG003

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