Pediatric Arthritis Study of Certolizumab Pegol | NCT01550003

Name	Class
PRA Health Sciences	INDUSTRY

Label	Type	Description	Intervention Names
Certolizumab Pegol	Experimental	Active treatment with Certolizumab Pegol; dose adjustment is based on weight.	Drug: Certolizumab Pegol (CZP)

Name	Type	Description	Arm Group Labels	Other Names
Certolizumab Pegol (CZP)	Drug	CZP will be administered subcutaneously as a fixed dose based on weight every 2 weeks (Q2W) or every 4 weeks (Q4W) throughout the study. CZP will be provided by UCB as a CZP 200 mg/ml solution for single subcutaneous (sc) injection, in a single use prefilled syringe (PFS). Each PFS contains an extractable volume of 0.25 mL, 0.5 mL or 1 mL of CZP solution. Eligible subjects will begin with 3 loading doses of CZP followed by a treatment dose for the duration of the study based on the weight range. Reduced CZP regimen (after implementation of protocol amendments 4 and 5): 10 to < 20 kg: Loading dose = 50 mg Q2W (1 x 0.25 mL sc); treatment dose = 50 mg Q4W (1 x 0.25 mL sc); 20 to < 40 kg: Loading dose = 100 mg Q2W (1 x 0.5 mL sc,); treatment dose = 50 mg Q2W (1 x 0.25 mL sc); ≥ 40 kg: Loading dose = 200 mg Q2W (1 x 1.0 mL sc); treatment dose = 100 mg Q2W (1 x 0.5 mL sc);

Measure	Description	Time Frame
Certolizumab Pegol (CZP) Plasma Concentration Level at Week 16	Certolizumab Pegol (CZP) plasma concentration level was measured in micrograms per milliliter (ug/ml).	Week 16
Certolizumab Pegol (CZP) Plasma Concentration Level at Week 48	Certolizumab Pegol (CZP) plasma concentration level was measured in ug/mL.	Week 48
Number of Participants With Anti-Certolizumab Pegol (Anti-CZP) Antibody Level at Week 16	Number of participants with anti-CZP antibodies were reported.	Week 16
Number of Participants With Anti-Certolizumab Pegol (Anti-CZP) Antibody Level at Week 48	Number of participants with anti-CZP antibodies were reported.	Week 48
Number of Participants With Serious Treatment-emergent Adverse Events (TEAEs) During the Study	A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: results in deaths, is life-threatening, requires in patient hospitalization or prolongation of existing hospitalization, is a congenital anomaly or birth defect and other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above. TEAEs are defined as AEs starting on or after first administration of CZP and up to 70 days after last dose of study medication.	From Baseline (Week 0) up to the Final Visit (70 days after final dose of CZP) (maximum up to 12 years)
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Permanent Withdrawal of the Investigational Medicinal Product (IMP) During the Study

Measure	Description	Time Frame
Percentage of Participants Meeting American College of Rheumatology Pediatric 30 % (PedACR30) Response Criteria at Week 16	PedACR30-at least 30% improvement from baseline in 3 of any 6 core set measures, with no more than 1 of remaining variables worsening by >30%: Number of joints with active arthritis Number of joints with limitation of range of motion Physician's Global Assessment of Disease Activity (using visual analog scale (VAS): 100mm; 0= very good, and 100= very poor) CHAQ (30 questions, 8 domains, scores for each domain are averaged to calculate total score [ 0= no disability to 3= very severe disability]) Parent's Global Assessment of Overall Well-Being (using VAS: 100mm; 0= Very well to 100= Very poor) C-reactive protein (CRP)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Study participant is 2 to 17 years of age (inclusive) at Baseline (Visit 2)
Study participants must weigh ≥10 kg (22lb) at Baseline (Visit 2)
Study participants must have had onset of signs and symptoms consistent with a diagnosis of Juvenile Idiopathic Arthritis (JIA) (according to the International League of Associations for Rheumatology Classification of Juvenile Idiopathic Arthritis, 2001) and initiation of JIA treatment for at least 6 months prior to Baseline (Visit 2). Eligible JIA categories include: polyarthritis rheumatoid factor-positive, polyarthritis rheumatoid factor-negative, extended oligoarthritis, juvenile psoriatic arthritis, and enthesitis-related arthritis (ERA)
Study participants must have active polyarticular-course disease, defined as ≥5 joints with active arthritis at Screening and at Baseline
Study participants must have had an inadequate response to, or intolerance to, at least 1 disease-modifying antirheumatic drug (DMARD) (nonbiologic or biologic). For example, study participant had prior inadequate response to methotrexate (MTX) (based on the Investigator's clinical judgment)
If the study participant is using MTX, then the study participant must have been on MTX for a minimum of 3 months at Screening. In addition, the dose must have been stable for at least 1 month before Screening at ≥10 to ≤15 mg/m^2 per week. If the study participant is not using MTX, then the treatment must have been previously withdrawn for documented reasons of intolerability or inadequate response
If the study participant is using oral corticosteroid therapy, the dose must have been stable for at least 7 days prior to the Baseline arthritis assessment at a maximum dose of 10 mg or 0.2 mg/kg prednisone (or equivalent) per day, whichever is the smaller dose

Exclusion Criteria:

Study participant has previously been exposed to more than 2 biologic agents
Study participant previously failed to respond to treatment with more than one tumor necrosis factor alpha (TNFα) antagonist drug
Study participant is currently receiving or has received any experimental (biological or nonbiological) therapy (within or outside a clinical study) in the 3 months or 5 half-lives prior to Baseline (Visit 2), whichever is longer
Study participant had previous treatment with a biological therapy for juvenile idiopathic arthritis (JIA) that resulted in a severe hypersensitivity reaction or an anaphylactic reaction
Study participant previously participated in this study or has previously been treated with CZP (whether in a study or not)
Study participant has a history of systemic JIA, with or without systemic features
Study participant has a secondary, noninflammatory type of rheumatic disease or of joint pains (eg, fibromyalgia) that in the Investigator's opinion is symptomatic enough to interfere with evaluation of the effect of study medication
Study participant has other inflammatory arthritis (eg, systemic lupus erythematosus, inflammatory bowel disease-related)
Study participant has active uveitis or a history of active uveitis within the preceding 6 months
Study participant has current, chronic or recurrent clinically significant infections
Study participant has a current sign or symptom which may indicate infection (eg, fever, cough), a history of chronic or recurrent infections within the same organ system (more than 3 episodes requiring antibiotics/antivirals during the 12 months prior to Screening [Visit 1]), had a recent (within the 6 months prior to Screening [Visit 1]) serious or life-threatening infection (including herpes zoster), or is at a high risk of infection in the Investigator's opinion (eg, study participants with leg ulcers, indwelling urinary catheter, and persistent or recurrent chest infections or permanently bed-ridden or wheelchair bound)

Name	Affiliation	Role
UCB Cares	001 844 599 2273 (UCB)	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Ra0043 71		Little Rock	Arkansas	72202	United States
Ra0043 79

ID	Title	Description
FG000	Any CZP Dose - Weight Group: 10 - < 20 kg	Participants received Certolizumab Pegol (CZP) subcutaneously (sc) as a fixed dose based on their body weight every 2 weeks (Q2W) or every 4 weeks (Q4W) throughout the study. Participants started with 3 loading doses of CZP at Weeks 0, 2, and 4 followed by a maintenance dose for the duration of the study (maximum up to 12 years).

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Apr 27, 2020	Sep 26, 2024

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

Certolizumab Pegol (CZP) Plasma Concentration Level at Week 16

Certolizumab Pegol (CZP) plasma concentration level was measured in micrograms per milliliter (ug/ml).

The Pharmacokinetic Per-Protocol (PK-PP) Set was a subset of the SS consisting of those study participants who took at least 1 dose of study medication, provided measurable plasma CZP concentration samples (with recorded sampling date/time or for which date/time can be reasonably assumed). Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Posted

Geometric Mean

95% Confidence Interval

ug/ml

Week 16

ID	Title	Description
OG000	Reduced CZP Dose -Weight Group: 10 - <20 kg	Participants received CZP 50 milligrams (mg) sc Q2W at Weeks 0, 2, and 4 (loading dose) followed by CZP 50 mg sc Q4W (maintenance dose) from Week 8 onwards.
OG001	Reduced CZP Dose - Weight Group: 20 - <40 kg	Participants received CZP 100 mg sc Q2W at Weeks 0, 2, and 4 (loading dose) followed by CZP 50 mg sc Q2W (maintenance dose) from Week 6 onwards.
OG002	Reduced CZP Dose - Weight Group: >=40 kg	Participants received CZP 200 mg sc Q2W at Weeks 0, 2, and 4 (loading dose) followed by CZP 100 mg sc Q2W (maintenance dose) from Week 6 onwards.
OG003	Original CZP Dose - Weight Group: 10 - <20 kg	Participants received CZP 100 mg sc Q2W at Weeks 0, 2, and 4 (loading dose) followed by CZP 50 mg sc Q2W (maintenance dose) from Week 6 onwards.
OG004	Original CZP Dose - Weight Group: 20 - <40 kg	Participants received CZP 200 mg sc Q2W at Weeks 0, 2, and 4 (loading dose) followed by CZP 100 mg sc Q2W (maintenance dose) from Week 6 onwards.
OG005	Original CZP Dose - Weight Group: >=40 kg	Participants received CZP 400 mg sc Q2W at Weeks 0, 2, and 4 (loading dose) followed by CZP 200 mg sc Q2W (maintenance dose) from Week 6 onwards.

Units	Counts
Participants	OG00010 OG00124 OG00236 OG003

Title

Denominators

Categories

Title	Measurements
	OG0001.6166(0.4720 to 5.5368) OG0019.2277(5.1453 to 16.5491) OG00213.8928(11.0030 to 17.5416)

Primary

Certolizumab Pegol (CZP) Plasma Concentration Level at Week 48

Certolizumab Pegol (CZP) plasma concentration level was measured in ug/mL.

Posted

Geometric Mean

95% Confidence Interval

ug/ml

Week 48

ID	Title	Description
OG000	Reduced CZP Dose -Weight Group: 10 - <20 kg	Participants received CZP 50 milligrams (mg) sc Q2W at Weeks 0, 2, and 4 (loading dose) followed by CZP 50 mg sc Q4W (maintenance dose) from Week 8 onwards.
OG001	Reduced CZP Dose - Weight Group: 20 - <40 kg	Participants received CZP 100 mg sc Q2W at Weeks 0, 2, and 4 (loading dose) followed by CZP 50 mg sc Q2W (maintenance dose) from Week 6 onwards.
OG002	Reduced CZP Dose - Weight Group: >=40 kg	Participants received CZP 200 mg sc Q2W at Weeks 0, 2, and 4 (loading dose) followed by CZP 100 mg sc Q2W (maintenance dose) from Week 6 onwards.

Primary

Number of Participants With Anti-Certolizumab Pegol (Anti-CZP) Antibody Level at Week 16

Number of participants with anti-CZP antibodies were reported.

Safety Set (SS) consisted of all study participants in the Enrolled Set (ES) who have received at least 1 dose of study medication. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Posted

Count of Participants

Participants

Week 16

ID	Title	Description
OG000	Reduced CZP Dose	Participants received reduced CZP sc as a fixed dose based on their body weight Q2W or Q4W throughout the study. Participants started with 3 loading doses of CZP at Weeks 0, 2, and 4 followed by a maintenance dose for the duration of the study.
OG001	Original CZP Dose	Participants received original CZP sc as a fixed dose based on their body weight Q2W throughout the study. Participants started with 3 loading doses of CZP at Weeks 0, 2, and 4 followed by a maintenance dose for the duration of the study.

Units	Counts
Participants

Primary

Number of Participants With Anti-Certolizumab Pegol (Anti-CZP) Antibody Level at Week 48

Number of participants with anti-CZP antibodies were reported.

Posted

Count of Participants

Participants

Week 48

ID	Title	Description
OG000	Reduced CZP Dose	Participants received reduced CZP sc as a fixed dose based on their body weight Q2W or Q4W throughout the study. Participants started with 3 loading doses of CZP at Weeks 0, 2, and 4 followed by a maintenance dose for the duration of the study.
OG001	Original CZP Dose	Participants received original CZP sc as a fixed dose based on their body weight Q2W throughout the study. Participants started with 3 loading doses of CZP at Weeks 0, 2, and 4 followed by a maintenance dose for the duration of the study.

Units	Counts
Participants

Primary

Number of Participants With Serious Treatment-emergent Adverse Events (TEAEs) During the Study

A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: results in deaths, is life-threatening, requires in patient hospitalization or prolongation of existing hospitalization, is a congenital anomaly or birth defect and other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above. TEAEs are defined as AEs starting on or after first administration of CZP and up to 70 days after last dose of study medication.

Safety Set (SS) consisted of all study participants in the Enrolled Set (ES) who have received at least 1 dose of study medication.

Posted

Count of Participants

Participants

From Baseline (Week 0) up to the Final Visit (70 days after final dose of CZP) (maximum up to 12 years)

ID	Title	Description
OG000	Any CZP Dose - Weight Group: 10 - <20 kg	Participants received CZP sc as a fixed dose based on their body weight Q2W or Q4W throughout the study. Participants started with 3 loading doses of CZP at Weeks 0, 2, and 4 followed by a maintenance dose for the duration of the study.
OG001	Any CZP Dose - Weight Group: 20 - <40 kg	Participants received CZP sc as a fixed dose based on their body weight Q2W throughout the study. Participants started with 3 loading doses of CZP at Weeks 0, 2, and 4 followed by a maintenance dose for the duration of the study.

Primary

Number of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Permanent Withdrawal of the Investigational Medicinal Product (IMP) During the Study

An AE is any untoward medical occurrence in a patient or clinical investigation study participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP. TEAEs are defined as AEs starting on or after first administration of CZP and up to 70 days after last dose of study medication. TEAEs leading to permanent withdrawal of the IMP during the study were reported in this outcome measure.

Safety Set (SS) consisted of all study participants in the Enrolled Set (ES) who have received at least 1 dose of study medication.

Posted

Count of Participants

Participants

From Baseline (Week 0) up to the Final Visit (70 days after final dose of CZP) (maximum up to 12 years)

ID	Title	Description
OG000	Any CZP Dose - Weight Group: 10 - <20 kg	Participants received CZP sc as a fixed dose based on their body weight Q2W or Q4W throughout the study. Participants started with 3 loading doses of CZP at Weeks 0, 2, and 4 followed by a maintenance dose for the duration of the study.
OG001	Any CZP Dose - Weight Group: 20 - <40 kg	Participants received CZP sc as a fixed dose based on their body weight Q2W throughout the study. Participants started with 3 loading doses of CZP at Weeks 0, 2, and 4 followed by a maintenance dose for the duration of the study.

Secondary

Percentage of Participants Meeting American College of Rheumatology Pediatric 30 % (PedACR30) Response Criteria at Week 16

PedACR30-at least 30% improvement from baseline in 3 of any 6 core set measures, with no more than 1 of remaining variables worsening by >30%:

Number of joints with active arthritis
Number of joints with limitation of range of motion
Physician's Global Assessment of Disease Activity (using visual analog scale (VAS): 100mm; 0= very good, and 100= very poor)
CHAQ (30 questions, 8 domains, scores for each domain are averaged to calculate total score [ 0= no disability to 3= very severe disability])
Parent's Global Assessment of Overall Well-Being (using VAS: 100mm; 0= Very well to 100= Very poor)
C-reactive protein (CRP)

Full analysis set (FAS): all study participants in SS who have no more than one of 6 core components missing at baseline (count of joints with active arthritis, count of joints with limitation of range of motion, Physician's Global Assessment of Disease Activity score, CHAQ score, Parent's Global Assessment of Overall Well-Being score and CRP result) for calculating PedACR30/50/70/90.

Posted

Number

95% Confidence Interval

percentage of participants

Week 16

ID	Title	Description
OG000	Any CZP Dose - Weight Group: 10 - <20 kg	Participants received CZP sc as a fixed dose based on their body weight Q2W or Q4W throughout the study. Participants started with 3 loading doses of CZP at Weeks 0, 2, and 4 followed by a maintenance dose for the duration of the study.
OG001	Any CZP Dose - Weight Group: 20 - <40 kg

Secondary

Percentage of Participants Meeting American College of Rheumatology Pediatric 50 % (PedACR50) Response Criteria at Week 16

PedACR50- at least 50% improvement from baseline in 3 of any 6 core set measures, with no more than 1 of remaining variables worsening by >30%:

Number of joints with active arthritis
Number of joints with limitation of range of motion
Physician's Global Assessment (PGA) of Disease Activity (using VAS: 100mm; 0= very good, and 100= very poor)
Childhood Health Assessment Questionnaire (CHAQ) (30 questions, 8 domains, scores for each domain are averaged to calculate total score [ 0= no disability to 3= very severe disability])
Parent's Global Assessment of Overall Well-Being (using VAS: 100mm; 0= Very well to 100= Very poor)
CRP

FAS:all study participants in SS who have no more than one of 6 core components missing at baseline (count of joints with active arthritis, count of joints with limitation of range of motion, PGA of Disease Activity score, CHAQ score, Parent's Global Assessment of Overall Well-Being score and CRP result) for calculating PedACR30/50/70/90.

Posted

Number

95% Confidence Interval

percentage of participants

Week 16

ID	Title	Description
OG000	Any CZP Dose - Weight Group: 10 - <20 kg	Participants received CZP sc as a fixed dose based on their body weight Q2W or Q4W throughout the study. Participants started with 3 loading doses of CZP at Weeks 0, 2, and 4 followed by a maintenance dose for the duration of the study.
OG001	Any CZP Dose - Weight Group: 20 - <40 kg

Secondary

Percentage of Participants Meeting American College of Rheumatology Pediatric 70 % (PedACR70) Response Criteria at Week 16

PedACR70- at least 70% improvement from baseline in 3 of any 6 following core set measures, with no more than 1 of remaining variables worsening by >30%:

Number of joints with active arthritis
Number of joints with limitation of range of motion
Physician's Global Assessment of Disease Activity (using VAS: 100mm; 0= very good, and 100= very poor)
CHAQ (30 questions, 8 domains, scores for each domain are averaged to calculate total score [ 0= no disability to 3= very severe disability])
Parent's Global Assessment of Overall Well-Being (using VAS: 100mm; 0= Very well to 100= Very poor)
CRP

FAS consisted of all study participants in SS who have no more than one of 6 core components missing at baseline (count of joints with active arthritis, count of joints with limitation of range of motion, Physician's Global Assessment of Disease Activity score, CHAQ score, Parent's Global Assessment of Overall Well-Being score and CRP result) for calculating PedACR30/50/70/90.

Posted

Number

95% Confidence Interval

percentage of participants

Week 16

ID	Title	Description
OG000	Any CZP Dose - Weight Group: 10 - <20 kg	Participants received CZP sc as a fixed dose based on their body weight Q2W or Q4W throughout the study. Participants started with 3 loading doses of CZP at Weeks 0, 2, and 4 followed by a maintenance dose for the duration of the study.
OG001	Any CZP Dose - Weight Group: 20 - <40 kg

Secondary

Percentage of Participants Meeting American College of Rheumatology Pediatric 90 % (PedACR90) Response Criteria at Week 16

PedACR90- at least 90% improvement from baseline in 3 of any 6 following core set measures, with no more than 1 of remaining variables worsening by >30%:

Number of joints with active arthritis
Number of joints with limitation of range of motion
Physician's Global Assessment of Disease Activity (using VAS: 100mm; 0= very good, and 100= very poor)
CHAQ (30 questions, 8 domains, scores for each domain are averaged to calculate total score [ 0= no disability to 3= very severe disability])
Parent's Global Assessment of Overall Well-Being (using VAS: 100mm; 0= Very well to 100= Very poor)
CRP

Posted

Number

95% Confidence Interval

percentage of participants

Week 16

ID	Title	Description
OG000	Any CZP Dose - Weight Group: 10 - <20 kg	Participants received CZP sc as a fixed dose based on their body weight Q2W or Q4W throughout the study. Participants started with 3 loading doses of CZP at Weeks 0, 2, and 4 followed by a maintenance dose for the duration of the study.
OG001	Any CZP Dose - Weight Group: 20 - <40 kg

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected63 at risk EG0022 events2 affected112 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected63 at risk EG0020 events0 affected112 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected63 at risk EG0021 events1 affected112 at risk
Adrenal suppression	Endocrine disorders	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected63 at risk EG0021 events1 affected112 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected63 at risk EG0021 events1 affected112 at risk
Vomiting	Gastrointestinal disorders	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected63 at risk EG0021 events1 affected112 at risk
Crohn's disease	Gastrointestinal disorders	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected63 at risk EG0020 events0 affected112 at risk
Dysphagia	Gastrointestinal disorders	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected63 at risk EG0021 events1 affected112 at risk
Gastrointestinal motility disorder	Gastrointestinal disorders	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected63 at risk EG0020 events0 affected112 at risk
Ileus	Gastrointestinal disorders	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected63 at risk EG0020 events0 affected112 at risk
Inflammatory bowel disease	Gastrointestinal disorders	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected63 at risk EG0021 events1 affected112 at risk
Pyrexia	General disorders	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected63 at risk EG0021 events1 affected112 at risk
Pain	General disorders	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected63 at risk EG0020 events0 affected112 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected63 at risk EG0020 events0 affected112 at risk
Drug hypersensitivity	Immune system disorders	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected63 at risk EG0020 events0 affected112 at risk
Pneumonia	Infections and infestations	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0015 events5 affected63 at risk EG0022 events2 affected112 at risk
Sepsis	Infections and infestations	MedDRA v23.1	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0011 events1 affected63 at risk EG0020 events0 affected112 at risk
Appendicitis	Infections and infestations	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected63 at risk EG0020 events0 affected112 at risk
Appendicitis perforated	Infections and infestations	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected63 at risk EG0020 events0 affected112 at risk
Breast abscess	Infections and infestations	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected63 at risk EG0020 events0 affected112 at risk
Disseminated tuberculosis	Infections and infestations	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected63 at risk EG0021 events1 affected112 at risk
Gastroenteritis	Infections and infestations	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected63 at risk EG0021 events1 affected112 at risk
Oesophageal candidiasis	Infections and infestations	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected63 at risk EG0021 events1 affected112 at risk
Pharyngitis	Infections and infestations	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected63 at risk EG0021 events1 affected112 at risk
Pilonidal cyst	Infections and infestations	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected63 at risk EG0021 events1 affected112 at risk
Pneumonia fungal	Infections and infestations	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected63 at risk EG0020 events0 affected112 at risk
Pyelonephritis acute	Infections and infestations	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected63 at risk EG0021 events1 affected112 at risk
Septic shock	Infections and infestations	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected63 at risk EG0021 events1 affected112 at risk
Serratia bacteraemia	Infections and infestations	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected63 at risk EG0021 events1 affected112 at risk
Tuberculosis	Infections and infestations	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected63 at risk EG0020 events0 affected112 at risk
Tuberculosis liver	Infections and infestations	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected63 at risk EG0022 events1 affected112 at risk
Varicella	Infections and infestations	MedDRA v23.1	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected63 at risk EG0020 events0 affected112 at risk
Varicella zoster virus infection	Infections and infestations	MedDRA v23.1	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected63 at risk EG0020 events0 affected112 at risk
Viral infection	Infections and infestations	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected63 at risk EG0021 events1 affected112 at risk
Forearm fracture	Injury, poisoning and procedural complications	MedDRA v23.1	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected63 at risk EG0020 events0 affected112 at risk
Jaw fracture	Injury, poisoning and procedural complications	MedDRA v23.1	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected63 at risk EG0020 events0 affected112 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected63 at risk EG0021 events1 affected112 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected63 at risk EG0021 events1 affected112 at risk
Transaminases increased	Investigations	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected63 at risk EG0021 events1 affected112 at risk
Juvenile idiopathic arthritis	Musculoskeletal and connective tissue disorders	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected63 at risk EG0021 events1 affected112 at risk
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected63 at risk EG0021 events1 affected112 at risk
Hair follicle tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected63 at risk EG0021 events1 affected112 at risk
Idiopathic generalised epilepsy	Nervous system disorders	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected63 at risk EG0020 events0 affected112 at risk
Pregnancy on contraceptive	Pregnancy, puerperium and perinatal conditions	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected63 at risk EG0022 events2 affected112 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected63 at risk EG0021 events1 affected112 at risk
Pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected63 at risk EG0020 events0 affected112 at risk
Alcoholism	Psychiatric disorders	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected63 at risk EG0021 events1 affected112 at risk
Anxiety	Psychiatric disorders	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected63 at risk EG0021 events1 affected112 at risk
Drug abuse	Psychiatric disorders	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected63 at risk EG0021 events1 affected112 at risk
Intentional self-injury	Psychiatric disorders	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected63 at risk EG0021 events1 affected112 at risk
Suicidal ideation	Psychiatric disorders	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected63 at risk EG0021 events1 affected112 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected63 at risk EG0020 events0 affected112 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0016 events5 affected63 at risk EG0024 events4 affected112 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA v23.1	Non-systematic Assessment	EG0002 events1 affected18 at risk EG0015 events4 affected63 at risk EG0027 events3 affected112 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA v23.1	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected63 at risk EG0021 events1 affected112 at risk
Lichen spinulosus	Congenital, familial and genetic disorders	MedDRA v23.1	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected63 at risk EG0020 events0 affected112 at risk
Ear pain	Ear and labyrinth disorders	MedDRA v23.1	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0015 events3 affected63 at risk EG0021 events1 affected112 at risk
Middle ear effusion	Ear and labyrinth disorders	MedDRA v23.1	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0011 events1 affected63 at risk EG0021 events1 affected112 at risk
Conjunctivitis allergic	Eye disorders	MedDRA v23.1	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0011 events1 affected63 at risk EG0022 events1 affected112 at risk
Uveitis	Eye disorders	MedDRA v23.1	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0013 events2 affected63 at risk EG0020 events0 affected112 at risk
Iritis	Eye disorders	MedDRA v23.1	Non-systematic Assessment	EG0002 events1 affected18 at risk EG0010 events0 affected63 at risk EG0022 events1 affected112 at risk
Hypermetropia	Eye disorders	MedDRA v23.1	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected63 at risk EG0020 events0 affected112 at risk
Ocular hyperaemia	Eye disorders	MedDRA v23.1	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected63 at risk EG0020 events0 affected112 at risk
Vomiting	Gastrointestinal disorders	MedDRA v23.1	Non-systematic Assessment	EG0003 events3 affected18 at risk EG0018 events6 affected63 at risk EG00222 events14 affected112 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA v23.1	Non-systematic Assessment	EG0004 events3 affected18 at risk EG0015 events5 affected63 at risk EG00214 events13 affected112 at risk
Nausea	Gastrointestinal disorders	MedDRA v23.1	Non-systematic Assessment	EG0002 events1 affected18 at risk EG0015 events3 affected63 at risk EG00219 events13 affected112 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0019 events8 affected63 at risk EG00212 events8 affected112 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0014 events4 affected63 at risk EG0022 events2 affected112 at risk
Stomatitis	Gastrointestinal disorders	MedDRA v23.1	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0012 events1 affected63 at risk EG0024 events4 affected112 at risk
Dental caries	Gastrointestinal disorders	MedDRA v23.1	Non-systematic Assessment	EG0003 events3 affected18 at risk EG0011 events1 affected63 at risk EG0020 events0 affected112 at risk
Retained deciduous tooth	Gastrointestinal disorders	MedDRA v23.1	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected63 at risk EG0020 events0 affected112 at risk
Salivary gland mass	Gastrointestinal disorders	MedDRA v23.1	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected63 at risk EG0020 events0 affected112 at risk
Pyrexia	General disorders	MedDRA v23.1	Non-systematic Assessment	EG0006 events3 affected18 at risk EG00118 events12 affected63 at risk EG00220 events11 affected112 at risk
Injection site pain	General disorders	MedDRA v23.1	Non-systematic Assessment	EG0002 events2 affected18 at risk EG00125 events5 affected63 at risk EG00230 events10 affected112 at risk
Fatigue	General disorders	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0016 events5 affected63 at risk EG00211 events9 affected112 at risk
Injection site reaction	General disorders	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0012 events1 affected63 at risk EG0029 events6 affected112 at risk
Condition aggravated	General disorders	MedDRA v23.1	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0011 events1 affected63 at risk EG0022 events2 affected112 at risk
Cyst	General disorders	MedDRA v23.1	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected63 at risk EG0022 events2 affected112 at risk
Drug intolerance	General disorders	MedDRA v23.1	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected63 at risk EG0022 events2 affected112 at risk
Nasopharyngitis	Infections and infestations	MedDRA v23.1	Non-systematic Assessment	EG0008 events4 affected18 at risk EG00146 events17 affected63 at risk EG00268 events32 affected112 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA v23.1	Non-systematic Assessment	EG00011 events4 affected18 at risk EG00141 events16 affected63 at risk EG00262 events28 affected112 at risk
Respiratory tract infection	Infections and infestations	MedDRA v23.1	Non-systematic Assessment	EG0006 events1 affected18 at risk EG00122 events12 affected63 at risk EG00215 events11 affected112 at risk
Viral infection	Infections and infestations	MedDRA v23.1	Non-systematic Assessment	EG0002 events2 affected18 at risk EG00112 events7 affected63 at risk EG00217 events13 affected112 at risk
Pharyngitis streptococcal	Infections and infestations	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG00116 events10 affected63 at risk EG00218 events9 affected112 at risk
Pharyngitis	Infections and infestations	MedDRA v23.1	Non-systematic Assessment	EG0001 events1 affected18 at risk EG00111 events9 affected63 at risk EG0029 events7 affected112 at risk
Sinusitis	Infections and infestations	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0016 events5 affected63 at risk EG00220 events12 affected112 at risk
Tonsillitis	Infections and infestations	MedDRA v23.1	Non-systematic Assessment	EG0003 events2 affected18 at risk EG0019 events9 affected63 at risk EG00211 events6 affected112 at risk
Influenza	Infections and infestations	MedDRA v23.1	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0018 events5 affected63 at risk EG00216 events10 affected112 at risk
Gastroenteritis	Infections and infestations	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0014 events4 affected63 at risk EG00219 events11 affected112 at risk
Rhinitis	Infections and infestations	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG00112 events8 affected63 at risk EG0029 events7 affected112 at risk
Urinary tract infection	Infections and infestations	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0014 events4 affected63 at risk EG00223 events10 affected112 at risk
Bronchitis	Infections and infestations	MedDRA v23.1	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0016 events6 affected63 at risk EG0026 events6 affected112 at risk
Conjunctivitis	Infections and infestations	MedDRA v23.1	Non-systematic Assessment	EG0002 events2 affected18 at risk EG0013 events3 affected63 at risk EG0027 events7 affected112 at risk
Latent tuberculosis	Infections and infestations	MedDRA v23.1	Non-systematic Assessment	EG0002 events2 affected18 at risk EG0017 events7 affected63 at risk EG0022 events2 affected112 at risk
Ear infection	Infections and infestations	MedDRA v23.1	Non-systematic Assessment	EG0002 events2 affected18 at risk EG0015 events4 affected63 at risk EG0026 events4 affected112 at risk
Varicella	Infections and infestations	MedDRA v23.1	Non-systematic Assessment	EG0004 events4 affected18 at risk EG0014 events4 affected63 at risk EG0020 events0 affected112 at risk
COVID-19	Infections and infestations	MedDRA v23.1	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected63 at risk EG0029 events6 affected112 at risk
Respiratory tract infection viral	Infections and infestations	MedDRA v23.1	Non-systematic Assessment	EG0002 events2 affected18 at risk EG0014 events4 affected63 at risk EG0021 events1 affected112 at risk
Gastroenteritis viral	Infections and infestations	MedDRA v23.1	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0013 events3 affected63 at risk EG0022 events2 affected112 at risk
Impetigo	Infections and infestations	MedDRA v23.1	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0013 events3 affected63 at risk EG0022 events2 affected112 at risk
Viral pharyngitis	Infections and infestations	MedDRA v23.1	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0011 events1 affected63 at risk EG0025 events4 affected112 at risk
Otitis media acute	Infections and infestations	MedDRA v23.1	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0011 events1 affected63 at risk EG0022 events2 affected112 at risk
Bacteriuria	Infections and infestations	MedDRA v23.1	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0012 events1 affected63 at risk EG0021 events1 affected112 at risk
Pneumonia	Infections and infestations	MedDRA v23.1	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0013 events2 affected63 at risk EG0020 events0 affected112 at risk
Viral rash	Infections and infestations	MedDRA v23.1	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0011 events1 affected63 at risk EG0021 events1 affected112 at risk
Tooth infection	Infections and infestations	MedDRA v23.1	Non-systematic Assessment	EG0002 events1 affected18 at risk EG0010 events0 affected63 at risk EG0021 events1 affected112 at risk
Ascariasis	Infections and infestations	MedDRA v23.1	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected63 at risk EG0020 events0 affected112 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0016 events5 affected63 at risk EG00211 events9 affected112 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0014 events3 affected63 at risk EG0027 events6 affected112 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA v23.1	Non-systematic Assessment	EG0002 events2 affected18 at risk EG0010 events0 affected63 at risk EG0023 events3 affected112 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA v23.1	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0012 events1 affected63 at risk EG0025 events2 affected112 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA v23.1	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0018 events5 affected63 at risk EG00212 events10 affected112 at risk
Alanine aminotransferase increased	Investigations	MedDRA v23.1	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0015 events5 affected63 at risk EG00212 events9 affected112 at risk
Aspartate aminotransferase increased	Investigations	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0013 events3 affected63 at risk EG0028 events6 affected112 at risk
C-reactive protein increased	Investigations	MedDRA v23.1	Non-systematic Assessment	EG0002 events2 affected18 at risk EG0012 events1 affected63 at risk EG0026 events6 affected112 at risk
Hepatic enzyme increased	Investigations	MedDRA v23.1	Non-systematic Assessment	EG0002 events2 affected18 at risk EG0011 events1 affected63 at risk EG0027 events6 affected112 at risk
Mycobacterium tuberculosis complex test positive	Investigations	MedDRA v23.1	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0012 events2 affected63 at risk EG0021 events1 affected112 at risk
Blood creatinine increased	Investigations	MedDRA v23.1	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0011 events1 affected63 at risk EG0020 events0 affected112 at risk
Transaminases increased	Investigations	MedDRA v23.1	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected63 at risk EG0021 events1 affected112 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA v23.1	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected63 at risk EG0020 events0 affected112 at risk
Juvenile idiopathic arthritis	Musculoskeletal and connective tissue disorders	MedDRA v23.1	Non-systematic Assessment	EG0003 events3 affected18 at risk EG00119 events12 affected63 at risk EG00237 events20 affected112 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA v23.1	Non-systematic Assessment	EG0002 events2 affected18 at risk EG00111 events6 affected63 at risk EG00217 events10 affected112 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0016 events4 affected63 at risk EG00213 events10 affected112 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0013 events2 affected63 at risk EG0027 events6 affected112 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA v23.1	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected63 at risk EG0025 events5 affected112 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA v23.1	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected63 at risk EG0026 events4 affected112 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA v23.1	Non-systematic Assessment	EG0002 events1 affected18 at risk EG0011 events1 affected63 at risk EG0022 events2 affected112 at risk
Headache	Nervous system disorders	MedDRA v23.1	Non-systematic Assessment	EG0002 events2 affected18 at risk EG00116 events7 affected63 at risk EG00256 events30 affected112 at risk
Migraine	Nervous system disorders	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected63 at risk EG0029 events6 affected112 at risk
Depression	Psychiatric disorders	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0012 events2 affected63 at risk EG00211 events8 affected112 at risk
Anxiety	Psychiatric disorders	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0012 events2 affected63 at risk EG0027 events7 affected112 at risk
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA v23.1	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0013 events1 affected63 at risk EG0026 events3 affected112 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA v23.1	Non-systematic Assessment	EG0002 events2 affected18 at risk EG00116 events10 affected63 at risk EG00221 events11 affected112 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG00112 events6 affected63 at risk EG00219 events15 affected112 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA v23.1	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0018 events6 affected63 at risk EG00212 events6 affected112 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA v23.1	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0014 events4 affected63 at risk EG00218 events7 affected112 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA v23.1	Non-systematic Assessment	EG0002 events2 affected18 at risk EG0014 events2 affected63 at risk EG0022 events2 affected112 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA v23.1	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0017 events7 affected63 at risk EG00213 events10 affected112 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA v23.1	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0017 events4 affected63 at risk EG0022 events2 affected112 at risk
Seborrhoeic dermatitis	Skin and subcutaneous tissue disorders	MedDRA v23.1	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0012 events2 affected63 at risk EG0022 events1 affected112 at risk
Dermatitis atopic	Skin and subcutaneous tissue disorders	MedDRA v23.1	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0011 events1 affected63 at risk EG0020 events0 affected112 at risk

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

ID	Term
D011092	Polyethylene Glycols
D011108	Polymers
D046911	Macromolecular Substances
D007140	Immunoglobulin Fab Fragments
D007128	Immunoglobulin Fragments
D010446	Peptide Fragments
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D012712	Serum Globulins
D005916	Globulins

ID	Title	Description
BG000	Any CZP Dose - Weight Group: 10 - <20 kg	Participants received CZP sc as a fixed dose based on their body weight Q2W or Q4W throughout the study. Participants started with 3 loading doses of CZP at Weeks 0, 2, and 4 followed by a maintenance dose for the duration of the study.
BG001	Any CZP Dose - Weight Group: 20 - <40 kg	Participants received CZP sc as a fixed dose based on their body weight Q2W throughout the study. Participants started with 3 loading doses of CZP at Weeks 0, 2, and 4 followed by a maintenance dose for the duration of the study.
BG002	Any CZP Dose - Weight Group: >=40 kg	Participants received CZP sc as a fixed dose based on their body weight Q2W throughout the study. Participants started with 3 loading doses of CZP at Weeks 0, 2, and 4 followed by a maintenance dose for the duration of the study.
BG003	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Any CZP Dose - Weight Group: 10 - <20 kg	Participants received CZP sc as a fixed dose based on their body weight Q2W or Q4W throughout the study. Participants started with 3 loading doses of CZP at Weeks 0, 2, and 4 followed by a maintenance dose for the duration of the study.	0	18	5	18	16	18
EG001	Any CZP Dose - Weight Group: 20 - <40 kg	Participants received CZP sc as a fixed dose based on their body weight Q2W throughout the study. Participants started with 3 loading doses of CZP at Weeks 0, 2, and 4 followed by a maintenance dose for the duration of the study.	0	63	20	63	59	63
EG002	Any CZP Dose - Weight Group: >=40 kg	Participants received CZP sc as a fixed dose based on their body weight Q2W throughout the study. Participants started with 3 loading doses of CZP at Weeks 0, 2, and 4 followed by a maintenance dose for the duration of the study.	3	112	21	112	98	112