Study to Evaluate the Efficacy and Safety of Tezepelumab... | NCT03406078

Status Module

Name	Class
Amgen	INDUSTRY

Label	Type	Description	Intervention Names
Tezepelumab	Experimental	Tezepelumab subcutaneous injection	Biological: Tezepelumab
Placebo	Placebo Comparator	Placebo subcutaneous injection	Other: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Tezepelumab	Biological	Tezepelumab subcutaneous injection	Tezepelumab

Measure	Description	Time Frame
Categorized Percent Reduction From Baseline in the Daily OCS Dose While Not Losing Asthma Control	Categorized percent reduction from baseline at Week 48. Percent change from baseline is defined as {final dose-baseline dose)/baseline dose}*100, and the categories of percent change from baseline in daily OCS dose are defined as: ≥90% to ≤100% reduction, ≥75% to <90% reduction, ≥50% to <75% reduction, >0% to <50% reduction, and, no change or any increase.	Baseline to Week 48

Measure	Description	Time Frame
Annualised Asthma Exacerbation Rate (AAER)	The annualized exacerbation rate is based on exacerbations reported by the investigator in the eCRF over 48 weeks.	Baseline to Week 48
Proportion of Subjects With 100% Reduction From Baseline in Daily OCS Dose at Week 48

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects must have received a physician-prescribed medium- or high-dose ICS as per GINA guideline for at least 12 months
Subjects must have received physician prescribed LABA and high dose ICS (total daily dose >500μg fluticasone propionate dry powder formulation equivalent) for at least 3 months. The ICS and LABA can be parts of a combination product, or given by separate inhalers.
Additional maintenance asthma controller medications are allowed according to standard practice of care i.e., leukotriene receptor antagonists (LTRAs), theophylline, long-acting muscarinic antagonists (LAMAs), secondary ICS and cromones. The use of these medications must be documented for at least 3 months
Subjects must have received OCS for the treatment of asthma for at least 6 months prior to screening and on a stable dose of between ≥ 7.5 to ≤ 30mg (prednisone or prednisolone equivalent) daily or daily equivalent for at least 1 month. The OCS dose may be administered every other day (or different doses every other day); Average dose over two days = The daily dose.
Morning pre-bronchodilator (BD) FEV1 must be < 80% predicted normal
Subjects must have evidence of asthma as documented by post-BD (albuterol/salbutatomol) reversibility of FEV1 ≥12% and ≥200 mL (15-30 min after administration of 4 puffs of albuterol/salbutamol), documented either in the previous 12 months
Subjects must have a history of at least 1 asthma exacerbation event within 12 months
Minimum 10 days compliance with the morning and evening eDiary completion and OCS,ICS,LABA as well as other asthma controller medications as captured in the eDiary during the 14 days prior to randomization
Documented physician-diagnosed asthma for at least 12 months

Exclusion Criteria:

Any clinically important pulmonary disease other than asthma (e.g. active lung infection, Chronic Obstructive Pulmonary Disease (COPD), bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and primary ciliary dyskinesia) or ever diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts (e.g. allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hypereosinophilic syndrome).
Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could:

Affect the safety of the subject throughout the study Influence the findings of the study or the interpretation Impede the subject's ability to complete the entire duration of study
History of cancer: Subjects who have had basal cell carcinoma, localized squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible to participate in the study provided that curative therapy was completed at least 12 months prior to visit 1.Subjects who have had other malignancies are eligible provided that curative therapy was completed at least 5 years
A helminth parasitic infection diagnosed within 6 months prior to screening that has not been treated with, or has failed to respond to, standard of care therapy.
Current smokers or subjects with smoking history ≥ 10 pack-years and subjects using vaping products, including electronic cigarettes. Former smokers with a smoking history of <10 pack years and users of vaping or e-cigarette products must have stopped for at least 6 months prior to visit 1 to be eligible.
History of chronic alcohol or drug abuse within 12 months
Tuberculosis requiring treatment within the 12 months
History of any known immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test.
Major surgery within 8 weeks prior to visit 1 or planned surgical procedures requiring general anaesthesia or in-subject status for >1 day during the conduct of the study.
Clinically significant asthma exacerbation, in the opinion of the Investigator, including those requiring use of systemic corticosteroids or increase in the maintenance dose of OCS within 30 days

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Bakersfield	California	93301	United States
Research Site

PubMed Identifier	Type	Citation	Retractions
36702146	Derived	Menzies-Gow A, Wechsler ME, Brightling CE, Korn S, Corren J, Israel E, Chupp G, Bednarczyk A, Ponnarambil S, Caveney S, Almqvist G, Golabek M, Simonsson L, Lawson K, Bowen K, Colice G; DESTINATION study investigators. Long-term safety and efficacy of tezepelumab in people with severe, uncontrolled asthma (DESTINATION): a randomised, placebo-controlled extension study. Lancet Respir Med. 2023 May;11(5):425-438. doi: 10.1016/S2213-2600(22)00492-1. Epub 2023 Jan 23.
35364018

Label	URL
CSP redacted	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

ID	Title	Description
FG000	Tezepelumab	Tezepelumab 210 mg administered every 4 weeks subcutaneously
FG001	Placebo	Placebo administered every 4 weeks subcutaneously

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	May 14, 2020	Sep 22, 2021

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

Categorized Percent Reduction From Baseline in the Daily OCS Dose While Not Losing Asthma Control

Categorized percent reduction from baseline at Week 48. Percent change from baseline is defined as {final dose-baseline dose)/baseline dose}*100, and the categories of percent change from baseline in daily OCS dose are defined as: ≥90% to ≤100% reduction, ≥75% to <90% reduction, ≥50% to <75% reduction, >0% to <50% reduction, and, no change or any increase.

Posted

Count of Participants

Participants

Baseline to Week 48

ID	Title	Description
OG000	Tezepelumab	Tezepelumab 210 mg administered every 4 weeks subcutaneously
OG001	Placebo	Placebo administered every 4 weeks subcutaneously

Units	Counts
Participants	OG00074 OG00176

Title

Denominators

Categories

Title	Measurements
>=90% to <=100% reduction	OG00040 OG00135
>=75% to <90% reduction	OG000

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		Proportional odds model	Response variable: categorised % reduction from baseline in final OCS dose. Covariates in the model: treatment, region and daily OCS dose at baseline.	0.434		Cumulative Odds Ratio	1.28			2-Sided	95	0.69	2.35					Superiority

Secondary

Annualised Asthma Exacerbation Rate (AAER)

The annualized exacerbation rate is based on exacerbations reported by the investigator in the eCRF over 48 weeks.

Posted

Least Squares Mean

95% Confidence Interval

Events per year

Baseline to Week 48

ID	Title	Description
OG000	Tezepelumab	Tezepelumab 210 mg administered every 4 weeks subcutaneously
OG001	Placebo	Placebo administered every 4 weeks subcutaneously

Units	Counts
Participants	OG000

Secondary

Proportion of Subjects With 100% Reduction From Baseline in Daily OCS Dose at Week 48

Proportion (expressed as a percentage) of subjects with 100% reduction from baseline in daily OCS dose at Week 48. Percent change from baseline is defined as {(final dose-baseline dose)/baseline dose}*100.

Posted

Number

Percentage of participants

Baseline to Week 48

ID	Title	Description
OG000	Tezepelumab	Tezepelumab 210 mg administered every 4 weeks subcutaneously
OG001	Placebo	Placebo administered every 4 weeks subcutaneously

Units	Counts
Participants	OG000

Secondary

Proportion of Subjects With Daily OCS Dose ≤5 mg at Week 48

Proportion (expressed as a percentage) of subjects with daily OCS dose ≤5 mg at Week 48.

Posted

Number

Percentage of participants

Week 48

ID	Title	Description
OG000	Tezepelumab	Tezepelumab 210 mg administered every 4 weeks subcutaneously
OG001	Placebo	Placebo administered every 4 weeks subcutaneously

Units	Counts
Participants	OG000

Secondary

Proportion of Subjects With ≥50% Reduction From Baseline in Daily OCS Dose at Week 48

Proportion (expressed as a percentage) of subjects with ≥50% reduction from baseline in daily OCS dose at Week 48. Percent change from baseline is defined as {(final dose-baseline dose)/baseline dose}*100.

Posted

Number

Percentage of participants

Baseline to Week 48

ID	Title	Description
OG000	Tezepelumab	Tezepelumab 210 mg administered every 4 weeks subcutaneously
OG001	Placebo	Placebo administered every 4 weeks subcutaneously

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Pre-bronchodilator (Pre-BD) Forced Expiratory Volume in 1 Second (FEV1)

Change from baseline in pre-BD FEV1 at Week 48. FEV1 is defined as the volume of air exhaled from the lungs in the first second of a forced expiration.

Number of participants analysed presents the number of subjects with an observation at Week 48. All subjects from the Full Analysis Set with at least one change from baseline value at any post baseline visit contributes to the analyses.

Posted

Least Squares Mean

Standard Error

Litre

Baseline to Week 48

ID	Title	Description
OG000	Tezepelumab	Tezepelumab 210 mg administered every 4 weeks subcutaneously
OG001	Placebo	Placebo administered every 4 weeks subcutaneously

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Weekly Mean Daily Asthma Symptom Score Via the Daily Asthma Symptom Diary

Change from baseline in Asthma Symptom Diary score at Week 48. The Asthma Symptom Diary comprises of 10 items (5 items in the morning; 5 items in the evening). Asthma symptoms during night time and daytime are recorded by the patient each morning and evening in the daily diary. A daily ASD score is the mean of the 10 items. Responses for all 10 items are required to calculate the daily ASD score; otherwise, it is treated as missing. For the 7-day average asthma symptom score, scoring is done with no imputation using the mean of at least 4 of the 7 daily ASD scores as a mean weekly item score. The 7-day average ASD score ranges from 0 to 4, where 0 indicates no asthma symptoms.

Posted

Least Squares Mean

Standard Error

Score on a scale

Baseline to Week 48

ID	Title	Description
OG000	Tezepelumab	Tezepelumab 210 mg administered every 4 weeks subcutaneously
OG001	Placebo	Placebo administered every 4 weeks subcutaneously

Secondary

Change From Baseline in Weekly Mean Rescue Medication Use

Change from baseline in weekly mean rescue medication use at Week 48. Daily rescue medication use is defined as: Number of night inhaler puffs + 2 x [number of night nebulizer times] + number of daytime inhaler puffs + 2 x [number of day nebulizer times]. Each timepoint is calculated as weekly means based on daily diary data.

Posted

Least Squares Mean

Standard Error

Weekly mean rescue medication use

Baseline to Week 48

ID	Title	Description
OG000	Tezepelumab	Tezepelumab 210 mg administered every 4 weeks subcutaneously
OG001	Placebo	Placebo administered every 4 weeks subcutaneously

Units	Counts
Participants

Secondary

Change From Baseline in Weekly Mean Home Peak Expiratory Flow (PEF) (Morning and Evening)

Change from baseline in weekly mean morning and evening peak expiratory flow (PEF) at Week 48. Home PEF testing will be performed by the subject in the morning upon awakening and in the evening at bedtime using an electronic, hand-held spirometer. Each timepoint is calculated as weekly means using at least 4 of the 7 days of PEF data.

Posted

Least Squares Mean

Standard Error

L/min

Baseline to Week 48

ID	Title	Description
OG000	Tezepelumab	Tezepelumab 210 mg administered every 4 weeks subcutaneously
OG001	Placebo	Placebo administered every 4 weeks subcutaneously

Units	Counts
Participants

Secondary

Change From Baseline in Weekly Mean Number of Night-time Awakening Due to Asthma

Change from baseline in weekly mean number (expressed as a percentage) of night time awakenings at Week 48. Night-time awakenings percentage defined as number of nights with awakenings due to asthma and requiring rescue medication divided by number of nights with data and multiplied by 100%. At least 4 out of 7 days of data is required to calculate a weekly mean.

Posted

Least Squares Mean

Standard Error

Percentage of nights with awakenings

Baseline to Week 48

ID	Title	Description
OG000	Tezepelumab	Tezepelumab 210 mg administered every 4 weeks subcutaneously
OG001	Placebo	Placebo administered every 4 weeks subcutaneously

Units	Counts
Participants

Secondary

Change From Baseline in Asthma Control Questionnaire 6 (ACQ-6) Score

Change from baseline in ACQ-6 at Week 48. The ACQ-6 captures asthma symptoms and short-acting β2-agonist use via subject-report. Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The ACQ-6 score is the mean of the responses.

Posted

Least Squares Mean

Standard Error

Score on a scale

Baseline to Week 48

ID	Title	Description
OG000	Tezepelumab	Tezepelumab 210 mg administered every 4 weeks subcutaneously
OG001	Placebo	Placebo administered every 4 weeks subcutaneously

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Standardized Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(s)+12) Total Score

Change from baseline in AQLQ(S)+12 as compared to placebo at Week 48. The AQLQ(S)+12 is a questionnaire that measures the health-related quality of life experienced by asthma subjects. The total score is defined as the average of all 32 questions in the AQLQ(S)+12 questionnaire. AQLQ(S)+12 is a 7-point scale questionnaire, ranging from 7 (no impairment) to 1 (severe impairment).

Posted

Least Squares Mean

Standard Error

Score on a scale

Baseline to Week 48

ID	Title	Description
OG000	Tezepelumab	Tezepelumab 210 mg administered every 4 weeks subcutaneously
OG001	Placebo	Placebo administered every 4 weeks subcutaneously

Units	Counts
Participants

Secondary

Change From Baseline in European Quality of Life - 5 Dimensions 5 Levels Questionnaire (EQ-5D-5L) Score

Change from baseline in EQ-5D-5L at Week 48. The EQ-5D-5L questionnaire assesses 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no/slight/moderate/severe/extreme problems) that reflect increasing levels of difficulty. The EQ-5D-5L scores are converted into a single index-based value (Health State Valuation), using the UK population-based weights. The Helth State Valuation is scored between 0 to 1, where higher score indicates a better health state.

Posted

Least Squares Mean

Standard Error

Score on a scale

Baseline to Week 48

ID	Title	Description
OG000	Tezepelumab	Tezepelumab 210 mg administered every 4 weeks subcutaneously
OG001	Placebo	Placebo administered every 4 weeks subcutaneously

Units	Counts

Secondary

Number of Participants With Asthma Specific Resource Utilizations

Number of participants with asthma specific resource utilizations (e.g. unscheduled physician visits, unscheduled phone calls to physicians, use of other asthma medications) over 48 weeks.

Posted

Number

Participants

Baseline to Week 48

ID	Title	Description
OG000	Tezepelumab	Tezepelumab 210 mg administered every 4 weeks subcutaneously
OG001	Placebo	Placebo administered every 4 weeks subcutaneously

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Work Productivity and Activity Impairment Questionnaire and Classroom Impairment Questionnaire (WPAI+CIQ) Score

Change from baseline in WPAI+CIQ score at Week 48. The WPAI+CIQ consists of 10 questions about how asthma and asthma related issues impact a subject's ability to work, attend classes, and perform regular daily activities.

Work (Class) productivity loss is derived by sum of percentage of missed work (class hours) due to asthma and product of percentage of actual working hours (class) times degree of asthma affecting work (class) productivity while working. Percentage of missed work (class hours) due to asthma is calculated by number of hours missed work (class) due to asthma divided by total number of hours missed work (class) plus number of hours actually worked (in class).

Activity impairment is the degree health affected regular activities (other than work or class) rated from 0 to 10, with 0 meaning no effect, divided by 10, and then expressed as a percentage.

The work productivity loss is only applicable to subjects who were employed, which is a subset of the study population. The class productivity loss is only applicable to subjects attending school, which is a subset of the study population. No subject in Placebo arm has selected the option 'in school' on the WPAI+CIQ questionnaire at Week 48.

Posted

Mean

Standard Deviation

Percentage

Baseline to Week 48

ID	Title	Description
OG000	Tezepelumab	Tezepelumab 210 mg administered every 4 weeks subcutaneously
OG001	Placebo

Secondary

Change From Baseline in FENO

Change from baseline in fractional exhaled nitric oxide (FeNO) at week 48.

Posted

Least Squares Mean

Standard Error

ppb

Baseline to Week 48

ID	Title	Description
OG000	Tezepelumab	Tezepelumab 210 mg administered every 4 weeks subcutaneously
OG001	Placebo	Placebo administered every 4 weeks subcutaneously

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Peripheral Blood Eosinophils

Change from baseline in blood eosinophil counts at week 48.

Posted

Least Squares Mean

Standard Error

cells/μL

Baseline to Week 48

ID	Title	Description
OG000	Tezepelumab	Tezepelumab 210 mg administered every 4 weeks subcutaneously
OG001	Placebo	Placebo administered every 4 weeks subcutaneously

Units	Counts
Participants	OG000

Secondary

Change From Baseline From Total Serum IgE

Change from baseline in total serum IgE at week 48.

Posted

Least Squares Mean

Standard Error

IU/mL

Baseline to Week 48

ID	Title	Description
OG000	Tezepelumab	Tezepelumab 210 mg administered every 4 weeks subcutaneously
OG001	Placebo	Placebo administered every 4 weeks subcutaneously

Units	Counts
Participants	OG000

Secondary

PK: Serum Trough Concentrations

Serum trough concentrations at each scheduled visit.

The placebo arm is not applicable since it is not the experimental product.

Posted

Geometric Mean

Geometric Coefficient of Variation

μg/mL

Pre-dose samples at Baseline, Week 4, Week 12, Week 24, Week 40, Week 48, Week 60

ID	Title	Description
OG000	Tezepelumab	Tezepelumab 210 mg administered every 4 weeks subcutaneously
OG001	Placebo	Placebo administered every 4 weeks subcutaneously

Units	Counts
Participants	OG000

Secondary

Immunogenicity: Incidence of Anti-drug Antibodies (ADA)

Anti-drug antibodies (ADA) responses at baseline and post baseline. Persistently positive is defined as positive at >=2 post baseline assessments (with >=16 weeks between the first and the last positive) or positive at last post baseline assessment. Transiently positive is defined as having at least one post baseline ADA positive assessment and not fulfilling the conditions of persistently positive. Treatment boosted ADA defined as baseline positive ADA that was boosted to a 4 fold or higher level following treatment. Treatment emergent ADA defined as sum of treatment induced ADA and treatment boosted ADA.

Posted

Number

Participants

Baseline to Week 60

ID	Title	Description
OG000	Tezepelumab	Tezepelumab 210 mg administered every 4 weeks subcutaneously
OG001	Placebo	Placebo administered every 4 weeks subcutaneously

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cardiac arrest	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected76 at risk
Cardiac failure	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected76 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0002 events1 affected74 at risk EG0010 events0 affected76 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected76 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected76 at risk
H1n1 influenza	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected76 at risk
Intervertebral discitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected76 at risk
Pneumonia	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected74 at risk EG0012 events2 affected76 at risk
Septic shock	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected76 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected76 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected76 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected76 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected76 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected76 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected76 at risk
Invasive breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected76 at risk
Headache	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected76 at risk
Migraine	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected76 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected76 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected76 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0006 events4 affected74 at risk EG00111 events8 affected76 at risk
Bronchial secretion retention	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected76 at risk
Nasal polyps	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected76 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cataract	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected74 at risk EG0013 events3 affected76 at risk
Influenza like illness	General disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected74 at risk EG0015 events5 affected76 at risk
Bronchitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0004 events4 affected74 at risk EG0013 events3 affected76 at risk
Bronchitis bacterial	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG00014 events6 affected74 at risk EG00110 events7 affected76 at risk
Nasopharyngitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG00014 events12 affected74 at risk EG00129 events19 affected76 at risk
Oral candidiasis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0004 events4 affected74 at risk EG0015 events4 affected76 at risk
Sinusitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected74 at risk EG0016 events5 affected76 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0009 events9 affected74 at risk EG0018 events8 affected76 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0003 events3 affected74 at risk EG0011 events1 affected76 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0005 events4 affected74 at risk EG0012 events1 affected76 at risk
Headache	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0003 events3 affected74 at risk EG0019 events8 affected76 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0007 events6 affected74 at risk EG00115 events8 affected76 at risk
Nasal polyps	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected74 at risk EG0016 events4 affected76 at risk
Hypertension	Vascular disorders	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected74 at risk EG0016 events6 affected76 at risk

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012130	Respiratory Hypersensitivity
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases

ID	Title	Description
BG000	Tezepelumab	Tezepelumab 210 mg administered every 4 weeks subcutaneously
BG001	Placebo	Placebo administered every 4 weeks subcutaneously
BG002	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	Tezepelumab	Tezepelumab 210 mg administered every 4 weeks subcutaneously	1	74	12	74	35	74
EG001	Placebo	Placebo administered every 4 weeks subcutaneously	0	76	16	76	48	76