Ages Eligible for Study: | 18 Years
to 75 Years |
Genders Eligible for Study: | Both |
Gender Based: | No |
Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subject must be 18 to 75 years of age.
- Documented physician-diagnosed asthma for at least 12 months.
- Subjects who have received a physician- prescribed asthma controller medication with medium or high dose ICS for at least 12 months; must be stable for at least 3 months prior to screening visit.
- At least one additional maintenance asthma controller medication is required according to standard practice of care and must be documented for at least 3 months.
-At enrolment, the subject must have a predicted normal value for the morning pre-bronchodilator FEV1>50% and more than 1L.
- Evidence of asthma as documented by reversibility of FEV1 ≥12% and ≥200 mL in the previous 12 months prior to screening, or during the screening period prior to randomization.
- ACQ-6 score ≥ 1.5 during the screening period prior to randomization.
Principal Exclusion Criteria:
- Any clinically important pulmonary disease other than asthma.
- History of cancer.
- Hospitalization or required OCS for asthma exacerbation within 6 weeks of enrolment or >3 exacerbations requiring OCS or hospitalization in the year prior to visit 1 or who had been intubated or admitted to ICU for asthma exacerbation in the year prior to enrolment.
- History of a clinically significant infection, including upper (URTI) or lower respiratory tract infection (LRTI), requiring treatment with antibiotics or antiviral medications finalized <2 weeks before visit 1 or during the run-in period.
- Current smokers or subjects with smoking history ≥10 pack-yrs, including e-cigarettes. Former smokers with a smoking history of <10 pack-yrs must have stopped for at least 6 months prior to visit 1, including e-cigarette use.
- History of chronic alcohol or drug abuse within 12 months prior to visit 1.
-Tuberculosis requiring treatment within 12 months prior to visit 1.
- History of known immunodeficiency disorder including a positive HIV test at visit 1, or the subject is taking antiretroviral medications as determined by medical history and/or subject's verbal report.
- History of anaphylaxis or documented immune complex disease (type III hypersensitivity reactions) following any biologic therapy
Subject randomized in a previous Tezepelumab study or in a current study with another investigational product.
-Pregnant, breastfeeding or lactating women.
Contacts
Contact:
AstraZeneca Clinical
Study Information Center
| 1-877-240-9479
| [email protected]
| |
Sponsors and Collaborators
AstraZeneca
Amgen
Investigators
Principal Investigator:
| Chris
Brightling |
| University of Leicester, United Kingdom |
Locations
Country | Location | Facility | Contact | Status | Canada
, AB | Research Site | Calgary,
AB,
Canada,
T2N 4Z6 | | Completed |
Canada
, BC | Research Site | Vancouver,
BC,
Canada,
V5Z 1M9 | | Completed |
United States of America
, TX | Research Site | Galveston,
TX,
United States of America,
77555 | | Completed |
United States of America
, MA | Research Site | Boston,
MA,
United States of America,
02115 | | Completed |
United States of America
, PA | Research Site | Pittsburgh,
PA,
United States of America,
15213 | | Completed |
Germany | Research Site | Frankfurt,
Germany,
60596 | | Completed |
Germany | Research Site | Frankfurt/Main,
Germany,
60389 | | Completed |
Germany | Research Site | Grosshansdorf,
Germany,
22927 | | Completed |
Germany | Research Site | Landsberg,
Germany,
86899 | | Completed |
United Kingdom | Research Site | Cambridge,
United Kingdom,
CB2 0QQ | | Completed |
United Kingdom | Research Site | Headington,
United Kingdom,
OX3 9DU | | Completed |
United Kingdom | Research Site | Leicester,
United Kingdom,
LE3 9QP | | Completed |
United Kingdom | Research Site | Liverpool,
United Kingdom,
L7 8XP | | Withdrawn |
United Kingdom | Research Site | London,
United Kingdom,
W1G 8HU | | Completed |
United Kingdom | Research Site | Nottingham,
United Kingdom,
NG5 1PB | | Completed |
United Kingdom | Research Site | Wythenshawe,
United Kingdom,
M23 9QZ | | Completed |
United States of America
, CO | Research Site | Denver,
CO,
United States of America,
80206 | | Completed |
United States of America
, CT | Research Site | New Haven,
CT,
United States of America,
06510 | | Completed |
Canada
, QC | Research Site | Montreal,
QC,
Canada,
H4A 3J1 | | Completed |
Canada
, QC | Research Site | Quebec,
QC,
Canada,
G1V 4G5 | | Completed |
Denmark | Research Site | Aarhus N,
Denmark,
8200 | | Completed |
Denmark | Research Site | Ålborg,
Denmark,
9000 | | Completed |
Denmark | Research Site | Hvidovre,
Denmark,
2650 | | Completed |
Denmark | Research Site | København NV,
Denmark,
2400 | | Completed |
Denmark | Research Site | Naestved,
Denmark,
4700 | | Completed |
Denmark | Research Site | Odense C,
Denmark,
5000 | | Completed |
Denmark | Research Site | Vejle,
Denmark,
7100 | | Completed |
Canada
, ON | Research Site | Hamilton,
ON,
Canada,
L8N 3Z5 | | Completed |
Canada
, ON | Research Site | Ottawa,
ON,
Canada,
K1H 8L6 | | Completed |
Participant Flow
Recruitment Details
Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations
|
---|
116 subjects randomized to Tezepelumab 210 mg Q4W or Placebo in 1:1 treatment allocation. All randomized subjects were treated. |
Pre-Assignment Details
Significant events and approaches for the overall
study following participant enrollment, but prior to group assignment
|
---|
The study randomized subjects across the spectrum of T2 status. Randomization was stratified by screening blood eosinophil level (<150 , 150 - <300, >=300 cells/µL). |
Reporting Groups
| Description |
---|
Teze 210 mg Q4W | Tezepelumab subcutaneous injection |
---|
Placebo | Placebo subcutaneous injection |
---|
Participant Flow: Overall Study
| Teze 210 mg Q4W | Placebo |
---|
STARTED | 59 | 57 |
---|
COMPLETED | 58 | 56 |
---|
NOT COMPLETED | 1 | 1 |
---|
Adverse Event
| 0 | 1 |
---|
Other
| 1 | 0 |
---|
Baseline Characteristics
Analysis Population Description --
Explanation of how the number of participants for analysis was determined.Full Analysis Set - Include all subjects randomised to study treatment who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study.
Reporting Groups
| Description |
---|
Teze 210 mg Q4W | Tezepelumab subcutaneous injection |
---|
Placebo | Placebo subcutaneous injection |
---|
Baseline Measures
| Teze 210 mg Q4W | Placebo | Total |
---|
Number of Participants
[units: Participants]
| 59 | 57 | 116 |
---|
Age Continuous
[1]
[units: Years]
Mean ± Standard Deviation |
---|
Age Categorical
[2]
[units: Participants]
|
---|
|
|
|
Sex: Female, Male
[3]
[units: Participants]
|
---|
|
|
Race/Ethnicity, Customized
[4]
[units: Participants]
|
---|
|
|
|
|
Race/Ethnicity, Customized
[5]
[units: Participants]
|
---|
|
|
Outcome Measures
1. Primary Outcome Measure: Airway submucosal inflammatory cells ratio change from baseline to EOT. [ Time Frame: First dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic). ]
Measure Type | Primary |
---|
Measure Name | Airway submucosal inflammatory cells ratio change from baseline to EOT. |
---|
Measure Description | The change from baseline to end of treatment (EOT) expressed as a ratio i.e. (EOT/baseline) in numbers of each of the airway submucosal inflammatory cells, determined by microscopic evaluation of bronchoscopic biopsies. |
---|
Time Frame | First dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic). |
---|
Safety Issue? | No |
---|
Population Description
Explanation of how the number of
participants for analysis was determined. Includes whether analysis was per protocol,
intention to treat, or another method. Also provides relevant details such as imputation
technique, as appropriate.
|
---|
Number of Participants Analyzed are all subjects randomized to study treatment who completed at least 20 weeks of study treatment and had an EOT visit not greater than 8 weeks after date of last dose of IP. In order to be included in analysis, the participants also had to have a non-missing baseline as well as a non-missing EOT assessment for the respective variable. |
Reporting Groups
| Description |
---|
Teze 210 mg Q4W | Tezepelumab subcutaneous injection |
---|
Placebo | Placebo subcutaneous injection |
---|
Measured Values
| Teze 210 mg Q4W | Placebo |
---|
Number of
Participants Analyzed
[units:participants]
| 54 | 56 |
---|
Airway submucosal inflammatory cells ratio change from baseline to EOT.
[units: Ratio] Geometric Least Squares Mean (90% Confidence Interval)
| | |
---|
Eosinophils | 0.11
(0.06 to 0.21)
| 0.75
(0.41 to 1.38)
|
Neutrophils | 1.11
(0.88 to 1.39)
| 0.81
(0.66 to 1.01)
|
T cells CD3+ | 0.91
(0.78 to 1.07)
| 0.81
(0.70 to 0.95)
|
T cells CD4+ | 0.96
(0.82 to 1.14)
| 0.81
(0.70 to 0.95)
|
Mast cells Tryptase+ | 0.84
(0.70 to 1.02)
| 1.01
(0.84 to 1.22)
|
Mast cells Chymase+ | 1.07
(0.76 to 1.52)
| 0.90
(0.65 to 1.26)
|
Statistical Analysis 1 for Airway submucosal inflammatory cells ratio change from baseline to EOT.
Groups
[1]
|
All groups
|
---|
Method
[3]
| ANCOVA |
---|
P-Value
[4]
| <0.001 |
---|
Other
[5]
| 0.15 |
---|
90% Confidence Interval | ( 0.06 to 0.35 ) |
---|
Statistical Analysis 2 for Airway submucosal inflammatory cells ratio change from baseline to EOT.
Groups
[1]
|
All groups
|
---|
Method
[3]
| ANCOVA |
---|
P-Value
[4]
| 0.106 |
---|
Other
[5]
| 1.36 |
---|
90% Confidence Interval | ( 0.99 to 1.86 ) |
---|
Statistical Analysis 3 for Airway submucosal inflammatory cells ratio change from baseline to EOT.
Groups
[1]
|
All groups
|
---|
Method
[3]
| ANCOVA |
---|
P-Value
[4]
| 0.389 |
---|
Other
[5]
| 1.12 |
---|
90% Confidence Interval | ( 0.90 to 1.40 ) |
---|
Statistical Analysis 4 for Airway submucosal inflammatory cells ratio change from baseline to EOT.
Groups
[1]
|
All groups
|
---|
Method
[3]
| ANCOVA |
---|
P-Value
[4]
| 0.216 |
---|
Other
[5]
| 1.18 |
---|
90% Confidence Interval | ( 0.94 to 1.48 ) |
---|
Statistical Analysis 5 for Airway submucosal inflammatory cells ratio change from baseline to EOT.
Groups
[1]
|
All groups
|
---|
Method
[3]
| ANCOVA |
---|
P-Value
[4]
| 0.260 |
---|
Other
[5]
| 0.83 |
---|
90% Confidence Interval | ( 0.64 to 1.09 ) |
---|
Statistical Analysis 6 for Airway submucosal inflammatory cells ratio change from baseline to EOT.
Groups
[1]
|
All groups
|
---|
Method
[3]
| ANCOVA |
---|
P-Value
[4]
| 0.546 |
---|
Other
[5]
| 1.19 |
---|
90% Confidence Interval | ( 0.74 to 1.92 ) |
---|
2. Secondary Outcome Measure: Reticular basement membrane (RBM) thickness ratio change from baseline to EOT. [ Time Frame: First dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic). ]
Measure Type | Secondary |
---|
Measure Name | Reticular basement membrane (RBM) thickness ratio change from baseline to EOT. |
---|
Measure Description | The change from baseline to EOT expressed as a ratio i.e. (EOT/baseline) in RBM thickness, determined by microscopic evaluation of bronchoscopic biopsies. |
---|
Time Frame | First dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic). |
---|
Safety Issue? | No |
---|
Population Description
Explanation of how the number of
participants for analysis was determined. Includes whether analysis was per protocol,
intention to treat, or another method. Also provides relevant details such as imputation
technique, as appropriate.
|
---|
All subjects randomised to study treatment who completed at least 20 weeks of study treatment and had a baseline assessment and an EOT assessment not greater than 8 weeks after date of last dose of IP. |
Reporting Groups
| Description |
---|
Teze 210 mg Q4W | Tezepelumab subcutaneous injection |
---|
Placebo | Placebo subcutaneous injection |
---|
Measured Values
| Teze 210 mg Q4W | Placebo |
---|
Number of
Participants Analyzed
[units:participants]
| 42 | 40 |
---|
Reticular basement membrane (RBM) thickness ratio change from baseline to EOT.
[units: Ratio] Geometric Least Squares Mean (90% Confidence Interval)
| 0.87
(0.79 to 0.95)
| 0.90
(0.81 to 0.99)
|
---|
3. Secondary Outcome Measure: Percent (%) airway epithelial integrity ratio change from baseline to EOT. [ Time Frame: First dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic). ]
Measure Type | Secondary |
---|
Measure Name | Percent (%) airway epithelial integrity ratio change from baseline to EOT. |
---|
Measure Description | The change from baseline to EOT expressed as a ratio i.e. (EOT/baseline) in % airway epithelial, determined by microscopic evaluation of bronchoscopic biopsies. |
---|
Time Frame | First dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic). |
---|
Safety Issue? | No |
---|
Population Description
Explanation of how the number of
participants for analysis was determined. Includes whether analysis was per protocol,
intention to treat, or another method. Also provides relevant details such as imputation
technique, as appropriate.
|
---|
Number of Participants Analyzed are all subjects randomized to study treatment who completed at least 20 weeks of study treatment and had an EOT visit not greater than 8 weeks after date of last dose of IP. In order to be included in analysis, the participants also had to have a non-missing baseline as well as a non-missing EOT assessment for the respective variable. |
Reporting Groups
| Description |
---|
Teze 210 mg Q4W | Tezepelumab subcutaneous injection |
---|
Placebo | Placebo subcutaneous injection |
---|
Measured Values
| Teze 210 mg Q4W | Placebo |
---|
Number of
Participants Analyzed
[units:participants]
| 54 | 56 |
---|
Percent (%) airway epithelial integrity ratio change from baseline to EOT.
[units: Ratio] Geometric Least Squares Mean (90% Confidence Interval)
| | |
---|
Intact epithelium | 0.87
(0.61 to 1.23)
| 0.84
(0.59 to 1.19)
|
Damaged epithelium | 1.01
(0.92 to 1.12)
| 0.95
(0.86 to 1.04)
|
Denuded epithelium | 1.05
(0.83 to 1.31)
| 1.34
(1.07 to 1.68)
|
Serious Adverse Events
Time Frame | From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic). |
---|
Additional Description | No text entered. |
---|
Reporting Groups
| Description |
---|
Placebo | Placebo subcutaneous injection |
---|
Teze 210 mg Q4W | Tezepelumab subcutaneous injection |
---|
Serious Adverse Events
| Placebo | Teze 210 mg Q4W |
---|
Total,
serious adverse events
| | |
---|
# participants
affected / at risk
| 7/57 (12.28%) | 3/59 (5.08%) |
Cardiac disorders | | |
---|
Myocarditis1, † | | |
# participants affected / at risk | 1/57 (1.75%) | 0/59 (0.00%) |
# events | 1 | 0 |
Gastrointestinal disorders | | |
---|
Abdominal pain1, † | | |
# participants affected / at risk | 1/57 (1.75%) | 0/59 (0.00%) |
# events | 1 | 0 |
Gastrointestinal disorders | | |
---|
Gastrooesophageal reflux disease1, † | | |
# participants affected / at risk | 0/57 (0.00%) | 1/59 (1.69%) |
# events | 0 | 1 |
Gastrointestinal disorders | | |
---|
Hiatus hernia1, † | | |
# participants affected / at risk | 0/57 (0.00%) | 1/59 (1.69%) |
# events | 0 | 1 |
Infections and infestations | | |
---|
Influenza1, † | | |
# participants affected / at risk | 0/57 (0.00%) | 1/59 (1.69%) |
# events | 0 | 1 |
Injury, poisoning and procedural complications | | |
---|
Post procedural complication1, † | | |
# participants affected / at risk | 2/57 (3.51%) | 0/59 (0.00%) |
# events | 2 | 0 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | | |
---|
Meningioma1, † | | |
# participants affected / at risk | 0/57 (0.00%) | 1/59 (1.69%) |
# events | 0 | 1 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | | |
---|
Pancreatic carcinoma1, † | | |
# participants affected / at risk | 1/57 (1.75%) | 0/59 (0.00%) |
# events | 1 | 0 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | | |
---|
Squamous cell carcinoma1, † | | |
# participants affected / at risk | 1/57 (1.75%) | 0/59 (0.00%) |
# events | 1 | 0 |
Renal and urinary disorders | | |
---|
Urinary retention1, † | | |
# participants affected / at risk | 1/57 (1.75%) | 0/59 (0.00%) |
# events | 1 | 0 |
Respiratory, thoracic and mediastinal disorders | | |
---|
Asthma1, † | | |
# participants affected / at risk | 1/57 (1.75%) | 0/59 (0.00%) |
# events | 1 | 0 |
|
Other Adverse Events
Time Frame | From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic). |
---|
Additional Description | No text entered. |
---|
Frequency Threshold
Threshold above which other adverse events are reported
| 3%
|
---|
Reporting Groups
| Description |
---|
Placebo | Placebo subcutaneous injection |
---|
Teze 210 mg Q4W | Tezepelumab subcutaneous injection |
---|
Other Adverse Events
| Placebo | Teze 210 mg Q4W |
---|
Total, other (not including serious) adverse events
| | |
---|
# participants affected / at risk
| 45/57 (78.95%) | 48/59 (81.36%) |
Eye disorders | | |
---|
Dry eye1, † | | |
# participants affected / at risk | 0/57 (0.00%) | 2/59 (3.39%) |
# events | 0 | 2 |
Gastrointestinal disorders | | |
---|
Diarrhoea1, † | | |
# participants affected / at risk | 0/57 (0.00%) | 5/59 (8.47%) |
# events | 0 | 6 |
Gastrointestinal disorders | | |
---|
Nausea1, † | | |
# participants affected / at risk | 2/57 (3.51%) | 2/59 (3.39%) |
# events | 2 | 2 |
Gastrointestinal disorders | | |
---|
Vomiting1, † | | |
# participants affected / at risk | 3/57 (5.26%) | 2/59 (3.39%) |
# events | 3 | 2 |
General disorders and administration site conditions | | |
---|
Influenza like illness1, † | | |
# participants affected / at risk | 3/57 (5.26%) | 3/59 (5.08%) |
# events | 3 | 3 |
General disorders and administration site conditions | | |
---|
Injection site erythema1, † | | |
# participants affected / at risk | 2/57 (3.51%) | 5/59 (8.47%) |
# events | 12 | 14 |
General disorders and administration site conditions | | |
---|
Injection site granuloma1, † | | |
# participants affected / at risk | 0/57 (0.00%) | 2/59 (3.39%) |
# events | 0 | 2 |
General disorders and administration site conditions | | |
---|
Injection site pruritus1, † | | |
# participants affected / at risk | 1/57 (1.75%) | 4/59 (6.78%) |
# events | 1 | 5 |
General disorders and administration site conditions | | |
---|
Oedema peripheral1, † | | |
# participants affected / at risk | 0/57 (0.00%) | 3/59 (5.08%) |
# events | 0 | 3 |
General disorders and administration site conditions | | |
---|
Pyrexia1, † | | |
# participants affected / at risk | 0/57 (0.00%) | 3/59 (5.08%) |
# events | 0 | 3 |
Infections and infestations | | |
---|
Bronchitis1, † | | |
# participants affected / at risk | 0/57 (0.00%) | 2/59 (3.39%) |
# events | 0 | 2 |
Infections and infestations | | |
---|
Candida infection1, † | | |
# participants affected / at risk | 0/57 (0.00%) | 2/59 (3.39%) |
# events | 0 | 2 |
Infections and infestations | | |
---|
Chronic sinusitis1, † | | |
# participants affected / at risk | 2/57 (3.51%) | 0/59 (0.00%) |
# events | 2 | 0 |
Infections and infestations | | |
---|
Conjunctivitis1, † | | |
# participants affected / at risk | 0/57 (0.00%) | 2/59 (3.39%) |
# events | 0 | 2 |
Infections and infestations | | |
---|
Gastroenteritis1, † | | |
# participants affected / at risk | 2/57 (3.51%) | 1/59 (1.69%) |
# events | 2 | 1 |
Infections and infestations | | |
---|
Lower respiratory tract infection1, † | | |
# participants affected / at risk | 1/57 (1.75%) | 2/59 (3.39%) |
# events | 1 | 2 |
Infections and infestations | | |
---|
Lower respiratory tract infection bacterial1, † | | |
# participants affected / at risk | 2/57 (3.51%) | 1/59 (1.69%) |
# events | 2 | 1 |
Infections and infestations | | |
---|
Nasopharyngitis1, † | | |
# participants affected / at risk | 21/57 (36.84%) | 22/59 (37.29%) |
# events | 22 | 28 |
Infections and infestations | | |
---|
Oral candidiasis1, † | | |
# participants affected / at risk | 0/57 (0.00%) | 2/59 (3.39%) |
# events | 0 | 4 |
Infections and infestations | | |
---|
Pneumonia1, † | | |
# participants affected / at risk | 1/57 (1.75%) | 2/59 (3.39%) |
# events | 1 | 2 |
Infections and infestations | | |
---|
Rhinitis1, † | | |
# participants affected / at risk | 2/57 (3.51%) | 1/59 (1.69%) |
# events | 2 | 1 |
Infections and infestations | | |
---|
Sinusitis1, † | | |
# participants affected / at risk | 2/57 (3.51%) | 0/59 (0.00%) |
# events | 2 | 0 |
Infections and infestations | | |
---|
Tonsillitis1, † | | |
# participants affected / at risk | 0/57 (0.00%) | 2/59 (3.39%) |
# events | 0 | 2 |
Infections and infestations | | |
---|
Upper respiratory tract infection1, † | | |
# participants affected / at risk | 4/57 (7.02%) | 3/59 (5.08%) |
# events | 4 | 3 |
Infections and infestations | | |
---|
Urinary tract infection1, † | | |
# participants affected / at risk | 2/57 (3.51%) | 3/59 (5.08%) |
# events | 5 | 4 |
Injury, poisoning and procedural complications | | |
---|
Contusion1, † | | |
# participants affected / at risk | 0/57 (0.00%) | 2/59 (3.39%) |
# events | 0 | 5 |
Injury, poisoning and procedural complications | | |
---|
Fall1, † | | |
# participants affected / at risk | 1/57 (1.75%) | 2/59 (3.39%) |
# events | 1 | 4 |
Injury, poisoning and procedural complications | | |
---|
Post procedural complication1, † | | |
# participants affected / at risk | 10/57 (17.54%) | 11/59 (18.64%) |
# events | 12 | 11 |
Injury, poisoning and procedural complications | | |
---|
Post procedural fever1, † | | |
# participants affected / at risk | 2/57 (3.51%) | 4/59 (6.78%) |
# events | 2 | 4 |
Injury, poisoning and procedural complications | | |
---|
Procedural pain1, † | | |
# participants affected / at risk | 0/57 (0.00%) | 3/59 (5.08%) |
# events | 0 | 3 |
Musculoskeletal and connective tissue disorders | | |
---|
Arthralgia1, † | | |
# participants affected / at risk | 3/57 (5.26%) | 3/59 (5.08%) |
# events | 4 | 3 |
Musculoskeletal and connective tissue disorders | | |
---|
Back pain1, † | | |
# participants affected / at risk | 2/57 (3.51%) | 2/59 (3.39%) |
# events | 2 | 2 |
Musculoskeletal and connective tissue disorders | | |
---|
Bursitis1, † | | |
# participants affected / at risk | 2/57 (3.51%) | 0/59 (0.00%) |
# events | 2 | 0 |
Musculoskeletal and connective tissue disorders | | |
---|
Musculoskeletal chest pain1, † | | |
# participants affected / at risk | 2/57 (3.51%) | 1/59 (1.69%) |
# events | 3 | 1 |
Musculoskeletal and connective tissue disorders | | |
---|
Myalgia1, † | | |
# participants affected / at risk | 1/57 (1.75%) | 3/59 (5.08%) |
# events | 1 | 3 |
Nervous system disorders | | |
---|
Headache1, † | | |
# participants affected / at risk | 8/57 (14.04%) | 6/59 (10.17%) |
# events | 8 | 9 |
Respiratory, thoracic and mediastinal disorders | | |
---|
Cough1, † | | |
# participants affected / at risk | 4/57 (7.02%) | 6/59 (10.17%) |
# events | 5 | 9 |
Respiratory, thoracic and mediastinal disorders | | |
---|
Dysphonia1, † | | |
# participants affected / at risk | 2/57 (3.51%) | 2/59 (3.39%) |
# events | 2 | 2 |
Respiratory, thoracic and mediastinal disorders | | |
---|
Nasal congestion1, † | | |
# participants affected / at risk | 2/57 (3.51%) | 1/59 (1.69%) |
# events | 2 | 1 |
Respiratory, thoracic and mediastinal disorders | | |
---|
Oropharyngeal pain1, † | | |
# participants affected / at risk | 2/57 (3.51%) | 6/59 (10.17%) |
# events | 2 | 6 |
Vascular disorders | | |
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Hypertension1, † | | |
# participants affected / at risk | 2/57 (3.51%) | 1/59 (1.69%) |
# events | 2 | 1 |
|
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
|
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
|
The agreement is:
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is less than or equal to 60 days.
The sponsor cannot require changes to the communication and cannot extend the embargo.
|
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is
more than 60 days but less than
or equal to 180 days
. The sponsor cannot require changes to the communication and cannot extend the embargo.
|
Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.
|
|
Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants
analyzed and technical problems with measurement leading to unreliable or uninterpretable data
|
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Results Point of Contact
Name/Title: | Globall Clinical Head |
Organization: | AstraZeneca |
Phone | +1 877-240-9479
|
E-mail: | [email protected] |
.