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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-003062-39 | EudraCT Number |
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| Name | Class |
|---|---|
| Amgen | INDUSTRY |
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A Multicentre, Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study of Tezepelumab in Participants with Severe Chronic Rhinosinusitis with Nasal Polyposis
This is a multicentre, randomised, double-blind, placebo controlled, parallel group study designed to evaluate the efficacy and safety of tezepelumab in adults with severe, chronic rhinosinusitis with nasal polyposis. Approximately 400 subjects will be randomized globally. Participants will receive tezepelumab, or placebo, administered via subcutaneous injection using the accessorized pre-filled syringe (APFS) every 4 weeks, over a 52-week treatment period. The study also includes a post-treatment follow-up period of 12-24 weeks for participants who complete the 52-week treatment period. All participants will have background mometasone furoate nasal spray or equivalent intranasal corticosteroid at a stable dose from Visit 1 and throughout the screening and study period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tezepelumab | Experimental | Tezepelumab subcutaneous injection in an accessorized pre-filled syringe every 4 weeks (Q4W) added to background mometasone furoate (MFNS) or equivalent intranasal corticosteroid (INCS). |
|
| Placebo | Placebo Comparator | Placebo subcutaneous injection in an accessorized pre-filled syringe Q4W added to background MFNS or equivalent INCS. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: Tezepelumab | Biological | Tezepelumab subcutaneous injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Total Nasal Polyp Score at Week 52 | The total nasal polyp score (NPS) is the sum of the right and left nostril scores (maximum of 8), as evaluated by nasal endoscopy. Higher scores indicate greater symptom severity. The left and right score will be based on a central read with a scale from 0 to 4. Each nasal endoscopy is evaluated by two independent physician reviewers. | Baseline to Week 52 |
| Change From Baseline in Bi-weekly Mean Nasal Congestion Score (NCS) at Week 52 | The NCS is captured by one item in the NPSD (nasal polyps symptom diary) asking participants to rate the severity of their worst NC over the past 24 hours using the following response options: 0 - None; 1 - Mild; 2 - Moderate; 3 - Severe. Baseline will be the mean of daily responses from Day -13 to Day 0. Bi-weekly (14-day) mean NCS will be calculated if at least 8 days in each 14-day period has evaluable data; otherwise the bi-weekly mean is set to missing. | Baseline to Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Bi-weekly Mean Loss of Smell at Week 52 | Participant reported sense of smell will be evaluated as part of the NPSD. Loss of smell is captured by the DSS item (difficulty with sense of smell) in the NPSD asking participants to rate the severity of their worst difficulty with sense of smell over the past 24 hours using the following response options: 0 - None; 1 - Mild; 2 - Moderate; 3 - Severe. Baseline will be the mean of daily responses to the from Day -13 to Day 0. Bi-weekly (14-day) mean loss of smell will be calculated if at least 8 days in each 14-day period has evaluable data; otherwise the bi-weekly mean is set to missing. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline Over Time in Nasal Polyp Score Through Week 52. | The total nasal polyp score (NPS) is the sum of the right and left nostril scores (maximum of 8), as evaluated by nasal endoscopy. Higher scores indicate greater symptom severity. The left and right score will be based on a central read with a scale from 0 to 4. Each nasal endoscopy is evaluated by two independent physician reviewers. | Baseline to Week 52 |
Inclusion Criteria:
Participants with physician-diagnosed CRSwNP for at least 12 months prior to Visit 1 that have:
SNOT-22 total score ≥ 30 at screening (Visit 1)
Any standard of care for treatment of CRSwNP provided the participant is stable on that treatment for 30 days prior to Visit 1
Documented treatment of nasal polyposis exacerbation with SCS for at least 3 consecutive days or one IM depo-injectable dose (or contraindications/intolerance to) within the past 12 months prior to Visit 1 but not within the last 3 months prior to Visit 1 and/or any history of NP surgery (or contraindications/intolerance to)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian Lipworth, MD | University of Dundee | Principal Investigator |
| Joseph K Han, MD | Eastern Virginia Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Birmingham | Alabama | 35209 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40106374 | Derived | Lipworth BJ, Han JK, Desrosiers M, Hopkins C, Lee SE, Mullol J, Pfaar O, Li T, Chen C, Almqvist G, Margolis MK, McLaren J, Jagadeesh S, MacKay J, Megally A, Hellqvist A, Mankad VS, Bahadori L, Ponnarambil SS; WAYPOINT Study Investigators. Tezepelumab in Adults with Severe Chronic Rhinosinusitis with Nasal Polyps. N Engl J Med. 2025 Mar 27;392(12):1178-1188. doi: 10.1056/NEJMoa2414482. Epub 2025 Mar 1. |
| Label | URL |
|---|---|
| D5242C00001\_CSP\_redacted | View source |
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Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.
All request will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
All patients completed a 5-week run-in period during which inclusion/exclusion criteria were assessed, medical history was recorded, nasal endoscopy and biopsy and CT scan were performed, and patient-reported outcomes (PROs) and clinical laboratory tests were performed.
A total of 416 participants were randomized, 6 of which were removed from analyses due to GCP issues, before study unblinding. The remaining 410 were randomized to either the treatment arm (204 participants) or placebo (206 participants) arms of the double-blind treatment period. Two participants were randomized but not dosed (one was withdrawal by subject, one did not meet inclusion/exclusion criteria). Therefore, 203 participants started in the treatment arm and 205 in the placebo arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tezepelumab | 210 mg tezepelumab injection delivered subcutaneously every 4 weeks + background mometasone furoate (MFNS) or equivalent intranasal corticosteroid (INCS). |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 17, 2024 | Sep 12, 2025 |
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Subjects will be randomized in a 1:1 ratio to either tezepelumab or matching placebo both administered subcutaneously.
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Double-Blind
| Placebo |
| Other |
Placebo subcutaneous injection |
|
| Mometasone furoate or equivalent intranasal corticosteroid | Drug | Background MFNS or equivalent INCS at stable dose |
|
| Baseline to Week 52 |
| Change From Baseline in SinoNasal Outcome Test 22 (SNOT-22) at Week 52 | SinoNasal Outcome Test 22 scores are participant-reported and assess physical problems, functional limitations and emotional consequences of SinoNasal conditions. Patient-reported symptom severity and symptom impact over the past 2 weeks are captured via a 6-point scale (0-No Problem to 5-Problem as bad as it can be). The total score is the sum of item scores and has a range from 0 to 110 (higher scores indicate poorer outcomes). | Baseline to Week 52 |
| Change From Baseline in Lund Mackay Score Evaluated by CT at Week 52. | The Lund-Mackay score scoring system is used to provide a quantitative assessment of nasal sinuses on sinus CT scans. Based on the sinus CT images, the five sinuses (maxillary, anterior ethmoid, posterior ethmoid, sphenoid and frontal) on each site are score by central radiologist as follows: (0-Normal; 1-Partial Opacification; 2-Total Opacification). The osteomeatal complex is scored for right and left sides (0 - Not occluded; 2- Occluded). The total score ranges from 0 to 24 (higher scores indicate poorer outcomes). | Week 52 |
| Percentage of Participants With Nasal Polyp Surgery Decision and/or Systemic Corticosteroid for Nasal Polyposis up to Week 52 | Surgery is defined as any procedure involving instruments resulting in incision and removal of tissue (e.g., polypectomy, endoscopic sinus surgery). Rescue treatment of NP is defined as requiring treatment with systemic corticosteroids (SCS) for at least 3 consecutive days (a single depo-injectable dose of corticosteroids will be considered equivalent to a 3-day course of systemic corticosteroids). Time to first NP surgery decision or SCS for NP = (date of the first NP surgery decision or start date of first SCS for NP use - date of randomisation)+1. Kaplan Meier estimates of percentage of participants with events and 95% confidence interval are provided for each treatment group. | Up to Week 52 |
| Percentage of Participants With Nasal Polyp Surgery Decision up to Week 52 | Surgery is defined as any procedure involving instruments resulting in incision and removal of tissue (e.g., polypectomy, endoscopic sinus surgery). Time to first NP surgery decision = (date of the first NP surgery decision - date of randomisation)+1. Kaplan Meier estimates of percentage of participants with events and 95% confidence interval are provided for each treatment group. | Up to Week 52 |
| Percentage of Participants With Systemic Corticosteroids for Nasal Polyposis up to Week 52 | Systemic corticosteroids (SCS) for nasal polyposis (NP) is defined as requiring at least 3 consecutive days (a single depo-injectable dose of corticosteroids was considered equivalent to a 3-day course of SCS) for NP. Time to first SCS for NP = (start date of first SCS for NP use - date of randomisation)+1. Kaplan Meier estimates of percentage of participants with events and 95% confidence interval are provided for each treatment group. | Up to Week 52 |
| Change From Baseline in Bi-weekly Mean Nasal Polyposis Symptom Diary Total Symptom Score at Week 52 | The participant completed the nasal polyposis symptom diary each morning throughout the study. The participant was asked to consider their experience with nasal polyposis/nasal polyps over the past 24 hours when responding to each question. Participants were asked to report their experience with nasal polyposis symptoms (nasal blockage, nasal congestion, runny nose, postnasal drip (mucus drainage down the throat), headache, facial pain, facial pressure, difficulty with sense of smell). Participants reported the severity of each symptom and symptom impact at its worst using a 4-point verbal rating scale (0-None to 3-Severe). A total symptom score (range from 0 to 24) was calculated by taking the sum of the 8 equally weighted symptom items. Higher scores indicate greater symptom severity. | Baseline to Week 52 |
| Change From Baseline in Pre-bronchodilator Forced Expiratory Volume (L) in 1 Second at Week 52. | For participants with comorbid asthma and aspirin exacerbated respiratory disease (AERD)/nonsteroidal anti-inflammatory drug exacerbated respiratory disease (NSAID-ERD), difference in change from baseline in pre-bronchodilator forced expiratory volume in 1 second (FEV1) in the tezepelumab arm as compared to placebo at Week 52. FEV1 is defined as the volume of air exhaled from the lungs in the first second of forced expiration. | Baseline to Week 52 |
| Proportion of Participants With ≥1 Point Reduction in the Nasal Polyp Score at Week 52 | The Nasal Polyp Score is the sum of the right and left nostril scores (maximum 8), as evaluated by nasal endoscopy. A participant with ≥1 point reduction in NPS at Week 52 in the absence of SCS for NP, biologic for NP, or NP surgery at or prior to that time point was defined as a responder, otherwise the participant was defined as a non-responder. | Baseline to Week 52 |
| Proportion of Participants With ≥2 Point Reduction in the Nasal Polyp Score at Week 52 | The Nasal Polyp Score is the sum of the right and left nostril scores (maximum 8), as evaluated by nasal endoscopy. A participant with ≥2 point reduction in NPS at Week 52 in the absence of SCS for NP, biologic for NP, or NP surgery at or prior to that time point was defined as a responder, otherwise the participant was defined as a non-responder. | Baseline to Week 52 |
| Change From Baseline Over Time in Bi-weekly Mean Nasal Congestion Score Evaluated by Nasal Polyposis Symptom Diary Through Week 52. | The NCS is captured by one item in the NPSD (nasal polyps symptom diary) asking participants to rate the severity of their worst NC over the past 24 hours using the following response options: 0 - None; 1 - Mild; 2 - Moderate; 3 - Severe. Baseline will be the mean of daily responses from Day -13 to Day 0. Bi-weekly (14-day) mean NCS will be calculated if at least 8 days in each 14-day period has evaluable data; otherwise the bi-weekly mean is set to missing. | Baseline to Week 52 |
| Change From Baseline in Loss of Smell Evaluated by University of Pennsylvania Smell Identification Test (UPSIT) at Week 52. | The University of Pennsylvania Smell Identification Test is a quantitative test of olfactory function which uses microencapsulated odorants that are released by scratching standardized odour-impregnated test booklets. Scores are based on number of correctly identified odours (score range 0-40, lower scores indicate poorer outcomes). | Baseline to Week 52 |
| Change From Baseline in Modified Lund Mackay Score Evaluated by CT at Week 52. | The Modified Lund-Mackay score scoring system was used to provide a semi-quantitative assessment of nasal sinuses on sinus CT scans. Based on the sinus CT images, the five sinuses (maxillary, anterior ethmoid, posterior ethmoid, sphenoid, and frontal) on each side were scored. Each sinus on each side was scored based on the percentage of opacification from mucosal thickening according to matrix: (score 0 for 0% Opacification; score 1 for 1-25% Opacification; score 2 for 26-50% Opacification; score 3 for 51-75% Opacification; score 4 for 76-99% Opacification; score 5 for 100% Opacification). The range of total Modified Lund Mackay score is from 0 to 50. Higher scores indicate greater symptom severity. | Baseline to Week 52 |
| Change From Baseline in Sinus Severity Score by Quantitative CT Assessment at Week 52 | Quantitative assessment of sinus CT image data were used to derive an objective measure of sinus disease burden called sinus severity score. The sinus severity score is defined as: (sinus mucosal volume)/(sinus mucosal volume + sinus air volume)×100%. The range of sinus severity score is 0 to 100. Higher scores indicate greater symptom severity. | Baseline to Week 52 |
| Exposure of Systemic Corticosteroids Over 52 Weeks | The number of courses of SCS for NP per year was analysed using a negative binomial model. The response variable was the number of courses of SCS for NP received by a participant over the planned treatment period. The model included treatment group, baseline co-morbid asthma/AERD/NSAID-ERD status, prior NP surgery status, and region as factors. The logarithm of the time at risk (in years) was used as an offset variable, to adjust different follow-up times. Time during a course was not included in the calculation of time at risk. | Over 52 weeks |
| Change From Baseline by Domain of the Nasal Polyposis Symptom Diary Through Week 52 | The participant will complete an 11-item nasal polyposis symptom diary each morning throughout the screening, treatment and follow-up periods. The participant is asked to consider their experience with nasal polyposis/nasal polyps over the past 24 hours when responding to each question. Participants are asked to report their experience with nasal polyposis symptoms (nasal blockage, nasal congestion, runny nose, postnasal drip (mucus drainage down the throat), headache, facial pain, facial pressure, and difficulty with sense of smell) and symptom impacts (difficulty with sleeping due to nasal symptoms and difficulty with daily activities due to nasal symptoms). Participants report the severity of each symptom and symptom impact at its worst using a 4-point verbal rating scale (0-None to 3-Severe). | Baseline to Week 52 |
| Change From Baseline in Nasal Peak Inspiratory Flow Through Week 52. | Nasal peak inspiratory flow evaluation represents a physiologic measure of the air flow through both nasal cavities during forced inspiration expressed in liters per minute. | Baseline to Week 52 |
| Change From Baseline in Asthma Control Questionnaire-6 at Week 52. | The Asthma Control Questionnaire is an assessment of asthma symptoms (nighttime waking, symptoms on waking, activity limitation, shortness of breath, wheezing, and short acting beta-agonist use). Participants are asked to recall their level of asthma control during the previous week by responding to one bronchodilator use question and 5 symptom questions. Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). | Baseline to Week 52 |
| Tezepelumab Pharmacokinetics | Serum concentrations of tezepelumab through Week 64. Logarithm transformation was used when calculating geometric mean of serum concentrations. The results were transformed back to original scale. | Pre-dose samples at Baseline, Week 4, Week 12, Week 24, Week 36, Week 52, and Week 64 |
| Immunogenicity of Tezepelumab for Non-China Subjects | Anti-drug antibodies (ADA) responses at baseline and post-baseline. ADA prevalence was defined as patients who are ADA positive at any time including baseline. Persistently positive was defined as having at least two post-baseline ADA positive measurements (with ≥16 weeks between first and last positive) or an ADA positive result at the last available post-baseline assessment. Transiently positive was defined as having at least one post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. Treatment boosted ADA was defined as baseline positive ADA titre that was boosted to a 4-fold or higher-level following treatment. Treatment emergent ADA (ADA incidence) was defined as the sum of treatment induced ADA and treatment boosted ADA. | Pre-dose samples at Baseline to Week 64 |
| Immunogenicity of Tezepelumab for China Subjects | Anti-drug antibodies (ADA) responses at baseline and post-baseline. ADA prevalence was defined as patients who are ADA positive at any time including baseline. Persistently positive was defined as having at least two post-baseline ADA positive measurements (with ≥16 weeks between first and last positive) or an ADA positive result at the last available post-baseline assessment. Transiently positive was defined as having at least one post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. Treatment boosted ADA was defined as baseline positive ADA titre that was boosted to a 4-fold or higher-level following treatment. Treatment emergent ADA (ADA incidence) was defined as the sum of treatment induced ADA and treatment boosted ADA. | Pre-dose samples at Baseline to Week 64 |
| Bakersfield |
| California |
| 93301 |
| United States |
| Research Site | Newport Beach | California | 92663 | United States |
| Research Site | Roseville | California | 95661 | United States |
| Research Site | Walnut Creek | California | 94598 | United States |
| Research Site | Colorado Springs | Colorado | 80923 | United States |
| Research Site | Denver | Colorado | 80230 | United States |
| Research Site | Boca Raton | Florida | 33487 | United States |
| Research Site | Chicago | Illinois | 60657 | United States |
| Research Site | Baltimore | Maryland | 21224 | United States |
| Research Site | White Marsh | Maryland | 21162 | United States |
| Research Site | Boston | Massachusetts | 02115 | United States |
| Research Site | Columbia | Missouri | 65212 | United States |
| Research Site | New York | New York | 10003 | United States |
| Research Site | Winston-Salem | North Carolina | 27103 | United States |
| Research Site | Oklahoma City | Oklahoma | 73120 | United States |
| Research Site | North Charleston | South Carolina | 29406 | United States |
| Research Site | Dallas | Texas | 75231 | United States |
| Research Site | Norfolk | Virginia | 23507 | United States |
| Research Site | Spokane | Washington | 99201 | United States |
| Research Site | Milwaukee | Wisconsin | 53228 | United States |
| Research Site | Vancouver | British Columbia | V6Z 1Y6 | Canada |
| Research Site | Hamilton | Ontario | L8S 1G5 | Canada |
| Research Site | London | Ontario | N6A 4V2 | Canada |
| Research Site | Montreal | Quebec | H2V 2K1 | Canada |
| Research Site | Montreal | Quebec | H2X 0A9 | Canada |
| Research Site | Montreal | Quebec | H4A 3J1 | Canada |
| Research Site | Québec | Quebec | G1S 4L8 | Canada |
| Research Site | Québec | Quebec | G1V 4G5 | Canada |
| Research Site | Québec | Quebec | G1V 4W2 | Canada |
| Research Site | Trois-Rivières | Quebec | G8T 7A1 | Canada |
| Research Site | Bengbu | 233004 | China |
| Research Site | Chengdu | 610072 | China |
| Research Site | Guangzhou | 510120 | China |
| Research Site | Hangzhou | 310003 | China |
| Research Site | Hangzhou | 310014 | China |
| Research Site | Hengyang | 421001 | China |
| Research Site | Lanzhou | 730030 | China |
| Research Site | Nanchang | 330006 | China |
| Research Site | Nanjing | 210009 | China |
| Research Site | Qingdao | 266011 | China |
| Research Site | Shanghai | 200031 | China |
| Research Site | Shanghai | 200433 | China |
| Research Site | Suzhou | 215006 | China |
| Research Site | Taizhou | 225300 | China |
| Research Site | Tianjin | 300121 | China |
| Research Site | Tianjin | 300211 | China |
| Research Site | Wenzhou | 325027 | China |
| Research Site | Wuhan | 430060 | China |
| Research Site | Xi'an | 710068 | China |
| Research Site | Yinchuan | 750001 | China |
| Research Site | Zunyi | 563100 | China |
| Research Site | Aalborg | 9000 | Denmark |
| Research Site | Aarhus N | 8200 | Denmark |
| Research Site | Hillerød | 3400 | Denmark |
| Research Site | Hvidovre | 2650 | Denmark |
| Research Site | København NV | 2400 | Denmark |
| Research Site | Køge | 4600 | Denmark |
| Research Site | Odense | 5000 | Denmark |
| Research Site | Vejle | 7100 | Denmark |
| Research Site | Berlin | 10629 | Germany |
| Research Site | Berlin | 13353 | Germany |
| Research Site | Dresden | 01307 | Germany |
| Research Site | Heidelberg | 69120 | Germany |
| Research Site | Lübeck | 23538 | Germany |
| Research Site | Marburg | 35043 | Germany |
| Research Site | Tübingen | 72076 | Germany |
| Research Site | Wiesbaden | 65183 | Germany |
| Research Site | Budapest | 1046 | Hungary |
| Research Site | Budapest | 1083 | Hungary |
| Research Site | Budapest | 1134 | Hungary |
| Research Site | Nyíregyháza | 4400 | Hungary |
| Research Site | Pécs | 7621 | Hungary |
| Research Site | Siófok | 8600 | Hungary |
| Research Site | Székesfehérvár | 8000 | Hungary |
| Research Site | Bunkyō City | 113-8431 | Japan |
| Research Site | Chuo-shi | 409-3898 | Japan |
| Research Site | Habikino-shi | 583-0886 | Japan |
| Research Site | Ichikawa-shi | 272-0111 | Japan |
| Research Site | Itabashi-ku | 173-8610 | Japan |
| Research Site | Kashiwa-shi | 277-0882 | Japan |
| Research Site | Kisarazu-shi | 292-8535 | Japan |
| Research Site | Miyazaki | 880-8510 | Japan |
| Research Site | Nagaoka-shi | 940-8621 | Japan |
| Research Site | Nerima-ku | 177-0035 | Japan |
| Research Site | Niigata | 951-8520 | Japan |
| Research Site | Osaka | 553-0003 | Japan |
| Research Site | Saitama-shi | 336-8522 | Japan |
| Research Site | Sapporo | 003-0022 | Japan |
| Research Site | Sendai | 983-8512 | Japan |
| Research Site | Suwa-shi | 392-8510 | Japan |
| Research Site | Toyonaka Shi | 560-0082 | Japan |
| Research Site | Yokohama | 227-8501 | Japan |
| Research Site | Yokohama | 236-0037 | Japan |
| Research Site | Bialystok | 15-879 | Poland |
| Research Site | Bydgoszcz | 85-231 | Poland |
| Research Site | Krakow | 31-513 | Poland |
| Research Site | Nadarzyn | 05-830 | Poland |
| Research Site | Wroclaw | 50-556 | Poland |
| Research Site | Wroclaw | 53-301 | Poland |
| Research Site | Zawadzkie | 47-120 | Poland |
| Research Site | Łodź | 90-153 | Poland |
| Research Site | Barakaldo | 48903 | Spain |
| Research Site | Barcelona | 08036 | Spain |
| Research Site | Jerez de la Frontera | 11407 | Spain |
| Research Site | Madrid | 28040 | Spain |
| Research Site | Santiago de Compostela | 15706 | Spain |
| Research Site | Seville | 41009 | Spain |
| Research Site | Dundee | DD1 9SY | United Kingdom |
| Research Site | London | SE1 9RT | United Kingdom |
| Research Site | Manchester | M13 9WL | United Kingdom |
| Research Site | Stockport | SK2 7JE | United Kingdom |
| D5242C00001\_SAP\_redacted | View source |
| D5242C00001\_CSR Synopsis\_redacted | View source |
Matching Placebo injection delivered subcutaneously every 4 weeks + background mometasone furoate (MFNS) or equivalent intranasal corticosteroid (INCS)
| COMPLETED |
|
| NOT COMPLETED |
|
|
All participants who were randomized and received any IP were included in the full analysis set.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Tezepelumab | 210 mg tezepelumab injection delivered subcutaneously every 4 weeks + background MFNS/INCS. |
| BG001 | Placebo | Matching Placebo injection delivered subcutaneously every 4 weeks + background MFNS/INCS. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Age group at screening visit | Count of Participants | Participants |
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| Age, Continuous | Age at screening visit | Mean | Standard Deviation | years |
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| Sex: Female, Male | Gender at screening visit | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change From Baseline in Total Nasal Polyp Score at Week 52 | The total nasal polyp score (NPS) is the sum of the right and left nostril scores (maximum of 8), as evaluated by nasal endoscopy. Higher scores indicate greater symptom severity. The left and right score will be based on a central read with a scale from 0 to 4. Each nasal endoscopy is evaluated by two independent physician reviewers. | Full analysis set (All randomized participants who received at least one dose of IP). | Posted | Least Squares Mean | 95% Confidence Interval | Score | Baseline to Week 52 |
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| Primary | Change From Baseline in Bi-weekly Mean Nasal Congestion Score (NCS) at Week 52 | The NCS is captured by one item in the NPSD (nasal polyps symptom diary) asking participants to rate the severity of their worst NC over the past 24 hours using the following response options: 0 - None; 1 - Mild; 2 - Moderate; 3 - Severe. Baseline will be the mean of daily responses from Day -13 to Day 0. Bi-weekly (14-day) mean NCS will be calculated if at least 8 days in each 14-day period has evaluable data; otherwise the bi-weekly mean is set to missing. | Full analysis set (All randomized participants who received at least one dose of IP). | Posted | Least Squares Mean | 95% Confidence Interval | Score | Baseline to Week 52 |
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| Secondary | Change From Baseline in Bi-weekly Mean Loss of Smell at Week 52 | Participant reported sense of smell will be evaluated as part of the NPSD. Loss of smell is captured by the DSS item (difficulty with sense of smell) in the NPSD asking participants to rate the severity of their worst difficulty with sense of smell over the past 24 hours using the following response options: 0 - None; 1 - Mild; 2 - Moderate; 3 - Severe. Baseline will be the mean of daily responses to the from Day -13 to Day 0. Bi-weekly (14-day) mean loss of smell will be calculated if at least 8 days in each 14-day period has evaluable data; otherwise the bi-weekly mean is set to missing. | Full analysis set (All randomized participants who received at least one dose of IP). | Posted | Least Squares Mean | 95% Confidence Interval | Score | Baseline to Week 52 |
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| Secondary | Change From Baseline in SinoNasal Outcome Test 22 (SNOT-22) at Week 52 | SinoNasal Outcome Test 22 scores are participant-reported and assess physical problems, functional limitations and emotional consequences of SinoNasal conditions. Patient-reported symptom severity and symptom impact over the past 2 weeks are captured via a 6-point scale (0-No Problem to 5-Problem as bad as it can be). The total score is the sum of item scores and has a range from 0 to 110 (higher scores indicate poorer outcomes). | Full analysis set (All randomized participants who received at least one dose of IP). | Posted | Least Squares Mean | 95% Confidence Interval | Score | Baseline to Week 52 |
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| Secondary | Change From Baseline in Lund Mackay Score Evaluated by CT at Week 52. | The Lund-Mackay score scoring system is used to provide a quantitative assessment of nasal sinuses on sinus CT scans. Based on the sinus CT images, the five sinuses (maxillary, anterior ethmoid, posterior ethmoid, sphenoid and frontal) on each site are score by central radiologist as follows: (0-Normal; 1-Partial Opacification; 2-Total Opacification). The osteomeatal complex is scored for right and left sides (0 - Not occluded; 2- Occluded). The total score ranges from 0 to 24 (higher scores indicate poorer outcomes). | Full analysis set (All randomized participants who received at least one dose of IP). | Posted | Least Squares Mean | 95% Confidence Interval | Score | Week 52 |
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| Secondary | Percentage of Participants With Nasal Polyp Surgery Decision and/or Systemic Corticosteroid for Nasal Polyposis up to Week 52 | Surgery is defined as any procedure involving instruments resulting in incision and removal of tissue (e.g., polypectomy, endoscopic sinus surgery). Rescue treatment of NP is defined as requiring treatment with systemic corticosteroids (SCS) for at least 3 consecutive days (a single depo-injectable dose of corticosteroids will be considered equivalent to a 3-day course of systemic corticosteroids). Time to first NP surgery decision or SCS for NP = (date of the first NP surgery decision or start date of first SCS for NP use - date of randomisation)+1. Kaplan Meier estimates of percentage of participants with events and 95% confidence interval are provided for each treatment group. | Full analysis set (All randomized participants who received at least one dose of IP). | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to Week 52 |
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| Secondary | Percentage of Participants With Nasal Polyp Surgery Decision up to Week 52 | Surgery is defined as any procedure involving instruments resulting in incision and removal of tissue (e.g., polypectomy, endoscopic sinus surgery). Time to first NP surgery decision = (date of the first NP surgery decision - date of randomisation)+1. Kaplan Meier estimates of percentage of participants with events and 95% confidence interval are provided for each treatment group. | Full analysis set (All randomized participants who received at least one dose of IP). | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to Week 52 |
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| Secondary | Percentage of Participants With Systemic Corticosteroids for Nasal Polyposis up to Week 52 | Systemic corticosteroids (SCS) for nasal polyposis (NP) is defined as requiring at least 3 consecutive days (a single depo-injectable dose of corticosteroids was considered equivalent to a 3-day course of SCS) for NP. Time to first SCS for NP = (start date of first SCS for NP use - date of randomisation)+1. Kaplan Meier estimates of percentage of participants with events and 95% confidence interval are provided for each treatment group. | Full analysis set (All randomized participants who received at least one dose of IP). | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to Week 52 |
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| Secondary | Change From Baseline in Bi-weekly Mean Nasal Polyposis Symptom Diary Total Symptom Score at Week 52 | The participant completed the nasal polyposis symptom diary each morning throughout the study. The participant was asked to consider their experience with nasal polyposis/nasal polyps over the past 24 hours when responding to each question. Participants were asked to report their experience with nasal polyposis symptoms (nasal blockage, nasal congestion, runny nose, postnasal drip (mucus drainage down the throat), headache, facial pain, facial pressure, difficulty with sense of smell). Participants reported the severity of each symptom and symptom impact at its worst using a 4-point verbal rating scale (0-None to 3-Severe). A total symptom score (range from 0 to 24) was calculated by taking the sum of the 8 equally weighted symptom items. Higher scores indicate greater symptom severity. | Full analysis set (All randomized participants who received at least one dose of IP). | Posted | Least Squares Mean | 95% Confidence Interval | Score | Baseline to Week 52 |
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| Secondary | Change From Baseline in Pre-bronchodilator Forced Expiratory Volume (L) in 1 Second at Week 52. | For participants with comorbid asthma and aspirin exacerbated respiratory disease (AERD)/nonsteroidal anti-inflammatory drug exacerbated respiratory disease (NSAID-ERD), difference in change from baseline in pre-bronchodilator forced expiratory volume in 1 second (FEV1) in the tezepelumab arm as compared to placebo at Week 52. FEV1 is defined as the volume of air exhaled from the lungs in the first second of forced expiration. | co-morbid asthma/AERD/NSAID-ERD subset (All randomized participants who baseline co-morbid asthma/AERD/NSAID-ERD=Yes). | Posted | Mean | 95% Confidence Interval | Liter | Baseline to Week 52 |
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| Other Pre-specified | Change From Baseline Over Time in Nasal Polyp Score Through Week 52. | The total nasal polyp score (NPS) is the sum of the right and left nostril scores (maximum of 8), as evaluated by nasal endoscopy. Higher scores indicate greater symptom severity. The left and right score will be based on a central read with a scale from 0 to 4. Each nasal endoscopy is evaluated by two independent physician reviewers. | Full analysis set (All randomized participants who received at least one dose of IP). | Posted | Least Squares Mean | 95% Confidence Interval | Score | Baseline to Week 52 |
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| Other Pre-specified | Proportion of Participants With ≥1 Point Reduction in the Nasal Polyp Score at Week 52 | The Nasal Polyp Score is the sum of the right and left nostril scores (maximum 8), as evaluated by nasal endoscopy. A participant with ≥1 point reduction in NPS at Week 52 in the absence of SCS for NP, biologic for NP, or NP surgery at or prior to that time point was defined as a responder, otherwise the participant was defined as a non-responder. | Posted | Count of Participants | Participants | Baseline to Week 52 |
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| Other Pre-specified | Proportion of Participants With ≥2 Point Reduction in the Nasal Polyp Score at Week 52 | The Nasal Polyp Score is the sum of the right and left nostril scores (maximum 8), as evaluated by nasal endoscopy. A participant with ≥2 point reduction in NPS at Week 52 in the absence of SCS for NP, biologic for NP, or NP surgery at or prior to that time point was defined as a responder, otherwise the participant was defined as a non-responder. | Posted | Count of Participants | Participants | Baseline to Week 52 |
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| Other Pre-specified | Change From Baseline Over Time in Bi-weekly Mean Nasal Congestion Score Evaluated by Nasal Polyposis Symptom Diary Through Week 52. | The NCS is captured by one item in the NPSD (nasal polyps symptom diary) asking participants to rate the severity of their worst NC over the past 24 hours using the following response options: 0 - None; 1 - Mild; 2 - Moderate; 3 - Severe. Baseline will be the mean of daily responses from Day -13 to Day 0. Bi-weekly (14-day) mean NCS will be calculated if at least 8 days in each 14-day period has evaluable data; otherwise the bi-weekly mean is set to missing. | Full analysis set (All randomized participants who received at least one dose of IP). | Posted | Least Squares Mean | 95% Confidence Interval | Score | Baseline to Week 52 |
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| Other Pre-specified | Change From Baseline in Loss of Smell Evaluated by University of Pennsylvania Smell Identification Test (UPSIT) at Week 52. | The University of Pennsylvania Smell Identification Test is a quantitative test of olfactory function which uses microencapsulated odorants that are released by scratching standardized odour-impregnated test booklets. Scores are based on number of correctly identified odours (score range 0-40, lower scores indicate poorer outcomes). | Full analysis set (All randomized participants who received at least one dose of IP). | Posted | Least Squares Mean | 95% Confidence Interval | Score | Baseline to Week 52 |
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| Other Pre-specified | Change From Baseline in Modified Lund Mackay Score Evaluated by CT at Week 52. | The Modified Lund-Mackay score scoring system was used to provide a semi-quantitative assessment of nasal sinuses on sinus CT scans. Based on the sinus CT images, the five sinuses (maxillary, anterior ethmoid, posterior ethmoid, sphenoid, and frontal) on each side were scored. Each sinus on each side was scored based on the percentage of opacification from mucosal thickening according to matrix: (score 0 for 0% Opacification; score 1 for 1-25% Opacification; score 2 for 26-50% Opacification; score 3 for 51-75% Opacification; score 4 for 76-99% Opacification; score 5 for 100% Opacification). The range of total Modified Lund Mackay score is from 0 to 50. Higher scores indicate greater symptom severity. | Full analysis set (All randomized participants who received at least one dose of IP). | Posted | Least Squares Mean | 95% Confidence Interval | Score | Baseline to Week 52 |
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| Other Pre-specified | Change From Baseline in Sinus Severity Score by Quantitative CT Assessment at Week 52 | Quantitative assessment of sinus CT image data were used to derive an objective measure of sinus disease burden called sinus severity score. The sinus severity score is defined as: (sinus mucosal volume)/(sinus mucosal volume + sinus air volume)×100%. The range of sinus severity score is 0 to 100. Higher scores indicate greater symptom severity. | Full analysis set (All randomized participants who received at least one dose of IP). | Posted | Least Squares Mean | 95% Confidence Interval | Score | Baseline to Week 52 |
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| Other Pre-specified | Exposure of Systemic Corticosteroids Over 52 Weeks | The number of courses of SCS for NP per year was analysed using a negative binomial model. The response variable was the number of courses of SCS for NP received by a participant over the planned treatment period. The model included treatment group, baseline co-morbid asthma/AERD/NSAID-ERD status, prior NP surgery status, and region as factors. The logarithm of the time at risk (in years) was used as an offset variable, to adjust different follow-up times. Time during a course was not included in the calculation of time at risk. | Posted | Least Squares Mean | 95% Confidence Interval | SCS courses per year | Over 52 weeks |
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| Other Pre-specified | Change From Baseline by Domain of the Nasal Polyposis Symptom Diary Through Week 52 | The participant will complete an 11-item nasal polyposis symptom diary each morning throughout the screening, treatment and follow-up periods. The participant is asked to consider their experience with nasal polyposis/nasal polyps over the past 24 hours when responding to each question. Participants are asked to report their experience with nasal polyposis symptoms (nasal blockage, nasal congestion, runny nose, postnasal drip (mucus drainage down the throat), headache, facial pain, facial pressure, and difficulty with sense of smell) and symptom impacts (difficulty with sleeping due to nasal symptoms and difficulty with daily activities due to nasal symptoms). Participants report the severity of each symptom and symptom impact at its worst using a 4-point verbal rating scale (0-None to 3-Severe). | Full analysis set (All randomized participants who received at least one dose of IP). | Posted | Least Squares Mean | 95% Confidence Interval | Score | Baseline to Week 52 |
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| Other Pre-specified | Change From Baseline in Nasal Peak Inspiratory Flow Through Week 52. | Nasal peak inspiratory flow evaluation represents a physiologic measure of the air flow through both nasal cavities during forced inspiration expressed in liters per minute. | Full analysis set (All randomized participants who received at least one dose of IP). | Posted | Least Squares Mean | 95% Confidence Interval | Liters per minute. | Baseline to Week 52 |
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| Other Pre-specified | Change From Baseline in Asthma Control Questionnaire-6 at Week 52. | The Asthma Control Questionnaire is an assessment of asthma symptoms (nighttime waking, symptoms on waking, activity limitation, shortness of breath, wheezing, and short acting beta-agonist use). Participants are asked to recall their level of asthma control during the previous week by responding to one bronchodilator use question and 5 symptom questions. Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). | Co-morbid asthma/AERD/NSAID-ERD subset | Posted | Least Squares Mean | 95% Confidence Interval | Score | Baseline to Week 52 |
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| Other Pre-specified | Tezepelumab Pharmacokinetics | Serum concentrations of tezepelumab through Week 64. Logarithm transformation was used when calculating geometric mean of serum concentrations. The results were transformed back to original scale. | PK Analysis Set (all participants who received tezepelumab and had at least one detectable tezepelumab serum concentration from a sample collected post-treatment that is assumed not to be affected by factors such as protocol deviations). Number analysed at each timepoint is a subset of this based on subjects who had sample results available at that timepoint after analysis window is applied. 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 36, Week 52, and Week 64 |
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| Other Pre-specified | Immunogenicity of Tezepelumab for Non-China Subjects | Anti-drug antibodies (ADA) responses at baseline and post-baseline. ADA prevalence was defined as patients who are ADA positive at any time including baseline. Persistently positive was defined as having at least two post-baseline ADA positive measurements (with ≥16 weeks between first and last positive) or an ADA positive result at the last available post-baseline assessment. Transiently positive was defined as having at least one post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. Treatment boosted ADA was defined as baseline positive ADA titre that was boosted to a 4-fold or higher-level following treatment. Treatment emergent ADA (ADA incidence) was defined as the sum of treatment induced ADA and treatment boosted ADA. | Non-China subjects in Safety analysis set (All participants who received at least one dose of IP). Number analysed of each ADA category is a subset of this based on subjects who met the definition and had sample results available after analysis window is applied. | Posted | Number | Participants | Pre-dose samples at Baseline to Week 64 |
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| Other Pre-specified | Immunogenicity of Tezepelumab for China Subjects | Anti-drug antibodies (ADA) responses at baseline and post-baseline. ADA prevalence was defined as patients who are ADA positive at any time including baseline. Persistently positive was defined as having at least two post-baseline ADA positive measurements (with ≥16 weeks between first and last positive) or an ADA positive result at the last available post-baseline assessment. Transiently positive was defined as having at least one post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. Treatment boosted ADA was defined as baseline positive ADA titre that was boosted to a 4-fold or higher-level following treatment. Treatment emergent ADA (ADA incidence) was defined as the sum of treatment induced ADA and treatment boosted ADA. | China subjects in Safety analysis set (All participants who received at least one dose of IP). Number analysed of each ADA category is a subset of this based on subjects who met the definition and had sample results available after analysis window is applied. | Posted | Number | Participants | Pre-dose samples at Baseline to Week 64 |
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From visit 1 (the date of the first study procedure) until end of study up to week 76.
For analysis of Adverse Events Safety analysis set is used. Safety analysis set : All randomized participants who received at least one dose of study drug.
AEs occurring during run-in period: date of Visit 1 ≤ AE onset date < date of first dose of IP.
AEs occurring during on-study period: date of first dose of IP ≤ AE onset date ≤ study completion or withdrawal date.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Run-in Period | Background mometasone furoate (MFNS) or equivalent intranasal corticosteroid (INCS) only. | 0 | 408 | 0 | 408 | 20 | 408 |
| EG001 | Tezepelumab | 210 mg tezepelumab injection delivered subcutaneously every 4 weeks + background MFNS/INCS. | 0 | 203 | 11 | 203 | 119 | 203 |
| EG002 | Placebo | Matching Placebo injection delivered subcutaneously every 4 weeks + background MFNS/INCS. | 1 | 205 | 14 | 205 | 119 | 205 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaphylactic shock | Immune system disorders | MedDRA version 27.0 | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA version 27.0 | Systematic Assessment |
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| Arthritis bacterial | Infections and infestations | MedDRA version 27.0 | Systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA version 27.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA version 27.0 | Systematic Assessment |
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| Myocardial ischaemia | Cardiac disorders | MedDRA version 27.0 | Systematic Assessment |
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| Encephalitis | Infections and infestations | MedDRA version 27.0 | Systematic Assessment |
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| Myopericarditis | Cardiac disorders | MedDRA version 27.0 | Systematic Assessment |
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| Escherichia urinary tract infection | Infections and infestations | MedDRA version 27.0 | Systematic Assessment |
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| Otitis media | Infections and infestations | MedDRA version 27.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 27.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA version 27.0 | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA version 27.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA version 27.0 | Systematic Assessment |
| |
| Invasive lobular breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.0 | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.0 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.0 | Systematic Assessment |
| |
| Basal ganglia stroke | Nervous system disorders | MedDRA version 27.0 | Systematic Assessment |
| |
| Graves' disease | Endocrine disorders | MedDRA version 27.0 | Systematic Assessment |
| |
| Intracranial aneurysm | Nervous system disorders | MedDRA version 27.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.0 | Systematic Assessment |
| |
| Epiretinal membrane | Eye disorders | MedDRA version 27.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA version 27.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA version 27.0 | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | MedDRA version 27.0 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA version 27.0 | Systematic Assessment |
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| Anaphylactic reaction | Immune system disorders | MedDRA version 27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA version 27.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA version 27.0 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA version 27.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA version 27.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 27.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.0 | Systematic Assessment |
| |
| Chronic rhinosinusitis with nasal polyps | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.0 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.0 | Systematic Assessment |
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The Institution and/or the Principal Investigator shall not include in or shall remove from any proposed publication any Confidential Information, errors or inaccuracies; and shall withhold publication, submission for publication or presentation for a period of ninety (90) days from the date on which the Company receives the material to allow the Company to take such measures as the Company considers necessary to preserve its proprietary rights and/or protect its Confidential Information.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Lead | AstraZeneca | 1-877-240-9479 | information.center@astrazeneca.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 21, 2024 | Sep 16, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D009298 | Nasal Polyps |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068656 | Mometasone Furoate |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| White |
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| Native Hawaiian or other Pacific Islander |
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| American Indian or Alaska Native |
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| Asian |
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| Other |
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| Not reported |
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For participants whose NPS data collected after NP surgery were replaced with the worst possible score (WPS). Data collected after SCS for NP were replaced with the worst post-baseline observation prior to the SCS for NP (WOCF). Missing data not due to intercurrent events were imputed using MI (MAR). Analysis was repeated on 100 imputed datasets, and results were combined using Rubin's formula.
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