Trial Outcomes & Findings for Tezepelumab COPD Exacerbation Study (NCT NCT04039113)

NCT ID: NCT04039113

Last Updated: 2025-02-18

Results Overview

A COPD exacerbation was defined as a change in the participant's usual COPD symptoms that is beyond normal day-to-day variation, is acute in onset, lasts 2 or more days, and may warrant a change in regular medication and leads to any of the following: Use of systemic corticosteroids for at least 3 days, use of antibiotics for at least 3 days, an inpatient hospitalisation due to COPD, or results in death. Analysis was done using a negative binomial model with the response variable as the number of COPD exacerbations experienced during the follow-up for exacerbations. The model included covariates of treatment group, region, and number of exacerbations reported at randomisation as recorded in IWRS (2, \>=3). The logarithm of the time at risk (in years) for exacerbation in the study is used as an offset variable.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 337 participants
• Primary outcome timeframe: From randomisation up to Week 52
• Results posted on: 2025-02-18

Participant Flow

The study was conducted at 80 centres in 10 countries. A total of 579 participants were screened of which 337 were randomised. Of the 337 randomised, 333 participants received treatment. 4 participants randomised in error and did not receive treatment. 187 participants not randomised were due to screen failures.

The study consisted of a screening period for approximately 6 weeks. At the end of the screening period, participants were randomised in 1:1 ratio for tezepelumab or placebo. Randomisation was stratified by region (North America, Europe, Asia), and number of prior exacerbations (2, >=3) recorded at randomisation in IWRS.

Participant milestones

Measure	Tezepelumab 420 mg Tezepelumab injection delivered subcutaneously every 4 weeks up to maximum of 52 weeks (last dose given at week 48).	Placebo Matching Placebo injection delivered subcutaneously every 4 weeks up to maximum of 52 weeks (last dose given at week 48).
Overall Study STARTED	169	168
Overall Study Received Treatment	165	168
Overall Study Completed Treatment	138	138
Overall Study COMPLETED	146	150
Overall Study NOT COMPLETED	23	18

Reasons for withdrawal

Measure	Tezepelumab 420 mg Tezepelumab injection delivered subcutaneously every 4 weeks up to maximum of 52 weeks (last dose given at week 48).	Placebo Matching Placebo injection delivered subcutaneously every 4 weeks up to maximum of 52 weeks (last dose given at week 48).
Overall Study Withdrawal by Subject	8	11
Overall Study Lost to Follow-up	1	1
Overall Study Adverse Event	2	2
Overall Study Death	2	4
Overall Study Site Closure	6	0
Overall Study Failure to meet randomisation criteria	4	0

Baseline Characteristics

Tezepelumab COPD Exacerbation Study

Baseline characteristics by cohort

Measure	Tezepelumab n=165 Participants 420 mg Tezepelumab injection delivered subcutaneously every 4 weeks up to maximum of 52 weeks (last dose given at week 48).	Placebo n=168 Participants Matching Placebo injection delivered subcutaneously every 4 weeks up to maximum of 52 weeks (last dose given at week 48).	Total n=333 Participants Total of all reporting groups
Age, Continuous Age (Years)	67.4 Years STANDARD_DEVIATION 6.75 • n=5 Participants	67.1 Years STANDARD_DEVIATION 7.24 • n=7 Participants	67.2 Years STANDARD_DEVIATION 7.00 • n=5 Participants
Age, Customized Age Group : >=40 - <65	52 Participants n=5 Participants	61 Participants n=7 Participants	113 Participants n=5 Participants
Age, Customized Age Group : >=65 - <=80	113 Participants n=5 Participants	107 Participants n=7 Participants	220 Participants n=5 Participants
Sex: Female, Male Sex · Female	77 Participants n=5 Participants	68 Participants n=7 Participants	145 Participants n=5 Participants
Sex: Female, Male Sex · Male	88 Participants n=5 Participants	100 Participants n=7 Participants	188 Participants n=5 Participants
Ethnicity (NIH/OMB) Ethnic Group · Hispanic or Latino	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Ethnic Group · Not Hispanic or Latino	158 Participants n=5 Participants	165 Participants n=7 Participants	323 Participants n=5 Participants
Ethnicity (NIH/OMB) Ethnic Group · Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	147 Participants n=5 Participants	146 Participants n=7 Participants	293 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	16 Participants n=5 Participants	18 Participants n=7 Participants	34 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: From randomisation up to Week 52

Population: Full analysis set under the primary estimand, which comprised all participants randomised to study treatment who received at least one dose and included all observed data over the 52-week period regardless of whether participants remained on randomised treatment and regardless of whether participants switched to an alternative biologic treatment.

A COPD exacerbation was defined as a change in the participant's usual COPD symptoms that is beyond normal day-to-day variation, is acute in onset, lasts 2 or more days, and may warrant a change in regular medication and leads to any of the following: Use of systemic corticosteroids for at least 3 days, use of antibiotics for at least 3 days, an inpatient hospitalisation due to COPD, or results in death.

Analysis was done using a negative binomial model with the response variable as the number of COPD exacerbations experienced during the follow-up for exacerbations. The model included covariates of treatment group, region, and number of exacerbations reported at randomisation as recorded in IWRS (2, >=3). The logarithm of the time at risk (in years) for exacerbation in the study is used as an offset variable.

Outcome measures

Measure	Tezepelumab n=165 Participants 420 mg Tezepelumab injection delivered subcutaneously every 4 weeks up to maximum of 52 weeks (last dose given at week 48).	Placebo n=168 Participants Matching Placebo injection delivered subcutaneously every 4 weeks up to maximum of 52 weeks (last dose given at week 48).
Rate of Moderate or Severe COPD Exacerbations in Participants With Moderate to Very Severe COPD.	1.75 exacerbations per year Interval 1.45 to 2.11	2.11 exacerbations per year Interval 1.77 to 2.53

SECONDARY outcome

Timeframe: From randomisation up to Week 52

Population: Full analysis set under the primary estimand, which comprised all participants randomised to study treatment who received at least one dose and included all observed data over the 52-week period regardless of whether participants remained on randomised treatment and regardless of whether participants switched to an alternative biologic treatment.

Time to first moderate/severe COPD exacerbation post-randomisation, presented as number of subjects with at least one moderate/severe COPD exacerbation.

Outcome measures

Measure	Tezepelumab n=165 Participants 420 mg Tezepelumab injection delivered subcutaneously every 4 weeks up to maximum of 52 weeks (last dose given at week 48).	Placebo n=168 Participants Matching Placebo injection delivered subcutaneously every 4 weeks up to maximum of 52 weeks (last dose given at week 48).
Time to First Moderate/Severe COPD Exacerbation	94 Participants	105 Participants

SECONDARY outcome

Timeframe: From randomisation up to Week 52

Population: Full analysis set under the primary estimand, which comprised all participants randomised to study treatment who received at least one dose and included all observed data over the 52-week period regardless of whether participants remained on randomised treatment and regardless of whether participants switched to an alternative biologic treatment.

An exacerbation event was defined as described in primary analysis. A participant was exacerbation free if they did not experience any moderate or severe exacerbations from randomisation to Week 52 (EOT).

Outcome measures

Measure	Tezepelumab n=165 Participants 420 mg Tezepelumab injection delivered subcutaneously every 4 weeks up to maximum of 52 weeks (last dose given at week 48).	Placebo n=168 Participants Matching Placebo injection delivered subcutaneously every 4 weeks up to maximum of 52 weeks (last dose given at week 48).
Proportion of Participants COPD Exacerbation Free at Week 52	71 Participants	63 Participants

SECONDARY outcome

Timeframe: From randomisation up to Week 52

Population: Full analysis set under the primary estimand, which comprised all participants randomised to study treatment who received at least one dose and included all observed data over the 52-week period regardless of whether participants remained on randomised treatment and regardless of whether participants switched to an alternative biologic treatment.

An exacerbation was considered severe if it results in at least 1 of the following: Hospitalisation due to the COPD exacerbation (defined as a participant being admitted for ≥ 24 hours to an observation area, the emergency department, or other equivalent healthcare facility), or death related to COPD or COPD exacerbation.

Outcome measures

Measure	Tezepelumab n=165 Participants 420 mg Tezepelumab injection delivered subcutaneously every 4 weeks up to maximum of 52 weeks (last dose given at week 48).	Placebo n=168 Participants Matching Placebo injection delivered subcutaneously every 4 weeks up to maximum of 52 weeks (last dose given at week 48).
Comparison of Annual Severe COPD Exacerbation Rates Over 52 Weeks	0.13 exacerbations per year Interval 0.07 to 0.24	0.25 exacerbations per year Interval 0.15 to 0.42

SECONDARY outcome

Timeframe: From randomisation up to Week 52

Population: Full analysis set under the primary estimand, which comprised all participants randomised to study treatment who received at least one dose and included all observed data over the 52-week period regardless of whether participants remained on randomised treatment and regardless of whether participants switched to an alternative biologic treatment.

An exacerbation was considered severe if it results in at least 1 of the following: Hospitalisation due to the COPD exacerbation (defined as a participant being admitted for ≥ 24 hours to an observation area, the emergency department, or other equivalent healthcare facility), or death related to COPD or COPD exacerbation.

Outcome measures

Measure	Tezepelumab n=165 Participants 420 mg Tezepelumab injection delivered subcutaneously every 4 weeks up to maximum of 52 weeks (last dose given at week 48).	Placebo n=168 Participants Matching Placebo injection delivered subcutaneously every 4 weeks up to maximum of 52 weeks (last dose given at week 48).
Proportion of Participants With >=1 Severe COPD Exacerbations Over 52 Weeks	16 Participants	22 Participants

SECONDARY outcome

Timeframe: From randomisation up to Week 52

Population: Full analysis set under the primary estimand, which comprised all participants randomised to study treatment who received at least one dose and included all observed data over the 52-week period regardless of whether participants remained on randomised treatment and regardless of whether participants switched to an alternative biologic treatment.

Time to first severe COPD exacerbation post-randomisation, presented as number of subjects with at least one severe COPD exacerbation.

Outcome measures

Measure	Tezepelumab n=165 Participants 420 mg Tezepelumab injection delivered subcutaneously every 4 weeks up to maximum of 52 weeks (last dose given at week 48).	Placebo n=168 Participants Matching Placebo injection delivered subcutaneously every 4 weeks up to maximum of 52 weeks (last dose given at week 48).
Time to First Severe COPD Exacerbation	16 Participants	22 Participants

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: Number of participants analyzed is the number of participants with an observation at Week 52. All participants from the Full Analysis Set with at least one change from baseline value at any post baseline visit contributes to the analyses.

Pre-Bronchodilator FEV1 (L) was determined by spirometry at the clinic visit. FEV1 is defined as the volume of air exhaled from the lungs in the first second of a forced expiration.

Change from baseline was obtained as an absolute difference between Week 52 measure and the baseline value.

Baseline was defined as the last assessment recorded prior to the first dose of study treatment.

Outcome measures

Measure	Tezepelumab n=163 Participants 420 mg Tezepelumab injection delivered subcutaneously every 4 weeks up to maximum of 52 weeks (last dose given at week 48).	Placebo n=166 Participants Matching Placebo injection delivered subcutaneously every 4 weeks up to maximum of 52 weeks (last dose given at week 48).
Least Square (LS) Mean Difference in Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in 1 (FEV1) at Week 52	0.026 Liters Standard Error 0.015	-0.029 Liters Standard Error 0.015

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: Number of participants analyzed is the number of participants with an observation at Week 52. All participants from the Full Analysis Set with at least one change from baseline value at any post baseline visit contributes to the analyses.

The SGRQ is a 50-item PRO instrument to measure the health status of participants with airway obstruction diseases. The total score indicates the impact of disease on overall health status. This total score is expressed as a percentage of overall impairment, in which 100 represents the worst possible health status and 0 indicates the best possible health status.

Baseline is the measurement recorded at Week 0 (Visit 3).

Outcome measures

Measure	Tezepelumab n=157 Participants 420 mg Tezepelumab injection delivered subcutaneously every 4 weeks up to maximum of 52 weeks (last dose given at week 48).	Placebo n=156 Participants Matching Placebo injection delivered subcutaneously every 4 weeks up to maximum of 52 weeks (last dose given at week 48).
Lease Square (LS) Mean Difference in Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 52	-4.796 units on a scale Standard Error 1.176	-1.863 units on a scale Standard Error 1.189

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: Number of participants analyzed is the number of participants from the Full Analysis Set with a baseline SGRQ score.

The SGRQ is a 50-item PRO instrument to measure the health status of participants with airway obstruction diseases. The total score indicates the impact of disease on overall health status. This total score is expressed as a percentage of overall impairment, in which 100 represents the worst possible health status and 0 indicates the best possible health status.

A responder was defined as an individual who had "improvement" at Week 52 (>=4 point decrease in SGRQ total score).

Outcome measures

Measure	Tezepelumab n=163 Participants 420 mg Tezepelumab injection delivered subcutaneously every 4 weeks up to maximum of 52 weeks (last dose given at week 48).	Placebo n=163 Participants Matching Placebo injection delivered subcutaneously every 4 weeks up to maximum of 52 weeks (last dose given at week 48).
Proportion of Participants Achieving a Minimum Clinically Important Difference of 4 Units or More in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 52	65 Participants	59 Participants

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: Number of participants analyzed is the number of participants with an observation at Week 52. All participants from the Full Analysis Set with at least one change from baseline value at any post baseline visit contributes to the analyses.

The CAT is an 8-item PRO developed to measure the impact of COPD on health status. A CAT total score is the sum of item responses. Scores range from 0-40 with higher scores indicative of greater COPD impact on health status.

Baseline was defined as the value at the randomisation visit (Visit 3). If the Visit 3 measurement was missing, the screening value was used as baseline instead.

Outcome measures

Measure	Tezepelumab n=159 Participants 420 mg Tezepelumab injection delivered subcutaneously every 4 weeks up to maximum of 52 weeks (last dose given at week 48).	Placebo n=162 Participants Matching Placebo injection delivered subcutaneously every 4 weeks up to maximum of 52 weeks (last dose given at week 48).
Least Square (LS) Mean Difference in Change From Baseline in COPD Assessment Tool (CAT) Total Score at Week 52	-3.037 units on a scale Standard Error 0.524	-1.182 units on a scale Standard Error 0.524

SECONDARY outcome

Timeframe: Pre-dose at weeks 0, 4, 12, 24, 36 and also at weeks 52 and 64 where no dosing was scheduled

Population: The Pharmacokinetic (PK) analysis set comprises all subjects who received at least one dose of tezepelumab and have at least one detectable serum concentration post first dose that is not affected by factors such as protocol deviations (e.g. disallowed medication or incorrect study medication received).

Blood samples were collected to determine the serum concentration of Tezepelumab.

With the exception of Week 0 and Week 64, only pre-dose data from samples collected between 21 and 35 days after previous dose of investigational product were included.

Outcome measures

Measure	Tezepelumab n=162 Participants 420 mg Tezepelumab injection delivered subcutaneously every 4 weeks up to maximum of 52 weeks (last dose given at week 48).	Placebo Matching Placebo injection delivered subcutaneously every 4 weeks up to maximum of 52 weeks (last dose given at week 48).
Serum Concentration of Tezepelumab Week 0	NA microgram per milliliter (mg/mL) Standard Deviation NA Below the lower limit of quantification (LLOQ). The LLOQ is 0.010 micrograms per milliliter.	—
Serum Concentration of Tezepelumab Week 4	25.881 microgram per milliliter (mg/mL) Standard Deviation 11.8828	—
Serum Concentration of Tezepelumab Week 12	44.316 microgram per milliliter (mg/mL) Standard Deviation 19.0716	—
Serum Concentration of Tezepelumab Week 24	49.093 microgram per milliliter (mg/mL) Standard Deviation 21.2414	—
Serum Concentration of Tezepelumab Week 36	48.667 microgram per milliliter (mg/mL) Standard Deviation 22.2241	—
Serum Concentration of Tezepelumab Week 52	52.659 microgram per milliliter (mg/mL) Standard Deviation 26.1703	—
Serum Concentration of Tezepelumab Follow-up Week 64	6.602 microgram per milliliter (mg/mL) Standard Deviation 6.1832	—

SECONDARY outcome

Timeframe: Pre-dose at weeks 0, 4, 12, 24, 36 and also at weeks 52 and 64 where no dosing was scheduled

Population: The safety analysis set included all subjects who received at least one dose of study drug.

Blood samples were measured for the presence of ADAs for tezepelumab using validated assays. Treatment-induced ADA positive was defined as ADA negative at baseline and post-baseline ADA positive. Treatment-boosted ADA positive was defined as baseline positive ADA titre that was boosted to a 4 fold or higher level following IP administration. TE-ADA positive was defined as the sum of treatment-induced ADA positive and treatment-boosted ADA positive. ADA incidence is the proportion of TE-ADA positive subjects in a population. ADA persistently positive was defined as ADA positive at >= 2 post-baseline assessments or ADA positive at last post-baseline assessment. ADA transiently positive was defined as having at least one post-baseline ADA positive assessment and not fulfilling the conditions of ADA persistently positive. Treatment-induced nAb positive was defined as nAb negative or ADA negative at baseline and nAb positive at any post-baseline visit.

Outcome measures

Measure	Tezepelumab n=165 Participants 420 mg Tezepelumab injection delivered subcutaneously every 4 weeks up to maximum of 52 weeks (last dose given at week 48).	Placebo n=168 Participants Matching Placebo injection delivered subcutaneously every 4 weeks up to maximum of 52 weeks (last dose given at week 48).
Number of Participants With Anti-Drug Antibody (ADA) Response to Tezepelumab ADA positive at baseline and/or post-baseline (ADA prevalence)	10 Participants	19 Participants
Number of Participants With Anti-Drug Antibody (ADA) Response to Tezepelumab Any post-baseline ADA positive	8 Participants	18 Participants
Number of Participants With Anti-Drug Antibody (ADA) Response to Tezepelumab Both baseline and at least one post-baseline ADA positive	3 Participants	7 Participants
Number of Participants With Anti-Drug Antibody (ADA) Response to Tezepelumab TE-ADA positive (ADA incidence)	5 Participants	11 Participants
Number of Participants With Anti-Drug Antibody (ADA) Response to Tezepelumab Any baseline ADA positive	5 Participants	8 Participants
Number of Participants With Anti-Drug Antibody (ADA) Response to Tezepelumab Only baseline ADA positive	2 Participants	1 Participants
Number of Participants With Anti-Drug Antibody (ADA) Response to Tezepelumab Treatment-induced ADA positive	5 Participants	11 Participants
Number of Participants With Anti-Drug Antibody (ADA) Response to Tezepelumab Treatment-boosted ADA positive	0 Participants	0 Participants
Number of Participants With Anti-Drug Antibody (ADA) Response to Tezepelumab ADA persistently positive	5 Participants	15 Participants
Number of Participants With Anti-Drug Antibody (ADA) Response to Tezepelumab ADA transiently positive	3 Participants	3 Participants
Number of Participants With Anti-Drug Antibody (ADA) Response to Tezepelumab nAb positive at baseline and/or post-baseline (nAb prevalence)	0 Participants	0 Participants
Number of Participants With Anti-Drug Antibody (ADA) Response to Tezepelumab Treatment-induced nAb positive (nAb incidence)	0 Participants	0 Participants

Adverse Events

Teze 420 mg Q4W

Serious events: 56 serious events

Other events: 78 other events

Deaths: 3 deaths

Placebo

Serious events: 58 serious events

Other events: 56 other events

Deaths: 6 deaths

Serious adverse events

Measure	Teze 420 mg Q4W n=165 participants at risk 420 mg Tezepelumab injection delivered subcutaneously every 4 weeks up to maximum of 52 weeks (last dose given at week 48).	Placebo n=168 participants at risk Matching Placebo injection delivered subcutaneously every 4 weeks up to maximum of 52 weeks (last dose given at week 48).
Cardiac disorders Angina pectoris	0.00% 0/165 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.60% 1/168 • Number of events 2 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
General disorders Non-cardiac chest pain	0.00% 0/165 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.60% 1/168 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
General disorders Vascular stent stenosis	0.61% 1/165 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.00% 0/168 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Hepatobiliary disorders Cholangitis	0.61% 1/165 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.00% 0/168 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Hepatobiliary disorders Cholecystitis	0.00% 0/165 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.60% 1/168 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Hepatobiliary disorders Cholecystitis acute	0.61% 1/165 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.00% 0/168 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Hepatobiliary disorders Cholelithiasis	0.61% 1/165 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.60% 1/168 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Hepatobiliary disorders Hepatitis alcoholic	0.00% 0/165 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.60% 1/168 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Immune system disorders Drug hypersensitivity	0.61% 1/165 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.60% 1/168 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Infections and infestations Appendicitis	0.00% 0/165 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.60% 1/168 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Infections and infestations COVID-19	1.2% 2/165 • Number of events 2 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	1.8% 3/168 • Number of events 3 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Infections and infestations COVID-19 pneumonia	0.61% 1/165 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.60% 1/168 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Infections and infestations Diverticulitis	1.2% 2/165 • Number of events 2 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.60% 1/168 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Cardiac disorders Atrial fibrillation	0.61% 1/165 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.60% 1/168 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Infections and infestations Herpes zoster	0.61% 1/165 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.00% 0/168 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Infections and infestations Influenza	0.61% 1/165 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.00% 0/168 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Infections and infestations Lower respiratory tract infection	0.61% 1/165 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.00% 0/168 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Infections and infestations Lower respiratory tract infection bacterial	0.00% 0/165 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.60% 1/168 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Infections and infestations Meningitis viral	0.61% 1/165 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.00% 0/168 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Cardiac disorders Atrioventricular block complete	0.00% 0/165 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.60% 1/168 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Infections and infestations Pneumonia	4.2% 7/165 • Number of events 7 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	3.0% 5/168 • Number of events 5 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Infections and infestations Pneumonia bacterial	1.8% 3/165 • Number of events 3 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	1.8% 3/168 • Number of events 4 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Infections and infestations Pneumonia klebsiella	0.61% 1/165 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.00% 0/168 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Infections and infestations Pneumonia mycoplasmal	0.00% 0/165 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.60% 1/168 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Infections and infestations Pneumonia pneumococcal	0.00% 0/165 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.60% 1/168 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Infections and infestations Pneumonia pseudomonal	0.61% 1/165 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.00% 0/168 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Infections and infestations Pneumonia viral	0.61% 1/165 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.00% 0/168 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Infections and infestations Post procedural infection	0.00% 0/165 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.60% 1/168 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Infections and infestations Pseudomonas bronchitis	0.00% 0/165 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.60% 1/168 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Infections and infestations Pyelonephritis	0.00% 0/165 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.60% 1/168 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Infections and infestations Sepsis	0.00% 0/165 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.60% 1/168 • Number of events 2 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Cardiac disorders Cardiac disorder	0.00% 0/165 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.60% 1/168 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Cardiac disorders Cardiac failure	0.61% 1/165 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.00% 0/168 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.61% 1/165 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.00% 0/168 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/165 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.60% 1/168 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Injury, poisoning and procedural complications Gun shot wound	0.00% 0/165 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.60% 1/168 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Injury, poisoning and procedural complications Limb traumatic amputation	0.61% 1/165 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.00% 0/168 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Injury, poisoning and procedural complications Pelvic fracture	0.00% 0/165 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.60% 1/168 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Injury, poisoning and procedural complications Procedural dizziness	0.00% 0/165 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.60% 1/168 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Injury, poisoning and procedural complications Procedural pneumothorax	0.00% 0/165 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.60% 1/168 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Injury, poisoning and procedural complications Road traffic accident	0.61% 1/165 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.00% 0/168 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Cardiac disorders Coronary artery disease	0.61% 1/165 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.00% 0/168 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/165 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.60% 1/168 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Metabolism and nutrition disorders Dehydration	0.00% 0/165 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.60% 1/168 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Cardiac disorders Left ventricular failure	0.00% 0/165 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.60% 1/168 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.61% 1/165 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.00% 0/168 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.61% 1/165 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.00% 0/168 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.61% 1/165 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.00% 0/168 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.61% 1/165 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.00% 0/168 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Cardiac disorders Myocardial infarction	1.2% 2/165 • Number of events 2 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.00% 0/168 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/165 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.60% 1/168 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma pancreas	0.61% 1/165 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.00% 0/168 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.61% 1/165 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.00% 0/168 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal melanoma	0.00% 0/165 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.60% 1/168 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma stage I	0.61% 1/165 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.00% 0/168 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma stage II	0.00% 0/165 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.60% 1/168 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung carcinoma cell type unspecified stage I	0.61% 1/165 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.00% 0/168 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/165 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.60% 1/168 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.61% 1/165 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.00% 0/168 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal adenocarcinoma stage IV	0.61% 1/165 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.00% 0/168 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal squamous cell carcinoma stage IV	0.00% 0/165 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.60% 1/168 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/165 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.60% 1/168 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer metastatic	0.00% 0/165 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.60% 1/168 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of lung	0.00% 0/165 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.60% 1/168 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine cancer	0.00% 0/165 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.60% 1/168 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Nervous system disorders Cerebral infarction	0.00% 0/165 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.60% 1/168 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Nervous system disorders Cerebrovascular accident	0.61% 1/165 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.00% 0/168 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Cardiac disorders Supraventricular extrasystoles	0.61% 1/165 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.00% 0/168 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Nervous system disorders Ischaemic cerebral infarction	0.61% 1/165 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.00% 0/168 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Nervous system disorders Subarachnoid haemorrhage	0.61% 1/165 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.00% 0/168 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Nervous system disorders Transient ischaemic attack	1.2% 2/165 • Number of events 2 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.00% 0/168 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Psychiatric disorders Anxiety	0.00% 0/165 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.60% 1/168 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Psychiatric disorders Depression	0.61% 1/165 • Number of events 2 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.00% 0/168 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Renal and urinary disorders Acute kidney injury	0.61% 1/165 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.60% 1/168 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Renal and urinary disorders Haematuria	0.00% 0/165 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.60% 1/168 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Renal and urinary disorders Hydronephrosis	0.61% 1/165 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.00% 0/168 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Renal and urinary disorders Renal artery occlusion	0.61% 1/165 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.00% 0/168 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Renal and urinary disorders Urinary retention	0.61% 1/165 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.00% 0/168 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Reproductive system and breast disorders Benign prostatic hyperplasia	1.2% 2/165 • Number of events 2 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.00% 0/168 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	1.2% 2/165 • Number of events 2 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.60% 1/168 • Number of events 2 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	12.1% 20/165 • Number of events 27 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	15.5% 26/168 • Number of events 39 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pneumothorax spontaneous	0.00% 0/165 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.60% 1/168 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary artery thrombosis	0.61% 1/165 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.00% 0/168 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/165 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.60% 1/168 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Blood and lymphatic system disorders Blood loss anaemia	0.61% 1/165 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.00% 0/168 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Vascular disorders Aortic aneurysm	0.61% 1/165 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.00% 0/168 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Vascular disorders Coeliac artery occlusion	0.61% 1/165 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.00% 0/168 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Vascular disorders Deep vein thrombosis	0.61% 1/165 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.00% 0/168 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Vascular disorders Iliac artery dissection	0.61% 1/165 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.00% 0/168 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Vascular disorders Peripheral artery occlusion	0.00% 0/165 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.60% 1/168 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Vascular disorders Peripheral artery thrombosis	0.61% 1/165 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.00% 0/168 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Gastrointestinal disorders Alcoholic pancreatitis	0.00% 0/165 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.60% 1/168 • Number of events 2 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/165 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.60% 1/168 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Gastrointestinal disorders Haemorrhoids	0.00% 0/165 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.60% 1/168 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Gastrointestinal disorders Inguinal hernia	1.2% 2/165 • Number of events 2 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.00% 0/168 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Gastrointestinal disorders Intestinal ischaemia	0.61% 1/165 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.00% 0/168 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Gastrointestinal disorders Mechanical ileus	0.61% 1/165 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.00% 0/168 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Gastrointestinal disorders Obstructive pancreatitis	0.61% 1/165 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.00% 0/168 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Gastrointestinal disorders Oesophageal ulcer	0.00% 0/165 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.60% 1/168 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Gastrointestinal disorders Retroperitoneal haemorrhage	0.61% 1/165 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.00% 0/168 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/165 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.60% 1/168 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Cardiac disorders Acute myocardial infarction	1.2% 2/165 • Number of events 2 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.60% 1/168 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.

Other adverse events

Measure	Teze 420 mg Q4W n=165 participants at risk 420 mg Tezepelumab injection delivered subcutaneously every 4 weeks up to maximum of 52 weeks (last dose given at week 48).	Placebo n=168 participants at risk Matching Placebo injection delivered subcutaneously every 4 weeks up to maximum of 52 weeks (last dose given at week 48).
General disorders Oedema peripheral	6.7% 11/165 • Number of events 11 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	4.8% 8/168 • Number of events 8 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Infections and infestations COVID-19	15.2% 25/165 • Number of events 26 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	9.5% 16/168 • Number of events 17 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Infections and infestations Nasopharyngitis	10.3% 17/165 • Number of events 18 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	5.4% 9/168 • Number of events 9 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Infections and infestations Urinary tract infection	3.0% 5/165 • Number of events 6 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	6.0% 10/168 • Number of events 12 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Injury, poisoning and procedural complications Contusion	6.1% 10/165 • Number of events 11 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.00% 0/168 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Injury, poisoning and procedural complications Fall	6.7% 11/165 • Number of events 12 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	6.0% 10/168 • Number of events 12 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Nervous system disorders Dizziness	5.5% 9/165 • Number of events 11 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	0.60% 1/168 • Number of events 1 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Nervous system disorders Headache	1.8% 3/165 • Number of events 4 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	6.0% 10/168 • Number of events 24 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Vascular disorders Hypertension	7.3% 12/165 • Number of events 13 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	3.0% 5/168 • Number of events 5 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.
Gastrointestinal disorders Diarrhoea	5.5% 9/165 • Number of events 10 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.	2.4% 4/168 • Number of events 4 • From first dose of study drug until end of study at Week 64. All AE data is based off the Safety Analysis Set, which includes all subjects who received at least one dose of study treatment.

Additional Information

Global Clinical Lead

AstraZeneca

Phone: 1-877-240-9479

Email: information.center@astrazeneca.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Investigator agrees to submit all manuscripts or abstracts to the sponsor before submission. This allows the sponsor to protect proprietary information and to provide comments.
• Publication restrictions are in place

Restriction type: OTHER