Dose-finding Study of QGE031 as add-on Therapy to Evaluat... | NCT02477332

ID	Type	Description	Link
2014-005559-16	EudraCT Number

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
QGE031 24 mg s.c. q4w	Experimental	ligelizumab 24 mg injection subcutaneous every 4 weeks	Biological: QGE031
QGE031 72 mg s.c. q4w	Experimental	ligelizumab 72 mg injection subcutaneous every 4 weeks	Biological: QGE031
QGE031 240 mg s.c. q4w	Experimental	ligelizumab 240 mg injection subcutaneous every 4 weeks	Biological: QGE031
Omalizumab 300 mg s.c. q4w	Active Comparator	omalizumab 300 mg injection subcutaneous every 4 weeks	Biological: Omalizumab
Placebo s.c. q4w	Placebo Comparator	placebo injection subcutaneous every 4 weeks	Other: Placebo
QGE031 120 mg s.c. s.d.	Experimental	ligelizumab 120 mg injection subcutaneous single dose

Name	Type	Description	Arm Group Labels	Other Names
QGE031	Biological		QGE031 120 mg s.c. s.d. QGE031 24 mg s.c. q4w QGE031 240 mg s.c. q4w QGE031 72 mg s.c. q4w

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Complete Hives Response (HSS7=0)	The primary objective was to establish the dose-response relationship of ligelizumab (24, 72 and 240 mg every 4 weeks) with respect to achievement of complete hives response (HSS7=0) at Week 12 and select an appropriate dose (or range of doses) which is likely to be superior to omalizumab at the highest approved dose (300 mg every 4 weeks). Hives Severity Score (HSS) is on a scale of 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the preceding 7 days, with a possible range of 0 - 21. Hives Severity Score scale: 0 - None - Mild (1-6 hives/12 hours) - Moderate (7-12 hives/12 hours) - Severe (>12 hives/12 hours) To confirm an overall dose-response signal based on MCP-Mod, and to estimate the minimal ligelizumab dose that shows a relevant superior effect over omalizumab, based on the selected dose response model, the lowest ligelizumab dose that provides a response rate 15% higher than the response of omalizumab 300 mg.	Week 12

Secondary Outcomes

Measure	Description	Time Frame
Complete Hives Response (HSS7=0) Rate at Week 12 Measured Over 7 Days	Hives Severity Score (HSS) is on a scale of 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21. Complete hives response defined as HSS7 = 0. Hives Severity Score scale: 0 - None - Mild (1-6 hives/12 hours) - Moderate (7-12 hives/12 hours) - Severe (>12 hives/12 hours)

Eligibility Module

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Birmingham	Alabama	35209	United States
Novartis Investigative Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36440464	Derived	Metz M, Bernstein JA, Gimenez-Arnau AM, Hide M, Maurer M, Sitz K, Soong W, Sussman G, Hua E, Barve A, Barbier N, Balp MM, Severin T. Ligelizumab improves angioedema, disease severity and quality-of-life in patients with chronic spontaneous urticaria. World Allergy Organ J. 2022 Nov 15;15(11):100716. doi: 10.1016/j.waojou.2022.100716. eCollection 2022 Nov.
34773261

Label	URL
A Plain Language Trial Summary is available on novartisclinicatrials.com	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

ID	Title	Description
FG000	QGE031 24 mg s.c. q4w	ligelizumab 24 mg injection subcutaneous every 4 weeks
FG001	QGE031 72 mg s.c. q4w	ligelizumab 72 mg injection subcutaneous every 4 weeks

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	QGE031 24 mg s.c. q4w	ligelizumab 24 mg injection subcutaneous every 4 weeks
BG001	QGE031 72 mg s.c. q4w	ligelizumab 72 mg injection subcutaneous every 4 weeks
BG002	QGE031 240 mg s.c. q4w	ligelizumab 240 mg injection subcutaneous every 4 weeks
BG003	Omalizumab 300 mg s.c. q4w	omalizumab 300 mg injection subcutaneous every 4 weeks
BG004	Placebo s.c. q4w	placebo injection subcutaneous every 4 weeks
BG005	QGE031 120 mg s.c. s.d.	ligelizumab 120 mg injection subcutaneous single dose
BG006	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
	BG00044.1± 14.36 BG00144.3± 12.38 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00031 BG00161 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 With Complete Hives Response (HSS7=0)

The primary objective was to establish the dose-response relationship of ligelizumab (24, 72 and 240 mg every 4 weeks) with respect to achievement of complete hives response (HSS7=0) at Week 12 and select an appropriate dose (or range of doses) which is likely to be superior to omalizumab at the highest approved dose (300 mg every 4 weeks).

Hives Severity Score (HSS) is on a scale of 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the preceding 7 days, with a possible range of 0 - 21.

Hives Severity Score scale:

0 - None

- Mild (1-6 hives/12 hours)
- Moderate (7-12 hives/12 hours)
- Severe (>12 hives/12 hours)

To confirm an overall dose-response signal based on MCP-Mod, and to estimate the minimal ligelizumab dose that shows a relevant superior effect over omalizumab, based on the selected dose response model, the lowest ligelizumab dose that provides a response rate 15% higher than the response of omalizumab 300 mg.

Full analysis set (FAS) included all randomized patients, removing misrandomized patients provided that study drug was not administered.

Posted

Number

95% Confidence Interval

Percentage of participants

Week 12

ID	Title	Description
OG000	QGE031 24 mg s.c. q4w	ligelizumab 24 mg injection subcutaneous every 4 weeks
OG001	QGE031 72 mg s.c. q4w	ligelizumab 72 mg injection subcutaneous every 4 weeks
OG002	QGE031 240 mg s.c. q4w	ligelizumab 240 mg injection subcutaneous every 4 weeks
OG003	Omalizumab 300 mg s.c. q4w	omalizumab 300 mg injection subcutaneous every 4 weeks
OG004	Placebo s.c. q4w	placebo injection subcutaneous every 4 weeks
OG005	QGE031 120 mg s.c. s.d.	ligelizumab 120 mg injection subcutaneous single dose

Units	Counts
Participants	OG00043 OG00184 OG00285 OG003

Title

Denominators

Categories

Title	Measurements
	OG00030.2(17.2 to 46.1) OG00151.2(40.0 to 62.3) OG00242.4(31.7 to 53.6) 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
OG000 OG001 OG002 OG003		Regression, Logistic	Target dose was based on this estimated dose response. The 60% CI included the 20 - 80th percentile of target dose estimated in the bootstrap samples.	<.05		Estimated target dose	32.5			2-Sided	60	27.5	42.5			Min dose with effect size >15%		Superiority

Secondary

Complete Hives Response (HSS7=0) Rate at Week 12 Measured Over 7 Days

Hives Severity Score (HSS) is on a scale of 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21.

Complete hives response defined as HSS7 = 0.

Hives Severity Score scale:

0 - None

- Mild (1-6 hives/12 hours)
- Moderate (7-12 hives/12 hours)
- Severe (>12 hives/12 hours)

Full analysis set (FAS) included all randomized patients, removing misrandomized patients provided that study drug was not administered. As per protocol and SAP, for the efficacy endpoints at Week 12 or Week 20, only the QGE031 24, 72 & 240 mg, omalizumab 300 mg and placebo arms were analyzed for efficacy comparison between treatment groups.

Posted

Number

Particpants

Week 12

ID	Title	Description
OG000	QGE031 24 mg s.c. q4w	ligelizumab 24 mg injection subcutaneous every 4 weeks
OG001	QGE031 72 mg s.c. q4w	ligelizumab 72 mg injection subcutaneous every 4 weeks
OG002	QGE031 240 mg s.c. q4w	ligelizumab 240 mg injection subcutaneous every 4 weeks

Secondary

Change From Baseline in Hives Severity Score (HSS7) at Week 12 Measured Over 7 Days

Hives Severity Score scale:

0 - None

- Mild (1-6 hives/12 hours)
- Moderate (7-12 hives/12 hours)
- Severe (>12 hives/12 hours)

Posted

Median

95% Confidence Interval

Score on a scale

Week 12

ID	Title	Description
OG000	QGE031 24 mg s.c. q4w	ligelizumab 24 mg injection subcutaneous every 4 weeks
OG001	QGE031 72 mg s.c. q4w	ligelizumab 72 mg injection subcutaneous every 4 weeks
OG002	QGE031 240 mg s.c. q4w	ligelizumab 240 mg injection subcutaneous every 4 weeks

Secondary

HSS7=0 Response: at Week 20 Measured Over 7 Days

Complete hives response defined as HSS7 = 0.

Hives Severity Score scale:

0 - None

- Mild (1-6 hives/12 hours)
- Moderate (7-12 hives/12 hours)
- Severe (>12 hives/12 hours)

Posted

Number

Participants

Week 20

ID	Title	Description
OG000	QGE031 24 mg s.c. q4w	ligelizumab 24 mg injection subcutaneous every 4 weeks
OG001	QGE031 72 mg s.c. q4w	ligelizumab 72 mg injection subcutaneous every 4 weeks
OG002	QGE031 240 mg s.c. q4w	ligelizumab 240 mg injection subcutaneous every 4 weeks

Secondary

Change From Baseline in Hives Severity Score (HSS7) at Week 20 Measured Over 7 Days

Hives Severity Score scale:

0 - None

- Mild (1-6 hives/12 hours)
- Moderate (7-12 hives/12 hours)
- Severe (>12 hives/12 hours)

Posted

Median

95% Confidence Interval

Score on a scale

Week 20

ID	Title	Description
OG000	QGE031 24 mg s.c. q4w	ligelizumab 24 mg injection subcutaneous every 4 weeks
OG001	QGE031 72 mg s.c. q4w	ligelizumab 72 mg injection subcutaneous every 4 weeks
OG002	QGE031 240 mg s.c. q4w	ligelizumab 240 mg injection subcutaneous every 4 weeks

Secondary

Change From Baseline in Itch Severity Score (ISS7) at Week 12 Measured Over 7 Days

Itch Severity Score (ISS) is on a scale of 0 to 3. A weekly score (ISS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21.

Itch Severity Score scale:

0 - None

- Mild (minimal awareness, easily tolerated)
- Moderate (definite awareness, bothersome but tolerable)
- Severe (difficult to tolerate)

Posted

Median

95% Confidence Interval

Score on a scale

Week 12

ID	Title	Description
OG000	QGE031 24 mg s.c. q4w	ligelizumab 24 mg injection subcutaneous every 4 weeks
OG001	QGE031 72 mg s.c. q4w	ligelizumab 72 mg injection subcutaneous every 4 weeks
OG002	QGE031 240 mg s.c. q4w	ligelizumab 240 mg injection subcutaneous every 4 weeks

Secondary

Change From Baseline in Itch Severity Score (ISS7) at Week 20 Measured Over 7 Days

Itch Severity Score scale:

0 - None

- Mild (minimal awareness, easily tolerated)
- Moderate (definite awareness, bothersome but tolerable)
- Severe (difficult to tolerate)

Posted

Median

95% Confidence Interval

Score on a scale

Week 20

ID	Title	Description
OG000	QGE031 24 mg s.c. q4w	ligelizumab 24 mg injection subcutaneous every 4 weeks
OG001	QGE031 72 mg s.c. q4w	ligelizumab 72 mg injection subcutaneous every 4 weeks
OG002	QGE031 240 mg s.c. q4w	ligelizumab 240 mg injection subcutaneous every 4 weeks

Secondary

Change From Baseline in Urticaria Activity Score (UAS7) at Week 12 Measured Over 7 Days

UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42.

Posted

Median

95% Confidence Interval

Score on a scale

Week 12

ID	Title	Description
OG000	QGE031 24 mg s.c. q4w	ligelizumab 24 mg injection subcutaneous every 4 weeks
OG001	QGE031 72 mg s.c. q4w	ligelizumab 72 mg injection subcutaneous every 4 weeks
OG002	QGE031 240 mg s.c. q4w	ligelizumab 240 mg injection subcutaneous every 4 weeks
OG003	Omalizumab 300 mg s.c. q4w	omalizumab 300 mg injection subcutaneous every 4 weeks

Secondary

Change From Baseline in Urticaria Activity Score (UAS7) at Week 20 Measured Over 7 Days

UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42.

Posted

Median

95% Confidence Interval

Score on a scale

Week 20

ID	Title	Description
OG000	QGE031 24 mg s.c. q4w	ligelizumab 24 mg injection subcutaneous every 4 weeks
OG001	QGE031 72 mg s.c. q4w	ligelizumab 72 mg injection subcutaneous every 4 weeks
OG002	QGE031 240 mg s.c. q4w	ligelizumab 240 mg injection subcutaneous every 4 weeks
OG003	Omalizumab 300 mg s.c. q4w	omalizumab 300 mg injection subcutaneous every 4 weeks

Secondary

Complete Urticaria Activity Score Response (UAS7=0) Rate at Week 12 Measured Over 7 Days

UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42.

Complete urticaria activity response is defined as UAS7 = 0.

Posted

Number

Participants

Week 12

ID	Title	Description
OG000	QGE031 24 mg s.c. q4w	ligelizumab 24 mg injection subcutaneous every 4 weeks
OG001	QGE031 72 mg s.c. q4w	ligelizumab 72 mg injection subcutaneous every 4 weeks
OG002	QGE031 240 mg s.c. q4w	ligelizumab 240 mg injection subcutaneous every 4 weeks
OG003	Omalizumab 300 mg s.c. q4w

Secondary

UAS7=0 Response: at Week 20 Measured Over 7 Days

UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42.

Complete urticaria activity response is defined as UAS7 = 0.

Posted

Number

participants

Week 20

ID	Title	Description
OG000	QGE031 24 mg s.c. q4w	ligelizumab 24 mg injection subcutaneous every 4 weeks
OG001	QGE031 72 mg s.c. q4w	ligelizumab 72 mg injection subcutaneous every 4 weeks
OG002	QGE031 240 mg s.c. q4w	ligelizumab 240 mg injection subcutaneous every 4 weeks
OG003	Omalizumab 300 mg s.c. q4w	omalizumab 300 mg injection subcutaneous every 4 weeks

Secondary

Complete Itch Response (ISS7=0) Rate at Week 12 Measured Over 7 Days

Complete itch response defined as ISS7 = 0.

Itch Severity Score scale:

0 - None

- Mild (minimal awareness, easily tolerated)
- Moderate (definite awareness, bothersome but tolerable)
- Severe (difficult to tolerate)

Posted

Number

participants

Week 12

ID	Title	Description
OG000	QGE031 24 mg s.c. q4w	ligelizumab 24 mg injection subcutaneous every 4 weeks
OG001	QGE031 72 mg s.c. q4w	ligelizumab 72 mg injection subcutaneous every 4 weeks
OG002	QGE031 240 mg s.c. q4w	ligelizumab 240 mg injection subcutaneous every 4 weeks

Secondary

ISS7=0 Response: at Week 20 Measured Over 7 Days

Complete itch response defined as ISS7 = 0.

Itch Severity Score scale:

0 - None

- Mild (minimal awareness, easily tolerated)
- Moderate (definite awareness, bothersome but tolerable)
- Severe (difficult to tolerate)

Posted

Number

participants

Week 20

ID	Title	Description
OG000	QGE031 24 mg s.c. q4w	ligelizumab 24 mg injection subcutaneous every 4 weeks
OG001	QGE031 72 mg s.c. q4w	ligelizumab 72 mg injection subcutaneous every 4 weeks
OG002	QGE031 240 mg s.c. q4w	ligelizumab 240 mg injection subcutaneous every 4 weeks

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	QGE031 24 mg s.c. q4w	ligelizumab 24 mg injection subcutaneous every 4 weeks	43	3	43	24	43
EG001	QGE031 72 mg s.c. q4w	ligelizumab 72 mg injection subcutaneous every 4 weeks	84	2	84	45	84
EG002	QGE031 240 mg s.c. q4w	ligelizumab 240 mg injection subcutaneous every 4 weeks	85	2	85	46	85
EG003	Omalizumab 300 mg s.c. q4w	omalizumab 300 mg injection subcutaneous every 4 weeks	85	3	85	44	85
EG004	Placebo s.c. q4w	placebo injection subcutaneous every 4 weeks	43	4	43	30	43
EG005	QGE031 120 mg s.c. s.d.	ligelizumab 120 mg injection subcutaneous single dose	42	4	42	28	42

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina pectoris	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected43 at risk EG0010 affected84 at risk EG0020 affected85 at risk EG0030 affected85 at risk EG0041 affected43 at risk EG0050 affected42 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected43 at risk EG0010 affected84 at risk EG0020 affected85 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected43 at risk EG0010 affected84 at risk EG0020 affected85 at risk EG003
Colon dysplasia	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected43 at risk EG0010 affected84 at risk EG0021 affected85 at risk EG003
Diverticular perforation	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected43 at risk EG0010 affected84 at risk EG0020 affected85 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected43 at risk EG0010 affected84 at risk EG0020 affected85 at risk EG003
Large intestine polyp	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected43 at risk EG0010 affected84 at risk EG0021 affected85 at risk EG003
Subileus	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected43 at risk EG0010 affected84 at risk EG0020 affected85 at risk EG003
Chest pain	General disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected43 at risk EG0010 affected84 at risk EG0020 affected85 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected43 at risk EG0010 affected84 at risk EG0020 affected85 at risk EG003
Hepatic cyst	Hepatobiliary disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected43 at risk EG0010 affected84 at risk EG0020 affected85 at risk EG003
Hepatitis acute	Hepatobiliary disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected43 at risk EG0010 affected84 at risk EG0020 affected85 at risk EG003
Diverticulitis	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0001 affected43 at risk EG0010 affected84 at risk EG0020 affected85 at risk EG003
Pilonidal cyst	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0000 affected43 at risk EG0010 affected84 at risk EG0021 affected85 at risk EG003
Pneumonia	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0001 affected43 at risk EG0010 affected84 at risk EG0020 affected85 at risk EG003
Fractured coccyx	Injury, poisoning and procedural complications	MedDRA (20.0)	Systematic Assessment	EG0000 affected43 at risk EG0011 affected84 at risk EG0020 affected85 at risk EG003
Radius fracture	Injury, poisoning and procedural complications	MedDRA (20.0)	Systematic Assessment	EG0000 affected43 at risk EG0010 affected84 at risk EG0020 affected85 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected43 at risk EG0010 affected84 at risk EG0020 affected85 at risk EG003
Sjogren's syndrome	Musculoskeletal and connective tissue disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected43 at risk EG0010 affected84 at risk EG0020 affected85 at risk EG003
Benign lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.0)	Systematic Assessment	EG0000 affected43 at risk EG0010 affected84 at risk EG0020 affected85 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.0)	Systematic Assessment	EG0000 affected43 at risk EG0010 affected84 at risk EG0020 affected85 at risk EG003
Breast neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.0)	Systematic Assessment	EG0000 affected43 at risk EG0011 affected84 at risk EG0020 affected85 at risk EG003
Haemangioma of liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.0)	Systematic Assessment	EG0000 affected43 at risk EG0010 affected84 at risk EG0020 affected85 at risk EG003
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.0)	Systematic Assessment	EG0000 affected43 at risk EG0010 affected84 at risk EG0020 affected85 at risk EG003
Angioedema	Skin and subcutaneous tissue disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected43 at risk EG0010 affected84 at risk EG0020 affected85 at risk EG003
Prurigo	Skin and subcutaneous tissue disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected43 at risk EG0010 affected84 at risk EG0020 affected85 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected43 at risk EG0010 affected84 at risk EG0020 affected85 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0002 affected43 at risk EG0014 affected84 at risk EG0025 affected85 at risk EG0036 affected85 at risk EG0042 affected43 at risk EG0052 affected42 at risk
Gastritis	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected43 at risk EG0010 affected84 at risk EG0020 affected85 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected43 at risk EG0011 affected84 at risk EG0022 affected85 at risk EG003
Injection site erythema	General disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected43 at risk EG0012 affected84 at risk EG0025 affected85 at risk EG003
Injection site reaction	General disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected43 at risk EG0013 affected84 at risk EG0026 affected85 at risk EG003
Bronchitis	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0001 affected43 at risk EG0011 affected84 at risk EG0020 affected85 at risk EG003
Influenza	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0001 affected43 at risk EG0014 affected84 at risk EG0024 affected85 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0007 affected43 at risk EG0017 affected84 at risk EG00210 affected85 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0000 affected43 at risk EG0015 affected84 at risk EG0024 affected85 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0007 affected43 at risk EG00113 affected84 at risk EG00217 affected85 at risk EG003
Blood creatinine increased	Investigations	MedDRA (20.0)	Systematic Assessment	EG0001 affected43 at risk EG0013 affected84 at risk EG0023 affected85 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected43 at risk EG0016 affected84 at risk EG0021 affected85 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected43 at risk EG0011 affected84 at risk EG0020 affected85 at risk EG003
Dizziness	Nervous system disorders	MedDRA (20.0)	Systematic Assessment	EG0002 affected43 at risk EG0015 affected84 at risk EG0022 affected85 at risk EG003
Headache	Nervous system disorders	MedDRA (20.0)	Systematic Assessment	EG0007 affected43 at risk EG0019 affected84 at risk EG0027 affected85 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected43 at risk EG0015 affected84 at risk EG0024 affected85 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected43 at risk EG0019 affected84 at risk EG0023 affected85 at risk EG003
Hypertension	Vascular disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected43 at risk EG0015 affected84 at risk EG0022 affected85 at risk EG003

Ancestor Terms

ID	Term
D017445	Skin Diseases, Vascular
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D000092124	Organizing Pneumonia
D001989	Bronchiolitis Obliterans
D001988	Bronchiolitis
D001991	Bronchitis
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D006086	Graft vs Host Disease

ID	Term
D000080223	Chronic Urticaria
D000092122	Bronchiolitis Obliterans Syndrome
D014581	Urticaria

ID	Term
D000888	Antibodies, Anti-Idiotypic
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D012712	Serum Globulins
D005916	Globulins