Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2025-12-25 @ 7:16 PM
Study NCT ID:
NCT04719832
Status:
COMPLETED
Last Update Posted:
2024-12-17
First Post:
2021-01-18
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Placebo-controlled Efficacy and Safety Study of GSK3511294 (Depemokimab) in Participants With Severe Asthma With an Eosinophilic Phenotype
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '8664357343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56.', 'description': 'All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 1 site with GCP violation. AEs were reported treatment-wise.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants received placebo SC injection once every 26 weeks (week 0 and week 26). Participants were to be maintained on their existing baseline maintenance asthma SOC treatment throughout the study.', 'otherNumAtRisk': 132, 'deathsNumAtRisk': 132, 'otherNumAffected': 78, 'seriousNumAtRisk': 132, 'deathsNumAffected': 0, 'seriousNumAffected': 22}, {'id': 'EG001', 'title': 'GSK3511294', 'description': 'Participants received a 100 mg dose of GSK3511294 SC injection once every 26 weeks (week 0 and week 26). Participants were to be maintained on their existing baseline maintenance asthma SOC treatment throughout the study.', 'otherNumAtRisk': 250, 'deathsNumAtRisk': 250, 'otherNumAffected': 145, 'seriousNumAtRisk': 250, 'deathsNumAffected': 0, 'seriousNumAffected': 15}], 'otherEvents': [{'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 18, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 30, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 51, 'numAffected': 51}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 21, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 32, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 37, 'numAffected': 29}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 11, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 16, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 17, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 14, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 22, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 39, 'numAffected': 25}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 11, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 17, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 23, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 15, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}], 'seriousEvents': [{'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Rhegmatogenous retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Large intestine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Jaundice cholestatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Bronchopulmonary aspergillosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hepatitis A', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Joint range of motion decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Adenocarcinoma of colon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cerebrovascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Genital prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Uterine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Annualized Rate of Clinically Significant Exacerbations up to 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo SC injection once every 26 weeks (week 0 and week 26). Participants were to be maintained on their existing baseline maintenance asthma SOC treatment throughout the study.'}, {'id': 'OG001', 'title': 'GSK3511294', 'description': 'Participants received a 100 mg dose of GSK3511294 SC injection once every 26 weeks (week 0 and week 26). Participants were to be maintained on their existing baseline maintenance asthma SOC treatment throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.11', 'spread': '0.86', 'groupId': 'OG000', 'lowerLimit': '0.86', 'upperLimit': '1.43'}, {'value': '0.46', 'spread': '0.36', 'groupId': 'OG001', 'lowerLimit': '0.36', 'upperLimit': '0.58'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.42', 'ciLowerLimit': '0.30', 'ciUpperLimit': '0.59', 'groupDescription': 'To demonstrate the superiority of GSK3511294 100 mg SC + SoC following two doses (at Week 0 and at Week 26) compared with placebo + SoC, assessed by the annualized rate of clinically significant exacerbations measured over the study intervention period of 52 weeks.', 'statisticalMethod': 'Negative binomial distribution', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Analysis performed using a negative binomial model with covariates of treatment, exacerbation history (2, 3, 4+), baseline inhaled CS dose (medium, high), geographical region, baseline percent predicted Forced Expiratory Volume in one second (FEV1), and offset of log (total time in the study in years).'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Up to Week 52', 'description': 'Clinically significant exacerbations recorded were defined as worsening of asthma requiring the use of systemic corticosteroids (CS) \\[such as intramuscular (IM), intravenous (IV) or oral\\] and/or hospitalization and/or Emergency Department (ED) visit. For all participants, IV or oral steroids (e.g., prednisone) for at least 3 days or a single IM corticosteroid dose is required. For participants on maintenance systemic corticosteroids, at least double the existing maintenance dose for at least 3 days is required. Exacerbations recorded in the electronic case report form (eCRF) were considered as verified clinically significant exacerbations and included in the primary analysis. Exacerbations separated by less than 7 days was treated as a continuation of the same exacerbation.', 'unitOfMeasure': 'Exacerbation per participant per year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "The FAS included all randomized participants who received at least one dose of study intervention excluding participants from 1 site with GCP violation. Participants were analyzed according to the intervention they were allocated at randomization. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for specified time points."}, {'type': 'SECONDARY', 'title': "Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 52", 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo SC injection once every 26 weeks (week 0 and week 26). Participants were to be maintained on their existing baseline maintenance asthma SOC treatment throughout the study.'}, {'id': 'OG001', 'title': 'GSK3511294', 'description': 'Participants received a 100 mg dose of GSK3511294 SC injection once every 26 weeks (week 0 and week 26). Participants were to be maintained on their existing baseline maintenance asthma SOC treatment throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.67', 'spread': '1.544', 'groupId': 'OG000', 'lowerLimit': '1.544'}, {'value': '-13.03', 'spread': '1.112', 'groupId': 'OG001', 'lowerLimit': '1.112'}]}]}], 'analyses': [{'pValue': '= 0.080', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.36', 'ciLowerLimit': '-7.11', 'ciUpperLimit': '0.39', 'groupDescription': 'Analysis performed using a repeated measures model with covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region, baseline SGRQ total score, baseline pre-bronchodilator percent predicted FEV1, visit, visit by baseline SGRQ total score and visit by treatment group', 'statisticalMethod': 'Mixed Models Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 1) and Week 52', 'description': 'The SGRQ is a 50-item patient-reported outcome tool used to measure Quality of Life in participants with airway obstruction diseases. The questions are designed to be self-completed by the participant. The total score was calculated by the symptom score, activity and impact score; and summarizing the impact of the disease on overall health status on 0-100 rating scale. Scores are expressed as a percentage of overall impairment where 100 representing worst possible health status and 0 indicating best possible health status. Higher scores indicating greater impairment of quality of life. Change from Baseline was defined as value at the indicated time point minus Baseline value.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "The FAS included all randomized participants who received at least one dose of study intervention excluding participants from 1 site with GCP violation. Participants were analyzed according to the intervention they were allocated at randomization. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for specified time points."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '241', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo SC injection once every 26 weeks (week 0 and week 26). Participants were to be maintained on their existing baseline maintenance asthma SOC treatment throughout the study.'}, {'id': 'OG001', 'title': 'GSK3511294', 'description': 'Participants received a 100 mg dose of GSK3511294 SC injection once every 26 weeks (week 0 and week 26). Participants were to be maintained on their existing baseline maintenance asthma SOC treatment throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.77', 'spread': '0.091', 'groupId': 'OG000', 'lowerLimit': '0.091'}, {'value': '-0.82', 'spread': '0.066', 'groupId': 'OG001', 'lowerLimit': '0.066'}]}]}], 'analyses': [{'pValue': '= 0.690', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.04', 'ciLowerLimit': '-0.27', 'ciUpperLimit': '0.18', 'groupDescription': 'Analysis performed using a repeated measures model with covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region, baseline ACQ-5 score, baseline pre-bronchodilator percent predicted FEV1, visit, visit by baseline ACQ-5 score and visit by treatment group.', 'statisticalMethod': 'Mixed Models Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 1) and Week 52', 'description': 'The ACQ-5 is a five-item questionnaire developed as a measure of participants asthma symptom control. The questions are designed to be self-completed by the participant. The 5 questions enquired to recall how their asthma had been during the previous week and to respond about the frequency and/or severity of symptoms (nocturnal awakening, waking in the morning, activity limitation, shortness of breath and wheezing). The overall ACQ-5 response option is the mean score of all 5 questions representing 0 with no impairment/limitation and 6 as total impairment/ limitation. Higher scores indicated more limitations and lower score with better asthma control. Change from Baseline was defined as value at the indicated time point minus Baseline value.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "The FAS included all randomized participants who received at least one dose of study intervention excluding participants from 1 site with GCP violation. Participants were analyzed according to the intervention they were allocated at randomization. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for specified time points."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second (FEV1) At Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo SC injection once every 26 weeks (week 0 and week 26). Participants were to be maintained on their existing baseline maintenance asthma SOC treatment throughout the study.'}, {'id': 'OG001', 'title': 'GSK3511294', 'description': 'Participants received a 100 mg dose of GSK3511294 SC injection once every 26 weeks (week 0 and week 26). Participants were to be maintained on their existing baseline maintenance asthma SOC treatment throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.160', 'spread': '0.0364', 'groupId': 'OG000', 'lowerLimit': '0.0364'}, {'value': '0.160', 'spread': '0.0263', 'groupId': 'OG001', 'lowerLimit': '0.0263'}]}]}], 'analyses': [{'pValue': '= 0.991', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.001', 'ciLowerLimit': '-0.089', 'ciUpperLimit': '0.088', 'groupDescription': 'Analysis performed using a repeated measures model with covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region, baseline pre-bronchodilator FEV1, visit, visit by baseline pre-bronchodilator FEV1 and visit by treatment group.', 'statisticalMethod': 'Mixed Models Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 1) and Week 52', 'description': 'Forced Expiratory Volume in One Second (FEV1) is defined as the volume of air that can be forced out in one second after taking a deep breath by a person and will be measured by spirometry testing. Change from Baseline in clinic pre-bronchodilator FEV1 was determined. Change from Baseline was defined as value at the indicated time point minus Baseline value.', 'unitOfMeasure': 'Liters (L)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "The FAS included all randomized participants who received at least one dose of study intervention excluding participants from 1 site with GCP violation. Participants were analyzed according to the intervention they were allocated at randomization. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for specified time points."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Asthma Nighttime Symptom Diary (ANSD) Weekly Mean Score at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo SC injection once every 26 weeks (week 0 and week 26). Participants were to be maintained on their existing baseline maintenance asthma SOC treatment throughout the study.'}, {'id': 'OG001', 'title': 'GSK3511294', 'description': 'Participants received a 100 mg dose of GSK3511294 SC injection once every 26 weeks (week 0 and week 26). Participants were to be maintained on their existing baseline maintenance asthma SOC treatment throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.30', 'spread': '0.168', 'groupId': 'OG000'}, {'value': '-1.39', 'spread': '0.120', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '= 0.650', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.09', 'ciLowerLimit': '-0.50', 'ciUpperLimit': '0.31', 'groupDescription': 'Analysis performed using a repeated measures model with covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region, baseline ANSD weekly mean score, baseline pre-bronchodilator percent predicted FEV1, visit, visit by baseline ANSD weekly mean score and visit by treatment group.', 'statisticalMethod': 'Mixed Models Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 52', 'description': "The ANSD is a 6-item self-administered patient reported diary developed by Patient Related Outcomes (PRO) Consortium's Asthma Working Group to facilitate comprehensive and reliable assessment of asthma symptoms from a participant's perspective. Participants were required to rate the severity of symptoms in 3 core categories: breathing symptoms (wheezing, shortness of breath), chest symptoms (chest tightness, chest pain) and cough. The ANSD was to be completed before going to bed and refers to asthma symptoms during the day. Symptoms are rated at their worst using an 11-point numeric rating scale ranging from 0 (None) to 10 (As bad as you can imagine). Higher scores indicate more severe symptoms. Mean daily scores of ANSD was calculated by weekly intervals. The baseline values were defined as the average score from Day -7 to Day -1 inclusive (at least 4 days must be non-missing). Change from Baseline was defined as value at each time point minus Baseline value.", 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "All participants in the FAS population (excluding participants from 1 site with GCP violation) for whom at least one ANSD questionnaire was administered. Participants were analyzed according to the intervention they were allocated at randomization. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for specified time points."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Asthma Daily Symptom Diary (ADSD) Weekly Mean Score at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '206', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo SC injection once every 26 weeks (week 0 and week 26). Participants were to be maintained on their existing baseline maintenance asthma SOC treatment throughout the study.'}, {'id': 'OG001', 'title': 'GSK3511294', 'description': 'Participants received a 100 mg dose of GSK3511294 SC injection once every 26 weeks (week 0 and week 26). Participants were to be maintained on their existing baseline maintenance asthma SOC treatment throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.25', 'spread': '0.140', 'groupId': 'OG000'}, {'value': '-1.33', 'spread': '0.101', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '= 0.647', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.08', 'ciLowerLimit': '-0.42', 'ciUpperLimit': '0.26', 'groupDescription': 'Analysis performed using a repeated measures model with covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region, baseline ADSD weekly mean score, baseline pre-bronchodilator percent predicted FEV1, visit, visit by baseline ADSD weekly mean score and visit by treatment group.', 'statisticalMethod': 'Mixed Models Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 52', 'description': "The ADSD is a 6-item self-administered patient reported diary developed by patient related outcomes (PRO) Consortium's Asthma Working Group to facilitate comprehensive and reliable assessment of asthma symptoms from a participant's perspective. Participants were required to rate the severity of symptoms in 3 core categories: breathing symptoms (wheezing, shortness of breath), chest symptoms (chest tightness, chest pain) and cough. The ADSD was to be completed upon waking and refers to asthma symptoms during the night-time. Symptoms are rated at their worst using an 11-point numeric rating scale ranging from 0 (None) to 10 (As bad as you can imagine). Higher scores indicate more severe symptoms. Mean daily scores of ADSD was calculated by weekly intervals. The baseline values were defined as the average score from Day -7 to Day -1 inclusive (at least 4 days must be non-missing). Change from Baseline was defined as value at each time point minus Baseline value.", 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "All participants in the FAS population (excluding participants from 1 site with GCP violation) for whom at least one ADSD questionnaire was administered. Participants were analyzed according to the intervention they were allocated at randomization. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for specified time points."}, {'type': 'SECONDARY', 'title': 'Annualized Rate of Exacerbations Requiring Hospitalization and/or Emergency Department (ED) Visit up to 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo SC injection once every 26 weeks (week 0 and week 26). Participants were to be maintained on their existing baseline maintenance asthma SOC treatment throughout the study.'}, {'id': 'OG001', 'title': 'GSK3511294', 'description': 'Participants received a 100 mg dose of GSK3511294 SC injection once every 26 weeks (week 0 and week 26). Participants were to be maintained on their existing baseline maintenance asthma SOC treatment throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 52', 'description': 'The data did not meet the condition (total of 20 or more exacerbations requiring hospitalization and/or ED visit) for conducting the statistical analysis. The number of exacerbations requiring Hospitalization and/or ED Visit are reported here.', 'unitOfMeasure': 'Exacerbations', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all randomized participants who received at least 1 dose of study intervention excluding participants from 1 site with GCP violation. Participants were analyzed according to the intervention they were allocated at randomization.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants received placebo subcutaneous (SC) injection once every 26 weeks (week 0 and week 26). Participants were to be maintained on their existing baseline maintenance asthma standard of care (SOC) treatment throughout the study.'}, {'id': 'FG001', 'title': 'GSK3511294', 'description': 'Participants received a 100 milligram (mg) dose of GSK3511294 SC injection once every 26 weeks (week 0 and week 26). Participants were to be maintained on their existing baseline maintenance asthma SOC treatment throughout the study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '136'}, {'groupId': 'FG001', 'numSubjects': '259'}]}, {'type': 'Full Analysis Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '132'}, {'groupId': 'FG001', 'numSubjects': '250'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '122'}, {'groupId': 'FG001', 'numSubjects': '237'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '22'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Randomized, not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'GCP violations', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}], 'recruitmentDetails': 'A total of 395 participants were randomized to the study. Of which 382 participants were included in Full analysis set (FAS) population. FAS included all randomized participants who received at least 1 dose of study intervention excluding 11 participants from 1 site with Good Clinical Practice (GCP)/data integrity issues. Two (2) participants were randomized in error and did not receive any study drug.', 'preAssignmentDetails': 'A total of 395 were randomized in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'BG000'}, {'value': '250', 'groupId': 'BG001'}, {'value': '382', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received placebo SC injection once every 26 weeks (week 0 and week 26). Participants were to be maintained on their existing baseline maintenance asthma SOC treatment throughout the study.'}, {'id': 'BG001', 'title': 'GSK3511294', 'description': 'Participants received a 100 mg dose of GSK3511294 SC injection once every 26 weeks (week 0 and week 26). Participants were to be maintained on their existing baseline maintenance asthma SOC treatment throughout the study.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.6', 'spread': '14.91', 'groupId': 'BG000'}, {'value': '54.1', 'spread': '13.82', 'groupId': 'BG001'}, {'value': '53.9', 'spread': '14.19', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '144', 'groupId': 'BG001'}, {'value': '223', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '159', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '207', 'groupId': 'BG001'}, {'value': '316', 'groupId': 'BG002'}]}, {'title': 'Others', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "Race categories (with 0\\<n\\<11) are combined into 'Others' category to minimize the possibility of re-identification of participants.", 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full analysis set population included all randomized participants who received at least one dose of study intervention excluding participants from 1 site with GCP violation. Participants were analyzed according to the intervention they were allocated at randomization.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-04-08', 'size': 2299961, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-11-21T05:39', 'hasProtocol': True}, {'date': '2023-12-14', 'size': 1331698, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-11-21T05:39', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 395}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-21', 'studyFirstSubmitDate': '2021-01-18', 'resultsFirstSubmitDate': '2024-11-21', 'studyFirstSubmitQcDate': '2021-01-18', 'lastUpdatePostDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-11-21', 'studyFirstPostDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Annualized Rate of Clinically Significant Exacerbations up to 52 Weeks', 'timeFrame': 'Up to Week 52', 'description': 'Clinically significant exacerbations recorded were defined as worsening of asthma requiring the use of systemic corticosteroids (CS) \\[such as intramuscular (IM), intravenous (IV) or oral\\] and/or hospitalization and/or Emergency Department (ED) visit. For all participants, IV or oral steroids (e.g., prednisone) for at least 3 days or a single IM corticosteroid dose is required. For participants on maintenance systemic corticosteroids, at least double the existing maintenance dose for at least 3 days is required. Exacerbations recorded in the electronic case report form (eCRF) were considered as verified clinically significant exacerbations and included in the primary analysis. Exacerbations separated by less than 7 days was treated as a continuation of the same exacerbation.'}], 'secondaryOutcomes': [{'measure': "Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 52", 'timeFrame': 'Baseline (Day 1) and Week 52', 'description': 'The SGRQ is a 50-item patient-reported outcome tool used to measure Quality of Life in participants with airway obstruction diseases. The questions are designed to be self-completed by the participant. The total score was calculated by the symptom score, activity and impact score; and summarizing the impact of the disease on overall health status on 0-100 rating scale. Scores are expressed as a percentage of overall impairment where 100 representing worst possible health status and 0 indicating best possible health status. Higher scores indicating greater impairment of quality of life. Change from Baseline was defined as value at the indicated time point minus Baseline value.'}, {'measure': 'Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score at Week 52', 'timeFrame': 'Baseline (Day 1) and Week 52', 'description': 'The ACQ-5 is a five-item questionnaire developed as a measure of participants asthma symptom control. The questions are designed to be self-completed by the participant. The 5 questions enquired to recall how their asthma had been during the previous week and to respond about the frequency and/or severity of symptoms (nocturnal awakening, waking in the morning, activity limitation, shortness of breath and wheezing). The overall ACQ-5 response option is the mean score of all 5 questions representing 0 with no impairment/limitation and 6 as total impairment/ limitation. Higher scores indicated more limitations and lower score with better asthma control. Change from Baseline was defined as value at the indicated time point minus Baseline value.'}, {'measure': 'Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second (FEV1) At Week 52', 'timeFrame': 'Baseline (Day 1) and Week 52', 'description': 'Forced Expiratory Volume in One Second (FEV1) is defined as the volume of air that can be forced out in one second after taking a deep breath by a person and will be measured by spirometry testing. Change from Baseline in clinic pre-bronchodilator FEV1 was determined. Change from Baseline was defined as value at the indicated time point minus Baseline value.'}, {'measure': 'Change From Baseline in Asthma Nighttime Symptom Diary (ANSD) Weekly Mean Score at Week 52', 'timeFrame': 'Baseline to Week 52', 'description': "The ANSD is a 6-item self-administered patient reported diary developed by Patient Related Outcomes (PRO) Consortium's Asthma Working Group to facilitate comprehensive and reliable assessment of asthma symptoms from a participant's perspective. Participants were required to rate the severity of symptoms in 3 core categories: breathing symptoms (wheezing, shortness of breath), chest symptoms (chest tightness, chest pain) and cough. The ANSD was to be completed before going to bed and refers to asthma symptoms during the day. Symptoms are rated at their worst using an 11-point numeric rating scale ranging from 0 (None) to 10 (As bad as you can imagine). Higher scores indicate more severe symptoms. Mean daily scores of ANSD was calculated by weekly intervals. The baseline values were defined as the average score from Day -7 to Day -1 inclusive (at least 4 days must be non-missing). Change from Baseline was defined as value at each time point minus Baseline value."}, {'measure': 'Change From Baseline in Asthma Daily Symptom Diary (ADSD) Weekly Mean Score at Week 52', 'timeFrame': 'Baseline to Week 52', 'description': "The ADSD is a 6-item self-administered patient reported diary developed by patient related outcomes (PRO) Consortium's Asthma Working Group to facilitate comprehensive and reliable assessment of asthma symptoms from a participant's perspective. Participants were required to rate the severity of symptoms in 3 core categories: breathing symptoms (wheezing, shortness of breath), chest symptoms (chest tightness, chest pain) and cough. The ADSD was to be completed upon waking and refers to asthma symptoms during the night-time. Symptoms are rated at their worst using an 11-point numeric rating scale ranging from 0 (None) to 10 (As bad as you can imagine). Higher scores indicate more severe symptoms. Mean daily scores of ADSD was calculated by weekly intervals. The baseline values were defined as the average score from Day -7 to Day -1 inclusive (at least 4 days must be non-missing). Change from Baseline was defined as value at each time point minus Baseline value."}, {'measure': 'Annualized Rate of Exacerbations Requiring Hospitalization and/or Emergency Department (ED) Visit up to 52 Weeks', 'timeFrame': 'Up to Week 52', 'description': 'The data did not meet the condition (total of 20 or more exacerbations requiring hospitalization and/or ED visit) for conducting the statistical analysis. The number of exacerbations requiring Hospitalization and/or ED Visit are reported here.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['GSK3511294 (Depemokimab)', 'Eosinophilic phenotype', 'Severe uncontrolled asthma', 'Exacerbations', 'Placebo'], 'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '39248309', 'type': 'DERIVED', 'citation': 'Jackson DJ, Wechsler ME, Jackson DJ, Bernstein D, Korn S, Pfeffer PE, Chen R, Saito J, de Luiz Martinez G, Dymek L, Jacques L, Bird N, Schalkwijk S, Smith D, Howarth P, Pavord ID; SWIFT-1 and SWIFT-2 Investigators; SWIFT-1 Investigators; SWIFT-2 Investigators. Twice-Yearly Depemokimab in Severe Asthma with an Eosinophilic Phenotype. N Engl J Med. 2024 Dec 19;391(24):2337-2349. doi: 10.1056/NEJMoa2406673. Epub 2024 Sep 9.'}]}, 'descriptionModule': {'briefSummary': 'This is a multi-center, randomized, placebo-controlled, double-blind, parallel group study that aims to assess the efficacy and safety of GSK3511294 (Depemokimab) in participants with severe uncontrolled asthma with an eosinophilic phenotype'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key inclusion Criteria:\n\n* Adults and adolescents greater than or equal to (\\>=)12 years of age, at the time of signing the informed consent/assent.\n* Participants must have a documented physician diagnosis of asthma for \\>=2 years that meets the National Heart, Lung, and Blood Institute (NHLBI) guidelines or Global Initiative for Asthma (GINA) guidelines and\n\n 1. Have, or with high likelihood of having, asthma with an eosinophilic phenotype\n 2. Have previously confirmed history of \\>=2 exacerbations requiring treatment with systemic corticosteroid (CS) (intramuscular \\[IM\\], intravenous \\[IV\\], or oral), in the 12 months prior to Visit 1, despite the use of medium to high-dose ICS. For participants receiving maintenance CS, the CS treatment for the exacerbations must have been a two-fold dose increase or greater.\n* Persistent airflow obstruction as indicated by:\n\n 1. For participants \\>=18 years of age at Visit 1, a pre-bronchodilator FEV1 less than (\\<)80% predicted (The Third National Health and Nutrition Examination Survey \\[NHANES III\\]) recorded at Visit 1\n 2. For participants 12-17 years of age at Visit 1:\n\n * A pre-bronchodilator FEV1 \\<90% predicted (NHANES III) recorded at Visit 1 OR\n * FEV1:Forced Vital Capacity (FVC) ratio \\<0.8 recorded at Visit 1.\n* A well-documented requirement for regular treatment with medium to high dose ICS (in the 12 months prior to Visit 1 with or without maintenance OCS). The maintenance ICS dose must be \\>=440 micrograms (mcg) Fluticasone propionate (FP) Hydrofluoroalkane (HFA) product daily, or clinically comparable (GINA). Participants who are treated with medium dose ICS will also need to be treated with LABA to qualify for inclusion.\n* Current treatment with at least one additional controller medication, besides ICS, for at least 3 months (for example \\[e.g.\\], LABA, LAMA, leukotriene receptor antagonist \\[LTRA\\], or theophylline).\n\nKey randomization inclusion criteria:\n\n* For blood eosinophilic count:\n\n 1. An elevated peripheral blood eosinophil count of \\>=300 cells/microliter (mcL) demonstrated in the past 12 months prior to Visit 1 that is related to asthma OR\n 2. An elevated peripheral blood eosinophil count of \\>=150 cells/mcL at Screening Visit 1 that is related to asthma.\n* Evidence of airway reversibility or responsiveness as documented by either:\n\n 1. Airway reversibility (FEV1\\>=12% and 200 milliliters \\[mL\\]) demonstrated at Visit 1 or Visit 2 using the Maximum Post Bronchodilator Procedure OR\n 2. Airway reversibility (FEV1\\>=12% and 200 mL) documented in the 24 months prior to Visit 2 (randomization visit) OR\n 3. Airway hyperresponsiveness (methacholine: Provocative concentration causing a 20% fall in FEV1 \\[PC20\\] of \\<8 milligrams (mg)/mL, histamine: PD20 of \\<7.8 micromoles, mannitol: decrease in FEV1 as per the labelled product instructions) documented in the 24 months prior to Visit 2 (randomization visit).\n\nKey exclusion Criteria:\n\n* Presence of a known pre-existing, clinically important lung condition other than asthma. This includes (but is not limited to) current infection, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, or diagnoses of emphysema or chronic bronchitis (chronic obstructive pulmonary disease other than asthma) or a history of lung cancer.\n* Participants with other conditions that could lead to elevated eosinophils such as hyper-eosinophilic syndromes including (but not limited to) Eosinophilic Granulomatosis with Polyangiitis (EGPA, formerly known as Churg-Strauss Syndrome) or Eosinophilic Esophagitis.\n* A current malignancy or previous history of cancer in remission for less than 12 months prior to screening (Participants that had localized carcinoma of the skin which was resected for cure will not be excluded).\n* Cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice.\n* Participants with current diagnosis of vasculitis. Participants with high clinical suspicion of vasculitis at screening will be evaluated and current vasculitis must be excluded prior to enrolment.\n* Participants who have received mepolizumab (Nucala), reslizumab (Cinqair/Cinqaero), or benralizumab (Fasenra) within 12 months prior to Visit 1 or who have a previous documented failure with anti-IL-5/5 receptor (R) therapy.\n* Participants who have received omalizumab (Xolair) or dupilumab (Dupixent) within 130 days prior to Visit.\n* Participants who have received any monoclonal antibody (mAb) within 5 half-lives of Visit 1.\n* Previously participated in any study with mepolizumab, reslizumab, or benralizumab and received study intervention (including placebo) within 12 months prior to Visit 1.\n* The QT interval corrected using Fridericia's formula (QTcF) \\>=450 milliseconds (msec) or QTcF \\>=480 msec for participants with Bundle Branch Block at screening Visit 1.\n* Current smokers or former smokers with a smoking history of \\>=10 pack years (number of pack years = \\[number of cigarettes per day/20\\] times number of years smoked). A former smoker is defined as a participant who quit smoking at least 6 months prior to Visit 1.\n* Participants with allergy/intolerance to the excipients of GSK3511294 or a any mAb or biologic.\n\nKey radomization exclusion criteria:\n\n* QTcF \\>=450 msec or QTcF \\>=480 msec for participants with Bundle Branch Block, at randomization Visit 2 are excluded. Participants are excluded if an abnormal ECG finding from the 12-lead ECG conducted at Screening Visit 1 is considered to be clinically significant and would impact the participant's participation during the study, based on the evaluation of the Investigator.\n* Participants with a clinically significant asthma exacerbation in the 7 days prior to randomization should have their randomization visit delayed until the investigator considers the participant's asthma to be stable .\n* Any changes in the dose or regimen of Baseline ICS and/or additional controller medication (except for treatment of an exacerbation) during the run-in period."}, 'identificationModule': {'nctId': 'NCT04719832', 'acronym': 'SWIFT-1', 'briefTitle': 'Placebo-controlled Efficacy and Safety Study of GSK3511294 (Depemokimab) in Participants With Severe Asthma With an Eosinophilic Phenotype', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A 52-week, Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre Study of the Efficacy and Safety of GSK3511294 Adjunctive Therapy in Adult and Adolescent Participants With Severe Uncontrolled Asthma With an Eosinophilic Phenotype', 'orgStudyIdInfo': {'id': '206713'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GSK3511294', 'description': 'Participants received a 100 milligram (mg) dose of GSK3511294 SC injection once every 26 weeks (week 0 and week 26). Participants were to be maintained on their existing baseline maintenance asthma SOC treatment throughout the study.', 'interventionNames': ['Biological: GSK3511294 (Depemokimab)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received placebo subcutaneous (SC) injection once every 26 weeks (week 0 and week 26). Participants were to be maintained on their existing baseline maintenance asthma standard of care (SOC) treatment throughout the study.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'GSK3511294 (Depemokimab)', 'type': 'BIOLOGICAL', 'description': 'GSK3511294 (Depemokimab) will be administered using a pre-filled syringe.', 'armGroupLabels': ['GSK3511294']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo will be administered as a normal saline using a pre-filled syringe.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92024', 'city': 'Encinitas', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.03699, 'lon': -117.29198}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '91105', 'city': 'Pasadena', 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