Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2025-12-25 @ 2:13 PM
Study NCT ID:
NCT03560466
Status:
COMPLETED
Last Update Posted:
2025-11-21
First Post:
2018-03-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Assessment of the Safety and Efficacy of Dupilumab in Children With Asthma (Liberty Asthma Excursion)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-10-20', 'type': 'ESTIMATED'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C582203', 'term': 'dupilumab'}, {'id': 'D011239', 'term': 'Prednisolone'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Contact-US@sanofi.com', 'phone': '800-633-1610', 'title': 'Trial Transparency Team', 'phoneExt': '6#', 'organization': 'Sanofi aventis recherche & développement'}, 'certainAgreement': {'otherDetails': 'The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'AEs: From first dose of study treatment (Day 1) up to 112 days post last dose of study treatment, approximately 64 weeks for main study and sub-study each. Deaths: From first dose of study treatment (Day 1) up to end of follow-up, approximately 353 weeks.', 'description': 'Analysis was performed on safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group, regardless of the dose regimen.', 'eventGroups': [{'id': 'EG000', 'title': 'Main Study: Placebo-Dupilumab', 'description': 'Participants who received placebo matched to dupilumab in the parent study EFC14153 received dupilumab for 52 weeks in the main study as follows: - 100 mg q2w as an SC injection or 300 mg q4w as an SC injection for participants with body weight ≤30 kg. - 200 mg q2w as an SC injection for participants with body weight \\>30 kg. Participants also received a stable-dose background therapy of medium-dose ICS with a second controller medication (i.e., LABA, LAMA, LTRA or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller medication. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication as instructed by Investigator.', 'otherNumAtRisk': 125, 'deathsNumAtRisk': 125, 'otherNumAffected': 63, 'seriousNumAtRisk': 125, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Main Study: Dupilumab-Dupilumab', 'description': 'Participants who received dupilumab in the parent study EFC14153 received dupilumab for 52 weeks in the main study as follows: - 100 mg q2w as an SC injection or 300 mg q4w as an SC injection for participants with body weight ≤30 kg. - 200 mg q2w as an SC injection for participants with body weight \\>30 kg. Participants also received a stable-dose background therapy of medium-dose ICS with a second controller medication (i.e., LABA, LAMA, LTRA or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller medication. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication as instructed by Investigator.', 'otherNumAtRisk': 240, 'deathsNumAtRisk': 240, 'otherNumAffected': 108, 'seriousNumAtRisk': 240, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG002', 'title': 'Japan Sub-study: Dupilumab', 'description': 'Participants received dupilumab for 52 weeks in the Japan sub-study as follows: - 100 mg q2w as an SC injection or 300 mg q4w as an SC injection for participants with body weight ≥15 kg and ≤30 kg. - 200 mg q2w as an SC injection for participants with body weight \\>30 kg. Participants also received a stable-dose background therapy of medium-dose ICS with a second controller medication (i.e., LABA, LAMA, LTRA or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller medication. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication as instructed by Investigator.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 13, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Eosinophilia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 27.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 27.1'}, {'term': 'Dental Caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 27.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 27.1'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 27.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 27.1'}, {'term': 'Injection Site Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 11, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 4, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 27.1'}, {'term': 'Injection Site Induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 27.1'}, {'term': 'Injection Site Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 73, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 46, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 27.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 27.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 27.1'}, {'term': 'Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 27.1'}, {'term': 'Herpes Zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 27.1'}, {'term': 'Hordeolum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 27.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 16, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 8, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 27.1'}, {'term': 'Lower Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 27.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 17, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 25, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 12, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 27.1'}, {'term': 'Oral Herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 27.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 27.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 27.1'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 27.1'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 28, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 6, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 27.1'}, {'term': 'Viral Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 27.1'}, {'term': 'Accidental Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 27.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 27.1'}, {'term': 'Eyelid Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 27.1'}, {'term': 'Ligament Sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 27.1'}, {'term': 'Scratch', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 27.1'}, {'term': 'Wrist Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 27.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 27.1'}, {'term': 'Osteochondrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 27.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 15, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 27.1'}, {'term': 'Tension Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 27.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 27.1'}, {'term': 'Rhinitis Allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 27.1'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 27.1'}, {'term': 'Dermatitis Contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 27.1'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 27.1'}, {'term': 'Miliaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 27.1'}], 'seriousEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 27.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 27.1'}, {'term': 'Complicated Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 27.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 27.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 27.1'}, {'term': 'Pulmonary Tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 27.1'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 27.1'}, {'term': 'Radius Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 27.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 5, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 27.1'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 27.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Main Study: Number of Participants With Any Treatment-Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Study: Placebo-Dupilumab', 'description': 'Participants who received placebo matched to dupilumab in the parent study EFC14153 received dupilumab for 52 weeks in the main study as follows:\n\n* 100 mg q2w as an SC injection or 300 mg q4w as an SC injection for participants with body weight ≤30 kg.\n* 200 mg q2w as an SC injection for participants with body weight \\>30 kg. Participants also received a stable-dose background therapy of medium-dose ICS with a second controller medication (i.e., LABA, LAMA, LTRA or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller medication. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication as instructed by Investigator.'}, {'id': 'OG001', 'title': 'Main Study: Dupilumab-Dupilumab', 'description': 'Participants who received dupilumab in the parent study EFC14153 received dupilumab for 52 weeks in the main study as follows:\n\n* 100 mg q2w as an SC injection or 300 mg q4w as an SC injection for participants with body weight ≤30 kg.\n* 200 mg q2w as an SC injection for participants with body weight \\>30 kg. Participants also received a stable-dose background therapy of medium-dose ICS with a second controller medication (i.e., LABA, LAMA, LTRA or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller medication. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication as instructed by Investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study treatment (Day 1) up to 112 days post last dose of study treatment, approximately 64 weeks', 'description': 'An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. TEAEs were AEs that developed or worsened or became serious during the TEAE period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants exposed to at least 1 dose or part of a dose of the study treatment during current study regardless of the amount of treatment administered.'}, {'type': 'PRIMARY', 'title': 'Japan Sub-study: Change From Baseline to Week 12 in Pre-Bronchodilator Percent Predicted Forced Expiratory Volume in 1 Second (FEV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Japan Sub-study: Dupilumab', 'description': 'Participants received dupilumab for 52 weeks in the Japan sub-study as follows:\n\n* 100 mg q2w as an SC injection or 300 mg q4w as an SC injection for participants with body weight ≥15 kg and ≤30 kg.\n* 200 mg q2w as an SC injection for participants with body weight \\>30 kg. Participants also received a stable-dose background therapy of medium-dose ICS with a second controller medication (i.e., LABA, LAMA, LTRA or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller medication. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication as instructed by Investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.08', 'spread': '6.78', 'groupId': 'OG000', 'lowerLimit': '6.78'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) to Week 12', 'description': 'FEV1 was the volume of air (in liters) 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. Baseline was defined as the last available measurement prior to the first study treatment dose if the participant was treated, or the last available value up to enrollment if the participant was not exposed to study treatment in the current study.', 'unitOfMeasure': 'percent predicted FEV1', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population included all participants in the enrolled population in the current study.'}, {'type': 'SECONDARY', 'title': 'Japan Sub-study: Number of Participants With Any Treatment-Emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Japan Sub-study: Dupilumab', 'description': 'Participants received dupilumab for 52 weeks in the Japan sub-study as follows:\n\n* 100 mg q2w as an SC injection or 300 mg q4w as an SC injection for participants with body weight ≥15 kg and ≤30 kg.\n* 200 mg q2w as an SC injection for participants with body weight \\>30 kg. Participants also received a stable-dose background therapy of medium-dose ICS with a second controller medication (i.e., LABA, LAMA, LTRA or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller medication. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication as instructed by Investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study treatment (Day 1) up to 112 days post last dose of study treatment, approximately 64 weeks', 'description': 'An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. TEAEs were AEs that developed or worsened or became serious during the TEAE period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all enrolled participants who took at least 1 dose of study treatment in the current study, regardless of the amount of treatment administered.'}, {'type': 'SECONDARY', 'title': 'Annualized Rate of Severe Asthma Exacerbation Events During the 52-Week Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Study: Placebo-Dupilumab', 'description': 'Participants who received placebo matched to dupilumab in the parent study EFC14153 received dupilumab for 52 weeks in the main study as follows:\n\n* 100 mg q2w as an SC injection or 300 mg q4w as an SC injection for participants with body weight ≤30 kg.\n* 200 mg q2w as an SC injection for participants with body weight \\>30 kg. Participants also received a stable-dose background therapy of medium-dose ICS with a second controller medication (i.e., LABA, LAMA, LTRA or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller medication. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication as instructed by Investigator.'}, {'id': 'OG001', 'title': 'Main Study: Dupilumab-Dupilumab', 'description': 'Participants who received dupilumab in the parent study EFC14153 received dupilumab for 52 weeks in the main study as follows:\n\n* 100 mg q2w as an SC injection or 300 mg q4w as an SC injection for participants with body weight ≤30 kg.\n* 200 mg q2w as an SC injection for participants with body weight \\>30 kg. Participants also received a stable-dose background therapy of medium-dose ICS with a second controller medication (i.e., LABA, LAMA, LTRA or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller medication. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication as instructed by Investigator.'}, {'id': 'OG002', 'title': 'Japan Sub-study: Dupilumab', 'description': 'Participants received dupilumab for 52 weeks in the Japan sub-study as follows:\n\n* 100 mg q2w as an SC injection or 300 mg q4w as an SC injection for participants with body weight ≥15 kg and ≤30 kg.\n* 200 mg q2w as an SC injection for participants with body weight \\>30 kg. Participants also received a stable-dose background therapy of medium-dose ICS with a second controller medication (i.e., LABA, LAMA, LTRA or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller medication. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication as instructed by Investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.114', 'groupId': 'OG000'}, {'value': '0.120', 'groupId': 'OG001'}, {'value': '0.462', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 52', 'description': 'A severe exacerbation event during study was defined as a deterioration of asthma requiring use of systemic corticosteroid (SCS) for ≥3 days or hospitalization/emergency room visit because of asthma, requiring SCS. Annualized severe exacerbation event rate was defined as total number of events that occurred during 52-week treatment period divided by total number of participant-years followed in 52-week treatment period.', 'unitOfMeasure': 'exacerbations per participant-years', 'reportingStatus': 'POSTED', 'populationDescription': 'Main study: safety population included all participants exposed to at least 1 dose or part of a dose of study treatment during current study regardless of amount of treatment administered. Sub-study: ITT population included all participants in enrolled population in the current study.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pre-Bronchodilator Percent Predicted Forced Expiratory Volume in 1 Second Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Study: Placebo-Dupilumab', 'description': 'Participants who received placebo matched to dupilumab in the parent study EFC14153 received dupilumab for 52 weeks in the main study as follows:\n\n* 100 mg q2w as an SC injection or 300 mg q4w as an SC injection for participants with body weight ≤30 kg.\n* 200 mg q2w as an SC injection for participants with body weight \\>30 kg. Participants also received a stable-dose background therapy of medium-dose ICS with a second controller medication (i.e., LABA, LAMA, LTRA or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller medication. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication as instructed by Investigator.'}, {'id': 'OG001', 'title': 'Main Study: Dupilumab-Dupilumab', 'description': 'Participants who received dupilumab in the parent study EFC14153 received dupilumab for 52 weeks in the main study as follows:\n\n* 100 mg q2w as an SC injection or 300 mg q4w as an SC injection for participants with body weight ≤30 kg.\n* 200 mg q2w as an SC injection for participants with body weight \\>30 kg. Participants also received a stable-dose background therapy of medium-dose ICS with a second controller medication (i.e., LABA, LAMA, LTRA or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller medication. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication as instructed by Investigator.'}, {'id': 'OG002', 'title': 'Japan Sub-study: Dupilumab', 'description': 'Participants received dupilumab for 52 weeks in the Japan sub-study as follows:\n\n* 100 mg q2w as an SC injection or 300 mg q4w as an SC injection for participants with body weight ≥15 kg and ≤30 kg.\n* 200 mg q2w as an SC injection for participants with body weight \\>30 kg. Participants also received a stable-dose background therapy of medium-dose ICS with a second controller medication (i.e., LABA, LAMA, LTRA or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller medication. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication as instructed by Investigator.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.06', 'spread': '15.71', 'groupId': 'OG000'}, {'value': '11.03', 'spread': '18.74', 'groupId': 'OG001'}, {'value': '7.50', 'spread': '9.29', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.00', 'spread': '7.12', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.93', 'spread': '14.88', 'groupId': 'OG000'}, {'value': '12.47', 'spread': '18.60', 'groupId': 'OG001'}, {'value': '6.31', 'spread': '8.97', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.31', 'spread': '14.70', 'groupId': 'OG000'}, {'value': '10.95', 'spread': '17.33', 'groupId': 'OG001'}, {'value': '7.08', 'spread': '6.78', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.37', 'spread': '15.48', 'groupId': 'OG000'}, {'value': '11.23', 'spread': '18.24', 'groupId': 'OG001'}, {'value': '4.08', 'spread': '8.75', 'groupId': 'OG002'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.81', 'spread': '16.18', 'groupId': 'OG000'}, {'value': '12.19', 'spread': '17.88', 'groupId': 'OG001'}, {'value': '6.73', 'spread': '8.09', 'groupId': 'OG002'}]}]}, {'title': 'Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.98', 'spread': '17.14', 'groupId': 'OG000'}, {'value': '10.67', 'spread': '17.19', 'groupId': 'OG001'}, {'value': '1.17', 'spread': '8.03', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and Weeks 2, 4 (Japan sub-study), 8, 12, 24, 52 and 64', 'description': 'FEV1 was volume of air (in liters) exhaled from the lungs in 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. Baseline (main study): original baseline of parent study EFC14153. Baseline (sub-study): last available measurement prior to first study treatment dose if participant was treated, or last available value up to enrollment if participant was not exposed to study treatment in current study.', 'unitOfMeasure': 'percent predicted FEV1', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Main study: safety population included all participants exposed to at least 1 dose or part of a dose of study treatment during current study regardless of amount of treatment administered. Sub-study: ITT population included all participants in enrolled population in current study. Only participants with data collected at the specified timepoints are reported.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Absolute Forced Expiratory Volume in 1 Second Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Study: Placebo-Dupilumab', 'description': 'Participants who received placebo matched to dupilumab in the parent study EFC14153 received dupilumab for 52 weeks in the main study as follows:\n\n* 100 mg q2w as an SC injection or 300 mg q4w as an SC injection for participants with body weight ≤30 kg.\n* 200 mg q2w as an SC injection for participants with body weight \\>30 kg. Participants also received a stable-dose background therapy of medium-dose ICS with a second controller medication (i.e., LABA, LAMA, LTRA or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller medication. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication as instructed by Investigator.'}, {'id': 'OG001', 'title': 'Main Study: Dupilumab-Dupilumab', 'description': 'Participants who received dupilumab in the parent study EFC14153 received dupilumab for 52 weeks in the main study as follows:\n\n* 100 mg q2w as an SC injection or 300 mg q4w as an SC injection for participants with body weight ≤30 kg.\n* 200 mg q2w as an SC injection for participants with body weight \\>30 kg. Participants also received a stable-dose background therapy of medium-dose ICS with a second controller medication (i.e., LABA, LAMA, LTRA or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller medication. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication as instructed by Investigator.'}, {'id': 'OG002', 'title': 'Japan Sub-study: Dupilumab', 'description': 'Participants received dupilumab for 52 weeks in the Japan sub-study as follows:\n\n* 100 mg q2w as an SC injection or 300 mg q4w as an SC injection for participants with body weight ≥15 kg and ≤30 kg.\n* 200 mg q2w as an SC injection for participants with body weight \\>30 kg. Participants also received a stable-dose background therapy of medium-dose ICS with a second controller medication (i.e., LABA, LAMA, LTRA or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller medication. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication as instructed by Investigator.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.36', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '0.42', 'spread': '0.38', 'groupId': 'OG001'}, {'value': '0.13', 'spread': '0.15', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.13', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.38', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '0.47', 'spread': '0.39', 'groupId': 'OG001'}, {'value': '0.12', 'spread': '0.15', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.41', 'spread': '0.31', 'groupId': 'OG000'}, {'value': '0.45', 'spread': '0.36', 'groupId': 'OG001'}, {'value': '0.17', 'spread': '0.13', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.46', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '0.51', 'spread': '0.39', 'groupId': 'OG001'}, {'value': '0.15', 'spread': '0.15', 'groupId': 'OG002'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.62', 'spread': '0.41', 'groupId': 'OG000'}, {'value': '0.66', 'spread': '0.41', 'groupId': 'OG001'}, {'value': '0.34', 'spread': '0.21', 'groupId': 'OG002'}]}]}, {'title': 'Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.66', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '0.70', 'spread': '0.44', 'groupId': 'OG001'}, {'value': '0.25', 'spread': '0.14', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and Weeks 2, 4 (Japan sub-study), 8, 12, 24, 52 and 64', 'description': 'FEV1 was volume of air (in liters) exhaled from the lungs in 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. Baseline (main study): original baseline of parent study EFC14153. Baseline (sub-study): last available measurement prior to first study treatment dose if participant was treated, or last available value up to enrollment if participant was not exposed to study treatment in current study.', 'unitOfMeasure': 'liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Main study: safety population included all participants exposed to at least 1 dose or part of a dose of study treatment during current study regardless of amount of treatment administered. Sub-study: ITT population included all participants in enrolled population in current study. Only participants with data collected at the specified timepoints are reported.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Forced Vital Capacity (FVC) Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Study: Placebo-Dupilumab', 'description': 'Participants who received placebo matched to dupilumab in the parent study EFC14153 received dupilumab for 52 weeks in the main study as follows:\n\n* 100 mg q2w as an SC injection or 300 mg q4w as an SC injection for participants with body weight ≤30 kg.\n* 200 mg q2w as an SC injection for participants with body weight \\>30 kg. Participants also received a stable-dose background therapy of medium-dose ICS with a second controller medication (i.e., LABA, LAMA, LTRA or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller medication. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication as instructed by Investigator.'}, {'id': 'OG001', 'title': 'Main Study: Dupilumab-Dupilumab', 'description': 'Participants who received dupilumab in the parent study EFC14153 received dupilumab for 52 weeks in the main study as follows:\n\n* 100 mg q2w as an SC injection or 300 mg q4w as an SC injection for participants with body weight ≤30 kg.\n* 200 mg q2w as an SC injection for participants with body weight \\>30 kg. Participants also received a stable-dose background therapy of medium-dose ICS with a second controller medication (i.e., LABA, LAMA, LTRA or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller medication. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication as instructed by Investigator.'}, {'id': 'OG002', 'title': 'Japan Sub-study: Dupilumab', 'description': 'Participants received dupilumab for 52 weeks in the Japan sub-study as follows:\n\n* 100 mg q2w as an SC injection or 300 mg q4w as an SC injection for participants with body weight ≥15 kg and ≤30 kg.\n* 200 mg q2w as an SC injection for participants with body weight \\>30 kg. Participants also received a stable-dose background therapy of medium-dose ICS with a second controller medication (i.e., LABA, LAMA, LTRA or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller medication. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication as instructed by Investigator.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.35', 'spread': '0.29', 'groupId': 'OG000'}, {'value': '0.38', 'spread': '0.38', 'groupId': 'OG001'}, {'value': '0.11', 'spread': '0.15', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.09', 'spread': '0.12', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.37', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '0.45', 'spread': '0.42', 'groupId': 'OG001'}, {'value': '0.11', 'spread': '0.14', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.40', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '0.43', 'spread': '0.39', 'groupId': 'OG001'}, {'value': '0.12', 'spread': '0.11', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.47', 'spread': '0.36', 'groupId': 'OG000'}, {'value': '0.50', 'spread': '0.40', 'groupId': 'OG001'}, {'value': '0.17', 'spread': '0.15', 'groupId': 'OG002'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.68', 'spread': '0.42', 'groupId': 'OG000'}, {'value': '0.70', 'spread': '0.45', 'groupId': 'OG001'}, {'value': '0.36', 'spread': '0.22', 'groupId': 'OG002'}]}]}, {'title': 'Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.74', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '0.75', 'spread': '0.48', 'groupId': 'OG001'}, {'value': '0.41', 'spread': '0.24', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and Weeks 2, 4 (Japan sub-study), 8, 12, 24, 52 and 64', 'description': 'FVC was defined as volume of air (in liters) that could be forcibly blown out after full inspiration in upright position as measured by spirometer. Spirometry was performed after wash out period of bronchodilators according to their action duration. Baseline (main study):original baseline of parent study EFC14153. Baseline (sub-study): last available measurement prior to first study treatment dose if participant was treated or last available value up to enrollment if participant was not exposed to study treatment in current study.', 'unitOfMeasure': 'liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Main study: safety population included all participants exposed to at least 1 dose or part of a dose of study treatment during current study regardless of amount of treatment administered. Sub-study: ITT population included all participants in enrolled population in current study. Only participants with data collected at the specified timepoints are reported.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Forced Expiratory Flow [FEF] 25% to 75% Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Study: Placebo-Dupilumab', 'description': 'Participants who received placebo matched to dupilumab in the parent study EFC14153 received dupilumab for 52 weeks in the main study as follows:\n\n* 100 mg q2w as an SC injection or 300 mg q4w as an SC injection for participants with body weight ≤30 kg.\n* 200 mg q2w as an SC injection for participants with body weight \\>30 kg. Participants also received a stable-dose background therapy of medium-dose ICS with a second controller medication (i.e., LABA, LAMA, LTRA or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller medication. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication as instructed by Investigator.'}, {'id': 'OG001', 'title': 'Main Study: Dupilumab-Dupilumab', 'description': 'Participants who received dupilumab in the parent study EFC14153 received dupilumab for 52 weeks in the main study as follows:\n\n* 100 mg q2w as an SC injection or 300 mg q4w as an SC injection for participants with body weight ≤30 kg.\n* 200 mg q2w as an SC injection for participants with body weight \\>30 kg. Participants also received a stable-dose background therapy of medium-dose ICS with a second controller medication (i.e., LABA, LAMA, LTRA or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller medication. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication as instructed by Investigator.'}, {'id': 'OG002', 'title': 'Japan Sub-study: Dupilumab', 'description': 'Participants received dupilumab for 52 weeks in the Japan sub-study as follows:\n\n* 100 mg q2w as an SC injection or 300 mg q4w as an SC injection for participants with body weight ≥15 kg and ≤30 kg.\n* 200 mg q2w as an SC injection for participants with body weight \\>30 kg. Participants also received a stable-dose background therapy of medium-dose ICS with a second controller medication (i.e., LABA, LAMA, LTRA or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller medication. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication as instructed by Investigator.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.49', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '0.58', 'spread': '0.66', 'groupId': 'OG001'}, {'value': '0.21', 'spread': '0.26', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.25', 'spread': '0.23', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.48', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '0.62', 'spread': '0.63', 'groupId': 'OG001'}, {'value': '0.15', 'spread': '0.30', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.54', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '0.59', 'spread': '0.61', 'groupId': 'OG001'}, {'value': '0.29', 'spread': '0.31', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.58', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '0.66', 'spread': '0.65', 'groupId': 'OG001'}, {'value': '0.15', 'spread': '0.37', 'groupId': 'OG002'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.73', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '0.77', 'spread': '0.67', 'groupId': 'OG001'}, {'value': '0.40', 'spread': '0.46', 'groupId': 'OG002'}]}]}, {'title': 'Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.77', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '0.79', 'spread': '0.70', 'groupId': 'OG001'}, {'value': '0.11', 'spread': '0.34', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and Weeks 2, 4 (Japan sub-study), 8, 12, 24, 52 and 64', 'description': 'FEF was defined as amount of air which can be forcibly exhaled from lungs in first second of forced exhalation. FEF 25-75% was the mean FEF between 25% and 75% of FVC. FVC was defined as volume of air that could be forcibly blown out after full inspiration in upright position. Spirometry was performed after wash out period of bronchodilators. Baseline (main study): original baseline of parent study EFC14153. Baseline (sub-study): last available measurement prior to first study treatment dose if participant was treated or last available value up to enrollment if participant was not exposed to study treatment in current study.', 'unitOfMeasure': 'liter per second', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Main study: safety population included all participants exposed to at least 1 dose or part of dose of study treatment during current regardless of amount of treatment administered. Sub-study: ITT population included all participants in enrolled population in current study. Only participants with data collected at specified timepoints are reported.'}, {'type': 'SECONDARY', 'title': 'Main Study: Change From Baseline in Percent Predicted Forced Vital Capacity Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Study: Placebo-Dupilumab', 'description': 'Participants who received placebo matched to dupilumab in the parent study EFC14153 received dupilumab for 52 weeks in the main study as follows:\n\n* 100 mg q2w as an SC injection or 300 mg q4w as an SC injection for participants with body weight ≤30 kg.\n* 200 mg q2w as an SC injection for participants with body weight \\>30 kg. Participants also received a stable-dose background therapy of medium-dose ICS with a second controller medication (i.e., LABA, LAMA, LTRA or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller medication. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication as instructed by Investigator.'}, {'id': 'OG001', 'title': 'Main Study: Dupilumab-Dupilumab', 'description': 'Participants who received dupilumab in the parent study EFC14153 received dupilumab for 52 weeks in the main study as follows:\n\n* 100 mg q2w as an SC injection or 300 mg q4w as an SC injection for participants with body weight ≤30 kg.\n* 200 mg q2w as an SC injection for participants with body weight \\>30 kg. Participants also received a stable-dose background therapy of medium-dose ICS with a second controller medication (i.e., LABA, LAMA, LTRA or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller medication. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication as instructed by Investigator.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.98', 'spread': '12.91', 'groupId': 'OG000'}, {'value': '5.02', 'spread': '16.33', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.88', 'spread': '12.17', 'groupId': 'OG000'}, {'value': '6.64', 'spread': '17.42', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.23', 'spread': '12.49', 'groupId': 'OG000'}, {'value': '5.03', 'spread': '16.45', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.19', 'spread': '13.35', 'groupId': 'OG000'}, {'value': '5.28', 'spread': '16.20', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.74', 'spread': '13.10', 'groupId': 'OG000'}, {'value': '6.43', 'spread': '16.40', 'groupId': 'OG001'}]}]}, {'title': 'Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.13', 'spread': '15.14', 'groupId': 'OG000'}, {'value': '4.83', 'spread': '16.09', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and Weeks 2, 8, 12, 24, 52 and 64', 'description': 'FVC was defined as volume of air (in liters) that could be forcibly blown out after full inspiration in upright position as measured by spirometer. Spirometry was performed after wash out period of bronchodilators according to their action duration. Baseline was defined as the original baseline of parent study EFC14153.', 'unitOfMeasure': 'percent predicted FVC', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants exposed to at least 1 dose or part of a dose of study treatment during current study regardless of amount of treatment administered. Only participants with data collected at the specified timepoints are reported.'}, {'type': 'SECONDARY', 'title': 'Japan Sub-study: Change From Baseline in Asthma Control Questionnaire-Interviewer Administered, 7-Question Version (ACQ-7-IA) Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Japan Sub-study: Dupilumab', 'description': 'Participants received dupilumab for 52 weeks in the Japan sub-study as follows:\n\n* 100 mg q2w as an SC injection or 300 mg q4w as an SC injection for participants with body weight ≥15 kg and ≤30 kg.\n* 200 mg q2w as an SC injection for participants with body weight \\>30 kg. Participants also received a stable-dose background therapy of medium-dose ICS with a second controller medication (i.e., LABA, LAMA, LTRA or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller medication. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication as instructed by Investigator.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.65', 'spread': '0.64', 'groupId': 'OG000'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.68', 'spread': '0.75', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.84', 'spread': '0.59', 'groupId': 'OG000'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.03', 'spread': '0.66', 'groupId': 'OG000'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.96', 'spread': '0.61', 'groupId': 'OG000'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.01', 'spread': '0.47', 'groupId': 'OG000'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.21', 'spread': '0.37', 'groupId': 'OG000'}]}]}, {'title': 'Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.99', 'spread': '0.52', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and Weeks 2, 4, 8, 12, 24, 36, 52 and 64', 'description': "ACQ-7-IA had 7 questions with first 5 items of ACQ-7 addressing most common asthma symptoms: frequency in past week awoken by asthma during night, severity of asthma symptoms in morning, limitation of daily activities due to asthma, shortness of breath due to asthma, wheeze; 2 questions on short-acting bronchodilator use and predicted bronchodilator use of FEV1. Participants/parents/guardians recalled child's previous week asthma and responded to questions on 7-point scale: 0=no impairment, 6=maximum impairment. Global ACQ-7-IA score was the mean of 7 questions, ranging from 0 (totally controlled) to 6 (severely uncontrolled). Higher scores indicated lower asthma control. Baseline: last available measurement prior to first study treatment dose if participant was treated or last available value up to enrollment if participant was not exposed to study treatment in current study.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants in enrolled population in current study. Only participants with data collected at specified timepoints are reported'}, {'type': 'SECONDARY', 'title': 'Japan Sub-study: Change From Baseline in Asthma Control Questionnaire-Interviewer Administered, 5-Question Version (ACQ-5-IA) Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Japan Sub-study: Dupilumab', 'description': 'Participants received dupilumab for 52 weeks in the Japan sub-study as follows:\n\n* 100 mg q2w as an SC injection or 300 mg q4w as an SC injection for participants with body weight ≥15 kg and ≤30 kg.\n* 200 mg q2w as an SC injection for participants with body weight \\>30 kg. Participants also received a stable-dose background therapy of medium-dose ICS with a second controller medication (i.e., LABA, LAMA, LTRA or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller medication. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication as instructed by Investigator.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.68', 'spread': '0.87', 'groupId': 'OG000'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.75', 'spread': '1.06', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.92', 'spread': '0.82', 'groupId': 'OG000'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.20', 'spread': '0.84', 'groupId': 'OG000'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.15', 'spread': '0.68', 'groupId': 'OG000'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.25', 'spread': '0.54', 'groupId': 'OG000'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.49', 'spread': '0.54', 'groupId': 'OG000'}]}]}, {'title': 'Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.28', 'spread': '0.59', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and Weeks 2, 4, 8, 12, 24, 36, 52 and 64', 'description': "The ACQ-5-IA had 5 questions addressing most common asthma symptoms: frequency in past week awoken by asthma during night, severity of asthma symptoms in morning, limitation of daily activities due to asthma, shortness of breath due to asthma and wheeze. Participants/parents/guardians recalled the child's previous week asthma and responded to symptom and bronchodilator use questions on a 7-point scale: 0=no impairment, 6=maximum impairment. Global ACQ-5-IA score was the mean of 5 questions, ranging from 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicated lower asthma control. Baseline: last available measurement prior to first study treatment dose if participant was treated, or last available value up to enrollment if participant was not exposed to study treatment in current study.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants in enrolled population in current study. Only participants with data collected at specified timepoints are reported'}, {'type': 'SECONDARY', 'title': 'Serum Concentrations of Dupilumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '299', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Study: Dupilumab 100 mg q2w', 'description': 'All participants from the main study who received dupilumab 100 mg q2w were included in this arm.'}, {'id': 'OG001', 'title': 'Main Study: Dupilumab 200 mg q2w', 'description': 'All participants from the main study who received dupilumab 200 mg q2w were included in this arm.'}, {'id': 'OG002', 'title': 'Main Study: Dupilumab 300 mg q4w', 'description': 'All participants from the main study who received dupilumab 300 mg q4w were included in this arm.'}, {'id': 'OG003', 'title': 'Japan Sub-study: Dupilumab 100 mg q2w', 'description': 'All participants from the Japan sub-study who received dupilumab 100 mg q2w were included in this arm.'}, {'id': 'OG004', 'title': 'Japan Sub-study: Dupilumab 200 mg q2w', 'description': 'All participants from the Japan sub-study who received dupilumab 200 mg q2w were included in this arm.'}, {'id': 'OG005', 'title': 'Japan Sub-study: Dupilumab 300 mg q4w', 'description': 'All participants from the Japan sub-study who received dupilumab 300 mg q4w were included in this arm.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '296', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '60740.38', 'spread': '23885.77', 'groupId': 'OG000'}, {'value': '80450.15', 'spread': '39865.24', 'groupId': 'OG001'}, {'value': '79600.00', 'spread': '25509.84', 'groupId': 'OG002'}, {'value': '38600.00', 'spread': '20850.18', 'groupId': 'OG003'}, {'value': '79128.57', 'spread': '24513.31', 'groupId': 'OG004'}, {'value': '53066.67', 'spread': '18569.96', 'groupId': 'OG005'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '64201.03', 'spread': '22890.02', 'groupId': 'OG000'}, {'value': '81849.66', 'spread': '42824.93', 'groupId': 'OG001'}, {'value': '80675.00', 'spread': '26921.27', 'groupId': 'OG002'}, {'value': '41300.00', 'spread': '22138.65', 'groupId': 'OG003'}, {'value': '98316.67', 'spread': '18066.81', 'groupId': 'OG004'}, {'value': '55166.67', 'spread': '14558.96', 'groupId': 'OG005'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '299', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '52808.85', 'spread': '21526.05', 'groupId': 'OG000'}, {'value': '71910.74', 'spread': '42290.54', 'groupId': 'OG001'}, {'value': '81289.94', 'spread': '31957.07', 'groupId': 'OG002'}, {'value': '41000.00', 'spread': '23157.94', 'groupId': 'OG003'}, {'value': '91128.57', 'spread': '28739.33', 'groupId': 'OG004'}, {'value': '59300.00', 'spread': '18107.46', 'groupId': 'OG005'}]}]}, {'title': 'Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1884.04', 'spread': '9763.01', 'groupId': 'OG000'}, {'value': '3391.86', 'spread': '16196.36', 'groupId': 'OG001'}, {'value': '184.69', 'spread': '582.75', 'groupId': 'OG002'}, {'value': '39.00', 'spread': '0.00', 'groupId': 'OG003'}, {'value': '39.00', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '39.00', 'spread': '0.00', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 12, 24, 52 and 64', 'description': 'Blood samples were collected at the specified timepoints for determination of functional dupilumab concentration in serum.', 'unitOfMeasure': 'nanogram per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Pharmacokinetic population:participants in safety population with atleast 1 nonmissing;evaluable predose serum concentration post 1st dose of dupilumab in current study.Only participants with data collected at specified timepoints are reported.As prespecified in SAP,serum concentration is presented by dose regimen.Main study:dose regimen was adjusted per participant's weight during study,hence some participants may be counted in more than 1 dose regimen across different weeks based on weight."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Anti-Drug Antibodies (ADAs) Against Dupilumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Study: Placebo-Dupilumab', 'description': 'Participants who received placebo matched to dupilumab in the parent study EFC14153 received dupilumab for 52 weeks in the main study as follows:\n\n* 100 mg q2w as an SC injection or 300 mg q4w as an SC injection for participants with body weight ≤30 kg.\n* 200 mg q2w as an SC injection for participants with body weight \\>30 kg. Participants also received a stable-dose background therapy of medium-dose ICS with a second controller medication (i.e., LABA, LAMA, LTRA or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller medication. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication as instructed by Investigator.'}, {'id': 'OG001', 'title': 'Main Study: Dupilumab-Dupilumab', 'description': 'Participants who received dupilumab in the parent study EFC14153 received dupilumab for 52 weeks in the main study as follows:\n\n* 100 mg q2w as an SC injection or 300 mg q4w as an SC injection for participants with body weight ≤30 kg.\n* 200 mg q2w as an SC injection for participants with body weight \\>30 kg. Participants also received a stable-dose background therapy of medium-dose ICS with a second controller medication (i.e., LABA, LAMA, LTRA or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller medication. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication as instructed by Investigator.'}, {'id': 'OG002', 'title': 'Japan Sub-study: Dupilumab', 'description': 'Participants received dupilumab for 52 weeks in the Japan sub-study as follows:\n\n* 100 mg q2w as an SC injection or 300 mg q4w as an SC injection for participants with body weight ≥15 kg and ≤30 kg.\n* 200 mg q2w as an SC injection for participants with body weight \\>30 kg. Participants also received a stable-dose background therapy of medium-dose ICS with a second controller medication (i.e., LABA, LAMA, LTRA or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller medication. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication as instructed by Investigator.'}], 'classes': [{'title': 'Treatment-boosted ADA Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Treatment-emergent ADA Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study treatment (Day 1) to Week 64', 'description': 'ADA positive was defined as either treatment-boosted or treatment-emergent response in the ADA assay. Treatment-boosted response was defined as a positive response in the ADA assay post first dose in the current study that was greater than or equal to 4-fold of the baseline titer levels, when baseline results were positive. Treatment-emergent response was defined as a positive response in the ADA assay post first dose in the current study, when baseline results were negative or missing. Baseline (main study): original baseline of parent study EFC14153. Baseline (sub-study): last available measurement prior to first study treatment dose if participant was treated, or last available value up to enrollment if participant was not exposed to study treatment in current study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ADA population (main and sub-study) included all the participants in the safety population with at least 1 non-missing ADA result following the first dose of dupilumab in the current study. Only participants with data collected for the specified categories are reported.'}, {'type': 'SECONDARY', 'title': 'Main Study: Percent Change From Baseline in Blood Eosinophil Count at Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Study: Placebo-Dupilumab', 'description': 'Participants who received placebo matched to dupilumab in the parent study EFC14153 received dupilumab for 52 weeks in the main study as follows:\n\n* 100 mg q2w as an SC injection or 300 mg q4w as an SC injection for participants with body weight ≤30 kg.\n* 200 mg q2w as an SC injection for participants with body weight \\>30 kg. Participants also received a stable-dose background therapy of medium-dose ICS with a second controller medication (i.e., LABA, LAMA, LTRA or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller medication. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication as instructed by Investigator.'}, {'id': 'OG001', 'title': 'Main Study: Dupilumab-Dupilumab', 'description': 'Participants who received dupilumab in the parent study EFC14153 received dupilumab for 52 weeks in the main study as follows:\n\n* 100 mg q2w as an SC injection or 300 mg q4w as an SC injection for participants with body weight ≤30 kg.\n* 200 mg q2w as an SC injection for participants with body weight \\>30 kg. Participants also received a stable-dose background therapy of medium-dose ICS with a second controller medication (i.e., LABA, LAMA, LTRA or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller medication. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication as instructed by Investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '34.528', 'spread': '207.067', 'groupId': 'OG000', 'lowerLimit': '207.067'}, {'value': '29.769', 'spread': '323.837', 'groupId': 'OG001', 'lowerLimit': '323.837'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) to Week 64', 'description': 'Blood samples were collected at specified timepoints to assess percent change from baseline in eosinophil count. Baseline was defined as the original baseline of parent study EFC14153.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants exposed to at least 1 dose or part of a dose of the study treatment during current study regardless of the amount of treatment administered. Only participants with data collected are reported.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Total Immunoglobulin (Ig) E in Serum at Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Study: Placebo-Dupilumab', 'description': 'Participants who received placebo matched to dupilumab in the parent study EFC14153 received dupilumab for 52 weeks in the main study as follows:\n\n* 100 mg q2w as an SC injection or 300 mg q4w as an SC injection for participants with body weight ≤30 kg.\n* 200 mg q2w as an SC injection for participants with body weight \\>30 kg. Participants also received a stable-dose background therapy of medium-dose ICS with a second controller medication (i.e., LABA, LAMA, LTRA or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller medication. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication as instructed by Investigator.'}, {'id': 'OG001', 'title': 'Main Study: Dupilumab-Dupilumab', 'description': 'Participants who received dupilumab in the parent study EFC14153 received dupilumab for 52 weeks in the main study as follows:\n\n* 100 mg q2w as an SC injection or 300 mg q4w as an SC injection for participants with body weight ≤30 kg.\n* 200 mg q2w as an SC injection for participants with body weight \\>30 kg. Participants also received a stable-dose background therapy of medium-dose ICS with a second controller medication (i.e., LABA, LAMA, LTRA or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller medication. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication as instructed by Investigator.'}, {'id': 'OG002', 'title': 'Japan Sub-study: Dupilumab', 'description': 'Participants received dupilumab for 52 weeks in the Japan sub-study as follows:\n\n* 100 mg q2w as an SC injection or 300 mg q4w as an SC injection for participants with body weight ≥15 kg and ≤30 kg.\n* 200 mg q2w as an SC injection for participants with body weight \\>30 kg. Participants also received a stable-dose background therapy of medium-dose ICS with a second controller medication (i.e., LABA, LAMA, LTRA or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller medication. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication as instructed by Investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '-76.9', 'spread': '-85.2', 'groupId': 'OG000', 'lowerLimit': '-85.2', 'upperLimit': '-63.4'}, {'value': '-86.8', 'spread': '-91.4', 'groupId': 'OG001', 'lowerLimit': '-91.4', 'upperLimit': '-77.3'}, {'value': '-75.0', 'spread': '-81.1', 'groupId': 'OG002', 'lowerLimit': '-81.1', 'upperLimit': '-70.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Day 1) to Week 64', 'description': 'Blood samples were collected at specified timepoints to assess percent change from baseline in total IgE in serum. Baseline (main study): the original baseline of parent study EFC14153. Baseline (sub-study): last available measurement prior to first study treatment dose if participant was treated, or last available value up to enrollment if participant was not exposed to study treatment in current study.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Main study: safety population included all participants exposed to at least 1 dose or part of a dose of the study treatment during current study regardless of the amount of treatment administered. Sub-study: safety population included all enrolled participants who took at least 1 dose of study treatment in the current study, regardless of the amount of treatment administered. Only participants with data collected are reported.'}, {'type': 'SECONDARY', 'title': 'Japan Sub-study: Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) at Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Japan Sub-study: Dupilumab', 'description': 'Participants received dupilumab for 52 weeks in the Japan sub-study as follows:\n\n* 100 mg q2w as an SC injection or 300 mg q4w as an SC injection for participants with body weight ≥15 kg and ≤30 kg.\n* 200 mg q2w as an SC injection for participants with body weight \\>30 kg. Participants also received a stable-dose background therapy of medium-dose ICS with a second controller medication (i.e., LABA, LAMA, LTRA or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller medication. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication as instructed by Investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.3', 'spread': '27.5', 'groupId': 'OG000', 'lowerLimit': '27.5'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) to Week 64', 'description': 'FeNO was analyzed using a NIOX instrument or similar analyzer using a flow rate of 50 milliliter per second. FeNO assessment was conducted prior to spirometry and following a fast of ≥1 hour. Baseline was defined as the last available measurement prior to first study treatment dose if participant was treated, or last available value up to enrollment if participant was not exposed to study treatment in the current study.', 'unitOfMeasure': 'parts per billion', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all enrolled participants who took at least 1 dose of study treatment in the current study, regardless of the amount of treatment administered. Only participants with data collected are reported.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Main Study: Placebo-Dupilumab', 'description': 'Participants who received placebo matched to dupilumab in the parent study EFC14153 received dupilumab for 52 weeks in the main study as follows:\n\n* 100 milligrams (mg) once every 2 weeks (q2w) as a subcutaneous (SC) injection or 300 mg once every 4 weeks (q4w) as an SC injection for participants with body weight ≤30 kilograms (kg).\n* 200 mg q2w as an SC injection for participants with body weight \\>30 kg. Participants also received a stable-dose background therapy of medium-dose inhaled corticosteroids (ICS) with a second controller medication (i.e., long-acting beta-2 agonists \\[LABA\\], long-acting muscarinic antagonists \\[LAMA\\], leukotriene receptor antagonists \\[LTRA\\] or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller medication. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication as instructed by Investigator.'}, {'id': 'FG001', 'title': 'Main Study: Dupilumab-Dupilumab', 'description': 'Participants who received dupilumab in the parent study EFC14153 received dupilumab for 52 weeks in the main study as follows:\n\n* 100 mg q2w as an SC injection or 300 mg q4w as an SC injection for participants with body weight ≤30 kg.\n* 200 mg q2w as an SC injection for participants with body weight \\>30 kg. Participants also received a stable-dose background therapy of medium-dose ICS with a second controller medication (i.e., LABA, LAMA, LTRA or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller medication. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication as instructed by Investigator.'}, {'id': 'FG002', 'title': 'Japan Sub-study: Dupilumab', 'description': 'Participants received dupilumab for 52 weeks in the Japan sub-study as follows:\n\n* 100 mg q2w as an SC injection or 300 mg q4w as an SC injection for participants with body weight ≥15 kg and ≤30 kg.\n* 200 mg q2w as an SC injection for participants with body weight \\>30 kg. Participants also received a stable-dose background therapy of medium-dose ICS with a second controller medication (i.e., LABA, LAMA, LTRA or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller medication. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication as instructed by Investigator.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '125'}, {'groupId': 'FG001', 'numSubjects': '240'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '118'}, {'groupId': 'FG001', 'numSubjects': '228'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Poor Compliance to Protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The main study was conducted at 70 centers in 17 countries, and the sub-study was conducted at 11 centers in Japan. 365 participants who rolled over from parent study EFC14153 (NCT02948959) were enrolled in the main study and 13 participants (not included in parent study EFC14153) were enrolled in Japan sub-study.', 'preAssignmentDetails': 'All participants received dupilumab dose based on body weight in the main study and Japan sub-study. As pre-specified in the protocol and statistical analysis plan (SAP), the results are presented by study and treatment group, regardless of the dose regimen.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'BG000'}, {'value': '240', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '378', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Main Study: Placebo-Dupilumab', 'description': 'Participants who received placebo matched to dupilumab in the parent study EFC14153 received dupilumab for 52 weeks in the main study as follows:\n\n* 100 mg q2w as an SC injection or 300 mg q4w as an SC injection for participants with body weight ≤30 kg.\n* 200 mg q2w as an SC injection for participants with body weight \\>30 kg. Participants also received a stable-dose background therapy of medium-dose ICS with a second controller medication (i.e., LABA, LAMA, LTRA or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller medication. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication as instructed by Investigator.'}, {'id': 'BG001', 'title': 'Main Study: Dupilumab-Dupilumab', 'description': 'Participants who received dupilumab in the parent study EFC14153 received dupilumab for 52 weeks in the main study as follows:\n\n* 100 mg q2w as an SC injection or 300 mg q4w as an SC injection for participants with body weight ≤30 kg.\n* 200 mg q2w as an SC injection for participants with body weight \\>30 kg. Participants also received a stable-dose background therapy of medium-dose ICS with a second controller medication (i.e., LABA, LAMA, LTRA or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller medication. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication as instructed by Investigator.'}, {'id': 'BG002', 'title': 'Japan Sub-study: Dupilumab', 'description': 'Participants received dupilumab for 52 weeks in the Japan sub-study as follows:\n\n* 100 mg q2w as an SC injection or 300 mg q4w as an SC injection for participants with body weight ≥15 kg and ≤30 kg.\n* 200 mg q2w as an SC injection for participants with body weight \\>30 kg. Participants also received a stable-dose background therapy of medium-dose ICS with a second controller medication (i.e., LABA, LAMA, LTRA or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller medication. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication as instructed by Investigator.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '9.9', 'spread': '1.6', 'groupId': 'BG000'}, {'value': '9.9', 'spread': '1.7', 'groupId': 'BG001'}, {'value': '9.69', 'spread': '1.11', 'groupId': 'BG002'}, {'value': '9.89', 'spread': '1.62', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '135', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '155', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '243', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Caucasian/White', 'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '215', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '326', 'groupId': 'BG003'}]}, {'title': 'Black/of African Descent', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}, {'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Other', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Main study: safety population included all participants exposed to at least 1 dose or part of a dose of the study treatment during current study regardless of the amount of treatment administered. Sub-study: enrolled population included all participants who signed the informed consent/assent and had a treatment kit number allocated and recorded in the interactive voice response system/interactive web response system database, regardless of whether the treatment kit was received or not.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-12-21', 'size': 2407766, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-10-03T14:06', 'hasProtocol': True}, {'date': '2024-06-25', 'size': 2228951, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-10-03T14:06', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 378}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-21', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-10', 'studyFirstSubmitDate': '2018-03-22', 'resultsFirstSubmitDate': '2025-10-03', 'studyFirstSubmitQcDate': '2018-06-06', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-11-10', 'studyFirstPostDateStruct': {'date': '2018-06-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Main Study: Number of Participants With Any Treatment-Emergent Adverse Events (TEAEs)', 'timeFrame': 'From first dose of study treatment (Day 1) up to 112 days post last dose of study treatment, approximately 64 weeks', 'description': 'An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. TEAEs were AEs that developed or worsened or became serious during the TEAE period.'}, {'measure': 'Japan Sub-study: Change From Baseline to Week 12 in Pre-Bronchodilator Percent Predicted Forced Expiratory Volume in 1 Second (FEV1)', 'timeFrame': 'Baseline (Day 1) to Week 12', 'description': 'FEV1 was the volume of air (in liters) 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. Baseline was defined as the last available measurement prior to the first study treatment dose if the participant was treated, or the last available value up to enrollment if the participant was not exposed to study treatment in the current study.'}], 'secondaryOutcomes': [{'measure': 'Japan Sub-study: Number of Participants With Any Treatment-Emergent Adverse Events', 'timeFrame': 'From first dose of study treatment (Day 1) up to 112 days post last dose of study treatment, approximately 64 weeks', 'description': 'An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. TEAEs were AEs that developed or worsened or became serious during the TEAE period.'}, {'measure': 'Annualized Rate of Severe Asthma Exacerbation Events During the 52-Week Treatment Period', 'timeFrame': 'Up to Week 52', 'description': 'A severe exacerbation event during study was defined as a deterioration of asthma requiring use of systemic corticosteroid (SCS) for ≥3 days or hospitalization/emergency room visit because of asthma, requiring SCS. Annualized severe exacerbation event rate was defined as total number of events that occurred during 52-week treatment period divided by total number of participant-years followed in 52-week treatment period.'}, {'measure': 'Change From Baseline in Pre-Bronchodilator Percent Predicted Forced Expiratory Volume in 1 Second Over Time', 'timeFrame': 'Baseline (Day 1) and Weeks 2, 4 (Japan sub-study), 8, 12, 24, 52 and 64', 'description': 'FEV1 was volume of air (in liters) exhaled from the lungs in 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. Baseline (main study): original baseline of parent study EFC14153. Baseline (sub-study): last available measurement prior to first study treatment dose if participant was treated, or last available value up to enrollment if participant was not exposed to study treatment in current study.'}, {'measure': 'Change From Baseline in Absolute Forced Expiratory Volume in 1 Second Over Time', 'timeFrame': 'Baseline (Day 1) and Weeks 2, 4 (Japan sub-study), 8, 12, 24, 52 and 64', 'description': 'FEV1 was volume of air (in liters) exhaled from the lungs in 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. Baseline (main study): original baseline of parent study EFC14153. Baseline (sub-study): last available measurement prior to first study treatment dose if participant was treated, or last available value up to enrollment if participant was not exposed to study treatment in current study.'}, {'measure': 'Change From Baseline in Forced Vital Capacity (FVC) Over Time', 'timeFrame': 'Baseline (Day 1) and Weeks 2, 4 (Japan sub-study), 8, 12, 24, 52 and 64', 'description': 'FVC was defined as volume of air (in liters) that could be forcibly blown out after full inspiration in upright position as measured by spirometer. Spirometry was performed after wash out period of bronchodilators according to their action duration. Baseline (main study):original baseline of parent study EFC14153. Baseline (sub-study): last available measurement prior to first study treatment dose if participant was treated or last available value up to enrollment if participant was not exposed to study treatment in current study.'}, {'measure': 'Change From Baseline in Forced Expiratory Flow [FEF] 25% to 75% Over Time', 'timeFrame': 'Baseline (Day 1) and Weeks 2, 4 (Japan sub-study), 8, 12, 24, 52 and 64', 'description': 'FEF was defined as amount of air which can be forcibly exhaled from lungs in first second of forced exhalation. FEF 25-75% was the mean FEF between 25% and 75% of FVC. FVC was defined as volume of air that could be forcibly blown out after full inspiration in upright position. Spirometry was performed after wash out period of bronchodilators. Baseline (main study): original baseline of parent study EFC14153. Baseline (sub-study): last available measurement prior to first study treatment dose if participant was treated or last available value up to enrollment if participant was not exposed to study treatment in current study.'}, {'measure': 'Main Study: Change From Baseline in Percent Predicted Forced Vital Capacity Over Time', 'timeFrame': 'Baseline (Day 1) and Weeks 2, 8, 12, 24, 52 and 64', 'description': 'FVC was defined as volume of air (in liters) that could be forcibly blown out after full inspiration in upright position as measured by spirometer. Spirometry was performed after wash out period of bronchodilators according to their action duration. Baseline was defined as the original baseline of parent study EFC14153.'}, {'measure': 'Japan Sub-study: Change From Baseline in Asthma Control Questionnaire-Interviewer Administered, 7-Question Version (ACQ-7-IA) Over Time', 'timeFrame': 'Baseline (Day 1) and Weeks 2, 4, 8, 12, 24, 36, 52 and 64', 'description': "ACQ-7-IA had 7 questions with first 5 items of ACQ-7 addressing most common asthma symptoms: frequency in past week awoken by asthma during night, severity of asthma symptoms in morning, limitation of daily activities due to asthma, shortness of breath due to asthma, wheeze; 2 questions on short-acting bronchodilator use and predicted bronchodilator use of FEV1. Participants/parents/guardians recalled child's previous week asthma and responded to questions on 7-point scale: 0=no impairment, 6=maximum impairment. Global ACQ-7-IA score was the mean of 7 questions, ranging from 0 (totally controlled) to 6 (severely uncontrolled). Higher scores indicated lower asthma control. Baseline: last available measurement prior to first study treatment dose if participant was treated or last available value up to enrollment if participant was not exposed to study treatment in current study."}, {'measure': 'Japan Sub-study: Change From Baseline in Asthma Control Questionnaire-Interviewer Administered, 5-Question Version (ACQ-5-IA) Over Time', 'timeFrame': 'Baseline (Day 1) and Weeks 2, 4, 8, 12, 24, 36, 52 and 64', 'description': "The ACQ-5-IA had 5 questions addressing most common asthma symptoms: frequency in past week awoken by asthma during night, severity of asthma symptoms in morning, limitation of daily activities due to asthma, shortness of breath due to asthma and wheeze. Participants/parents/guardians recalled the child's previous week asthma and responded to symptom and bronchodilator use questions on a 7-point scale: 0=no impairment, 6=maximum impairment. Global ACQ-5-IA score was the mean of 5 questions, ranging from 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicated lower asthma control. Baseline: last available measurement prior to first study treatment dose if participant was treated, or last available value up to enrollment if participant was not exposed to study treatment in current study."}, {'measure': 'Serum Concentrations of Dupilumab', 'timeFrame': 'Weeks 12, 24, 52 and 64', 'description': 'Blood samples were collected at the specified timepoints for determination of functional dupilumab concentration in serum.'}, {'measure': 'Number of Participants With Anti-Drug Antibodies (ADAs) Against Dupilumab', 'timeFrame': 'From first dose of study treatment (Day 1) to Week 64', 'description': 'ADA positive was defined as either treatment-boosted or treatment-emergent response in the ADA assay. Treatment-boosted response was defined as a positive response in the ADA assay post first dose in the current study that was greater than or equal to 4-fold of the baseline titer levels, when baseline results were positive. Treatment-emergent response was defined as a positive response in the ADA assay post first dose in the current study, when baseline results were negative or missing. Baseline (main study): original baseline of parent study EFC14153. Baseline (sub-study): last available measurement prior to first study treatment dose if participant was treated, or last available value up to enrollment if participant was not exposed to study treatment in current study.'}, {'measure': 'Main Study: Percent Change From Baseline in Blood Eosinophil Count at Week 64', 'timeFrame': 'Baseline (Day 1) to Week 64', 'description': 'Blood samples were collected at specified timepoints to assess percent change from baseline in eosinophil count. Baseline was defined as the original baseline of parent study EFC14153.'}, {'measure': 'Percent Change From Baseline in Total Immunoglobulin (Ig) E in Serum at Week 64', 'timeFrame': 'Baseline (Day 1) to Week 64', 'description': 'Blood samples were collected at specified timepoints to assess percent change from baseline in total IgE in serum. Baseline (main study): the original baseline of parent study EFC14153. Baseline (sub-study): last available measurement prior to first study treatment dose if participant was treated, or last available value up to enrollment if participant was not exposed to study treatment in current study.'}, {'measure': 'Japan Sub-study: Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) at Week 64', 'timeFrame': 'Baseline (Day 1) to Week 64', 'description': 'FeNO was analyzed using a NIOX instrument or similar analyzer using a flow rate of 50 milliliter per second. FeNO assessment was conducted prior to spirometry and following a fast of ≥1 hour. Baseline was defined as the last available measurement prior to first study treatment dose if participant was treated, or last available value up to enrollment if participant was not exposed to study treatment in the current study.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '37956679', 'type': 'DERIVED', 'citation': 'Bacharier LB, Maspero JF, Katelaris CH, Fiocchi AG, Gagnon R, de Mir I, Guilbert TW, Jackson DJ, Staudinger HW, Laws E, Mannent LP, Akinlade B, Maloney J, Tawo K, Khokhar FA, Li N, Hardin M, Abdulai RM, Lederer DJ, Robinson LB; Liberty Asthma EXCURSION Investigators. Assessment of long-term safety and efficacy of dupilumab in children with asthma (LIBERTY ASTHMA EXCURSION): an open-label extension study. Lancet Respir Med. 2024 Jan;12(1):45-54. doi: 10.1016/S2213-2600(23)00303-X. Epub 2023 Nov 10.'}]}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\n* To evaluate the long-term safety and tolerability of dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study.\n* To evaluate the efficacy of dupilumab in children of 6 to \\<12 years of age with uncontrolled persistent asthma in the Japan sub-study.\n\nSecondary Objectives:\n\n* To evaluate the long-term efficacy of dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study.\n* To evaluate dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study with regard to:\n\n * Systemic exposure.\n * Anti-drug antibodies (ADAs).\n * Biomarkers.\n* To evaluate the safety and tolerability of dupilumab in pediatric patients with asthma in the Japan sub-study\n* To evaluate dupilumab in pediatric patients with asthma in the Japan substudy with regard to:\n\n * Systemic exposure,\n * Anti-drug antibodies (ADAs),\n * Biomarkers', 'detailedDescription': 'Study duration per participant is approximatively 64 weeks including a 52 weeks treatment period and 12 weeks post treatment follow-up.\n\nJapan substudy:\n\nStudy duration per participant is approximately 68 weeks including 3-5 weeks screening period, 52 weeks treatment period and 12 weeks post treatment follow-up period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria :\n\n* Pediatric patients with asthma who completed the treatment in a dupilumab asthma trial (EFC14153).\n* Signed written informed consent/assent. Specific for Brazil: EFC14153 patients from Brazil, who prematurely discontinued Investigational Medicinal Product (IMP) to receive Yellow Fever vaccine (a live attenuated vaccine) during Yellow Fever outbreak, are allowed to be enrolled in LTS14424 after completing the required procedures in EFC14153 (completion of remaining visits and procedures until end of treatment (EOT) V28, considered as V1 for LTS14424).\n\nPatients who are not able to complete their treatment in Study EFC14153 due to the COVID-19 pandemic will be allowed to enroll into Study LTS14424. Patients who enroll in LTS14424 after completing the EFC14153 EOS visit should have eligibility for LTS14424 reevaluated including background medication check and laboratory assessments (including complete blood count \\[CBC\\] with differential and basic chemistry) within 1 month prior to LTS14424 Visit 1.\n\nFor Japan sub-study\n\n* Signed written inform consent/assent\n* Children 6 to \\<12 years of age, with a physician diagnosis of persistent asthma for ≥12 months prior to screening\n* Blood eosinophil count ≥150 cells/μL or fractional exhaled nitric oxide (FeNO) ≥20 parts per billion (ppb) at screening visit (Visit 0).\n\nExclusion criteria:\n\n* Any chronic lung disease other than asthma (eg, cystic fibrosis, bronchopulmonary dysplasia) which may impair lung function.\n* Inability to follow the procedures of the study/noncompliance (eg, due to language problems or psychological disorders).\n* Patients receiving concomitant treatment or required a new concomitant treatment prohibited in the study.\n* Patients or his/her parent(s)/caregiver(s)/legal guardian(s) is related to the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other staff thereof directly involved in the conduct of the study.\n* Patients who experienced any hypersensitivity reactions to dupilumab in a previous dupilumab study, which, in the opinion of the Investigator, could indicate that continued treatment with dupilumab may present an unreasonable risk for the patient.\n* Any abnormalities or adverse events at screening (last treatment visit in the study EFC14153 will be the screening visit) that per Investigator judgment would adversely affect patient's participation in this study or would require permanent IMP discontinuation.\n* For female patients who have commenced menstruating at any time during the study and are either:\n* Found to have a positive urine pregnancy test, or\n* Sexually active, not using an established acceptable contraceptive method.\n* Planned live, attenuated vaccinations during the study.\n* Patients with active autoimmune disease or patients using immunosuppressive therapy for autoimmune disease (eg, juvenile idiopathic arthritis, inflammatory bowel disease, systemic lupus erythematosus) at enrollment.\n\nFor Japan sub-study:\n\n* Any chronic lung disease other than asthma (eg, cystic fibrosis, bronchopulmonary dysplasia) which may impair lung function.\n* Inability to follow the procedures of the study/noncompliance (eg, due to language problems or psychological disorders).\n* Patients receiving concomitant treatment or required a new concomitant treatment prohibited in the study at the screening and enrollment visits.\n* Patients who previously have been treated with dupilumab\n* Diagnosed with active parasitic infection (helminthes); suspected or high risk of parasitic infection, unless clinical and (if necessary) laboratory assessments have ruled out active infection before randomization\n* Known or suspected history of immunosuppression, including history of invasive opportunistic infections (eg, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis), despite infection resolution; or unusually frequent, recurrent, or prolonged infections, per Investigator's judgment.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT03560466', 'briefTitle': 'Assessment of the Safety and Efficacy of Dupilumab in Children With Asthma (Liberty Asthma Excursion)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'One Year Study to Evaluate the Long-term Safety and Tolerability of Dupilumab in Pediatric Patients With Asthma Who Participated in a Previous Dupilumab Asthma Clinical Study', 'orgStudyIdInfo': {'id': 'LTS14424'}, 'secondaryIdInfos': [{'id': 'U1111-1200-1757', 'type': 'REGISTRY', 'domain': 'ICTRP'}, {'id': '2017-003317-25', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dupilumab', 'description': 'Doses of dupilumab will be administered every 2 weeks or every 4 weeks added to current controller medications for 52 weeks', 'interventionNames': ['Drug: Dupilumab (SAR231893/REGN668)', 'Drug: Asthma controller therapies (incl. prednisone/prednisolone)', 'Drug: Asthma reliever therapies']}], 'interventions': [{'name': 'Dupilumab (SAR231893/REGN668)', 'type': 'DRUG', 'description': 'Pharmaceutical form: solution for injection\n\nRoute of administration: subcutaneous (sc)', 'armGroupLabels': ['Dupilumab']}, {'name': 'Asthma controller therapies (incl. prednisone/prednisolone)', 'type': 'DRUG', 'description': 'Pharmaceutical form: powder, or solution, or pill\n\nRoute of administration: inhaled, oral or parenteral', 'armGroupLabels': ['Dupilumab']}, {'name': 'Asthma reliever therapies', 'type': 'DRUG', 'description': 'Pharmaceutical form: powder or solution\n\nRoute of administration: inhaled', 'armGroupLabels': ['Dupilumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85234', 'city': 'Gilbert', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Allergy and Immunology Research- Site Number : 8400002', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '85274', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Asthma and Airway Disease Research Center Site Number : 8400012', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '90274', 'city': 'Rolling Hills Estates', 'state': 'California', 'country': 'United States', 'facility': 'Peninsula Research Associates Site Number : 8400001', 'geoPoint': {'lat': 33.78779, 'lon': -118.35813}}, {'zip': '63110-1077', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Division of Pulmonary Medicine and Allergy Medicine- Site Number : 8400006', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68505', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Somnos Clinical Research Site Number : 8400022', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '11021', 'city': 'Great Neck', 'state': 'New York', 'country': 'United States', 'facility': 'Northwell Health- Site Number : 8400023', 'geoPoint': {'lat': 40.80066, 'lon': -73.72846}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center- Site Number : 8400013', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14607', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Rochester Regional Health- Site Number : 8400007', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '28277', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Immunocarolina LLC Site Number : 8400004', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center Site Number : 8400008", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '73034', 'city': 'Edmond', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'OK Clinical Research, LLC- Site Number : 8400024', 'geoPoint': {'lat': 35.65283, 'lon': -97.4781}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Allergy & Asthma Research Center- Site Number : 8400003', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': 'C1122AAK', 'city': 'CABA', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Investigational Site Number : 0320002'}, {'zip': 'C1414AIF', 'city': 'CABA', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Investigational Site Number : 0320001'}, {'zip': 'B1602DQD', 'city': 'Vicente Lopez', 'state': 'Buenos Aires F.D.', 'country': 'Argentina', 'facility': 'Investigational Site Number : 0320004'}, {'zip': 'C1121ABE', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Investigational Site Number : 0320003', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': '5500', 'city': 'Mendoza', 'country': 'Argentina', 'facility': 'Investigational Site Number : 0320006', 'geoPoint': {'lat': -32.88946, 'lon': -68.84582}}, {'zip': '5006', 'city': 'North Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Investigational Site Number : 0360005', 'geoPoint': {'lat': -34.90733, 'lon': 138.59141}}, {'zip': '90020-090', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Irmandade da Santa Casa de Misericordia de Porto Alegre- Site Number : 0760001', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '90610-000', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital 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