Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-02-24 @ 10:52 AM
Study NCT ID:
NCT03927157
Status:
COMPLETED
Last Update Posted:
2025-07-01
First Post:
2019-04-23
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate Tezepelumab in Adults With Severe Uncontrolled Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000622721', 'term': 'tezepelumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'information.center@astrazeneca.com', 'phone': '1-877-240-9479', 'title': 'Global Clinical Head', 'organization': 'AstraZeneca'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events is collected from time of signature of the informed consent form until end of study at Week 64.', 'eventGroups': [{'id': 'EG000', 'title': 'Tezepelumab 210mg Q4W', 'description': 'Tezepelumab administered every 4 weeks subcutaneously', 'otherNumAtRisk': 201, 'deathsNumAtRisk': 201, 'otherNumAffected': 114, 'seriousNumAtRisk': 201, 'deathsNumAffected': 0, 'seriousNumAffected': 16}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously', 'otherNumAtRisk': 199, 'deathsNumAtRisk': 199, 'otherNumAffected': 125, 'seriousNumAtRisk': 199, 'deathsNumAffected': 2, 'seriousNumAffected': 36}], 'otherEvents': [{'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 30, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 25, 'numAffected': 25}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 26, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 15, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Suspected covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 25, 'numAffected': 25}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 127, 'numAffected': 71}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 114, 'numAffected': 68}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 11, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 13, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}], 'seriousEvents': [{'term': 'Large intestine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Salivary gland mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Chronic sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Coronavirus pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Mastoiditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pneumonia pseudomonal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pneumonia respiratory syncytial viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Connective tissue disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Lumbar spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Neuroendocrine tumour of the lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Ischaemic cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Post-traumatic stress disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Adenomyosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Endometrial thickening', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Ovarian cyst ruptured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 9, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 27, 'numAffected': 17}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Nasal polyps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Nasal septum deviation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Nasal turbinate abnormality', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Myocardial bridging', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Rhinitis hypertrophic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Diabetic retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Annual Asthma Exacerbation Rate (AERR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tezepelumab 210mg Q4W', 'description': 'Tezepelumab administered every 4 weeks subcutaneously'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously'}], 'classes': [{'categories': [{'measurements': [{'value': '0.42', 'groupId': 'OG000', 'lowerLimit': '0.30', 'upperLimit': '0.59'}, {'value': '1.63', 'groupId': 'OG001', 'lowerLimit': '1.22', 'upperLimit': '2.19'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.26', 'ciLowerLimit': '0.17', 'ciUpperLimit': '0.39', 'statisticalMethod': 'Negative Binomial Regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Randomization to Week 52', 'description': 'The annual exacerbation rate is based on exacerbations reported by the investigator in the eCRF over 52 weeks', 'unitOfMeasure': 'Events per year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Pre-dose/Pre-bronchodilator (Pre-BD) Forced Expiratory Volume in 1 Second (FEV1) at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tezepelumab 210mg Q4W', 'description': 'Tezepelumab administered every 4 weeks subcutaneously'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously'}], 'classes': [{'categories': [{'measurements': [{'value': '0.35', 'spread': '0.029', 'groupId': 'OG000'}, {'value': '0.11', 'spread': '0.030', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.24', 'ciLowerLimit': '0.16', 'ciUpperLimit': '0.32', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Randomization to Week 52', 'description': 'Mean change from baseline in FEV1 as compared to placebo at Week 52. FEV1 is defined as the volume of air exhaled from the lungs in the first second of a forced expiration.', 'unitOfMeasure': 'Litre', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants from the Full Analysis Set with at least one change from baseline value at any post-baseline visit contributes to the analysis.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Standardized Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12) Total Score at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tezepelumab 210mg Q4W', 'description': 'Tezepelumab administered every 4 weeks subcutaneously'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously'}], 'classes': [{'categories': [{'measurements': [{'value': '1.29', 'spread': '0.074', 'groupId': 'OG000'}, {'value': '0.94', 'spread': '0.076', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Means Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.35', 'ciLowerLimit': '0.14', 'ciUpperLimit': '0.55', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Randomization to Week 52', 'description': 'Mean change from baseline in AQLQ(S)+12 as compared to placebo at Week 52. The AQLQ(S)+12 is a questionnaire that measures the health-related quality of life experienced by asthma participants. The total score is defined as the average of all 32 questions in the AQLQ(S)+12 questionnaire. AQLQ(S)+12 is a 7-point scale questionnaire, ranging from 7 (no impairment) to 1 (severe impairment).', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants from the Full Analysis Set with at least one change from baseline value at any post-baseline visit contribute to the analysis.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6) Score at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tezepelumab 210mg Q4W', 'description': 'Tezepelumab administered every 4 weeks subcutaneously'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.34', 'spread': '0.058', 'groupId': 'OG000'}, {'value': '-1.03', 'spread': '0.059', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Means Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.31', 'ciLowerLimit': '-0.47', 'ciUpperLimit': '-0.15', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Randomization to Week 52', 'description': 'Mean change from baseline in ACQ-6 as compared to placebo at Week 52. The ACQ-6 captures asthma symptoms and short-acting β2-agonist use via subject-report. Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The ACQ-6 score is the mean of the responses.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants from the Full Analysis Set with at least one change from baseline value at any post-baseline visit contribute to the analysis.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Weekly Mean Daily Asthma Symptom Diary Score at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tezepelumab 210mg Q4W', 'description': 'Tezepelumab administered every 4 weeks subcutaneously'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.61', 'spread': '0.036', 'groupId': 'OG000'}, {'value': '-0.44', 'spread': '0.037', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Means Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.16', 'ciLowerLimit': '-0.27', 'ciUpperLimit': '-0.06', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Randomization to Week 52', 'description': 'Mean change from baseline in Asthma Symptom Diary score as compared to placebo at Week 52. The Asthma Symptom Diary comprises of 10 items (5 items in the morning; 5 items in the evening). Asthma symptoms during night time and daytime are recorded by the patient each morning and evening in the daily diary. A daily ASD score is the mean of the 10 items. A higher value indicates a worse outcome. Responses for all 10 items are required to calculate the daily ASD score; otherwise, it is treated as missing. For the 7-day average asthma symptom score, scoring is done with no imputation using the mean of at least 4 of the 7 daily ASD scores as a mean weekly item score. The 7-day average ASD score ranges from 0 to 4.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants from the Full Analysis Set with at least one change from baseline value at any post-baseline week contribute to the analysis.'}, {'type': 'SECONDARY', 'title': 'Time to First Asthma Exacerbation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tezepelumab 210mg Q4W', 'description': 'Tezepelumab administered every 4 weeks subcutaneously'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously'}], 'classes': [{'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Randomization to Week 52', 'description': 'Time to the first occurrence of asthma exacerbation post randomization, presented as number of participants with at least one asthma exacerbation reported in the eCRF', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Fractional Exhaled Nitric Oxide at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tezepelumab 210mg Q4W', 'description': 'Tezepelumab administered every 4 weeks subcutaneously'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously'}], 'classes': [{'categories': [{'measurements': [{'value': '-15.88', 'spread': '1.628', 'groupId': 'OG000'}, {'value': '-3.15', 'spread': '1.658', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Randomization to Week 52', 'description': 'Mean change from baseline in FENO (ppb) at week 52 to assess the effect of 210 mg of tezepelumab SC Q4W on biomarkers', 'unitOfMeasure': 'ppb', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Asthma Specific Resource Utilization Over 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tezepelumab 210mg Q4W', 'description': 'Tezepelumab administered every 4 weeks subcutaneously'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously'}], 'classes': [{'title': 'Hospitalisation', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Emergency room visit', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Unscheduled visit to specialist', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}]}, {'title': 'Home visit', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Telephone call', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}, {'title': 'Ambulance transport', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization to Week 52', 'description': 'Number of participants with asthma specific resource utilization (e.g. unscheduled physician visits, unscheduled phone calls to physicians, use of other asthma medications) over 52 weeks.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics of Tezepelumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tezepelumab 210mg Q4W', 'description': 'Tezepelumab administered every 4 weeks subcutaneously'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '21.3513', 'spread': '43.96', 'groupId': 'OG000'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '21.2222', 'spread': '41.51', 'groupId': 'OG000'}]}]}, {'title': 'Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.4450', 'spread': '157.46', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline, Week 24, Week 52, Week 64', 'description': 'Mean serum trough PK concentrations taken pre-dose at each scheduled visit to evaluate the pharmacokinetics (PK) of tezepelumab', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Set: participants who received at least one dose of tezepelumab. The placebo arm is not applicable. Number analyzed at each timepoint is a subset of PK Analysis Set based on participants who had sample results available at that timepoint.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in EQ-5D-5L VAS Score at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tezepelumab 210mg Q4W', 'description': 'Tezepelumab administered every 4 weeks subcutaneously'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously'}], 'classes': [{'categories': [{'measurements': [{'value': '12.80', 'spread': '1.009', 'groupId': 'OG000'}, {'value': '9.67', 'spread': '1.028', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At Week 52', 'description': 'Mean change from baseline in EQ-5D-5L VAS at week 52. EQ-5D-5L visual analogue scale (VAS) allows participants to rate current health status on a scale of 0-100, with 0 being the worst imaginable health state.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Blood Eosinophils (Cells/uL) at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tezepelumab 210mg Q4W', 'description': 'Tezepelumab administered every 4 weeks subcutaneously'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously'}], 'classes': [{'categories': [{'measurements': [{'value': '-193.44', 'spread': '21.538', 'groupId': 'OG000'}, {'value': '-38.86', 'spread': '21.984', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Randomization to Week 52', 'description': 'Mean change from baseline in blood eosinophil counts at week 52 to assess the effect of 210 mg of tezepelumab SC Q4W on biomarkers.', 'unitOfMeasure': 'cells/uL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Total Serum IgE (IU/mL) at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tezepelumab 210mg Q4W', 'description': 'Tezepelumab administered every 4 weeks subcutaneously'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously'}], 'classes': [{'categories': [{'measurements': [{'value': '-92.77', 'spread': '27.460', 'groupId': 'OG000'}, {'value': '0.30', 'spread': '28.013', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Randomization to Week 52', 'description': 'Mean change from baseline in IgE at week 52 to assess the effect of 210 mg of tezepelumab SC Q4W on biomarkers.', 'unitOfMeasure': 'IU/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Night Time Awakenings (Percentage) at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tezepelumab 210mg Q4W', 'description': 'Tezepelumab administered every 4 weeks subcutaneously'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously'}], 'classes': [{'categories': [{'measurements': [{'value': '-18.74', 'spread': '1.035', 'groupId': 'OG000'}, {'value': '-15.99', 'spread': '1.093', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Randomization to Week 52', 'description': 'Mean change from baseline in night time awakenings due to asthma at Week 52. Night time awakenings percentage is defined as number of nights with awakenings due to asthma and requiring rescue medication divided by number of nights with available data and multiplied by 100%. At least 4 out of 7 days of data is required to calculate a weekly mean.', 'unitOfMeasure': 'Percentage of nights with awakenings', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Immunogenicity of Tezepelumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tezepelumab 210mg Q4W (China Cohort)', 'description': 'Tezepelumab administered every 4 weeks subcutaneously; China cohort'}, {'id': 'OG001', 'title': 'Placebo (China Cohort)', 'description': 'Placebo administered subcutaneously; China cohort'}, {'id': 'OG002', 'title': 'Tezepelumab 210mg Q4W (Non-China Cohort)', 'description': 'Tezepelumab administered every 4 weeks subcutaneously; non-China cohort'}, {'id': 'OG003', 'title': 'Placebo (Non-China Cohort)', 'description': 'Placebo administered subcutaneously; non-China cohort'}], 'classes': [{'title': 'ADA positive at baseline and/or post-baseline', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'Any baseline ADA positive', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'Only baseline ADA positive', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'Any post-baseline ADA positive', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Both baseline and at least one post-baseline ADA positive', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Treatment-induced ADA positive', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Treatment-boosted ADA positive', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'TE-ADA positive', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'ADA persistently positive', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'ADA transiently positive', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 64', 'description': 'Anti-drug antibodies (ADA) responses at baseline and post baseline. Persistently positive is defined as positive at \\>=2 post baseline assessments (with \\>=16 weeks between the first and the last positive) or positive at last post baseline assessment. Transiently positive is defined as having at least one post baseline ADA positive assessment and not fulfilling the conditions of persistently positive. Treatment boosted ADA defined as baseline positive ADA that was boosted to a 4 fold or higher level following treatment. Treatment emergent ADA defined as sum of treatment induced ADA and treatment boosted ADA.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Daily Rescue Medication Use (Weekly Means) at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tezepelumab 210mg Q4W', 'description': 'Tezepelumab administered every 4 weeks subcutaneously'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.81', 'spread': '0.064', 'groupId': 'OG000'}, {'value': '-0.70', 'spread': '0.066', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Randomization to Week 52', 'description': 'Daily rescue medication use is defined as: Number of night inhaler puffs + 2 x \\[number of night nebulizer times\\] + number of daytime inhaler puffs + 2 x \\[number of day nebulizer times\\]. Weekly means are calculated using at least 4 of 7 days of daily rescue medication use.', 'unitOfMeasure': 'Inhalations and nebulizers per week', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Home Based Morning Peak Expiratory Flow (PEF) at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tezepelumab 210mg Q4W', 'description': 'Tezepelumab administered every 4 weeks subcutaneously'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously'}], 'classes': [{'categories': [{'measurements': [{'value': '46.70', 'spread': '4.586', 'groupId': 'OG000'}, {'value': '18.96', 'spread': '4.730', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Randomization to Week 52', 'description': 'Mean change from baseline in home based morning PEF (L/min) at Week 52. Home PEF testing was performed by participant in the morning upon awakening and in the evening at bedtime using an electronic, hand-held spirometer. Weekly means are calculated using at least 4 of the 7 days of PEF data.', 'unitOfMeasure': 'L/min', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Home Based Evening Peak Expiratory Flow (PEF) at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tezepelumab 210mg Q4W', 'description': 'Tezepelumab administered every 4 weeks subcutaneously'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously'}], 'classes': [{'categories': [{'measurements': [{'value': '42.14', 'spread': '4.558', 'groupId': 'OG000'}, {'value': '16.81', 'spread': '4.700', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Randomization to Week 52', 'description': 'Mean change from baseline in home based evening PEF (L/min) at Week 52. Home PEF testing was performed by participant in the morning upon awakening and in the evening at bedtime using an electronic, hand-held spirometer. Weekly means are calculated using at least 4 of the 7 days of PEF data.', 'unitOfMeasure': 'L/min', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Annual Asthma Exacerbation Rate Resulting in Emergency Room Visit or Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tezepelumab 210mg Q4W', 'description': 'Tezepelumab administered every 4 weeks subcutaneously'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously'}], 'classes': [{'categories': [{'measurements': [{'value': '0.07', 'groupId': 'OG000', 'lowerLimit': '0.03', 'upperLimit': '0.15'}, {'value': '0.18', 'groupId': 'OG001', 'lowerLimit': '0.09', 'upperLimit': '0.34'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Randomization to Week 52', 'description': 'The annual exacerbation rate is based on exacerbations reported by the investigator that are associated with an emergency room visit, urgent care visit, or a hospitalization (where urgent care visit was captured as an emergency room visit on the eCRF).', 'unitOfMeasure': 'Events per year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants Who Had no Asthma Exacerbations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tezepelumab 210mg Q4W', 'description': 'Tezepelumab administered every 4 weeks subcutaneously'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously'}], 'classes': [{'categories': [{'measurements': [{'value': '74.6', 'groupId': 'OG000'}, {'value': '50.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization to Week 52', 'description': 'The proportion of participants who had no asthma exacerbations is presented as the percentage of participants with no exacerbations. This is defined as participants who meet both the following criteria: (1) completed the 52 week treatment period and (2) did not report an exacerbation during this period.', 'unitOfMeasure': 'Percentage', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tezepelumab 210mg Q4W', 'description': 'Tezepelumab administered every 4 weeks subcutaneously'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '201'}, {'groupId': 'FG001', 'numSubjects': '199'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '186'}, {'groupId': 'FG001', 'numSubjects': '168'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '31'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'Due to COVID-19 pandemic', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol-specified withdrawal criterion met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Other than above', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'A total of 401 participants were randomized at 74 sites in 3 Asian countries to receive treatment with tezepelumab 210mg Q4W or placebo.', 'preAssignmentDetails': 'Of the 401 randomized, 400 (99.8%) participants received treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '400', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Tezepelumab 210mg Q4W', 'description': 'Tezepelumab administered every 4 weeks subcutaneously'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '166', 'groupId': 'BG000'}, {'value': '167', 'groupId': 'BG001'}, {'value': '333', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.3', 'spread': '12.4', 'groupId': 'BG000'}, {'value': '54.3', 'spread': '10.3', 'groupId': 'BG001'}, {'value': '53.3', 'spread': '11.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '119', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '231', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '169', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '201', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '400', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '201', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '400', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 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'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-05-09T05:34', 'hasProtocol': True}, {'date': '2024-05-22', 'size': 1192226, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-05-09T05:34', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Double-Blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomized in a 1:1 ratio to either tezepelumab or matching placebo both administered subcutaneously.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 405}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-13', 'studyFirstSubmitDate': '2019-04-23', 'resultsFirstSubmitDate': '2025-05-09', 'studyFirstSubmitQcDate': '2019-04-23', 'lastUpdatePostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-13', 'studyFirstPostDateStruct': {'date': '2019-04-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Annual Asthma Exacerbation Rate (AERR)', 'timeFrame': 'Randomization to Week 52', 'description': 'The annual exacerbation rate is based on exacerbations reported by the investigator in the eCRF over 52 weeks'}], 'secondaryOutcomes': [{'measure': 'Mean Change From Baseline in Pre-dose/Pre-bronchodilator (Pre-BD) Forced Expiratory Volume in 1 Second (FEV1) at Week 52', 'timeFrame': 'Randomization to Week 52', 'description': 'Mean change from baseline in FEV1 as compared to placebo at Week 52. FEV1 is defined as the volume of air exhaled from the lungs in the first second of a forced expiration.'}, {'measure': 'Mean Change From Baseline in Standardized Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12) Total Score at Week 52', 'timeFrame': 'Randomization to Week 52', 'description': 'Mean change from baseline in AQLQ(S)+12 as compared to placebo at Week 52. The AQLQ(S)+12 is a questionnaire that measures the health-related quality of life experienced by asthma participants. The total score is defined as the average of all 32 questions in the AQLQ(S)+12 questionnaire. AQLQ(S)+12 is a 7-point scale questionnaire, ranging from 7 (no impairment) to 1 (severe impairment).'}, {'measure': 'Mean Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6) Score at Week 52', 'timeFrame': 'Randomization to Week 52', 'description': 'Mean change from baseline in ACQ-6 as compared to placebo at Week 52. The ACQ-6 captures asthma symptoms and short-acting β2-agonist use via subject-report. Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The ACQ-6 score is the mean of the responses.'}, {'measure': 'Mean Change From Baseline in Weekly Mean Daily Asthma Symptom Diary Score at Week 52', 'timeFrame': 'Randomization to Week 52', 'description': 'Mean change from baseline in Asthma Symptom Diary score as compared to placebo at Week 52. The Asthma Symptom Diary comprises of 10 items (5 items in the morning; 5 items in the evening). Asthma symptoms during night time and daytime are recorded by the patient each morning and evening in the daily diary. A daily ASD score is the mean of the 10 items. A higher value indicates a worse outcome. Responses for all 10 items are required to calculate the daily ASD score; otherwise, it is treated as missing. For the 7-day average asthma symptom score, scoring is done with no imputation using the mean of at least 4 of the 7 daily ASD scores as a mean weekly item score. The 7-day average ASD score ranges from 0 to 4.'}, {'measure': 'Time to First Asthma Exacerbation', 'timeFrame': 'Randomization to Week 52', 'description': 'Time to the first occurrence of asthma exacerbation post randomization, presented as number of participants with at least one asthma exacerbation reported in the eCRF'}, {'measure': 'Mean Change From Baseline in Fractional Exhaled Nitric Oxide at Week 52', 'timeFrame': 'Randomization to Week 52', 'description': 'Mean change from baseline in FENO (ppb) at week 52 to assess the effect of 210 mg of tezepelumab SC Q4W on biomarkers'}, {'measure': 'Number of Participants With Asthma Specific Resource Utilization Over 52 Weeks', 'timeFrame': 'Randomization to Week 52', 'description': 'Number of participants with asthma specific resource utilization (e.g. unscheduled physician visits, unscheduled phone calls to physicians, use of other asthma medications) over 52 weeks.'}, {'measure': 'Pharmacokinetics of Tezepelumab', 'timeFrame': 'Baseline, Week 24, Week 52, Week 64', 'description': 'Mean serum trough PK concentrations taken pre-dose at each scheduled visit to evaluate the pharmacokinetics (PK) of tezepelumab'}, {'measure': 'Mean Change From Baseline in EQ-5D-5L VAS Score at Week 52', 'timeFrame': 'At Week 52', 'description': 'Mean change from baseline in EQ-5D-5L VAS at week 52. EQ-5D-5L visual analogue scale (VAS) allows participants to rate current health status on a scale of 0-100, with 0 being the worst imaginable health state.'}, {'measure': 'Mean Change From Baseline in Blood Eosinophils (Cells/uL) at Week 52', 'timeFrame': 'Randomization to Week 52', 'description': 'Mean change from baseline in blood eosinophil counts at week 52 to assess the effect of 210 mg of tezepelumab SC Q4W on biomarkers.'}, {'measure': 'Mean Change From Baseline in Total Serum IgE (IU/mL) at Week 52', 'timeFrame': 'Randomization to Week 52', 'description': 'Mean change from baseline in IgE at week 52 to assess the effect of 210 mg of tezepelumab SC Q4W on biomarkers.'}, {'measure': 'Mean Change From Baseline in Night Time Awakenings (Percentage) at Week 52', 'timeFrame': 'Randomization to Week 52', 'description': 'Mean change from baseline in night time awakenings due to asthma at Week 52. Night time awakenings percentage is defined as number of nights with awakenings due to asthma and requiring rescue medication divided by number of nights with available data and multiplied by 100%. At least 4 out of 7 days of data is required to calculate a weekly mean.'}, {'measure': 'Immunogenicity of Tezepelumab', 'timeFrame': 'Baseline to Week 64', 'description': 'Anti-drug antibodies (ADA) responses at baseline and post baseline. Persistently positive is defined as positive at \\>=2 post baseline assessments (with \\>=16 weeks between the first and the last positive) or positive at last post baseline assessment. Transiently positive is defined as having at least one post baseline ADA positive assessment and not fulfilling the conditions of persistently positive. Treatment boosted ADA defined as baseline positive ADA that was boosted to a 4 fold or higher level following treatment. Treatment emergent ADA defined as sum of treatment induced ADA and treatment boosted ADA.'}, {'measure': 'Mean Change From Baseline in Daily Rescue Medication Use (Weekly Means) at Week 52', 'timeFrame': 'Randomization to Week 52', 'description': 'Daily rescue medication use is defined as: Number of night inhaler puffs + 2 x \\[number of night nebulizer times\\] + number of daytime inhaler puffs + 2 x \\[number of day nebulizer times\\]. Weekly means are calculated using at least 4 of 7 days of daily rescue medication use.'}, {'measure': 'Mean Change From Baseline in Home Based Morning Peak Expiratory Flow (PEF) at Week 52', 'timeFrame': 'Randomization to Week 52', 'description': 'Mean change from baseline in home based morning PEF (L/min) at Week 52. Home PEF testing was performed by participant in the morning upon awakening and in the evening at bedtime using an electronic, hand-held spirometer. Weekly means are calculated using at least 4 of the 7 days of PEF data.'}, {'measure': 'Mean Change From Baseline in Home Based Evening Peak Expiratory Flow (PEF) at Week 52', 'timeFrame': 'Randomization to Week 52', 'description': 'Mean change from baseline in home based evening PEF (L/min) at Week 52. Home PEF testing was performed by participant in the morning upon awakening and in the evening at bedtime using an electronic, hand-held spirometer. Weekly means are calculated using at least 4 of the 7 days of PEF data.'}, {'measure': 'Annual Asthma Exacerbation Rate Resulting in Emergency Room Visit or Hospitalization', 'timeFrame': 'Randomization to Week 52', 'description': 'The annual exacerbation rate is based on exacerbations reported by the investigator that are associated with an emergency room visit, urgent care visit, or a hospitalization (where urgent care visit was captured as an emergency room visit on the eCRF).'}, {'measure': 'Proportion of Participants Who Had no Asthma Exacerbations', 'timeFrame': 'Randomization to Week 52', 'description': 'The proportion of participants who had no asthma exacerbations is presented as the percentage of participants with no exacerbations. This is defined as participants who meet both the following criteria: (1) completed the 52 week treatment period and (2) did not report an exacerbation during this period.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Asthma', 'Uncontrolled Asthma', 'Severe Uncontrolled Asthma'], 'conditions': ['Asthma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D5180C00021&attachmentIdentifier=3f72a345-e246-4de4-8c5d-b0cf83127dc0&fileName=D5180C00021-Primary_CSR_Synopsis_Redacted.pdf&versionIdentifier=', 'label': 'D5180C00021-Primary CSR Synopsis Redacted'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D5180C00021&attachmentIdentifier=2fd5959d-d1d1-4532-af2e-f258447dccb3&fileName=D5180C00021-Final_CSR_Synopsis_Redacted.pdf&versionIdentifier=', 'label': 'D5180C00021-Final CSR Synopsis Redacted'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D5180C00021&attachmentIdentifier=bdcb0f1d-99a8-47d7-8cca-967c2e36c7c1&fileName=D5180C00021_SAP_Redacted.pdf&versionIdentifier=', 'label': 'D5180C00021 SAP Redacted'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D5180C00021&attachmentIdentifier=3ae5f974-d4c4-4d0c-949b-b0add12d16bb&fileName=D5180C00021_CSP_Redacted.pdf&versionIdentifier=', 'label': 'D5180C00021 CSP Redacted'}]}, 'descriptionModule': {'briefSummary': 'A Regional, Multicentre, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults with Severe Uncontrolled Asthma', 'detailedDescription': 'This is a regional, multicentre, randomized, double-blind, placebo controlled, parallel group, phase 3 study designed to evaluate the efficacy and safety of 210 mg Q4W (SC) of tezepelumab in adults with severe, uncontrolled asthma on medium to high-dose ICS and at least one additional asthma controller medication with or without OCS. Approximately 396 participants will be randomized regionally (China/non-China). Participants will receive tezepelumab, or placebo, administered via subcutaneous injection at the study site, over a 52-week treatment period. The study also includes a post-treatment follow-up period of 12 weeks'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age. 18-80\n* Documented physician-diagnosed asthma for at least 12 months\n* Participants who have received a physician-prescribed asthma controller medication with medium or high dose ICS for at least 6 months.\n* Documented treatment with a total daily dose of either medium or high dose ICS (≥ 500 µg fluticasone propionate dry powder formulation equivalent total daily dose) for at least 3 months.\n* 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.\n* Morning pre-BD FEV1 \\<80% predicted normal\n* Evidence of asthma as documented by either: Documented historical reversibility of FEV1 ≥12% and ≥200 mL in the previous 12 months OR Post-BD (albuterol/salbutamol) reversibility of FEV1 ≥12% and ≥200 mL during screening.\n* Documented history of at least 2 asthma exacerbation events within 12 months, and at least one of the exacerbations should occur during the treatment of medium-to-high dose ICS.\n* ACQ-6 score ≥1.5 at screening and on day of randomization\n\nExclusion Criteria:\n\n* Pulmonary disease other than asthma.\n* History of cancer.\n* History of a clinically significant infection.\n* Current smokers or participants with smoking history ≥10 pack-yrs.\n* History of chronic alcohol or drug abuse within 12 months.\n* Hepatitis B, C or HIV.\n* Pregnant or breastfeeding.\n* History of anaphylaxis following any biologic therapy.\n* participant randomized in the current study or previous tezepelumab studies.'}, 'identificationModule': {'nctId': 'NCT03927157', 'acronym': 'DIRECTION', 'briefTitle': 'Study to Evaluate Tezepelumab in Adults With Severe Uncontrolled Asthma', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Regional, Multicentre, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults With Severe Uncontrolled Asthma', 'orgStudyIdInfo': {'id': 'D5180C00021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tezepelumab', 'description': 'Tezepelumab: Tezepelumab subcutaneous injection', 'interventionNames': ['Biological: Experimental: Tezepelumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo: Placebo subcutaneous injection', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Experimental: Tezepelumab', 'type': 'BIOLOGICAL', 'otherNames': ['Tezepelumab'], 'description': 'Tezepelumab subcutaneous injection', 'armGroupLabels': ['Tezepelumab']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo subcutaneous injection', 'armGroupLabels': ['Placebo']}]}, 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