Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2026-02-24 @ 7:29 AM
Study NCT ID:
NCT03930732
Status:
COMPLETED
Last Update Posted:
2024-02-28
First Post:
2019-04-26
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate-to-severe COPD With Type 2 Inflammation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C582203', 'term': 'dupilumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Contact-US@sanofi.com', 'phone': '800-633-1610', 'title': 'Trial Transparency Team', 'phoneExt': '6#', 'organization': 'Sanofi aventis recherche & développement'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'TEAEs were collected from the time from the first administration of study treatment to the last administration of the study treatment + 98 days, up to 491 days', 'description': 'Analysis was performed on the Safety population. One participant was exposed to different treatment other than planned (was randomized to placebo arm but received dupilumab on Day 40). The actual arm was considered as dupilumab 300 mg q2w. In safety analyses, the actual arms are used.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to dupilumab 300 mg as SC injections q2w up to a maximum of 52 weeks (last dose administered at Week 50, EOT visit occurred 2 weeks after last administration of treatment i.e., at Week 52).', 'otherNumAtRisk': 470, 'deathsNumAtRisk': 470, 'otherNumAffected': 172, 'seriousNumAtRisk': 470, 'deathsNumAffected': 9, 'seriousNumAffected': 74}, {'id': 'EG001', 'title': 'Dupilumab 300 mg q2w', 'description': 'Participants received dupilumab 300 mg administered as SC injections q2w up to a maximum of 52 weeks (last dose administered at Week 50, EOT visit occurred 2 weeks after last administration of treatment i.e., at Week 52).', 'otherNumAtRisk': 469, 'deathsNumAtRisk': 469, 'otherNumAffected': 168, 'seriousNumAtRisk': 469, 'deathsNumAffected': 8, 'seriousNumAffected': 65}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 60, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 55, 'numAffected': 45}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 66, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 49, 'numAffected': 37}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 39, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 57, 'numAffected': 38}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 32, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 34, 'numAffected': 25}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 27, 'numAffected': 25}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Accidental Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 36, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 28, 'numAffected': 26}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}], 'seriousEvents': [{'term': 'Abdominal Wall Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Bronchitis Bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Bronchopulmonary Aspergillosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Covid-19 Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Cholecystitis Infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Epiglottitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Herpes Zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Lower Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Pneumonia Bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Pneumonia Pneumococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Pulmonary Tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Septic Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Subcutaneous Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Bladder Transitional Cell Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Ductal Adenocarcinoma Of Pancreas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Glioblastoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Invasive Ductal Breast Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Lung Adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Lung Carcinoma Cell Type Unspecified Stage Iv', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Lung Neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Lung Neoplasm Malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Pancreatic Carcinoma Metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Prostate Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Rectal Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Squamous Cell Carcinoma Of Lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Squamous Cell Carcinoma Of Skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Blood Loss Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Polycythaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Anaphylactic Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Hyperparathyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Diabetes Mellitus Inadequate Control', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Type 2 Diabetes Mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Psychotic Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Basal Ganglia Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Cerebral Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Cerebral Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Cerebrovascular Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Generalised Tonic-Clonic Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Ischaemic Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Transient Ischaemic Attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Acute Coronary Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Acute Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Angina Unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 1, 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Cor Pulmonale Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Coronary Artery Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 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Traffic Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Skin Abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Spinal Compression Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Tibia Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 470, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 469, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Annualized Rate of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Over the 52-Week Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '471', 'groupId': 'OG000'}, {'value': '468', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to dupilumab 300 mg as SC injections q2w up to a maximum of 52 weeks (last dose administered at Week 50, EOT visit occurred 2 weeks after last administration of treatment i.e., at Week 52).'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg q2w', 'description': 'Participants received dupilumab 300 mg administered as SC injections q2w up to a maximum of 52 weeks (last dose administered at Week 50, EOT visit occurred 2 weeks after last administration of treatment i.e., at Week 52).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.01', 'groupId': 'OG000', 'lowerLimit': '0.931', 'upperLimit': '1.301'}, {'value': '0.776', 'groupId': 'OG001', 'lowerLimit': '0.645', 'upperLimit': '0.934'}]}]}], 'analyses': [{'pValue': '0.0005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.324', 'ciLowerLimit': '-0.508', 'ciUpperLimit': '-0.140', 'estimateComment': 'Derived using delta method.', 'groupDescription': 'Derived using negative binomial model with the total number of the events occurring during the 52-week treatment period as the response variable, and treatment group, region (pooled country), inhaled corticosteroid (ICS) dose, smoking status at screening, baseline disease severity, and number of moderate or severe COPD exacerbation events within one year prior to the study as covariates, and log-transformed treatment duration as an offset variable.', 'statisticalMethod': 'Negative binomial model', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'A hierarchical testing procedure was used to control type I error and handle primary and a few secondary endpoint analyses at a 2-sided significance level of 0.049. Testing was then performed sequentially in the order the endpoints are reported (till OM 9). The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.049 level.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1) to Week 52', 'description': 'Moderate exacerbations were recorded by the Investigator and defined as acute exacerbation of COPD (AECOPD) that required either systemic corticosteroids (such as intramuscular, intravenous or oral) and/or antibiotics. Severe exacerbations were also recorded by the Investigator and defined as AECOPD requiring hospitalization, or observation for \\>24 hours in an emergency department/urgent care facility or resulting in death. For both moderate and severe events to be counted as separate events, they were separated by at least 14 days. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated. Events were adjudicated by independent third party.', 'unitOfMeasure': 'exacerbation per participant-year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population consisted of the randomized population analyzed according to the treatment group allocated by randomization.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pre-Bronchodilator (BD) Forced Expiratory Volume in One Second (FEV1) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '469', 'groupId': 'OG000'}, {'value': '466', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to dupilumab 300 mg as SC injections q2w up to a maximum of 52 weeks (last dose administered at Week 50, EOT visit occurred 2 weeks after last administration of treatment i.e., at Week 52).'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg q2w', 'description': 'Participants received dupilumab 300 mg administered as SC injections q2w up to a maximum of 52 weeks (last dose administered at Week 50, EOT visit occurred 2 weeks after last administration of treatment i.e., at Week 52).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.077', 'spread': '0.018', 'groupId': 'OG000'}, {'value': '0.160', 'spread': '0.018', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Square (LS) Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.083', 'ciLowerLimit': '0.042', 'ciUpperLimit': '0.125', 'pValueComment': 'Threshold for significance at 0.049 level.', 'groupDescription': 'Derived from mixed-effect model with repeated measures (MMRM) model with the change from baseline in pre-BD FEV1 up to Week 12 as response variables, and treatment group, age, sex, height, region (pooled country), ICS dose, smoking status at screening, visit, treatment-by-visit interaction, baseline pre-BD FEV1, and FEV1 baseline-by-visit interaction as covariates. Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).', 'statisticalMethod': 'MMRM model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 1) to Week 12', 'description': 'The FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. Spirometry was performed after a wash out period of bronchodilators according to their action duration.', 'unitOfMeasure': 'liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of the randomized population analyzed according to the treatment group allocated by randomization. Only those participants with data available were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pre-BD FEV1 at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '469', 'groupId': 'OG000'}, {'value': '466', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to dupilumab 300 mg as SC injections q2w up to a maximum of 52 weeks (last dose administered at Week 50, EOT visit occurred 2 weeks after last administration of treatment i.e., at Week 52).'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg q2w', 'description': 'Participants received dupilumab 300 mg administered as SC injections q2w up to a maximum of 52 weeks (last dose administered at Week 50, EOT visit occurred 2 weeks after last administration of treatment i.e., at Week 52).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.070', 'spread': '0.019', 'groupId': 'OG000'}, {'value': '0.153', 'spread': '0.019', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.083', 'ciLowerLimit': '0.038', 'ciUpperLimit': '0.128', 'pValueComment': 'Threshold for significance at 0.049 level.', 'groupDescription': 'Derived from MMRM model with the change from baseline in pre-BDFEV1 up to Week 52 as response variables, and treatment group, age, sex, height, region (pooled country), ICS dose, smoking status at screening, visit, treatment-by-visit interaction, baseline pre-BD FEV1, and FEV1 baseline-by-visit interaction as covariates. Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).', 'statisticalMethod': 'MMRM model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 1) to Week 52', 'description': 'The FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. Spirometry was performed after a wash out period of bronchodilators according to their action duration.', 'unitOfMeasure': 'liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of the randomized population analyzed according to the treatment group allocated by randomization. Only those participants with data available were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pre-BD FEV1 at Week 12 in Subgroup of Participants With Baseline Fractional Exhaled Nitric Oxide (FeNO) >=20 Parts Per Billion (Ppb)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to dupilumab 300 mg as SC injections q2w up to a maximum of 52 weeks (last dose administered at Week 50, EOT visit occurred 2 weeks after last administration of treatment i.e., at Week 52).'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg q2w', 'description': 'Participants received dupilumab 300 mg administered as SC injections q2w up to a maximum of 52 weeks (last dose administered at Week 50, EOT visit occurred 2 weeks after last administration of treatment i.e., at Week 52).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.108', 'spread': '0.035', 'groupId': 'OG000'}, {'value': '0.232', 'spread': '0.034', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0022', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.124', 'ciLowerLimit': '0.045', 'ciUpperLimit': '0.203', 'pValueComment': 'Threshold for significance at 0.049 level.', 'groupDescription': 'Derived from MMRM model with the change from baseline in pre-BD FEV1 up to Week 12 as response variables, and treatment group, age, sex, height, region (pooled country), ICS dose, smoking status at screening, visit, treatment-by-visit interaction, baseline pre-BD FEV1, and FEV1 baseline-by-visit interaction as covariates. Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).', 'statisticalMethod': 'MMRM model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 1) to Week 12', 'description': 'FeNO is a demonstrated biomarker of type 2 airway inflammation in respiratory diseases. FeNO was analyzed using a NIOX instrument or similar analyzer using a flow rate of 50 milliliter per second (mL/s) and reported in ppb. This assessment was conducted prior to spirometry and following a fast of at least 1 hour.', 'unitOfMeasure': 'liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The subgroup of participants with baseline FeNO \\>=20 ppb within the ITT population were included. Only those participants with data available were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pre-BD FEV1 at Week 52 in Subgroup of Participants With Baseline FeNO >=20 Ppb', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to dupilumab 300 mg as SC injections q2w up to a maximum of 52 weeks (last dose administered at Week 50, EOT visit occurred 2 weeks after last administration of treatment i.e., at Week 52).'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg q2w', 'description': 'Participants received dupilumab 300 mg administered as SC injections q2w up to a maximum of 52 weeks (last dose administered at Week 50, EOT visit occurred 2 weeks after last administration of treatment i.e., at Week 52).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.120', 'spread': '0.037', 'groupId': 'OG000'}, {'value': '0.247', 'spread': '0.036', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0034', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.127', 'ciLowerLimit': '0.042', 'ciUpperLimit': '0.212', 'pValueComment': 'Threshold for significance at 0.049 level.', 'groupDescription': 'Derived from MMRM model with the change from baseline in pre-BD FEV1 up to Week 52 as response variables, and treatment group, age, sex, height, region (pooled country), ICS dose, smoking status at screening, visit, treatment-by-visit interaction, baseline pre-BD FEV1, and FEV1 baseline-by-visit interaction as covariates. Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).', 'statisticalMethod': 'MMRM model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 1) to Week 52', 'description': 'FeNO is a demonstrated biomarker of type 2 airway inflammation in respiratory diseases. FeNO was analyzed using a NIOX instrument or similar analyzer using a flow rate of 50 mL/s and reported in ppb. This assessment was conducted prior to spirometry and following a fast of at least 1 hour.', 'unitOfMeasure': 'liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The subgroup of participants with baseline FeNO \\>=20 ppb within the ITT population were included. Only those participants with data available were analyzed.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Saint (St.) George's Respiratory Questionnaire (SGRQ) Total Score at Week 52", 'denoms': [{'units': 'Participants', 'counts': [{'value': '456', 'groupId': 'OG000'}, {'value': '456', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to dupilumab 300 mg as SC injections q2w up to a maximum of 52 weeks (last dose administered at Week 50, EOT visit occurred 2 weeks after last administration of treatment i.e., at Week 52).'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg q2w', 'description': 'Participants received dupilumab 300 mg administered as SC injections q2w up to a maximum of 52 weeks (last dose administered at Week 50, EOT visit occurred 2 weeks after last administration of treatment i.e., at Week 52).'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.369', 'spread': '0.816', 'groupId': 'OG000'}, {'value': '-9.732', 'spread': '0.810', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0017', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.363', 'ciLowerLimit': '-5.459', 'ciUpperLimit': '-1.266', 'pValueComment': 'Threshold for significance at 0.049 level.', 'groupDescription': 'Derived from MMRM model with the change from baseline in SGRQ total score up to Week 52 as response variables, and treatment group, region (pooled country), ICS dose, smoking status at screening, treatment-by-visit interaction, baseline SGRQ total score, and SGRQ baseline-by-visit interaction as covariates. Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).', 'statisticalMethod': 'MMRM model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 1) to Week 52', 'description': 'The SGRQ was a 50-item self-administered questionnaire designed to measure and quantify health status in adult participants with chronic airflow limitation and rated on electronic diary. Scores by dimension were calculated for 3 domains: symptoms, activity and impacts (psycho-social) as well as a total score. Global and domain scores range from 0 to 100, with 100 representing the worst possible health status and 0 indicating the best possible health status. Higher score indicates worse health status/heath related quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of the randomized population analyzed according to the treatment group allocated by randomization. Only those participants with data available were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With SGRQ Improvement >=4 Points at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '471', 'groupId': 'OG000'}, {'value': '468', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to dupilumab 300 mg as SC injections q2w up to a maximum of 52 weeks (last dose administered at Week 50, EOT visit occurred 2 weeks after last administration of treatment i.e., at Week 52).'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg q2w', 'description': 'Participants received dupilumab 300 mg administered as SC injections q2w up to a maximum of 52 weeks (last dose administered at Week 50, EOT visit occurred 2 weeks after last administration of treatment i.e., at Week 52).'}], 'classes': [{'categories': [{'measurements': [{'value': '43.1', 'groupId': 'OG000'}, {'value': '51.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0089', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.439', 'ciLowerLimit': '1.096', 'ciUpperLimit': '1.890', 'pValueComment': 'Threshold for significance at 0.049 level.', 'groupDescription': 'Derived from logistic regression model which includes treatment group, region (pooled country), ICS dose, smoking status at screening, and baseline SGRQ total score as covariates. Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1) to Week 52', 'description': 'A responder was defined as a participant with improvement from baseline in SGRQ total score at Week 52 by \\>=4 points. Participants with improvement \\<4 points or with missing values were considered as non-responders. The percentage of participants who achieved a clinically meaningful response in SGRQ total score (reduction \\[improvement\\] by \\>=4 points)/responders are reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of the randomized population analyzed according to the treatment group allocated by randomization.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Evaluating Respiratory Symptoms (E-RS) in COPD (E-RS: COPD) RS-Total Score at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '467', 'groupId': 'OG000'}, {'value': '461', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to dupilumab 300 mg as SC injections q2w up to a maximum of 52 weeks (last dose administered at Week 50, EOT visit occurred 2 weeks after last administration of treatment i.e., at Week 52).'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg q2w', 'description': 'Participants received dupilumab 300 mg administered as SC injections q2w up to a maximum of 52 weeks (last dose administered at Week 50, EOT visit occurred 2 weeks after last administration of treatment i.e., at Week 52).'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.558', 'spread': '0.256', 'groupId': 'OG000'}, {'value': '-2.694', 'spread': '0.257', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0012', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.137', 'ciLowerLimit': '-1.823', 'ciUpperLimit': '-0.450', 'pValueComment': 'Threshold for significance at 0.049 level.', 'groupDescription': 'Derived from MMRM model with the change from baseline in E-RS: COPD RS-Total Score to Week 52 as response variables, and treatment group, region (pooled country), ICS dose, smoking status at screening, visit, treatment-by-visit interaction, baseline E-RS: COPD RS-Total Score, and baseline E-RS: COPD RS-Total Score-by-visit interaction as covariates. Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).', 'statisticalMethod': 'MMRM model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 1) to Week 52', 'description': 'The E-RS in COPD scale was a part of the exacerbations of chronic pulmonary disease tool (EXACT). It was a derivative instrument used to measure the effect of treatment on the severity of respiratory symptoms in stable COPD. E-RS: COPD RS-Total Score was derived based on weekly averages of daily assessed 11 respiratory symptom items contained in the 14-item EXACT questionnaire. The RS-Total score represented overall respiratory symptom severity, ranged from 0 to 40. Summation procedure was used to derive the three daily domain scores: 1). RS-Breathlessness (range 0-17), 2) RS-Cough and Sputum (score range 0-11), 3) RS-Chest Symptoms (score range 0-12). The higher the score, more severe were the symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of the randomized population analyzed according to the treatment group allocated by randomization. Only those participants with data available were analyzed.'}, {'type': 'SECONDARY', 'title': 'Annualized Rate of Moderate or Severe COPD Exacerbation Over the 52-Week Treatment Period in Subgroup of Participants With Baseline FeNO >=20 Ppb', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to dupilumab 300 mg as SC injections q2w up to a maximum of 52 weeks (last dose administered at Week 50, EOT visit occurred 2 weeks after last administration of treatment i.e., at Week 52).'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg q2w', 'description': 'Participants received dupilumab 300 mg administered as SC injections q2w up to a maximum of 52 weeks (last dose administered at Week 50, EOT visit occurred 2 weeks after last administration of treatment i.e., at Week 52).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.117', 'groupId': 'OG000', 'lowerLimit': '0.831', 'upperLimit': '1.502'}, {'value': '0.699', 'groupId': 'OG001', 'lowerLimit': '0.510', 'upperLimit': '0.958'}]}]}], 'analyses': [{'pValue': '0.0052', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.418', 'ciLowerLimit': '-0.728', 'ciUpperLimit': '-0.109', 'pValueComment': 'Threshold for significance at 0.049 level.', 'estimateComment': 'Derived using delta method.', 'groupDescription': 'Derived using negative binomial model with the total number of the events occurring during the 52-week treatment period as the response variable, and treatment group, region (pooled country), ICS dose, smoking status at screening, baseline disease severity, and number of moderate or severe COPD exacerbation events within one year prior to the study as covariates, and log-transformed treatment duration as an offset variable.', 'statisticalMethod': 'Negative binomial model', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1) to Week 52', 'description': 'Moderate exacerbations were recorded by the Investigator and defined as AECOPD that required either systemic corticosteroids (such as intramuscular, intravenous or oral) and/or antibiotics. Severe exacerbations were also recorded by the investigator and defined as AECOPD requiring hospitalization, or observation for \\>24 hours in an emergency department/urgent care facility or resulting in death. For both moderate and severe events to be counted as separate events, they were separated by at least 14 days. Annualized event rate among participants with baseline FeNO \\>=20 ppb was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated. Events were adjudicated by independent third party.', 'unitOfMeasure': 'exacerbation per participant-year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The subgroup of participants with baseline FeNO \\>=20 ppb within the ITT population were included.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pre-BD FEV1 to Weeks 2, 4, 8, 24, 36 and 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '469', 'groupId': 'OG000'}, {'value': '466', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to dupilumab 300 mg as SC injections q2w up to a maximum of 52 weeks (last dose administered at Week 50, EOT visit occurred 2 weeks after last administration of treatment i.e., at Week 52).'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg q2w', 'description': 'Participants received dupilumab 300 mg administered as SC injections q2w up to a maximum of 52 weeks (last dose administered at Week 50, EOT visit occurred 2 weeks after last administration of treatment i.e., at Week 52).'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '0.075', 'spread': '0.017', 'groupId': 'OG000'}, {'value': '0.159', 'spread': '0.017', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '0.069', 'spread': '0.017', 'groupId': 'OG000'}, {'value': '0.163', 'spread': '0.017', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '0.069', 'spread': '0.017', 'groupId': 'OG000'}, {'value': '0.149', 'spread': '0.017', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '0.068', 'spread': '0.018', 'groupId': 'OG000'}, {'value': '0.170', 'spread': '0.018', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '0.072', 'spread': '0.018', 'groupId': 'OG000'}, {'value': '0.155', 'spread': '0.018', 'groupId': 'OG001'}]}]}, {'title': 'Week 44', 'categories': [{'measurements': [{'value': '0.089', 'spread': '0.019', 'groupId': 'OG000'}, {'value': '0.176', 'spread': '0.019', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 1) to Weeks 2, 4, 8, 24, 36 and 44', 'description': 'The FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. Spirometry was performed after a wash out period of bronchodilators according to their action duration.', 'unitOfMeasure': 'liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of the randomized population analyzed according to the treatment group allocated by randomization. Only those participants with data available were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Post-BD FEV1 to Weeks 2, 4, 8, 12, 24, 36 and 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '469', 'groupId': 'OG000'}, {'value': '467', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to dupilumab 300 mg as subcutaneous (SC) injections q2w up to a maximum of 52 weeks (last dose administered at Week 50, end of treatment \\[EOT\\] visit occurred 2 weeks after last administration of treatment i.e., at Week 52).'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg q2w', 'description': 'Participants received dupilumab 300 mg administered as SC injections q2w up to a maximum of 52 weeks (last dose administered at Week 50, EOT visit occurred 2 weeks after last administration of treatment i.e., at Week 52).'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '0.071', 'spread': '0.017', 'groupId': 'OG000'}, {'value': '0.158', 'spread': '0.017', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '0.080', 'spread': '0.017', 'groupId': 'OG000'}, {'value': '0.158', 'spread': '0.017', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '0.077', 'spread': '0.018', 'groupId': 'OG000'}, {'value': '0.153', 'spread': '0.018', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '0.084', 'spread': '0.018', 'groupId': 'OG000'}, {'value': '0.156', 'spread': '0.018', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '0.072', 'spread': '0.019', 'groupId': 'OG000'}, {'value': '0.169', 'spread': '0.019', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '0.072', 'spread': '0.019', 'groupId': 'OG000'}, {'value': '0.155', 'spread': '0.019', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '0.058', 'spread': '0.019', 'groupId': 'OG000'}, {'value': '0.138', 'spread': '0.019', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 1) to Weeks 2, 4, 8, 12, 24, 36 and 52', 'description': 'The FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. Post-BD FEV1 referred to the spirometry performed within 30 minutes after administration of bronchodilator.', 'unitOfMeasure': 'liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of the randomized population analyzed according to the treatment group allocated by randomization.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pre-BD Forced Expiratory Flow at 25 Percent (%) to 75% (FEF 25-75%) of Forced Vital Capacity (FVC) to Weeks 2, 4, 8, 12, 24, 36, 44, and 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '469', 'groupId': 'OG000'}, {'value': '466', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to dupilumab 300 mg as subcutaneous (SC) injections q2w up to a maximum of 52 weeks (last dose administered at Week 50, end of treatment \\[EOT\\] visit occurred 2 weeks after last administration of treatment i.e., at Week 52).'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg q2w', 'description': 'Participants received dupilumab 300 mg administered as SC injections q2w up to a maximum of 52 weeks (last dose administered at Week 50, EOT visit occurred 2 weeks after last administration of treatment i.e., at Week 52).'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '0.065', 'spread': '0.016', 'groupId': 'OG000'}, {'value': '0.110', 'spread': '0.016', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '0.066', 'spread': '0.015', 'groupId': 'OG000'}, {'value': '0.115', 'spread': '0.015', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '0.069', 'spread': '0.016', 'groupId': 'OG000'}, {'value': '0.114', 'spread': '0.016', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '0.076', 'spread': '0.016', 'groupId': 'OG000'}, {'value': '0.137', 'spread': '0.016', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '0.080', 'spread': '0.017', 'groupId': 'OG000'}, {'value': '0.142', 'spread': '0.017', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '0.087', 'spread': '0.017', 'groupId': 'OG000'}, {'value': '0.132', 'spread': '0.017', 'groupId': 'OG001'}]}]}, {'title': 'Week 44', 'categories': [{'measurements': [{'value': '0.091', 'spread': '0.017', 'groupId': 'OG000'}, {'value': '0.162', 'spread': '0.017', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '0.088', 'spread': '0.017', 'groupId': 'OG000'}, {'value': '0.135', 'spread': '0.017', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 1) to Weeks 2, 4, 8, 12, 24, 36, 44 and 52', 'description': 'FEF is the amount of air (in liters) which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEF 25-75% was defined as the mean FEF between 25% and 75% of the FVC, where FVC was defined as the volume of air (in liters) that can be forcibly blown out after full inspiration in the upright position. Spirometry was performed after a wash out period of bronchodilators according to their action duration.', 'unitOfMeasure': 'liters/second', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of the randomized population analyzed according to the treatment group allocated by randomization. Only those participants with data available were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Post-BD FEF 25-75% to Weeks 2, 4, 8, 12, 24, 36 and 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '469', 'groupId': 'OG000'}, {'value': '467', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to dupilumab 300 mg as subcutaneous (SC) injections q2w up to a maximum of 52 weeks (last dose administered at Week 50, end of treatment \\[EOT\\] visit occurred 2 weeks after last administration of treatment i.e., at Week 52).'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg q2w', 'description': 'Participants received dupilumab 300 mg administered as SC injections q2w up to a maximum of 52 weeks (last dose administered at Week 50, EOT visit occurred 2 weeks after last administration of treatment i.e., at Week 52).'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '0.074', 'spread': '0.017', 'groupId': 'OG000'}, {'value': '0.135', 'spread': '0.017', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '0.087', 'spread': '0.017', 'groupId': 'OG000'}, {'value': '0.144', 'spread': '0.017', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '0.083', 'spread': '0.017', 'groupId': 'OG000'}, {'value': '0.144', 'spread': '0.017', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '0.089', 'spread': '0.018', 'groupId': 'OG000'}, {'value': '0.161', 'spread': '0.018', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '0.093', 'spread': '0.019', 'groupId': 'OG000'}, {'value': '0.169', 'spread': '0.019', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '0.093', 'spread': '0.019', 'groupId': 'OG000'}, {'value': '0.161', 'spread': '0.018', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '0.093', 'spread': '0.019', 'groupId': 'OG000'}, {'value': '0.153', 'spread': '0.019', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 1) to Weeks 2, 4, 8, 12, 24, 36 and 52', 'description': 'FEF is the amount of air (in liters) which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEF 25-75% was defined as the mean FEF between 25% and 75% of the FVC, where FVC was defined as the volume of air (in liters) that can be forcibly blown out after full inspiration in the upright position. Spirometry was performed after a wash out period of bronchodilators according to their action duration.', 'unitOfMeasure': 'liters/second', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of the randomized population analyzed according to the treatment group allocated by randomization. Only those participants with data available were analyzed.'}, {'type': 'SECONDARY', 'title': 'Annualized Rate of Severe COPD Exacerbations Over the 52-Week Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '471', 'groupId': 'OG000'}, {'value': '468', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to dupilumab 300 mg as subcutaneous (SC) injections q2w up to a maximum of 52 weeks (last dose administered at Week 50, end of treatment \\[EOT\\] visit occurred 2 weeks after last administration of treatment i.e., at Week 52).'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg q2w', 'description': 'Participants received dupilumab 300 mg administered as SC injections q2w up to a maximum of 52 weeks (last dose administered at Week 50, EOT visit occurred 2 weeks after last administration of treatment i.e., at Week 52).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.086', 'groupId': 'OG000', 'lowerLimit': '0.050', 'upperLimit': '0.147'}, {'value': '0.072', 'groupId': 'OG001', 'lowerLimit': '0.040', 'upperLimit': '0.132'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1) to Week 52', 'description': 'Moderate exacerbations were recorded by the Investigator and defined as AECOPD that required either systemic corticosteroids (such as intramuscular, intravenous or oral) and/or antibiotics. Severe exacerbations were also recorded by the Investigator and defined as AECOPD requiring hospitalization, or observation for \\>24 hours in an emergency department/urgent care facility or resulting in death. For both moderate and severe events to be counted as separate events, they were separated by at least 14 days. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated. Events were adjudicated by independent third party.', 'unitOfMeasure': 'exacerbation per participant-year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of the randomized population analyzed according to the treatment group allocated by randomization.'}, {'type': 'SECONDARY', 'title': 'Time to First Moderate or Severe COPD Exacerbation During the 52-Week Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '471', 'groupId': 'OG000'}, {'value': '468', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to dupilumab 300 mg as subcutaneous (SC) injections q2w up to a maximum of 52 weeks (last dose administered at Week 50, end of treatment \\[EOT\\] visit occurred 2 weeks after last administration of treatment i.e., at Week 52).'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg q2w', 'description': 'Participants received dupilumab 300 mg administered as SC injections q2w up to a maximum of 52 weeks (last dose administered at Week 50, EOT visit occurred 2 weeks after last administration of treatment i.e., at Week 52).'}], 'classes': [{'title': 'Up to Week 12', 'categories': [{'measurements': [{'value': '0.019', 'groupId': 'OG000', 'lowerLimit': '0.009', 'upperLimit': '0.035'}, {'value': '0.024', 'groupId': 'OG001', 'lowerLimit': '0.013', 'upperLimit': '0.041'}]}]}, {'title': 'Up to Week 24', 'categories': [{'measurements': [{'value': '0.039', 'groupId': 'OG000', 'lowerLimit': '0.024', 'upperLimit': '0.059'}, {'value': '0.034', 'groupId': 'OG001', 'lowerLimit': '0.021', 'upperLimit': '0.054'}]}]}, {'title': 'Up to Week 36', 'categories': [{'measurements': [{'value': '0.045', 'groupId': 'OG000', 'lowerLimit': '0.029', 'upperLimit': '0.067'}, {'value': '0.039', 'groupId': 'OG001', 'lowerLimit': '0.024', 'upperLimit': '0.059'}]}]}, {'title': 'Up to Week 52', 'categories': [{'measurements': [{'value': '0.061', 'groupId': 'OG000', 'lowerLimit': '0.042', 'upperLimit': '0.086'}, {'value': '0.043', 'groupId': 'OG001', 'lowerLimit': '0.027', 'upperLimit': '0.065'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Day 1) and up to Weeks 12, 24, 36 and 52', 'description': 'The time to first moderate or severe exacerbation was defined as date of the first event minus randomization date +1. The median time to first severe exacerbation was derived from Cox regression model. Moderate exacerbations events were recorded by the investigator and defined as AECOPD that require either systemic corticosteroids (such as intramuscular, intravenous or oral) and/or antibiotics. Severe exacerbations were recorded by the Investigator and defined as AECOPD requiring hospitalization, or observation for \\>24 hours in an emergency department/urgent care facility or resulting in death. For both moderate and severe events to be counted as separate events, they were separated by at least 14 days.', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of the randomized population analyzed according to the treatment group allocated by randomization.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '470', 'groupId': 'OG000'}, {'value': '469', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to dupilumab 300 mg as SC injections q2w up to a maximum of 52 weeks (last dose administered at Week 50, EOT visit occurred 2 weeks after last administration of treatment i.e., at Week 52).'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg q2w', 'description': 'Participants received dupilumab 300 mg administered as SC injections q2w up to a maximum of 52 weeks (last dose administered at Week 50, EOT visit occurred 2 weeks after last administration of treatment i.e., at Week 52).'}], 'classes': [{'title': 'Any TEAE', 'categories': [{'measurements': [{'value': '359', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}]}, {'title': 'Any TESAE', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'TEAEs were collected from the time from the first administration of study treatment to the last administration of the study treatment + 98 days, up to 491 days', 'description': 'An Adverse Event (AE) was defined as any untoward medical occurrence in a participant temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAEs were defined as AEs that developed or worsened in grade or became serious during TE period which was defined as the period from the time of first dose of study treatment until the last visit in the study. Serious adverse events (SAE) were defined as any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety population consisted of all participants who actually received at least 1 dose or partial of a dose of the study treatment, analyzed according to the treatment participants actually received. One participant was exposed to different treatment other than planned (was randomized to placebo arm but received dupilumab on Day 40). The actual arm was considered as dupilumab 300 mg q2w. In safety analyses, the actual arms are used.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Anti-Drug Antibodies (ADA) to Dupilumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '453', 'groupId': 'OG000'}, {'value': '462', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to dupilumab 300 mg as SC injections q2w up to a maximum of 52 weeks (last dose administered at Week 50, EOT visit occurred 2 weeks after last administration of treatment i.e., at Week 52).'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg q2w', 'description': 'Participants received dupilumab 300 mg administered as SC injections q2w up to a maximum of 52 weeks (last dose administered at Week 50, EOT visit occurred 2 weeks after last administration of treatment i.e., at Week 52).'}], 'classes': [{'title': 'Low titer', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'Moderate titer', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'High titer', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 52', 'description': 'Number of participants with treatment-emergent response to dupilumab with peak post-baseline titers during the on-treatment period are reported. Treatment-emergent response was defined as a positive response in the ADA assay post first dose, when baseline results were negative or missing. Categories were based on titer values and included: low (Titer \\<1000); moderate (1000\\<=Titer\\<=10,000); and high (Titer \\>10,000). On-treatment period was defined as last study treatment administration plus 14 days; that is, Week 52.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "The ADA population consisted of all participants in the Safety population with at least 1 reportable ADA results (either 'ADA negative' or 'ADA positive') after first dose of the study treatment."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to dupilumab 300 mg as subcutaneous (SC) injections q2w up to a maximum of 52 weeks (last dose administered at Week 50, end of treatment \\[EOT\\] visit occurred 2 weeks after last administration of treatment i.e., at Week 52).'}, {'id': 'FG001', 'title': 'Dupilumab 300 mg q2w', 'description': 'Participants received dupilumab 300 mg administered as SC injections q2w up to a maximum of 52 weeks (last dose administered at Week 50, EOT visit occurred 2 weeks after last administration of treatment i.e., at Week 52).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Randomized', 'achievements': [{'groupId': 'FG000', 'numSubjects': '471'}, {'groupId': 'FG001', 'numSubjects': '468'}]}, {'type': 'Safety Population', 'comment': 'One participant was exposed to different treatment other than planned (was randomized to placebo arm but received dupilumab on Day 40). The actual arm was considered as dupilumab 300 mg q2w. In safety analyses, the actual arms are used.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '470'}, {'groupId': 'FG001', 'numSubjects': '469'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '434'}, {'groupId': 'FG001', 'numSubjects': '440'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '28'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Poor compliance to protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Other reason related to Coronavirus Disease-2019 (COVID-19)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other reason not related to COVID-19', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '8'}]}]}], 'recruitmentDetails': 'The study was conducted at 275 centers in 24 countries. A total of 2599 participants were screened from 15 Apr 2019 to 12 Jan 2022, of which 1660 were screen failures due to not meeting eligibility criteria.', 'preAssignmentDetails': 'A total of 939 participants were randomized in a 1:1 ratio to receive either dupilumab 300 milligrams (mg) every 2 weeks (q2w) or matching placebo for 52 weeks.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '471', 'groupId': 'BG000'}, {'value': '468', 'groupId': 'BG001'}, {'value': '939', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to dupilumab 300 mg as SC injections q2w up to a maximum of 52 weeks (last dose administered at Week 50, EOT visit occurred 2 weeks after last administration of treatment i.e., at Week 52).'}, {'id': 'BG001', 'title': 'Dupilumab 300 mg q2w', 'description': 'Participants received dupilumab 300 mg administered as SC injections q2w up to a maximum of 52 weeks (last dose administered at Week 50, EOT visit occurred 2 weeks after last administration of treatment i.e., at Week 52).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.2', 'spread': '8.1', 'groupId': 'BG000'}, {'value': '65.0', 'spread': '8.0', 'groupId': 'BG001'}, {'value': '65.1', 'spread': '8.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '149', 'groupId': 'BG000'}, {'value': '170', 'groupId': 'BG001'}, {'value': '319', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '322', 'groupId': 'BG000'}, {'value': '298', 'groupId': 'BG001'}, {'value': '620', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '397', 'groupId': 'BG000'}, {'value': '393', 'groupId': 'BG001'}, {'value': '790', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Randomized population consisted of any participant who was allocated to a randomized treatment regardless of whether the treatment kit was used.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-11-07', 'size': 2507823, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-01-30T05:13', 'hasProtocol': True}, {'date': '2020-03-23', 'size': 1924483, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-01-30T05:16', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 939}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-15', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-05-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-30', 'studyFirstSubmitDate': '2019-04-26', 'resultsFirstSubmitDate': '2024-01-30', 'studyFirstSubmitQcDate': '2019-04-26', 'lastUpdatePostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-01-30', 'studyFirstPostDateStruct': {'date': '2019-04-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Annualized Rate of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Over the 52-Week Treatment Period', 'timeFrame': 'Baseline (Day 1) to Week 52', 'description': 'Moderate exacerbations were recorded by the Investigator and defined as acute exacerbation of COPD (AECOPD) that required either systemic corticosteroids (such as intramuscular, intravenous or oral) and/or antibiotics. Severe exacerbations were also recorded by the Investigator and defined as AECOPD requiring hospitalization, or observation for \\>24 hours in an emergency department/urgent care facility or resulting in death. For both moderate and severe events to be counted as separate events, they were separated by at least 14 days. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated. Events were adjudicated by independent third party.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Pre-Bronchodilator (BD) Forced Expiratory Volume in One Second (FEV1) at Week 12', 'timeFrame': 'Baseline (Day 1) to Week 12', 'description': 'The FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. Spirometry was performed after a wash out period of bronchodilators according to their action duration.'}, {'measure': 'Change From Baseline in Pre-BD FEV1 at Week 52', 'timeFrame': 'Baseline (Day 1) to Week 52', 'description': 'The FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. Spirometry was performed after a wash out period of bronchodilators according to their action duration.'}, {'measure': 'Change From Baseline in Pre-BD FEV1 at Week 12 in Subgroup of Participants With Baseline Fractional Exhaled Nitric Oxide (FeNO) >=20 Parts Per Billion (Ppb)', 'timeFrame': 'Baseline (Day 1) to Week 12', 'description': 'FeNO is a demonstrated biomarker of type 2 airway inflammation in respiratory diseases. FeNO was analyzed using a NIOX instrument or similar analyzer using a flow rate of 50 milliliter per second (mL/s) and reported in ppb. This assessment was conducted prior to spirometry and following a fast of at least 1 hour.'}, {'measure': 'Change From Baseline in Pre-BD FEV1 at Week 52 in Subgroup of Participants With Baseline FeNO >=20 Ppb', 'timeFrame': 'Baseline (Day 1) to Week 52', 'description': 'FeNO is a demonstrated biomarker of type 2 airway inflammation in respiratory diseases. FeNO was analyzed using a NIOX instrument or similar analyzer using a flow rate of 50 mL/s and reported in ppb. This assessment was conducted prior to spirometry and following a fast of at least 1 hour.'}, {'measure': "Change From Baseline in Saint (St.) George's Respiratory Questionnaire (SGRQ) Total Score at Week 52", 'timeFrame': 'Baseline (Day 1) to Week 52', 'description': 'The SGRQ was a 50-item self-administered questionnaire designed to measure and quantify health status in adult participants with chronic airflow limitation and rated on electronic diary. Scores by dimension were calculated for 3 domains: symptoms, activity and impacts (psycho-social) as well as a total score. Global and domain scores range from 0 to 100, with 100 representing the worst possible health status and 0 indicating the best possible health status. Higher score indicates worse health status/heath related quality of life.'}, {'measure': 'Percentage of Participants With SGRQ Improvement >=4 Points at Week 52', 'timeFrame': 'Baseline (Day 1) to Week 52', 'description': 'A responder was defined as a participant with improvement from baseline in SGRQ total score at Week 52 by \\>=4 points. Participants with improvement \\<4 points or with missing values were considered as non-responders. The percentage of participants who achieved a clinically meaningful response in SGRQ total score (reduction \\[improvement\\] by \\>=4 points)/responders are reported.'}, {'measure': 'Change From Baseline in Evaluating Respiratory Symptoms (E-RS) in COPD (E-RS: COPD) RS-Total Score at Week 52', 'timeFrame': 'Baseline (Day 1) to Week 52', 'description': 'The E-RS in COPD scale was a part of the exacerbations of chronic pulmonary disease tool (EXACT). It was a derivative instrument used to measure the effect of treatment on the severity of respiratory symptoms in stable COPD. E-RS: COPD RS-Total Score was derived based on weekly averages of daily assessed 11 respiratory symptom items contained in the 14-item EXACT questionnaire. The RS-Total score represented overall respiratory symptom severity, ranged from 0 to 40. Summation procedure was used to derive the three daily domain scores: 1). RS-Breathlessness (range 0-17), 2) RS-Cough and Sputum (score range 0-11), 3) RS-Chest Symptoms (score range 0-12). The higher the score, more severe were the symptoms.'}, {'measure': 'Annualized Rate of Moderate or Severe COPD Exacerbation Over the 52-Week Treatment Period in Subgroup of Participants With Baseline FeNO >=20 Ppb', 'timeFrame': 'Baseline (Day 1) to Week 52', 'description': 'Moderate exacerbations were recorded by the Investigator and defined as AECOPD that required either systemic corticosteroids (such as intramuscular, intravenous or oral) and/or antibiotics. Severe exacerbations were also recorded by the investigator and defined as AECOPD requiring hospitalization, or observation for \\>24 hours in an emergency department/urgent care facility or resulting in death. For both moderate and severe events to be counted as separate events, they were separated by at least 14 days. Annualized event rate among participants with baseline FeNO \\>=20 ppb was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated. Events were adjudicated by independent third party.'}, {'measure': 'Change From Baseline in Pre-BD FEV1 to Weeks 2, 4, 8, 24, 36 and 44', 'timeFrame': 'Baseline (Day 1) to Weeks 2, 4, 8, 24, 36 and 44', 'description': 'The FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. Spirometry was performed after a wash out period of bronchodilators according to their action duration.'}, {'measure': 'Change From Baseline in Post-BD FEV1 to Weeks 2, 4, 8, 12, 24, 36 and 52', 'timeFrame': 'Baseline (Day 1) to Weeks 2, 4, 8, 12, 24, 36 and 52', 'description': 'The FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. Post-BD FEV1 referred to the spirometry performed within 30 minutes after administration of bronchodilator.'}, {'measure': 'Change From Baseline in Pre-BD Forced Expiratory Flow at 25 Percent (%) to 75% (FEF 25-75%) of Forced Vital Capacity (FVC) to Weeks 2, 4, 8, 12, 24, 36, 44, and 52', 'timeFrame': 'Baseline (Day 1) to Weeks 2, 4, 8, 12, 24, 36, 44 and 52', 'description': 'FEF is the amount of air (in liters) which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEF 25-75% was defined as the mean FEF between 25% and 75% of the FVC, where FVC was defined as the volume of air (in liters) that can be forcibly blown out after full inspiration in the upright position. Spirometry was performed after a wash out period of bronchodilators according to their action duration.'}, {'measure': 'Change From Baseline in Post-BD FEF 25-75% to Weeks 2, 4, 8, 12, 24, 36 and 52', 'timeFrame': 'Baseline (Day 1) to Weeks 2, 4, 8, 12, 24, 36 and 52', 'description': 'FEF is the amount of air (in liters) which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEF 25-75% was defined as the mean FEF between 25% and 75% of the FVC, where FVC was defined as the volume of air (in liters) that can be forcibly blown out after full inspiration in the upright position. Spirometry was performed after a wash out period of bronchodilators according to their action duration.'}, {'measure': 'Annualized Rate of Severe COPD Exacerbations Over the 52-Week Treatment Period', 'timeFrame': 'Baseline (Day 1) to Week 52', 'description': 'Moderate exacerbations were recorded by the Investigator and defined as AECOPD that required either systemic corticosteroids (such as intramuscular, intravenous or oral) and/or antibiotics. Severe exacerbations were also recorded by the Investigator and defined as AECOPD requiring hospitalization, or observation for \\>24 hours in an emergency department/urgent care facility or resulting in death. For both moderate and severe events to be counted as separate events, they were separated by at least 14 days. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated. Events were adjudicated by independent third party.'}, {'measure': 'Time to First Moderate or Severe COPD Exacerbation During the 52-Week Treatment Period', 'timeFrame': 'Baseline (Day 1) and up to Weeks 12, 24, 36 and 52', 'description': 'The time to first moderate or severe exacerbation was defined as date of the first event minus randomization date +1. The median time to first severe exacerbation was derived from Cox regression model. Moderate exacerbations events were recorded by the investigator and defined as AECOPD that require either systemic corticosteroids (such as intramuscular, intravenous or oral) and/or antibiotics. Severe exacerbations were recorded by the Investigator and defined as AECOPD requiring hospitalization, or observation for \\>24 hours in an emergency department/urgent care facility or resulting in death. For both moderate and severe events to be counted as separate events, they were separated by at least 14 days.'}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)', 'timeFrame': 'TEAEs were collected from the time from the first administration of study treatment to the last administration of the study treatment + 98 days, up to 491 days', 'description': 'An Adverse Event (AE) was defined as any untoward medical occurrence in a participant temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAEs were defined as AEs that developed or worsened in grade or became serious during TE period which was defined as the period from the time of first dose of study treatment until the last visit in the study. Serious adverse events (SAE) were defined as any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event.'}, {'measure': 'Number of Participants With Anti-Drug Antibodies (ADA) to Dupilumab', 'timeFrame': 'Up to Week 52', 'description': 'Number of participants with treatment-emergent response to dupilumab with peak post-baseline titers during the on-treatment period are reported. Treatment-emergent response was defined as a positive response in the ADA assay post first dose, when baseline results were negative or missing. Categories were based on titer values and included: low (Titer \\<1000); moderate (1000\\<=Titer\\<=10,000); and high (Titer \\>10,000). On-treatment period was defined as last study treatment administration plus 14 days; that is, Week 52.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'referencesModule': {'references': [{'pmid': '40651490', 'type': 'DERIVED', 'citation': 'Christenson SA, Hanania NA, Bhatt SP, Bafadhel M, Rabe KF, Vogelmeier CF, Papi A, Singh D, Laws E, Dakin P, Bansal A, Lu X, Bauer D, Maloney J, Robinson LB, Abdulai RM. Type 2 inflammation biomarkers and their association with response to dupilumab in COPD (BOREAS): an analysis of a randomised, placebo-controlled, phase 3 trial. Lancet Respir Med. 2025 Aug;13(8):687-697. doi: 10.1016/S2213-2600(25)00044-X. Epub 2025 Jul 9.'}, {'pmid': '40024335', 'type': 'DERIVED', 'citation': 'Vogelmeier CF, Rabe KF, Bhatt SP, Hanania NA, Bafadhel M, Christenson SA, Papi A, Singh D, Laws E, Maloney J, Dakin P, Lu X, Bauer D, Bansal A, Robinson LB, Abdulai RM. Dupilumab reduces acute exacerbations and improves lung function in patients with COPD with type 2 inflammation irrespective of body mass index, airflow obstruction, dyspnea, and exercise capacity index scores. Respir Med. 2025 May;241:108015. doi: 10.1016/j.rmed.2025.108015. Epub 2025 Feb 28.'}, {'pmid': '39894389', 'type': 'DERIVED', 'citation': 'Bhatt SP, Rabe KF, Hanania NA, Vogelmeier CF, Bafadhel M, Christenson SA, Papi A, Singh D, Laws E, Dakin P, Maloney J, Lu X, Bauer D, Bansal A, Abdulai RM, Robinson LB. Effect of Dupilumab on Health-Related Quality of Life and Respiratory Symptoms in Patients With COPD and Type 2 Inflammation: BOREAS and NOTUS. Chest. 2025 Jul;168(1):56-66. doi: 10.1016/j.chest.2025.01.029. Epub 2025 Jan 31.'}, {'pmid': '39481660', 'type': 'DERIVED', 'citation': 'Bhatt SP, Rabe KF, Hanania NA, Vogelmeier CF, Bafadhel M, Christenson SA, Papi A, Singh D, Laws E, Dakin P, Maloney J, Lu X, Bauer D, Bansal A, Robinson LB, Abdulai RM. Dupilumab reduces exacerbations and improves lung function in patients with chronic obstructive pulmonary disease and emphysema: Phase 3 randomized trial (BOREAS). Respir Med. 2025 Jan;236:107846. doi: 10.1016/j.rmed.2024.107846. Epub 2024 Oct 30.'}, {'pmid': '37272521', 'type': 'DERIVED', 'citation': 'Bhatt SP, Rabe KF, Hanania NA, Vogelmeier CF, Cole J, Bafadhel M, Christenson SA, Papi A, Singh D, Laws E, Mannent LP, Patel N, Staudinger HW, Yancopoulos GD, Mortensen ER, Akinlade B, Maloney J, Lu X, Bauer D, Bansal A, Robinson LB, Abdulai RM; BOREAS Investigators. Dupilumab for COPD with Type 2 Inflammation Indicated by Eosinophil Counts. N Engl J Med. 2023 Jul 20;389(3):205-214. doi: 10.1056/NEJMoa2303951. Epub 2023 May 21.'}]}, 'descriptionModule': {'briefSummary': "Primary Objective:\n\nTo evaluate the efficacy of dupilumab administered every 2 weeks in patients with moderate-or severe Chronic Obstructive Pulmonary Disease (COPD) as measured by\n\n* Annualized rate of acute moderate and severe COPD exacerbation (AECOPD)\n\nSecondary Objectives:\n\nTo evaluate the effect of dupilumab administered every 2 weeks on\n\n* Pre-bronchodilator forced expiratory volume in 1 second (FEV1) over 12 weeks compared to placebo\n* Health related quality of life, assessed by the change from baseline to Week 52 in the St. George's Respiratory Questionnaire (SGRQ)\n* Pre-bronchodilator FEV1 over 52 weeks compared to placebo\n* Lung function assessments\n* Moderate and severe COPD exacerbations\n* To evaluate safety and tolerability\n* To evaluate dupilumab systemic exposure and incidence of anti-drug antibodies (ADA)", 'detailedDescription': 'Approximately 68 weeks including a 4-week screening period, a 52-week treatment period, and 12 weeks of follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Participants with a physician diagnosis of COPD who met the following criteria at screening:\n\n * Current or former smokers with a smoking history of ≥10 pack-years.\n * Moderate-to-severe COPD (post-bronchodilator FEV1/ forced vital capacity \\[FVC\\] ratio \\<0.70 and post-bronchodilator FEV1 % predicted \\>30% and ≤70%).\n * Medical Research Council (MRC) Dyspnea Scale grade ≥2.\n * Patient-reported history of signs and symptoms of chronic bronchitis (chronic productive cough) for 3 months in the year up to screening in the absence of other known causes of chronic cough.\n * Documented history of high exacerbation risk defined as exacerbation history of ≥2 moderate or ≥1 severe within the year prior to inclusion. At least one exacerbation should have occurred while the patient was taking inhaled corticosteroid (ICS)/long acting beta agonist (LABA)/long acting muscarinic antagonist (LAMA) (or LABA/LAMA if ICS is contraindicated). Moderate exacerbations were recorded by the investigator and defined as acute exacerbation of COPD (AECOPD) that required either systemic corticosteroids (intramuscular, intravenous, or oral) and/or antibiotics. One of the two required moderate exacerbations had to require the use of systemic corticosteroids. Severe exacerbations were recorded by the investigator and defined as AECOPD requiring hospitalization or observation \\>24 hours in emergency department/urgent care facility.\n * Background triple therapy (ICS + LABA + LAMA) for 3 months prior to randomization with a stable dose of medication for ≥1 month prior to Visit 1; Double therapy (LABA + LAMA) allowed if ICS was contraindicated.\n* Evidence of Type 2 inflammation: Patients with blood eosinophils ≥300 cells/microliter at Visit 1.\n\nExclusion criteria:\n\n* COPD diagnosis for less than 12 months prior to randomization.\n* A current diagnosis of asthma or history of asthma according to the 2018 Global Initiative for Asthma (GINA) guidelines or other accepted guidelines.\n* Significant pulmonary disease other than COPD (e.g., lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, bronchiectasis, Churg-Strauss Syndrome etc) or another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts.\n* Cor pulmonale, evidence of right cardiac failure.\n* Treatment with oxygen of more than 12 hours per day.\n* Hypercapnia requiring Bi-level ventilation.\n* AECOPD as defined in inclusion criteria within 4 weeks prior to screening, or during the screening period.\n* Respiratory tract infection within 4 weeks prior to screening, or during the screening period.\n* History of, or planned pneumonectomy or lung volume reduction surgery. Patients who were participating in the acute phase of a pulmonary rehabilitation program, ie, who started rehabilitation \\<4 weeks prior to screening (Note: patients in the maintenance phase of a rehabilitation program could be included).\n* Diagnosis of α-1 anti-trypsin deficiency.\n\nThe above information was not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT03930732', 'acronym': 'BOREAS', 'briefTitle': 'Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate-to-severe COPD With Type 2 Inflammation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) With Type 2 Inflammation', 'orgStudyIdInfo': {'id': 'EFC15804'}, 'secondaryIdInfos': [{'id': '2018-001953-28', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1211-8804', 'type': 'OTHER', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dupilumab', 'description': 'Participants received dupilumab 300 mg administered as SC injections q2w up to a maximum of 52 weeks (last dose administered at Week 50, EOT visit occurred 2 weeks after last administration of treatment i.e., at Week 52).', 'interventionNames': ['Drug: Dupilumab SAR231893', 'Drug: Inhaled Corticosteroid', 'Drug: Inhaled Long-Acting Beta Agonist', 'Drug: Inhaled Long-Acting Muscarinic Antagonist']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received placebo matched to dupilumab 300 mg as subcutaneous (SC) injections q2w up to a maximum of 52 weeks (last dose administered at Week 50, end of treatment \\[EOT\\] visit occurred 2 weeks after last administration of treatment i.e., at Week 52).', 'interventionNames': ['Drug: Inhaled Corticosteroid', 'Drug: Inhaled Long-Acting Beta Agonist', 'Drug: Inhaled Long-Acting Muscarinic Antagonist', 'Drug: Placebo']}], 'interventions': [{'name': 'Dupilumab SAR231893', 'type': 'DRUG', 'otherNames': ['Dupixent'], 'description': 'Pharmaceutical form: Solution for injection\n\nRoute of administration: Subcutaneous', 'armGroupLabels': ['Dupilumab']}, {'name': 'Inhaled Corticosteroid', 'type': 'DRUG', 'description': 'Pharmaceutical form: Inhaled Powder\n\nRoute of administration: Oral inhalation', 'armGroupLabels': ['Dupilumab', 'Placebo']}, {'name': 'Inhaled Long-Acting Beta Agonist', 'type': 'DRUG', 'description': 'Pharmaceutical form: Inhaled Powder\n\nRoute of administration: Oral inhalation', 'armGroupLabels': ['Dupilumab', 'Placebo']}, {'name': 'Inhaled Long-Acting Muscarinic Antagonist', 'type': 'DRUG', 'description': 'Pharmaceutical form: Inhaled Powder\n\nRoute of administration: Oral inhalation', 'armGroupLabels': ['Dupilumab', 'Placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Pharmaceutical form: Solution for injection\n\nRoute of administration: Subcutaneous', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36420', 'city': 'Andalusia', 'state': 'Alabama', 'country': 'United States', 'facility': 'SEC Clinical Research, LLC-Site Number:8400030', 'geoPoint': {'lat': 31.30808, 'lon': -86.48243}}, {'zip': '35209-6802', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Clinical Research Center of Alabama, LLC-Site Number:8400041', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'UAB Lung Health Center-Site Number:8400013', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36303', 'city': 'Dothan', 'state': 'Alabama', 'country': 'United States', 'facility': 'SEC Clinical Research, LLC-Site Number:8400059', 'geoPoint': {'lat': 31.22323, 'lon': -85.39049}}, {'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Pulmonary Associates of Mobile, P.C.-Site Number:8400057', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '80907', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Asthma and Allergy Associates, PC-Site Number:8400034', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '33765', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Research Of West Florida Inc-Site Number:8400010', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '33467', 'city': 'Greenacres City', 'state': 'Florida', 'country': 'United States', 'facility': 'Finlay Medical Research-Site Number:8400014', 'geoPoint': {'lat': 26.62368, 'lon': -80.12532}}, {'zip': '33125', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Project 4 research, 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