Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-06-25 @ 1:00 AM
Study NCT ID:
NCT02952820
Status:
COMPLETED
Last Update Posted:
2020-02-06
First Post:
2016-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Long-term Study of Lemborexant in Insomnia Disorder (SUNRISE 2)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Chile', 'Hong Kong', 'Taiwan']}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000634104', 'term': 'lemborexant'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'esi_medinfo@eisai.com', 'phone': '+1-888-274-2378', 'title': 'Eisai Medical Information', 'organization': 'Eisai, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From start of study drug administration up to Week 54', 'description': 'Placebo arm included AE data for participants who received placebo in Period 1. Lemborexant 5 mg and 10 mg arms included AE data of participants who received either lemborexant 5 mg or 10 mg throughout the study (Period 1 and 2 both) and participants re-randomized from placebo (in Period 1) to either lemborexant 5 mg or lemborexant 10 mg in Period 2.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to lemborexant tablet, orally, once daily for up to 6 months. Then they were re-randomized to Lemborexant 5 mg or Lemborexant 10 mg.', 'otherNumAtRisk': 319, 'deathsNumAtRisk': 319, 'otherNumAffected': 75, 'seriousNumAtRisk': 319, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Lemborexant 5 mg', 'description': 'Participants received lemborexant 5 mg/placebo, tablets, orally, once daily through Month 1-6 (in Period 1) and lemborexant 5 mg, tablets, orally, once daily through Month 7-12 (in Period 2).', 'otherNumAtRisk': 447, 'deathsNumAtRisk': 447, 'otherNumAffected': 129, 'seriousNumAtRisk': 447, 'deathsNumAffected': 0, 'seriousNumAffected': 18}, {'id': 'EG002', 'title': 'Lemborexant 10 mg', 'description': 'Participants received lemborexant 10 mg/placebo, tablets, orally, once daily through Month 1-6 (in Period 1) and lemborexant 10 mg, tablets, orally, once daily through Month 7-12 (in Period 2).', 'otherNumAtRisk': 437, 'deathsNumAtRisk': 437, 'otherNumAffected': 140, 'seriousNumAtRisk': 437, 'deathsNumAffected': 0, 'seriousNumAffected': 16}], 'otherEvents': [{'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 319, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 29, 'numAffected': 26}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 319, 'numEvents': 43, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 67, 'numAffected': 51}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 56, 'numAffected': 48}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 319, 'numEvents': 33, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 76, 'numAffected': 43}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 41, 'numAffected': 32}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 319, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 44, 'numAffected': 38}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 64, 'numAffected': 60}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'seriousEvents': [{'term': 'Angina Pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Goitre', 'stats': [{'groupId': 'EG000', 'numAtRisk': 319, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Diabetic Retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 319, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Cholestasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hepatotoxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 319, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Postoperative Wound Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Lower Limb Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pelvic Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 319, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Rib Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 319, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Tibia Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 319, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Type 2 Diabetes Mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Jaw Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 319, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Jaw Fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 319, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Intraductal Proliferative Breast Lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Cerebrovascular Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Diabetic Neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Disturbance In Attention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hydrosalpinx', 'stats': [{'groupId': 'EG000', 'numAtRisk': 319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Chronic Obstructive Pulmonary Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Deep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Floppy eyelid syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Alcoholic pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Gastrointestinal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hiatus hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hand fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Meniscus injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Intentional Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Laryngeal Inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Dermal Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 447, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Subjective Sleep Onset Latency (sSOL) at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '316', 'groupId': 'OG001'}, {'value': '315', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received lemborexant-matched placebo, tablet, orally, once daily for up to Month 6 in the placebo-controlled treatment period. Then they were re-randomized to lemborexant 5 mg or lemborexant 10 mg up to Month 12.'}, {'id': 'OG001', 'title': 'Lemborexant 5 mg', 'description': 'Participants received lemborexant 5 mg, tablets, orally, once daily through Month 1-6 (in Period 1) and Month 7-12 (in Period 2).'}, {'id': 'OG002', 'title': 'Lemborexant 10 mg', 'description': 'Participants received lemborexant 10 mg, tablets, orally, once daily through Month 1-6 (in Period 1) and Month 7-12 (in Period 2).'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '316', 'groupId': 'OG000'}, {'value': '314', 'groupId': 'OG001'}, {'value': '312', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '64.03', 'spread': '45.209', 'groupId': 'OG000'}, {'value': '62.19', 'spread': '45.674', 'groupId': 'OG001'}, {'value': '64.97', 'spread': '44.020', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '245', 'groupId': 'OG001'}, {'value': '229', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-16.57', 'spread': '35.313', 'groupId': 'OG000'}, {'value': '-29.39', 'spread': '33.261', 'groupId': 'OG001'}, {'value': '-32.49', 'spread': '35.962', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'least squares geometric mean (LSGM)ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.732', 'ciLowerLimit': '0.636', 'ciUpperLimit': '0.843', 'groupDescription': 'Analysis was based on mixed effect model repeated measurement analysis (MMRM) model with log transformation of sSOL and factors for age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effects, and the study baseline sSOL as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (missing not at random/complete case missing value \\[MNAR/CCMV\\]).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSGM ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.701', 'ciLowerLimit': '0.607', 'ciUpperLimit': '0.810', 'groupDescription': 'Analysis was based on MMRM model with log transformation of sSOL and factors for age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effects, and the study baseline sSOL as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 6', 'description': 'sSOL was defined as estimated minutes from the time that the participant attempted to sleep until sleep onset.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS was the group of randomized participants who received at least one dose of randomized study drug and had at least one postdose primary efficacy measurement. Number analyzed refers to participants evaluable for this outcome measure at specified time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in sSOL at the Beginning of Treatment (Mean of the 7 Nights After the First Dose in Placebo-Controlled Period), and at Months 1 and 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '316', 'groupId': 'OG001'}, {'value': '315', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received lemborexant-matched placebo, tablet, orally, once daily for up to Month 6 in the placebo-controlled treatment period. Then they were re-randomized to lemborexant 5 mg or lemborexant 10 mg up to Month 12.'}, {'id': 'OG001', 'title': 'Lemborexant 5 mg', 'description': 'Participants received lemborexant 5 mg, tablets, orally, once daily through Month 1-6 (in Period 1) and Month 7-12 (in Period 2).'}, {'id': 'OG002', 'title': 'Lemborexant 10 mg', 'description': 'Participants received lemborexant 10 mg, tablets, orally, once daily through Month 1-6 (in Period 1) and Month 7-12 (in Period 2).'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '316', 'groupId': 'OG000'}, {'value': '314', 'groupId': 'OG001'}, {'value': '312', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '64.03', 'spread': '45.209', 'groupId': 'OG000'}, {'value': '62.19', 'spread': '45.674', 'groupId': 'OG001'}, {'value': '64.97', 'spread': '44.020', 'groupId': 'OG002'}]}]}, {'title': 'Change at 1st 7 nights', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'OG000'}, {'value': '310', 'groupId': 'OG001'}, {'value': '310', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-4.11', 'spread': '27.671', 'groupId': 'OG000'}, {'value': '-16.86', 'spread': '27.784', 'groupId': 'OG001'}, {'value': '-18.89', 'spread': '31.003', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}, {'value': '297', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-11.48', 'spread': '32.726', 'groupId': 'OG000'}, {'value': '-19.41', 'spread': '32.221', 'groupId': 'OG001'}, {'value': '-24.06', 'spread': '35.234', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '279', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}, {'value': '264', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-13.84', 'spread': '35.277', 'groupId': 'OG000'}, {'value': '-25.08', 'spread': '34.081', 'groupId': 'OG001'}, {'value': '-27.94', 'spread': '39.192', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSGM ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.781', 'ciLowerLimit': '0.725', 'ciUpperLimit': '0.842', 'groupDescription': 'First 7 nights after the first dose (Statistical analysis 1): Based on MMRM model with log transformation of sSOL and factors for age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effects, and the study baseline sSOL as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSGM ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.752', 'ciLowerLimit': '0.698', 'ciUpperLimit': '0.811', 'groupDescription': 'First 7 nights after the first dose (Statistical analysis 2): Based on MMRM model with log transformation of sSOL and factors for age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effects, and the study baseline sSOL as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSGM ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.810', 'ciLowerLimit': '0.735', 'ciUpperLimit': '0.893', 'groupDescription': 'Month 1 (Statistical analysis 3): Based on MMRM model with log transformation of sSOL and factors for age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effects, and the study baseline sSOL as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSGM ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.770', 'ciLowerLimit': '0.698', 'ciUpperLimit': '0.848', 'groupDescription': 'Month 1 (Statistical analysis 4): Based on MMRM model with log transformation of sSOL and factors for age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effects, and the study baseline sSOL as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSGM ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.778', 'ciLowerLimit': '0.690', 'ciUpperLimit': '0.878', 'groupDescription': 'Month 3 (Statistical analysis 5): Based on MMRM model with log transformation of sSOL and factors for age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effects, and the study baseline sSOL as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSGM ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.770', 'ciLowerLimit': '0.681', 'ciUpperLimit': '0.869', 'groupDescription': 'Month 3 (Statistical analysis 6): Based on MMRM model with log transformation of sSOL and factors for age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effects, and the study baseline sSOL as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, (mean of 7 nights [approximately Week 1]), Months 1 and 3', 'description': 'sSOL was defined as estimated minutes from time attempted to sleep to sleep onset.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS was the group of randomized participants who received at least one dose of randomized study drug and had at least one postdose primary efficacy measurement. Number analyzed refers to participants evaluable for this outcome measure at specified time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Subjective Sleep Efficiency (sSE) at the Beginning of Treatment (Mean of the 7 Nights After the First Dose in Placebo-Controlled Period), and at Months 1, 3 and 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '316', 'groupId': 'OG001'}, {'value': '315', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received lemborexant-matched placebo, tablet, orally, once daily for up to Month 6 in the placebo-controlled treatment period. Then they were re-randomized to lemborexant 5 mg or lemborexant 10 mg up to Month 12.'}, {'id': 'OG001', 'title': 'Lemborexant 5 mg', 'description': 'Participants received lemborexant 5 mg, tablets, orally, once daily through Month 1-6 (in Period 1) and Month 7-12 (in Period 2).'}, {'id': 'OG002', 'title': 'Lemborexant 10 mg', 'description': 'Participants received lemborexant 10 mg, tablets, orally, once daily through Month 1-6 (in Period 1) and Month 7-12 (in Period 2).'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'OG000'}, {'value': '302', 'groupId': 'OG001'}, {'value': '299', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '61.34', 'spread': '17.836', 'groupId': 'OG000'}, {'value': '63.14', 'spread': '18.231', 'groupId': 'OG001'}, {'value': '62.03', 'spread': '17.248', 'groupId': 'OG002'}]}]}, {'title': 'Change at 1st 7 nights', 'denoms': [{'units': 'Participants', 'counts': [{'value': '303', 'groupId': 'OG000'}, {'value': '295', 'groupId': 'OG001'}, {'value': '296', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.68', 'spread': '10.765', 'groupId': 'OG000'}, {'value': '6.61', 'spread': '10.386', 'groupId': 'OG001'}, {'value': '8.27', 'spread': '10.566', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}, {'value': '282', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.11', 'spread': '12.876', 'groupId': 'OG000'}, {'value': '7.87', 'spread': '12.263', 'groupId': 'OG001'}, {'value': '9.92', 'spread': '12.922', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '269', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}, {'value': '251', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.16', 'spread': '13.644', 'groupId': 'OG000'}, {'value': '13.03', 'spread': '13.522', 'groupId': 'OG001'}, {'value': '13.61', 'spread': '14.035', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '235', 'groupId': 'OG001'}, {'value': '220', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10.36', 'spread': '13.799', 'groupId': 'OG000'}, {'value': '15.34', 'spread': '14.613', 'groupId': 'OG001'}, {'value': '15.55', 'spread': '15.617', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.299', 'ciLowerLimit': '2.638', 'ciUpperLimit': '5.961', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.848', 'groupDescription': 'First 7 nights (Statistical analysis 1): Based on MMRM model with factors of age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effect, and the study baseline sSE as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.793', 'ciLowerLimit': '4.133', 'ciUpperLimit': '7.452', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.846', 'groupDescription': 'First 7 nights (Statistical analysis 2): Based on MMRM model with factors of age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effect, and the study baseline sSE as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0230', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.227', 'ciLowerLimit': '0.307', 'ciUpperLimit': '4.146', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.979', 'groupDescription': 'Month 1 (Statistical analysis 3): Based on MMRM model with factors of age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effect, and the study baseline sSE as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0003', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.615', 'ciLowerLimit': '1.635', 'ciUpperLimit': '5.595', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.010', 'groupDescription': 'Month 1 (Statistical analysis 4): Based on MMRM model with factors of age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effect, and the study baseline sSE as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.222', 'ciLowerLimit': '2.068', 'ciUpperLimit': '6.377', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.099', 'groupDescription': 'Month 3 (Statistical analysis 5): Based on MMRM model with factors of age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effect, and the study baseline sSE as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.361', 'ciLowerLimit': '2.220', 'ciUpperLimit': '6.501', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.092', 'groupDescription': 'Month 3 (Statistical analysis 6): Based on MMRM model with factors of age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effect, and the study baseline sSE as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.549', 'ciLowerLimit': '2.236', 'ciUpperLimit': '6.861', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.179', 'groupDescription': 'Month 6 (Statistical analysis 7): Based on MMRM model with factors of age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effect, and the study baseline sSE as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.667', 'ciLowerLimit': '2.373', 'ciUpperLimit': '6.960', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.170', 'groupDescription': 'Month 6 (Statistical analysis 8): Based on MMRM model with factors of age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effect, and the study baseline sSE as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, (mean of 7 nights [approximately Week 1]), Months 1, 3 and 6', 'description': 'sSE was defined as percentage of subjective total sleep time (sTST) divided by subjective time spent in bed, calculated as the interval from the time the participant reported attempting to sleep until the time participant stopped trying to sleep for the night (operationalized as the time the participant got out of bed for the day), and time spent asleep derived from subjective time spent in bed minus sWASO.', 'unitOfMeasure': 'percentage of sTST', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS was the group of randomized participants who received at least one dose of randomized study drug and had at least one postdose primary efficacy measurement. Number analyzed refers to participants evaluable for this outcome measure at specified time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Subjective Wake After Sleep Onset (sWASO) at the Beginning of Treatment (Mean of the 7 Nights After the First Dose in Placebo-Controlled Period), and at Months 1, 3 and 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '316', 'groupId': 'OG001'}, {'value': '315', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received lemborexant-matched placebo, tablet, orally, once daily for up to Month 6 in the placebo-controlled treatment period. Then they were re-randomized to lemborexant 5 mg or lemborexant 10 mg up to Month 12.'}, {'id': 'OG001', 'title': 'Lemborexant 5 mg', 'description': 'Participants received lemborexant 5 mg, tablets, orally, once daily through Month 1-6 (in Period 1) and Month 7-12 (in Period 2).'}, {'id': 'OG002', 'title': 'Lemborexant 10 mg', 'description': 'Participants received lemborexant 10 mg, tablets, orally, once daily through Month 1-6 (in Period 1) and Month 7-12 (in Period 2).'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'OG000'}, {'value': '313', 'groupId': 'OG001'}, {'value': '311', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '132.49', 'spread': '80.198', 'groupId': 'OG000'}, {'value': '132.77', 'spread': '82.518', 'groupId': 'OG001'}, {'value': '136.83', 'spread': '87.391', 'groupId': 'OG002'}]}]}, {'title': 'Change at first 7 nights', 'denoms': [{'units': 'Participants', 'counts': [{'value': '312', 'groupId': 'OG000'}, {'value': '308', 'groupId': 'OG001'}, {'value': '309', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-6.12', 'spread': '45.893', 'groupId': 'OG000'}, {'value': '-20.21', 'spread': '46.015', 'groupId': 'OG001'}, {'value': '-23.30', 'spread': '47.700', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}, {'value': '297', 'groupId': 'OG001'}, {'value': '293', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-19.01', 'spread': '50.279', 'groupId': 'OG000'}, {'value': '-23.42', 'spread': '56.251', 'groupId': 'OG001'}, {'value': '-26.82', 'spread': '56.989', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '278', 'groupId': 'OG000'}, {'value': '267', 'groupId': 'OG001'}, {'value': '262', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-27.08', 'spread': '54.408', 'groupId': 'OG000'}, {'value': '-42.98', 'spread': '60.064', 'groupId': 'OG001'}, {'value': '-39.42', 'spread': '62.783', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '244', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-32.14', 'spread': '55.279', 'groupId': 'OG000'}, {'value': '-51.45', 'spread': '67.295', 'groupId': 'OG001'}, {'value': '-48.12', 'spread': '68.550', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean (LSM) Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-14.328', 'ciLowerLimit': '-21.411', 'ciUpperLimit': '-7.245', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.614', 'groupDescription': 'First 7 nights (Statistical analysis 1): Based on MMRM model with factors of age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effect, and the study baseline sWASO as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.720', 'ciLowerLimit': '-23.813', 'ciUpperLimit': '-9.626', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.619', 'groupDescription': 'First 7 nights (Statistical analysis 2): Based on MMRM model with factors of age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effect, and the study baseline sWASO as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1796', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.514', 'ciLowerLimit': '-13.568', 'ciUpperLimit': '2.540', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.109', 'groupDescription': 'Month 1 (Statistical analysis 3): Based on MMRM model with factors of age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effect, and the study baseline sWASO as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0898', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.005', 'ciLowerLimit': '-15.098', 'ciUpperLimit': '1.088', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.129', 'groupDescription': 'Month 1 (Statistical analysis 4): Based on MMRM model with factors of age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effect, and the study baseline sWASO as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0028', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.424', 'ciLowerLimit': '-22.218', 'ciUpperLimit': '-4.631', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.486', 'groupDescription': 'Month 3 (Statistical analysis 5): Based on MMRM model with factors of age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effect, and the study baseline sWASO as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0277', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.079', 'ciLowerLimit': '-19.053', 'ciUpperLimit': '-1.104', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.578', 'groupDescription': 'Month 3 (Statistical analysis 6): Based on MMRM model with factors of age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effect, and the study baseline sWASO as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-17.474', 'ciLowerLimit': '-27.306', 'ciUpperLimit': '-7.643', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.014', 'groupDescription': 'Month 6 (Statistical analysis 7): Based on MMRM model with factors of age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effect, and the study baseline sWASO as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0105', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.671', 'ciLowerLimit': '-22.378', 'ciUpperLimit': '-2.964', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.951', 'groupDescription': 'Month 6 (Statistical analysis 8): Based on MMRM model with factors of age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effect, and the study baseline sWASO as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, (mean of 7 nights [approximately Week 1]), Months 1, 3 and 6', 'description': 'sWASO was defined as sum of estimated minutes of wake during the night after initial sleep onset until the time the participant stopped trying to sleep for the night, operationalized as the time the participant got out of bed for the day.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS was the group of randomized participants who received at least one dose of randomized study drug and had at least one postdose primary efficacy measurement. Number analyzed refers to participants evaluable for this outcome measure at specified time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in sTST at the Beginning of Treatment (Mean of the 7 Nights After the First Dose in Placebo-Controlled Period), and at Months 1, 3 and 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '316', 'groupId': 'OG001'}, {'value': '315', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received lemborexant-matched placebo, tablet, orally, once daily for up to Month 6 in the placebo-controlled treatment period. Then they were re-randomized to lemborexant 5 mg or lemborexant 10 mg up to Month 12.'}, {'id': 'OG001', 'title': 'Lemborexant 5 mg', 'description': 'Participants received lemborexant 5 mg, tablets, orally, once daily through Month 1-6 (in Period 1) and Month 7-12 (in Period 2).'}, {'id': 'OG002', 'title': 'Lemborexant 10 mg', 'description': 'Participants received lemborexant 10 mg, tablets, orally, once daily through Month 1-6 (in Period 1) and Month 7-12 (in Period 2).'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'OG000'}, {'value': '302', 'groupId': 'OG001'}, {'value': '299', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '304.25', 'spread': '91.459', 'groupId': 'OG000'}, {'value': '315.52', 'spread': '93.498', 'groupId': 'OG001'}, {'value': '306.89', 'spread': '88.031', 'groupId': 'OG002'}]}]}, {'title': 'Change at first 7 nights', 'denoms': [{'units': 'Participants', 'counts': [{'value': '303', 'groupId': 'OG000'}, {'value': '295', 'groupId': 'OG001'}, {'value': '296', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '14.78', 'spread': '54.995', 'groupId': 'OG000'}, {'value': '34.29', 'spread': '54.142', 'groupId': 'OG001'}, {'value': '46.01', 'spread': '55.110', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}, {'value': '282', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '30.74', 'spread': '70.687', 'groupId': 'OG000'}, {'value': '39.32', 'spread': '63.548', 'groupId': 'OG001'}, {'value': '53.22', 'spread': '67.910', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '269', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}, {'value': '251', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '48.16', 'spread': '75.859', 'groupId': 'OG000'}, {'value': '65.82', 'spread': '71.331', 'groupId': 'OG001'}, {'value': '70.95', 'spread': '70.913', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '235', 'groupId': 'OG001'}, {'value': '220', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '53.53', 'spread': '74.539', 'groupId': 'OG000'}, {'value': '76.21', 'spread': '77.714', 'groupId': 'OG001'}, {'value': '78.32', 'spread': '80.741', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '22.034', 'ciLowerLimit': '13.488', 'ciUpperLimit': '30.579', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.354', 'groupDescription': 'First 7 Nights After the First Dose (Statistical analysis 1): Based on MMRM model with factors of age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effect, and the study baseline sTST as a covariate. Missing values are not imputed and assumed to be MAR.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '31.796', 'ciLowerLimit': '23.258', 'ciUpperLimit': '40.334', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.350', 'groupDescription': 'First 7 nights after the first dose (Statistical analysis 2): Based on MMRM model with factors of age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effect, and the study baseline sTST as a covariate. Missing values are not imputed and assumed to be MAR.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0259', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.760', 'ciLowerLimit': '1.418', 'ciUpperLimit': '22.102', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.269', 'groupDescription': 'Month 1 (Statistical analysis 3): Based on MMRM model with factors of age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effect, and the study baseline sTST as a covariate. Missing values are not imputed and assumed to be MAR.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '22.131', 'ciLowerLimit': '11.757', 'ciUpperLimit': '32.505', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.286', 'groupDescription': 'Month 1 (Statistical analysis 4): Based on MMRM model with factors of age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effect, and the study baseline sTST as a covariate. Missing values are not imputed and assumed to be MAR.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0034', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.374', 'ciLowerLimit': '5.781', 'ciUpperLimit': '28.968', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.906', 'groupDescription': 'Month 3 (Statistical analysis 5): Based on MMRM model with factors of age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effect, and the study baseline sTST as a covariate. Missing values are not imputed and assumed to be MAR.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0003', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '21.686', 'ciLowerLimit': '10.014', 'ciUpperLimit': '33.359', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.946', 'groupDescription': 'Month 3 (Statistical analysis 6): Based on MMRM model with factors of age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effect, and the study baseline sTST as a covariate. Missing values are not imputed and assumed to be MAR.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0034', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.555', 'ciLowerLimit': '6.140', 'ciUpperLimit': '30.969', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.324', 'groupDescription': 'Month 6 (Statistical analysis 7): Based on MMRM model with factors of age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effect, and the study baseline sTST as a covariate. Missing values are not imputed and assumed to be missing at random (MAR).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0004', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '22.686', 'ciLowerLimit': '10.137', 'ciUpperLimit': '35.234', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.392', 'groupDescription': 'Month 6 (Statistical analysis 8): Based on MMRM model with factors of age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effect, and the study baseline sTST as a covariate. Missing values are not imputed and assumed to be MAR.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, (mean of 7 nights [approximately Week 1]), Months 1, 3 and 6', 'description': 'sTST was defined as minutes of sleep from sleep onset to time stopped trying to sleep for the night.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS was the group of randomized participants who received at least one dose of randomized study drug and had at least one postdose primary efficacy measurement. Number analyzed refers to participants evaluable for this outcome measure at specified time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Sleep Onset Responders and Sleep Maintenance Responders at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '316', 'groupId': 'OG001'}, {'value': '315', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received lemborexant-matched placebo, tablet, orally, once daily for up to Month 6 in the placebo-controlled treatment period. Then they were re-randomized to lemborexant 5 mg or lemborexant 10 mg up to Month 12.'}, {'id': 'OG001', 'title': 'Lemborexant 5 mg', 'description': 'Participants received lemborexant 5 mg, tablets, orally, once daily through Month 1-6 (in Period 1) and Month 7-12 (in Period 2).'}, {'id': 'OG002', 'title': 'Lemborexant 10 mg', 'description': 'Participants received lemborexant 10 mg, tablets, orally, once daily through Month 1-6 (in Period 1) and Month 7-12 (in Period 2).'}], 'classes': [{'title': 'Sleep Onset Responders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}, {'value': '249', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '17.7', 'groupId': 'OG000'}, {'value': '31.2', 'groupId': 'OG001'}, {'value': '30.1', 'groupId': 'OG002'}]}]}, {'title': 'Sleep Maintenance Responders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '250', 'groupId': 'OG000'}, {'value': '263', 'groupId': 'OG001'}, {'value': '257', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '20.4', 'groupId': 'OG000'}, {'value': '35.0', 'groupId': 'OG001'}, {'value': '30.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.67', 'ciLowerLimit': '6.24', 'ciUpperLimit': '21.10', 'groupDescription': 'Sleep onset responders: Statistical analysis 1', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0009', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.53', 'ciLowerLimit': '5.20', 'ciUpperLimit': '19.86', 'groupDescription': 'Sleep Onset Responders: Statistical analysis 2', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.65', 'ciLowerLimit': '6.97', 'ciUpperLimit': '22.33', 'groupDescription': 'Sleep Maintenance Responders: Statistical analysis 3', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0110', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.82', 'ciLowerLimit': '2.29', 'ciUpperLimit': '17.35', 'groupDescription': 'Sleep Maintenance Responders: Statistical analysis 4', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6', 'description': 'Sleep onset responder was defined as follows: sSOL at study Baseline was greater than or equal to (\\>=) 30 minutes and mean sSOL at 6 months was less than or equal to (\\<=) 20 minutes. Sleep maintenance responder was defined as follows: sWASO at study Baseline was \\>=60 minutes and mean sWASO at 6 months was \\<=60 minutes and showed a reduction of greater than (\\>)10 minutes compared to Study Baseline.', 'unitOfMeasure': 'percentage of responders', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS was the group of randomized participants who received at least one dose of randomized study drug and had at least one postdose primary efficacy measurement. Number analyzed refers to number of participants evaluable for specified category.'}, {'type': 'SECONDARY', 'title': 'Percentage of Sleep Onset Responders and Sleep Maintenance Responders at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '444', 'groupId': 'OG000'}, {'value': '437', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lemborexant 5 mg', 'description': 'Participants received lemborexant 5 mg/placebo, tablets, orally, once daily through Month 1-6 (in Period 1) and lemborexant 5 mg, tablets, orally, once daily through Month 7-12 (in Period 2).'}, {'id': 'OG001', 'title': 'Lemborexant 10 mg', 'description': 'Participants received lemborexant 10 mg/placebo, tablets, orally, once daily through Month 1-6 (in Period 1) and lemborexant 10 mg, tablets, orally, once daily through Month 7-12 (in Period 2).'}], 'classes': [{'title': 'Sleep Onset Responders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'OG000'}, {'value': '285', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34.2', 'groupId': 'OG000'}, {'value': '37.2', 'groupId': 'OG001'}]}]}, {'title': 'Sleep Maintainance Responders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '317', 'groupId': 'OG000'}, {'value': '280', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35.0', 'groupId': 'OG000'}, {'value': '39.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12', 'description': 'Sleep onset responder was defined as follows: sSOL at study Baseline was \\>=30 minutes and mean sSOL at 6 months was \\<=20 minutes. Sleep maintenance responder was defined as follows: sWASO at study Baseline was \\>=60 minutes and mean sWASO at 6 months was \\<=60 minutes and showed a reduction of \\> 10 minutes compared to study Baseline.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall participants analyzed based on number in "On-Treatment FAS (Participants who received at least 1 dose of lemborexant and had at least 1 postdose primary efficacy measurement)". Hence, these numbers include lemborexant data from participants re-randomized from placebo in Period 1. Number analyzed=participants analyzed at specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Insomnia Severity Index (ISI) Daytime Functioning Score at Months 1, 3, and 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '316', 'groupId': 'OG001'}, {'value': '315', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received lemborexant-matched placebo, tablet, orally, once daily for up to Month 6 in the placebo-controlled treatment period. Then they were re-randomized to Lemborexant 5 mg or Lemborexant 10 mg.'}, {'id': 'OG001', 'title': 'Lemborexant 5 mg', 'description': 'Participants received lemborexant 5 mg, tablets, orally, once daily through Month 1-6 (in Period 1) and Month 7-12 (in Period 2).'}, {'id': 'OG002', 'title': 'Lemborexant 10 mg', 'description': 'Participants received lemborexant 10 mg, tablets, orally, once daily through Month 1-6 (in Period 1) and Month 7-12 (in Period 2).'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '316', 'groupId': 'OG001'}, {'value': '315', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '11.0', 'spread': '2.10', 'groupId': 'OG000'}, {'value': '11.4', 'spread': '2.02', 'groupId': 'OG001'}, {'value': '11.0', 'spread': '2.15', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}, {'value': '286', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.1', 'spread': '3.41', 'groupId': 'OG000'}, {'value': '-4.1', 'spread': '3.66', 'groupId': 'OG001'}, {'value': '-4.2', 'spread': '4.01', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '274', 'groupId': 'OG001'}, {'value': '259', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.7', 'spread': '3.55', 'groupId': 'OG000'}, {'value': '-5.2', 'spread': '3.88', 'groupId': 'OG001'}, {'value': '-5.2', 'spread': '4.05', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}, {'value': '234', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-4.3', 'spread': '3.66', 'groupId': 'OG000'}, {'value': '-6.0', 'spread': '3.76', 'groupId': 'OG001'}, {'value': '-5.7', 'spread': '4.00', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0137', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.71', 'ciLowerLimit': '-1.27', 'ciUpperLimit': '-0.15', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.287', 'groupDescription': 'Month 1 (Statistical analysis 1): Based on MMRM model with factors for age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effects, and study baseline ISI score as a covariate. Missing values are not imputed and assumed to be MAR.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0011', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.94', 'ciLowerLimit': '-1.51', 'ciUpperLimit': '-0.38', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.289', 'groupDescription': 'Month 1 (Statistical analysis 2): Based on MMRM model with factors for age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effects, and study baseline ISI score as a covariate. Missing values are not imputed and assumed to be MAR.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.16', 'ciLowerLimit': '-1.75', 'ciUpperLimit': '-0.57', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.302', 'groupDescription': 'Month 3 (Statistical analysis 3): Based on MMRM model with factors for age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effects, and study baseline ISI score as a covariate. Missing values are not imputed and assumed to be MAR.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.36', 'ciLowerLimit': '-1.96', 'ciUpperLimit': '-0.76', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.305', 'groupDescription': 'Month 3 (Statistical analysis 4): Based on MMRM model with factors for age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effects, and study baseline ISI score as a covariate. Missing values are not imputed and assumed to be MAR.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.30', 'ciLowerLimit': '-1.90', 'ciUpperLimit': '-0.71', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.302', 'groupDescription': 'Month 6 (Statistical analysis 5): Based on MMRM model with factors for age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effects, and study baseline ISI score as a covariate. Missing values are not imputed and assumed to be MAR.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.32', 'ciLowerLimit': '-1.92', 'ciUpperLimit': '-0.71', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.307', 'groupDescription': 'Month 6 (Statistical analysis 6): Based on MMRM model with factors for age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effects, and study baseline ISI score as a covariate. Missing values are not imputed and assumed to be MAR.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 1, 3, and 6', 'description': 'The ISI is a 4-7 item, self-report questionnaire assessing the nature, severity, and impact of insomnia. The dimensions evaluated were: 1. severity of sleep onset; 2. sleep maintenance; 3. early morning awakening problems; 4. sleep dissatisfaction; 5. interference of sleep difficulties with daytime functioning; 6. noticeability of the sleep problems by others; and 7. distress caused by the sleep difficulties. A 5-point Likert scale was used to rate each item (from 0=no problem to 4=very severe problem). Daytime functioning score (sum of items 4 to 7) were analyzed. Higher score indicated severe insomnia problem. The total score range for sum of items is 0-16.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS was the group of randomized participants who received at least one dose of randomized study drug and had at least one postdose primary efficacy measurement. Number analyzed refers to participants evaluable for this outcome measure at specified time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fatigue Severity Scale (FSS) Total Score at Months 1, 3 and 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '316', 'groupId': 'OG001'}, {'value': '315', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received lemborexant-matched placebo, tablet, orally, once daily for up to Month 6 in the placebo-controlled treatment period. Then they were re-randomized to lemborexant 5 mg or lemborexant 10 mg up to Month 12.'}, {'id': 'OG001', 'title': 'Lemborexant 5 mg', 'description': 'Participants received lemborexant 5 mg, tablets, orally, once daily through Month 1-6 (in Period 1) and Month 7-12 (in Period 2).'}, {'id': 'OG002', 'title': 'Lemborexant 10 mg', 'description': 'Participants received lemborexant 10 mg, tablets, orally, once daily through Month 1-6 (in Period 1) and Month 7-12 (in Period 2).'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '316', 'groupId': 'OG001'}, {'value': '315', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '35.2', 'spread': '13.55', 'groupId': 'OG000'}, {'value': '37.4', 'spread': '12.74', 'groupId': 'OG001'}, {'value': '36.0', 'spread': '13.01', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}, {'value': '286', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.9', 'spread': '11.62', 'groupId': 'OG000'}, {'value': '-6.6', 'spread': '11.83', 'groupId': 'OG001'}, {'value': '-6.4', 'spread': '13.68', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '274', 'groupId': 'OG001'}, {'value': '259', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-4.3', 'spread': '11.37', 'groupId': 'OG000'}, {'value': '-7.7', 'spread': '12.97', 'groupId': 'OG001'}, {'value': '-7.9', 'spread': '13.56', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}, {'value': '234', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-6.3', 'spread': '12.07', 'groupId': 'OG000'}, {'value': '-10.1', 'spread': '13.56', 'groupId': 'OG001'}, {'value': '-8.9', 'spread': '14.91', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0670', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.66', 'ciLowerLimit': '-3.44', 'ciUpperLimit': '0.12', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.905', 'groupDescription': 'Month 1 (Statistical analysis 1): Based on MMRM model with factors for age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effects, and study baseline FSS score as a covariate. Missing values are not imputed and assumed to be MAR.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0257', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.04', 'ciLowerLimit': '-3.83', 'ciUpperLimit': '-0.25', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.913', 'groupDescription': 'Month 1 (Statistical analysis 2): Based on MMRM model with factors for age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effects, and study baseline FSS score as a covariate. Missing values are not imputed and assumed to be MAR.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0206', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.18', 'ciLowerLimit': '-4.02', 'ciUpperLimit': '-0.34', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.939', 'groupDescription': 'Month 3 (Statistical analysis 3): Based on MMRM model with factors for age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effects, and study baseline FSS score as a covariate. Missing values are not imputed and assumed to be MAR.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0014', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.04', 'ciLowerLimit': '-4.91', 'ciUpperLimit': '-1.18', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.950', 'groupDescription': 'Month 3 (Statistical analysis 4): Based on MMRM model with factors for age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effects, and study baseline FSS score as a covariate. Missing values are not imputed and assumed to be MAR.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0134', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.50', 'ciLowerLimit': '-4.48', 'ciUpperLimit': '-0.52', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.112', 'groupDescription': 'Month 6 (Statistical analysis 5): Based on MMRM model with factors for age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effects, and study baseline FSS score as a covariate. Missing values are not imputed and assumed to be MAR.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0128', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.56', 'ciLowerLimit': '-4.57', 'ciUpperLimit': '-0.54', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.026', 'groupDescription': 'Month 6 (Statistical analysis 6): Based on MMRM model with factors for age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effects, and study baseline FSS score as a covariate. Missing values are not imputed and assumed to be MAR.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 1, 3 and 6', 'description': 'The FSS is a self-reported scale on which participants were instructed to choose a number from 1 to 7 that indicated their degree of agreement with 9 statements about their fatigue where "1" indicates strongly disagree and "7", strongly agree. The FSS total score was the sum of all responses to the 9 questions. Higher total scores and average item scores indicated greater fatigue. Total score range is 9 to 63.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS was the group of randomized participants who received at least one dose of randomized study drug and had at least one postdose primary efficacy measurement. Number analyzed refers to participants evaluable for this outcome measure at specified time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Rating on the Morning Sleepiness Item of the Sleep Diary at the Beginning of Treatment (Mean of the 7 Nights After the First Dose in Placebo-Controlled Period), and at Months 1, 3 and 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '316', 'groupId': 'OG001'}, {'value': '315', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received lemborexant-matched placebo, tablet, orally, once daily for up to Month 6 in the placebo-controlled treatment period. Then they were re-randomized to lemborexant 5 mg or lemborexant 10 mg up to Month 12.'}, {'id': 'OG001', 'title': 'Lemborexant 5 mg', 'description': 'Participants received lemborexant 5 mg, tablets, orally, once daily through Month 1-6 (in Period 1) and Month 7-12 (in Period 2).'}, {'id': 'OG002', 'title': 'Lemborexant 10 mg', 'description': 'Participants received lemborexant 10 mg, tablets, orally, once daily through Month 1-6 (in Period 1) and Month 7-12 (in Period 2).'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '316', 'groupId': 'OG000'}, {'value': '314', 'groupId': 'OG001'}, {'value': '312', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.94', 'spread': '1.558', 'groupId': 'OG000'}, {'value': '3.93', 'spread': '1.349', 'groupId': 'OG001'}, {'value': '3.93', 'spread': '1.324', 'groupId': 'OG002'}]}]}, {'title': 'Change at First 7 nights', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'OG000'}, {'value': '310', 'groupId': 'OG001'}, {'value': '310', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.15', 'spread': '0.991', 'groupId': 'OG000'}, {'value': '0.36', 'spread': '0.964', 'groupId': 'OG001'}, {'value': '0.33', 'spread': '1.018', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}, {'value': '297', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.44', 'spread': '1.233', 'groupId': 'OG000'}, {'value': '0.53', 'spread': '1.172', 'groupId': 'OG001'}, {'value': '0.55', 'spread': '1.298', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}, {'value': '264', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.62', 'spread': '1.366', 'groupId': 'OG000'}, {'value': '0.74', 'spread': '1.325', 'groupId': 'OG001'}, {'value': '0.90', 'spread': '1.452', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '245', 'groupId': 'OG001'}, {'value': '229', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.79', 'spread': '1.392', 'groupId': 'OG000'}, {'value': '0.98', 'spread': '1.463', 'groupId': 'OG001'}, {'value': '1.05', 'spread': '1.524', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0067', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.205', 'ciLowerLimit': '0.057', 'ciUpperLimit': '0.353', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.076', 'groupDescription': 'First 7 nights (Statistical analysis): Based on MMRM model with factors of age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effect, and the study baseline Mean Rating on Morning Sleepiness as a covariate. Missing values are not imputed and assumed to be MAR.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0237', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.171', 'ciLowerLimit': '0.023', 'ciUpperLimit': '0.320', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.076', 'groupDescription': 'First 7 nights (Statistical analysis 2): Based on MMRM model with factors of age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effect, and the study baseline Mean Rating on Morning Sleepiness as a covariate. Missing values are not imputed and assumed to be MAR.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4120', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.077', 'ciLowerLimit': '-0.107', 'ciUpperLimit': '0.261', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.094', 'groupDescription': 'Month 1 (Statistical analysis 3): Based on MMRM model with factors of age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effect, and the study baseline Mean Rating on Morning Sleepiness as a covariate. Missing values are not imputed and assumed to be MAR.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4347', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.073', 'ciLowerLimit': '-0.111', 'ciUpperLimit': '0.258', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.094', 'groupDescription': 'Month 1 (Statistical analysis 4): Based on MMRM model with factors of age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effect, and the study baseline Mean Rating on Morning Sleepiness as a covariate. Missing values are not imputed and assumed to be MAR.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4992', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.074', 'ciLowerLimit': '-0.141', 'ciUpperLimit': '0.289', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.109', 'groupDescription': 'Month 3 (Statistical analysis 5): Based on MMRM model with factors of age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effect, and the study baseline Mean Rating on Morning Sleepiness as a covariate. Missing values are not imputed and assumed to be MAR.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0208', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.255', 'ciLowerLimit': '0.039', 'ciUpperLimit': '0.471', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.110', 'groupDescription': 'Month 3 (Statistical analysis 6): Based on MMRM model with factors of age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effect, and the study baseline Mean Rating on Morning Sleepiness as a covariate. Missing values are not imputed and assumed to be MAR.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2248', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.144', 'ciLowerLimit': '-0.089', 'ciUpperLimit': '0.378', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.119', 'groupDescription': 'Month 6 (Statistical analysis 7): Based on MMRM model with factors of age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effect, and the study baseline Mean Rating on Morning Sleepiness as a covariate. Missing values are not imputed and assumed to be MAR.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0298', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.261', 'ciLowerLimit': '0.026', 'ciUpperLimit': '0.497', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.120', 'groupDescription': 'Month 6 (Statistical analysis 8): Based on MMRM model with factors of age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effect, and the study baseline Mean Rating on Morning Sleepiness as a covariate. Missing values are not imputed and assumed to be MAR.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, (mean of 7 nights [approximately Week 1]) in placebo-controlled period, Month 1, 3, 6', 'description': 'The Sleep Diary was used to assess subjective ratings of morning sleepiness with the following question:\n\n"How sleepy/alert do you feel this morning?" Participants rated their sleepiness/alertness level on a scale from 1 to 9, with 1 being extremely poor (sleepy) and 9 being extremely good (alert). Higher score indicated better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS was the group of randomized participants who received at least one dose of randomized study drug and had at least one postdose primary efficacy measurement. Number analyzed refers to participants evaluable for this outcome measure at specified time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Rating on the Morning Sleepiness Item of the Sleep Diary at the Beginning of Treatment (Mean of the 7 Nights After the First Dose in Active Treatment Period)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '444', 'groupId': 'OG000'}, {'value': '437', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lemborexant 5 mg', 'description': 'Participants received lemborexant 5 mg/placebo, tablets, orally, once daily through Month 1-6 (in Period 1) and lemborexant 5 mg, tablets, orally, once daily through Month 7-12 (in Period 2).'}, {'id': 'OG001', 'title': 'Lemborexant 10 mg', 'description': 'Participants received lemborexant 10 mg/placebo, tablets, orally, once daily through Month 1-6 (in Period 1) and lemborexant 10 mg, tablets, orally, once daily through Month 7-12 (in Period 2).'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '442', 'groupId': 'OG000'}, {'value': '434', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.15', 'spread': '1.516', 'groupId': 'OG000'}, {'value': '4.16', 'spread': '1.428', 'groupId': 'OG001'}]}]}, {'title': 'Change at First 7 nights', 'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'OG000'}, {'value': '310', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.36', 'spread': '0.964', 'groupId': 'OG000'}, {'value': '0.33', 'spread': '1.018', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, First 7 nights (approximately Week 1) in active treatment period', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall participants analyzed based on number in "On-Treatment FAS (Participants who received at least 1 dose of lemborexant and had at least 1 postdose primary efficacy measurement)". Hence, these numbers include lemborexant data from participants re-randomized from placebo in Period 1. Number analyzed=participants analyzed at specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Screening in Mean Rating on the Morning Sleepiness Item of the Sleep Diary at the First and Second 7 Mornings of the Follow-up Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '444', 'groupId': 'OG000'}, {'value': '437', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lemborexant 5 mg', 'description': 'Participants received lemborexant 5 mg/placebo, tablets, orally, once daily through Month 1-6 (in Period 1) and lemborexant 5 mg, tablets, orally, once daily through Month 7-12 (in Period 2).'}, {'id': 'OG001', 'title': 'Lemborexant 10 mg', 'description': 'Participants received lemborexant 10 mg/placebo, tablets, orally, once daily through Month 1-6 (in Period 1) and lemborexant 10 mg, tablets, orally, once daily through Month 7-12 (in Period 2).'}], 'classes': [{'title': 'Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '440', 'groupId': 'OG000'}, {'value': '436', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.63', 'spread': '1.393', 'groupId': 'OG000'}, {'value': '3.54', 'spread': '1.197', 'groupId': 'OG001'}]}]}, {'title': 'Change at First 7 mornings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'OG000'}, {'value': '328', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.03', 'spread': '1.615', 'groupId': 'OG000'}, {'value': '1.32', 'spread': '1.611', 'groupId': 'OG001'}]}]}, {'title': 'Change at Second 7 mornings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '327', 'groupId': 'OG000'}, {'value': '313', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.98', 'spread': '1.699', 'groupId': 'OG000'}, {'value': '1.22', 'spread': '1.635', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening, First and second 7 mornings in follow-up period (Week 52 to 54)', 'description': 'The Sleep Diary was used to assess subjective ratings of morning sleepiness with the following question:\n\n"How sleepy/alert do you feel this morning?" Participants rated their sleepiness/alertness level on a scale from 1 to 9, with 1 being extremely poor (sleepy) and 9 being extremely good (alert). Higher score indicated better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall participants analyzed based on number in "On-Treatment FAS (Participants who received at least 1 dose of lemborexant and had at least 1 postdose primary efficacy measurement)". Hence, these numbers include lemborexant data from participants re-randomized from placebo in Period 1. Number analyzed=participants analyzed at specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Rating on the Morning Sleepiness Item of the Sleep Diary at Months 1, 3, 6, 9 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '444', 'groupId': 'OG000'}, {'value': '437', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lemborexant 5 mg', 'description': 'Participants received lemborexant 5 mg/placebo, tablets, orally, once daily through Month 1-6 (in Period 1) and lemborexant 5 mg, tablets, orally, once daily through Month 7-12 (in Period 2).'}, {'id': 'OG001', 'title': 'Lemborexant 10 mg', 'description': 'Participants received lemborexant 10 mg/placebo, tablets, orally, once daily through Month 1-6 (in Period 1) and lemborexant 10 mg, tablets, orally, once daily through Month 7-12 (in Period 2).'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '442', 'groupId': 'OG000'}, {'value': '434', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.15', 'spread': '1.516', 'groupId': 'OG000'}, {'value': '4.16', 'spread': '1.428', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 1 of exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '415', 'groupId': 'OG000'}, {'value': '412', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.46', 'spread': '1.082', 'groupId': 'OG000'}, {'value': '0.42', 'spread': '1.223', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 3 of exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '386', 'groupId': 'OG000'}, {'value': '375', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.60', 'spread': '1.264', 'groupId': 'OG000'}, {'value': '0.70', 'spread': '1.356', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 6 of exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '352', 'groupId': 'OG000'}, {'value': '331', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.78', 'spread': '1.424', 'groupId': 'OG000'}, {'value': '0.86', 'spread': '1.461', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 9 of exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.00', 'spread': '1.512', 'groupId': 'OG000'}, {'value': '1.08', 'spread': '1.489', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 12 of exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.11', 'spread': '1.499', 'groupId': 'OG000'}, {'value': '1.31', 'spread': '1.604', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 1, 3, 6, 9 and 12', 'description': 'The Sleep Diary was used to assess subjective ratings of morning sleepiness with the following question:\n\n"How sleepy/alert do you feel this morning?" Participants rated their sleepiness/alertness level on a scale from 1 to 9, with 1 being extremely poor (sleepy) and 9 being extremely good (alert). Higher score indicated better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall participants analyzed based on number in "On-Treatment FAS (Participants who received at least 1 dose of lemborexant and had at least 1 postdose primary efficacy measurement)". Hence, these numbers include lemborexant data from participants re-randomized from placebo in Period 1. Number analyzed=participants analyzed at specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Rebound Insomnia: Mean sSOL on Each of the First 3 Nights, First 7 Nights, and Last 7 Nights of the Follow-up Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '444', 'groupId': 'OG000'}, {'value': '437', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lemborexant 5 mg', 'description': 'Participants received lemborexant 5 mg/placebo, tablets, orally, once daily through Month 1-6 (in Period 1) and lemborexant 5 mg, tablets, orally, once daily through Month 7-12 (in Period 2).'}, {'id': 'OG001', 'title': 'Lemborexant 10 mg', 'description': 'Participants received lemborexant 10 mg/placebo, tablets, orally, once daily through Month 1-6 (in Period 1) and lemborexant 10 mg, tablets, orally, once daily through Month 7-12 (in Period 2).'}], 'classes': [{'title': 'Mean of first 3 nights', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '40.35', 'spread': '48.661', 'groupId': 'OG000'}, {'value': '41.73', 'spread': '55.694', 'groupId': 'OG001'}]}]}, {'title': 'Mean sSOL of the first 7 nights', 'denoms': [{'units': 'Participants', 'counts': [{'value': '337', 'groupId': 'OG000'}, {'value': '328', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.35', 'spread': '38.967', 'groupId': 'OG000'}, {'value': '41.90', 'spread': '47.826', 'groupId': 'OG001'}]}]}, {'title': 'Mean sSOL of the second 7 nights', 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44.10', 'spread': '38.030', 'groupId': 'OG000'}, {'value': '41.30', 'spread': '47.471', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'First 3 nights, first and Last 7 nights of the follow up period (Week 52 to 54)', 'description': 'Rebound Insomnia: Rebound insomnia was defined as insomnia that occurred following discontinuation of a sedative substance taken to relieve primary insomnia. sSOL was defined as estimated minutes from the time that the participant attempted to sleep until sleep onset.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall participants analyzed based on number in "On-Treatment FAS (Participants who received at least 1 dose of lemborexant and had at least 1 postdose primary efficacy measurement)". Hence, these numbers include lemborexant data from participants re-randomized from placebo in Period 1. Number analyzed=participants analyzed at specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Rebound Insomnia: Mean sWASO on Each of the First 3 Nights, First 7 Nights, and Last 7 Nights of the Follow-up Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '444', 'groupId': 'OG000'}, {'value': '437', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lemborexant 5 mg', 'description': 'Participants received lemborexant 5 mg/placebo, tablets, orally, once daily through Month 1-6 (in Period 1) and lemborexant 5 mg, tablets, orally, once daily through Month 7-12 (in Period 2).'}, {'id': 'OG001', 'title': 'Lemborexant 10 mg', 'description': 'Participants received lemborexant 10 mg/placebo, tablets, orally, once daily through Month 1-6 (in Period 1) and lemborexant 10 mg, tablets, orally, once daily through Month 7-12 (in Period 2).'}], 'classes': [{'title': 'Mean of first 3 nights', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '86.66', 'spread': '80.038', 'groupId': 'OG000'}, {'value': '97.88', 'spread': '83.302', 'groupId': 'OG001'}]}]}, {'title': 'Mean of the first 7 nights', 'denoms': [{'units': 'Participants', 'counts': [{'value': '337', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '91.56', 'spread': '81.738', 'groupId': 'OG000'}, {'value': '95.79', 'spread': '79.784', 'groupId': 'OG001'}]}]}, {'title': 'Mean of the Last 7 nights', 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '92.62', 'spread': '82.672', 'groupId': 'OG000'}, {'value': '98.19', 'spread': '80.668', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'First 3 nights, first and last 7 nights of the follow up period (Week 52 to 54)', 'description': 'Rebound Insomnia: Rebound insomnia was defined as insomnia that occurred following discontinuation of a sedative substance taken to relieve primary insomnia. sWASO was defined as sum of estimated minutes of wake during the night after initial sleep onset until the time the participant stopped trying to sleep for the night, operationalized as the time the participant got out of bed for the day.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall participants analyzed based on number in "On-Treatment FAS (Participants who received at least 1 dose of lemborexant and had at least 1 postdose primary efficacy measurement)". Hence, these numbers include lemborexant data from participants re-randomized from placebo in Period 1. Number analyzed=participants analyzed at specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Rebound Insomnia: Percentage of Participants Whose sSOL Was Longer Than at Screening for First 3 Nights of the Follow-up Period, or Whom Mean sSOL Was Longer Than at Screening for First 7 Nights or Last 7 Nights of the Follow-up Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '444', 'groupId': 'OG000'}, {'value': '437', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lemborexant 5 mg', 'description': 'Participants received lemborexant 5 mg/placebo, tablets, orally, once daily through Month 1-6 (in Period 1) and lemborexant 5 mg, tablets, orally, once daily through Month 7-12 (in Period 2).'}, {'id': 'OG001', 'title': 'Lemborexant 10 mg', 'description': 'Participants received lemborexant 10 mg/placebo, tablets, orally, once daily through Month 1-6 (in Period 1) and lemborexant 10 mg, tablets, orally, once daily through Month 7-12 (in Period 2).'}], 'classes': [{'title': 'Average of first 3 nights', 'denoms': [{'units': 'Participants', 'counts': [{'value': '285', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.46', 'groupId': 'OG000'}, {'value': '9.38', 'groupId': 'OG001'}]}]}, {'title': 'Average of first 7 nights', 'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'OG000'}, {'value': '328', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.94', 'groupId': 'OG000'}, {'value': '10.53', 'groupId': 'OG001'}]}]}, {'title': 'Average of second 7 nights', 'denoms': [{'units': 'Participants', 'counts': [{'value': '327', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.71', 'groupId': 'OG000'}, {'value': '9.38', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First 3 nights, first and last 7 nights of the follow up period (Week 52 to 54)', 'description': 'Rebound Insomnia: Rebound insomnia was defined as insomnia that occurred following discontinuation of a sedative substance taken to relieve primary insomnia. sSOL was defined as estimated minutes from the time that the participant attempted to sleep until sleep onset.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall participants analyzed based on number in "On-Treatment FAS (Participants who received at least 1 dose of lemborexant and had at least 1 postdose primary efficacy measurement)". Hence, these numbers include lemborexant data from participants re-randomized from placebo in Period 1. Number analyzed=participants analyzed at specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Rebound Insomnia: Percentage of Participants Whose sWASO is Higher Than at Screening for First 3 Nights of the Follow-up Period, or Whose Mean sWASO is Higher Than at Screening for the First 7 Nights or Last 7 Nights of the Follow-up Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '444', 'groupId': 'OG000'}, {'value': '437', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lemborexant 5 mg', 'description': 'Participants received lemborexant 5 mg/placebo, tablets, orally, once daily through Month 1-6 (in Period 1) and lemborexant 5 mg, tablets, orally, once daily through Month 7-12 (in Period 2).'}, {'id': 'OG001', 'title': 'Lemborexant 10 mg', 'description': 'Participants received lemborexant 10 mg/placebo, tablets, orally, once daily through Month 1-6 (in Period 1) and lemborexant 10 mg, tablets, orally, once daily through Month 7-12 (in Period 2).'}], 'classes': [{'title': 'Average of first 3 nights', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.26', 'groupId': 'OG000'}, {'value': '12.59', 'groupId': 'OG001'}]}]}, {'title': 'Average of first 7 nights', 'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'OG000'}, {'value': '325', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.39', 'groupId': 'OG000'}, {'value': '14.19', 'groupId': 'OG001'}]}]}, {'title': 'Average of second 7 nights', 'denoms': [{'units': 'Participants', 'counts': [{'value': '327', 'groupId': 'OG000'}, {'value': '311', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.51', 'groupId': 'OG000'}, {'value': '11.90', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First 3 nights, First and Last 7 nights of the follow up period (Week 52 to 54)', 'description': 'Rebound Insomnia: Rebound insomnia was defined as insomnia that occurred following discontinuation of a sedative substance taken to relieve primary insomnia. sWASO was defined as sum of estimated minutes of wake during the night after initial sleep onset until the time the participant stopped trying to sleep for the night, operationalized as the time the participant got out of bed for the day.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall participants analyzed based on number in "On-Treatment FAS (Participants who received at least 1 dose of lemborexant and had at least 1 postdose primary efficacy measurement)". Hence, these numbers include lemborexant data from participants re-randomized from placebo in Period 1. Number analyzed=participants analyzed at specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Persistence of Effect: Mean Change From Baseline in sSOL, sWASO, and sTST at Months 3, 6, 9, and 12 Compared to Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '444', 'groupId': 'OG000'}, {'value': '437', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lemborexant 5 mg', 'description': 'Participants received lemborexant 5 mg/placebo, tablets, orally, once daily through Month 1-6 (in Period 1) and lemborexant 5 mg, tablets, orally, once daily through Month 7-12 (in Period 2).'}, {'id': 'OG001', 'title': 'Lemborexant 10 mg', 'description': 'Participants received lemborexant 10 mg/placebo, tablets, orally, once daily through Month 1-6 (in Period 1) and lemborexant 10 mg, tablets, orally, once daily through Month 7-12 (in Period 2).'}], 'classes': [{'title': 'sSOL: Change at Month 1 of exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '415', 'groupId': 'OG000'}, {'value': '412', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-17.17', 'groupId': 'OG000', 'lowerLimit': '-19.76', 'upperLimit': '-14.58'}, {'value': '-18.64', 'groupId': 'OG001', 'lowerLimit': '-21.26', 'upperLimit': '-16.02'}]}]}, {'title': 'sSOL: Change at Month 3 of exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '386', 'groupId': 'OG000'}, {'value': '375', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-21.47', 'groupId': 'OG000', 'lowerLimit': '-24.46', 'upperLimit': '-18.48'}, {'value': '-21.58', 'groupId': 'OG001', 'lowerLimit': '-24.61', 'upperLimit': '-18.54'}]}]}, {'title': 'sSOL: Change at Month 6 of exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '352', 'groupId': 'OG000'}, {'value': '331', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-24.13', 'groupId': 'OG000', 'lowerLimit': '-27.22', 'upperLimit': '-21.04'}, {'value': '-22.99', 'groupId': 'OG001', 'lowerLimit': '-26.14', 'upperLimit': '-19.83'}]}]}, {'title': 'sSOL: Change at Month 9 of exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-26.00', 'groupId': 'OG000', 'lowerLimit': '-29.25', 'upperLimit': '-22.75'}, {'value': '-27.36', 'groupId': 'OG001', 'lowerLimit': '-30.70', 'upperLimit': '-24.01'}]}]}, {'title': 'sSOL: Change at Month 12 of exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-25.83', 'groupId': 'OG000', 'lowerLimit': '-29.44', 'upperLimit': '-22.22'}, {'value': '-26.32', 'groupId': 'OG001', 'lowerLimit': '-30.03', 'upperLimit': '-22.61'}]}]}, {'title': 'sWASO: Change at Month 1 of exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '414', 'groupId': 'OG000'}, {'value': '408', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-17.26', 'groupId': 'OG000', 'lowerLimit': '-22.54', 'upperLimit': '-11.97'}, {'value': '-18.69', 'groupId': 'OG001', 'lowerLimit': '-24.05', 'upperLimit': '-13.33'}]}]}, {'title': 'sWASO: Change at Month 3 of exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '385', 'groupId': 'OG000'}, {'value': '373', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-31.34', 'groupId': 'OG000', 'lowerLimit': '-37.12', 'upperLimit': '-25.57'}, {'value': '-28.97', 'groupId': 'OG001', 'lowerLimit': '-34.86', 'upperLimit': '-23.09'}]}]}, {'title': 'sWASO: Change at Month 6 of exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '351', 'groupId': 'OG000'}, {'value': '329', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-36.10', 'groupId': 'OG000', 'lowerLimit': '-42.57', 'upperLimit': '-29.63'}, {'value': '-31.54', 'groupId': 'OG001', 'lowerLimit': '-38.16', 'upperLimit': '-24.91'}]}]}, {'title': 'sWASO: Change at Month 9 of exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-39.28', 'groupId': 'OG000', 'lowerLimit': '-46.74', 'upperLimit': '-31.83'}, {'value': '-40.39', 'groupId': 'OG001', 'lowerLimit': '-48.08', 'upperLimit': '-32.71'}]}]}, {'title': 'sWASO: Change at Month 12 of exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-42.87', 'groupId': 'OG000', 'lowerLimit': '-50.13', 'upperLimit': '-35.61'}, {'value': '-43.76', 'groupId': 'OG001', 'lowerLimit': '-51.21', 'upperLimit': '-36.31'}]}]}, {'title': 'sTST: Change at Month 1 of exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '400', 'groupId': 'OG000'}, {'value': '396', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.98', 'groupId': 'OG000', 'lowerLimit': '25.54', 'upperLimit': '38.42'}, {'value': '38.04', 'groupId': 'OG001', 'lowerLimit': '31.51', 'upperLimit': '44.57'}]}]}, {'title': 'sTST: Change at Month 3 of exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '373', 'groupId': 'OG000'}, {'value': '361', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '49.27', 'groupId': 'OG000', 'lowerLimit': '42.33', 'upperLimit': '56.22'}, {'value': '53.51', 'groupId': 'OG001', 'lowerLimit': '46.42', 'upperLimit': '60.61'}]}]}, {'title': 'sTST: Change at Month 6 of exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '321', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '54.99', 'groupId': 'OG000', 'lowerLimit': '47.18', 'upperLimit': '62.80'}, {'value': '56.36', 'groupId': 'OG001', 'lowerLimit': '48.35', 'upperLimit': '64.36'}]}]}, {'title': 'sTST: Change at Month 9 of exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '55.41', 'groupId': 'OG000', 'lowerLimit': '46.49', 'upperLimit': '64.33'}, {'value': '61.13', 'groupId': 'OG001', 'lowerLimit': '51.93', 'upperLimit': '70.32'}]}]}, {'title': 'sTST: Change at Month 12 of exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58.15', 'groupId': 'OG000', 'lowerLimit': '49.29', 'upperLimit': '67.01'}, {'value': '66.50', 'groupId': 'OG001', 'lowerLimit': '57.41', 'upperLimit': '75.60'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 1, 3, 6, 9, 12', 'description': 'sSOL was defined as estimated minutes from the time that the participant attempted to sleep until sleep onset. sWASO was defined as sum of estimated minutes of wake during the night after initial sleep onset until the time the participant stopped trying to sleep for the night, operationalized as the time the participant got out of bed for the day. sTST: minutes of sleep from sleep onset to time stopped trying to sleep for the night. At each month beyond Month 1, the change from Baseline was compared to either the lower bound of the 95% CI (for sTST) or the upper bound of the 95% CI (for sSOL and sWASO) at Month 1. Persistence of efficacy was defined as present if the mean change from Baseline at Month 6 was above the lower bound of the 95% CI at Month 1 for sTST and below the upper bound of the 95% CI at Month 1 for sSOL and sWASO.', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall participants analyzed based on number in "On-Treatment FAS (Participants who received at least 1 dose of lemborexant and had at least 1 postdose primary efficacy measurement)". Hence, these numbers include lemborexant data from participants re-randomized from placebo in Period 1. Number analyzed=participants analyzed at specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Persistence of Effect: Mean Change From Baseline in sSE at Months 3, 6, 9, and 12 Compared to Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '444', 'groupId': 'OG000'}, {'value': '437', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lemborexant 5 mg', 'description': 'Participants received lemborexant 5 mg/placebo, tablets, orally, once daily through Month 1-6 (in Period 1) and lemborexant 5 mg, tablets, orally, once daily through Month 7-12 (in Period 2).'}, {'id': 'OG001', 'title': 'Lemborexant 10 mg', 'description': 'Participants received lemborexant 10 mg/placebo, tablets, orally, once daily through Month 1-6 (in Period 1) and lemborexant 10 mg, tablets, orally, once daily through Month 7-12 (in Period 2).'}], 'classes': [{'title': 'Change at Month 1 of exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '400', 'groupId': 'OG000'}, {'value': '396', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.35', 'groupId': 'OG000', 'lowerLimit': '5.13', 'upperLimit': '7.57'}, {'value': '7.32', 'groupId': 'OG001', 'lowerLimit': '6.09', 'upperLimit': '8.56'}]}]}, {'title': 'Change at Month 3 of exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '373', 'groupId': 'OG000'}, {'value': '361', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.01', 'groupId': 'OG000', 'lowerLimit': '8.69', 'upperLimit': '11.34'}, {'value': '10.25', 'groupId': 'OG001', 'lowerLimit': '8.90', 'upperLimit': '11.60'}]}]}, {'title': 'Change at Month 6 of exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '321', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.10', 'groupId': 'OG000', 'lowerLimit': '9.61', 'upperLimit': '12.58'}, {'value': '11.08', 'groupId': 'OG001', 'lowerLimit': '9.56', 'upperLimit': '12.60'}]}]}, {'title': 'Change at Month 9 of exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.85', 'groupId': 'OG000', 'lowerLimit': '10.13', 'upperLimit': '13.56'}, {'value': '12.84', 'groupId': 'OG001', 'lowerLimit': '11.08', 'upperLimit': '14.61'}]}]}, {'title': 'Change at Month 12 of exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.61', 'groupId': 'OG000', 'lowerLimit': '10.92', 'upperLimit': '14.31'}, {'value': '13.66', 'groupId': 'OG001', 'lowerLimit': '11.92', 'upperLimit': '15.40'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Months 1, 3, 6, 9, and 12', 'description': 'sSE was defined as percentage of sTST per subjective time spent in bed, calculated as the interval from the time the participant reports attempting to sleep until the time the participant stopped trying to sleep for the night (operationalized as the time the participant got out of bed for the day), and time spent asleep derived from subjective time spent in bed minus sWASO. At each month beyond Month 1, the change from Baseline was compared to the lower bound of the 95% CI at Month 1. Persistence of efficacy was defined as present if the mean change from Baseline at Month 6 was above the lower bound of the 95% CI at Month 1 for sSE.', 'unitOfMeasure': 'percentage of sTST', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall participants analyzed based on number in "On-Treatment FAS (Participants who received at least 1 dose of lemborexant and had at least 1 postdose primary efficacy measurement)". Hence, these numbers include lemborexant data from participants re-randomized from placebo in Period 1. Number analyzed=participants analyzed at specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Persistence of Effect: Mean Change From Period 2 Baseline (Month 6) in sSOL, sWASO, and sTST at Months 9 and 12 Compared to Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '444', 'groupId': 'OG000'}, {'value': '437', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lemborexant 5 mg', 'description': 'Participants received lemborexant 5 mg/placebo, tablets, orally, once daily through Month 1-6 (in Period 1) and lemborexant 5 mg, tablets, orally, once daily through Month 7-12 (in Period 2).'}, {'id': 'OG001', 'title': 'Lemborexant 10 mg', 'description': 'Participants received lemborexant 10 mg/placebo, tablets, orally, once daily through Month 1-6 (in Period 1) and lemborexant 10 mg, tablets, orally, once daily through Month 7-12 (in Period 2).'}], 'classes': [{'title': 'sSOL: Change at Month 7 of exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '355', 'groupId': 'OG000'}, {'value': '334', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-28.55', 'groupId': 'OG000', 'lowerLimit': '-32.39', 'upperLimit': '-24.70'}, {'value': '-29.46', 'groupId': 'OG001', 'lowerLimit': '-33.42', 'upperLimit': '-25.50'}]}]}, {'title': 'sSOL: Change at Month 9 of exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '349', 'groupId': 'OG000'}, {'value': '324', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-32.10', 'groupId': 'OG000', 'lowerLimit': '-35.39', 'upperLimit': '-28.80'}, {'value': '-30.91', 'groupId': 'OG001', 'lowerLimit': '-34.31', 'upperLimit': '-27.52'}]}]}, {'title': 'sSOL: Change at Month 12 of exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'OG000'}, {'value': '306', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-31.40', 'groupId': 'OG000', 'lowerLimit': '-34.85', 'upperLimit': '-27.96'}, {'value': '-31.33', 'groupId': 'OG001', 'lowerLimit': '-34.88', 'upperLimit': '-27.78'}]}]}, {'title': 'sWASO: Change at Month 7 of exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '355', 'groupId': 'OG000'}, {'value': '334', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-45.62', 'groupId': 'OG000', 'lowerLimit': '-52.53', 'upperLimit': '-38.70'}, {'value': '-43.09', 'groupId': 'OG001', 'lowerLimit': '-50.20', 'upperLimit': '-35.99'}]}]}, {'title': 'sWASO: Change at Month 9 of exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '349', 'groupId': 'OG000'}, {'value': '324', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-47.70', 'groupId': 'OG000', 'lowerLimit': '-54.54', 'upperLimit': '-40.86'}, {'value': '-48.87', 'groupId': 'OG001', 'lowerLimit': '-55.92', 'upperLimit': '-41.82'}]}]}, {'title': 'sWASO: Change at Month 12 of exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'OG000'}, {'value': '306', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-48.46', 'groupId': 'OG000', 'lowerLimit': '-55.35', 'upperLimit': '-41.57'}, {'value': '-49.28', 'groupId': 'OG001', 'lowerLimit': '-56.36', 'upperLimit': '-42.19'}]}]}, {'title': 'sTST: Change at Month 7 of exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '355', 'groupId': 'OG000'}, {'value': '334', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.00', 'groupId': 'OG000', 'lowerLimit': '65.30', 'upperLimit': '84.71'}, {'value': '76.95', 'groupId': 'OG001', 'lowerLimit': '66.97', 'upperLimit': '86.92'}]}]}, {'title': 'sTST: Change at Month 9 of exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '349', 'groupId': 'OG000'}, {'value': '324', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '78.69', 'groupId': 'OG000', 'lowerLimit': '68.99', 'upperLimit': '88.39'}, {'value': '81.24', 'groupId': 'OG001', 'lowerLimit': '71.26', 'upperLimit': '91.23'}]}]}, {'title': 'sTST: Change at Month 12 of exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'OG000'}, {'value': '306', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '78.61', 'groupId': 'OG000', 'lowerLimit': '68.61', 'upperLimit': '88.61'}, {'value': '83.61', 'groupId': 'OG001', 'lowerLimit': '73.33', 'upperLimit': '93.90'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 7, 9, 12', 'description': 'sSOL is defined as estimated minutes from the time that the participant attempted to sleep until sleep onset. sWASO: sum of estimated minutes of wake during the night after initial sleep onset until the time the participant stopped trying to sleep for the night, operationalized as the time the participant got out of bed for the day. sTST: minutes of sleep from sleep onset to time stopped trying to sleep for the night. At each month beyond Month 7, the change from Baseline was compared to either the lower bound of the 95% CI for sTST or the upper bound of the 95% CI (for sSOL and sWASO) at Month 7. Persistence of effect was defined as present if the mean change from Baseline at Month 12 was above the lower bound of the 95% CI at Month 7 for sTST and below the upper bound of the 95% CI at Month 7 for sSOL and sWASO.', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall participants analyzed based on number in "On-Treatment FAS (Participants who received at least 1 dose of lemborexant and had at least 1 postdose primary efficacy measurement)". Hence, these numbers include lemborexant data from participants re-randomized from placebo in Period 1. Number analyzed=participants analyzed at specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Persistence of Effect: Mean Change From Period 2 Baseline (Month 6) in sSE at Months 9 and 12 Compared to Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '444', 'groupId': 'OG000'}, {'value': '437', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lemborexant 5 mg', 'description': 'Participants received lemborexant 5 mg/placebo, tablets, orally, once daily through Month 1-6 (in Period 1) and lemborexant 5 mg, tablets, orally, once daily through Month 7-12 (in Period 2).'}, {'id': 'OG001', 'title': 'Lemborexant 10 mg', 'description': 'Participants received lemborexant 10 mg/placebo, tablets, orally, once daily through Month 1-6 (in Period 1) and lemborexant 10 mg, tablets, orally, once daily through Month 7-12 (in Period 2).'}], 'classes': [{'title': 'Change at Month 7 of exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'OG000'}, {'value': '334', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.88', 'groupId': 'OG000', 'lowerLimit': '9.01', 'upperLimit': '16.75'}, {'value': '15.12', 'groupId': 'OG001', 'lowerLimit': '11.13', 'upperLimit': '19.10'}]}]}, {'title': 'Change at Month 9 of exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '349', 'groupId': 'OG000'}, {'value': '324', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.54', 'groupId': 'OG000', 'lowerLimit': '14.88', 'upperLimit': '18.20'}, {'value': '16.49', 'groupId': 'OG001', 'lowerLimit': '14.78', 'upperLimit': '18.20'}]}]}, {'title': 'Change at Month 12 of exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'OG000'}, {'value': '306', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.34', 'groupId': 'OG000', 'lowerLimit': '14.70', 'upperLimit': '17.98'}, {'value': '16.82', 'groupId': 'OG001', 'lowerLimit': '15.13', 'upperLimit': '18.50'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 7, 9, 12', 'description': 'sSE: percentage of sTST per subjective time spent in bed, calculated as the interval from the time the participant reports attempting to sleep until the time the participant stopped trying to sleep for the night (operationalized as the time the subject got out of bed for the day), and time spent asleep derived from subjective time spent in bed minus sWASO. At each month beyond Month 7, the change from Baseline was compared to the lower bound of the 95% CI for sSE at Month 7. Persistence of effect was defined as present if the mean change from Baseline at Month 12 was above the lower bound of the 95% CI at Month 7 for sSE.', 'unitOfMeasure': 'percentage of sTST', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall participants analyzed based on number in "On-Treatment FAS (Participants who received at least 1 dose of lemborexant and had at least 1 postdose primary efficacy measurement)". Hence, these numbers include lemborexant data from participants re-randomized from placebo in Period 1. Number analyzed=participants analyzed at specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Persistence of Effect: Mean Change From Study Baseline and Period 2 Baseline (Month 6) in sSOL, sWASO, and sTST at Months 3 and 6 Exposure Compared to Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '444', 'groupId': 'OG000'}, {'value': '437', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lemborexant 5 mg', 'description': 'Participants received lemborexant 5 mg/placebo, tablets, orally, once daily through Month 1-6 (in Period 1) and lemborexant 5 mg, tablets, orally, once daily through Month 7-12 (in Period 2).'}, {'id': 'OG001', 'title': 'Lemborexant 10 mg', 'description': 'Participants received lemborexant 10 mg/placebo, tablets, orally, once daily through Month 1-6 (in Period 1) and lemborexant 10 mg, tablets, orally, once daily through Month 7-12 (in Period 2).'}], 'classes': [{'title': 'sSOL: Change at Month 1 of exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '415', 'groupId': 'OG000'}, {'value': '412', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-17.17', 'groupId': 'OG000', 'lowerLimit': '-19.76', 'upperLimit': '-14.58'}, {'value': '-18.64', 'groupId': 'OG001', 'lowerLimit': '-21.26', 'upperLimit': '-16.02'}]}]}, {'title': 'sSOL: Change at Month 3 of exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '386', 'groupId': 'OG000'}, {'value': '375', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-21.47', 'groupId': 'OG000', 'lowerLimit': '-24.46', 'upperLimit': '-18.48'}, {'value': '-21.58', 'groupId': 'OG001', 'lowerLimit': '-24.61', 'upperLimit': '-18.54'}]}]}, {'title': 'sSOL: Change at Month 6 of exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '352', 'groupId': 'OG000'}, {'value': '331', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-24.13', 'groupId': 'OG000', 'lowerLimit': '-27.22', 'upperLimit': '-21.04'}, {'value': '-22.99', 'groupId': 'OG001', 'lowerLimit': '-26.14', 'upperLimit': '-19.83'}]}]}, {'title': 'sWASO: Change at Month 1 of exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '414', 'groupId': 'OG000'}, {'value': '408', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-17.26', 'groupId': 'OG000', 'lowerLimit': '-22.54', 'upperLimit': '-11.97'}, {'value': '-18.69', 'groupId': 'OG001', 'lowerLimit': '-24.05', 'upperLimit': '-13.33'}]}]}, {'title': 'sWASO: Change at Month 3 of exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '385', 'groupId': 'OG000'}, {'value': '373', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-31.34', 'groupId': 'OG000', 'lowerLimit': '-37.12', 'upperLimit': '-25.57'}, {'value': '-28.97', 'groupId': 'OG001', 'lowerLimit': '-34.86', 'upperLimit': '-23.09'}]}]}, {'title': 'sWASO: Change at Month 6 of exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '351', 'groupId': 'OG000'}, {'value': '329', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-36.10', 'groupId': 'OG000', 'lowerLimit': '-42.57', 'upperLimit': '-29.63'}, {'value': '-31.54', 'groupId': 'OG001', 'lowerLimit': '-38.16', 'upperLimit': '-24.91'}]}]}, {'title': 'sTST: Change at Month 1 of exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '400', 'groupId': 'OG000'}, {'value': '396', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.98', 'groupId': 'OG000', 'lowerLimit': '25.54', 'upperLimit': '38.42'}, {'value': '38.04', 'groupId': 'OG001', 'lowerLimit': '31.51', 'upperLimit': '44.57'}]}]}, {'title': 'sTST: Change at Month 3 of exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '373', 'groupId': 'OG000'}, {'value': '361', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '49.27', 'groupId': 'OG000', 'lowerLimit': '42.33', 'upperLimit': '56.22'}, {'value': '53.51', 'groupId': 'OG001', 'lowerLimit': '46.42', 'upperLimit': '60.61'}]}]}, {'title': 'sTST: Change at Month 6 of exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '321', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '54.99', 'groupId': 'OG000', 'lowerLimit': '47.18', 'upperLimit': '62.80'}, {'value': '56.36', 'groupId': 'OG001', 'lowerLimit': '48.35', 'upperLimit': '64.36'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 1, 3, 6', 'description': 'sSOL was defined as estimated minutes from the time that the participant attempted to sleep until sleep onset. sWASO: sum of estimated minutes of wake during the night after initial sleep onset until the time the participant stopped trying to sleep for the night, operationalized as the time the participant got out of bed for the day. sTST: minutes of sleep from sleep onset to time stopped trying to sleep for the night. At 3 and 6 months of exposure, the change from Baseline was compared to either the lower bound of the 95% CI for sTST or the upper bound of the 95% CI (for sSOL and sWASO) at 1 month of exposure. Persistence of effect was defined as present if the mean change from Baseline at 6 months of exposure was above the lower bound of the 95% CI at 1 month of exposure for sTST and below the upper bound of the 95% CI at 1 month of exposure for sSOL and sWASO.', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall participants analyzed based on number in "On-Treatment FAS (Participants who received at least 1 dose of lemborexant and had at least 1 postdose primary efficacy measurement)". Hence, these numbers include lemborexant data from participants re-randomized from placebo in Period 1. Number analyzed=participants analyzed at specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Persistence of Effect: Mean Change From Study Baseline and Period 2 Baseline (Month 6) in sSE at Months 3 and 6 Exposure Compared to Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '444', 'groupId': 'OG000'}, {'value': '437', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lemborexant 5 mg', 'description': 'Participants received lemborexant 5 mg/placebo, tablets, orally, once daily through Month 1-6 (in Period 1) and lemborexant 5 mg, tablets, orally, once daily through Month 7-12 (in Period 2).'}, {'id': 'OG001', 'title': 'Lemborexant 10 mg', 'description': 'Participants received lemborexant 10 mg/placebo, tablets, orally, once daily through Month 1-6 (in Period 1) and lemborexant 10 mg, tablets, orally, once daily through Month 7-12 (in Period 2).'}], 'classes': [{'title': 'Change at Month 1 of exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '400', 'groupId': 'OG000'}, {'value': '396', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.35', 'groupId': 'OG000', 'lowerLimit': '5.13', 'upperLimit': '7.57'}, {'value': '7.32', 'groupId': 'OG001', 'lowerLimit': '6.09', 'upperLimit': '8.56'}]}]}, {'title': 'Change at Month 3 of exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '373', 'groupId': 'OG000'}, {'value': '361', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.01', 'groupId': 'OG000', 'lowerLimit': '8.69', 'upperLimit': '11.34'}, {'value': '10.25', 'groupId': 'OG001', 'lowerLimit': '8.90', 'upperLimit': '11.60'}]}]}, {'title': 'Change at Month 6 of exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '321', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.10', 'groupId': 'OG000', 'lowerLimit': '9.61', 'upperLimit': '12.58'}, {'value': '11.08', 'groupId': 'OG001', 'lowerLimit': '9.56', 'upperLimit': '12.60'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 1, 3, 6', 'description': 'sSE was defined as percentage of sTST per subjective time spent in bed, calculated as the interval from the time the participant reports attempting to sleep until the time the participant stopped trying to sleep for the night (operationalized as the time the participant got out of bed for the day), and time spent asleep derived from subjective time spent in bed minus sWASO. At 3 and 6 months of exposure, the change from Baseline was compared to the lower bound of the 95% CI for sSE at 1 month of exposure. Persistence of effect was defined as present if the mean change from Baseline at 6 months of exposure was above the lower bound of the 95% CI at 1 month of exposure for sSE.', 'unitOfMeasure': 'percentage of sTST', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'On-treatment FAS was the group of participants who received at least 1 dose of lemborexant and had at least 1 post dose primary efficacy measurement. Overall Participants Analyzed here is based on the number in the "On-Treatment FAS". Hence these numbers include the lemborexant data from the participants re-randomized from placebo in Period 1.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants received lemborexant-matched placebo, tablet, orally, once daily for up to Month 6 in the placebo-controlled treatment period. Then they were re-randomized to lemborexant 5 milligram (mg) or lemborexant 10 mg up to Month 12.'}, {'id': 'FG001', 'title': 'Lemborexant 5 mg', 'description': 'Participants received lemborexant 5 mg, tablets, orally, once daily through Month 1-6 (in Period 1) and Month 7-12 (in Period 2).'}, {'id': 'FG002', 'title': 'Lemborexant 10 mg', 'description': 'Participants received lemborexant 10 mg, tablets, orally, once daily through Month 1-6 (in Period 1) and Month 7-12 (in Period 2).'}], 'periods': [{'title': 'Placebo-Controlled Treatment (6 Months)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '325'}, {'groupId': 'FG001', 'numSubjects': '323'}, {'groupId': 'FG002', 'numSubjects': '323'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '321'}, {'groupId': 'FG001', 'numSubjects': '319'}, {'groupId': 'FG002', 'numSubjects': '319'}]}, {'type': 'Safety Analysis Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '319'}, {'groupId': 'FG001', 'numSubjects': '314'}, {'groupId': 'FG002', 'numSubjects': '314'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '261'}, {'groupId': 'FG001', 'numSubjects': '254'}, {'groupId': 'FG002', 'numSubjects': '235'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '69'}, {'groupId': 'FG002', 'numSubjects': '88'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '16'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Subject choice', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '17'}]}, {'type': 'Inadequate therapeutic effect', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'Other than specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'Withdrawal of consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '21'}]}, {'type': 'Not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}]}]}, {'title': 'Active Treatment Period (6 Months)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Participants from Placebo were re-randomized to Lemborexant 5 mg and Lemborexant 10 mg.', 'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '384'}, {'groupId': 'FG002', 'numSubjects': '352'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '346'}, {'groupId': 'FG002', 'numSubjects': '321'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '38'}, {'groupId': 'FG002', 'numSubjects': '31'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Subject choice', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Inadequate therapeutic effect', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal of consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Other than specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 119 investigative sites in Japan, Korea, Finland, Germany, Italy, New Zealand, Poland, Romania, Spain, Canada, Mexico, and the United States from 15 November 2016 to 08 January 2019.', 'preAssignmentDetails': 'A total of 2059 participants were screened, of which 1088 were screen failures and 971 participants were randomized to receive study treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'BG000'}, {'value': '316', 'groupId': 'BG001'}, {'value': '315', 'groupId': 'BG002'}, {'value': '949', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received lemborexant-matched placebo, tablet, orally, once daily for up to Month 6 in the placebo-controlled treatment period. Then they were re-randomized to lemborexant 5 mg or lemborexant 10 mg up to Month 12.'}, {'id': 'BG001', 'title': 'Lemborexant 5 mg', 'description': 'Participants received lemborexant 5 mg, tablets, orally, once daily through Month 1-6 (in Period 1) and Month 7-12 (in Period 2).'}, {'id': 'BG002', 'title': 'Lemborexant 10 mg', 'description': 'Participants received lemborexant 10 mg, tablets, orally, once daily through Month 1-6 (in Period 1) and Month 7-12 (in Period 2).'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.5', 'spread': '14.01', 'groupId': 'BG000'}, {'value': '54.2', 'spread': '13.74', 'groupId': 'BG001'}, {'value': '54.8', 'spread': '13.68', 'groupId': 'BG002'}, {'value': '54.5', 'spread': '13.80', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '216', 'groupId': 'BG000'}, {'value': '209', 'groupId': 'BG001'}, {'value': '222', 'groupId': 'BG002'}, {'value': '647', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}, {'value': '302', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '284', 'groupId': 'BG000'}, {'value': '297', 'groupId': 'BG001'}, {'value': '296', 'groupId': 'BG002'}, {'value': '877', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '232', 'groupId': 'BG000'}, {'value': '222', 'groupId': 'BG001'}, {'value': '225', 'groupId': 'BG002'}, {'value': '679', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '76', 'groupId': 'BG003'}]}, {'title': 'Japanese', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '161', 'groupId': 'BG003'}]}, {'title': 'Chinese', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Other Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}, {'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Other', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Full Analysis Set (FAS) was the group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose primary efficacy measurement.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-08-13', 'size': 1352495, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-01-24T11:17', 'hasProtocol': True}, {'date': '2018-08-21', 'size': 1137720, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-01-24T11:19', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 971}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2019-01-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-24', 'studyFirstSubmitDate': '2016-10-31', 'resultsFirstSubmitDate': '2020-01-08', 'studyFirstSubmitQcDate': '2016-10-31', 'lastUpdatePostDateStruct': {'date': '2020-02-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-01-08', 'studyFirstPostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-01-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Subjective Sleep Onset Latency (sSOL) at Month 6', 'timeFrame': 'Baseline and Month 6', 'description': 'sSOL was defined as estimated minutes from the time that the participant attempted to sleep until sleep onset.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in sSOL at the Beginning of Treatment (Mean of the 7 Nights After the First Dose in Placebo-Controlled Period), and at Months 1 and 3', 'timeFrame': 'Baseline, (mean of 7 nights [approximately Week 1]), Months 1 and 3', 'description': 'sSOL was defined as estimated minutes from time attempted to sleep to sleep onset.'}, {'measure': 'Change From Baseline in Subjective Sleep Efficiency (sSE) at the Beginning of Treatment (Mean of the 7 Nights After the First Dose in Placebo-Controlled Period), and at Months 1, 3 and 6', 'timeFrame': 'Baseline, (mean of 7 nights [approximately Week 1]), Months 1, 3 and 6', 'description': 'sSE was defined as percentage of subjective total sleep time (sTST) divided by subjective time spent in bed, calculated as the interval from the time the participant reported attempting to sleep until the time participant stopped trying to sleep for the night (operationalized as the time the participant got out of bed for the day), and time spent asleep derived from subjective time spent in bed minus sWASO.'}, {'measure': 'Change From Baseline in Subjective Wake After Sleep Onset (sWASO) at the Beginning of Treatment (Mean of the 7 Nights After the First Dose in Placebo-Controlled Period), and at Months 1, 3 and 6', 'timeFrame': 'Baseline, (mean of 7 nights [approximately Week 1]), Months 1, 3 and 6', 'description': 'sWASO was defined as sum of estimated minutes of wake during the night after initial sleep onset until the time the participant stopped trying to sleep for the night, operationalized as the time the participant got out of bed for the day.'}, {'measure': 'Change From Baseline in sTST at the Beginning of Treatment (Mean of the 7 Nights After the First Dose in Placebo-Controlled Period), and at Months 1, 3 and 6', 'timeFrame': 'Baseline, (mean of 7 nights [approximately Week 1]), Months 1, 3 and 6', 'description': 'sTST was defined as minutes of sleep from sleep onset to time stopped trying to sleep for the night.'}, {'measure': 'Percentage of Sleep Onset Responders and Sleep Maintenance Responders at Month 6', 'timeFrame': 'Month 6', 'description': 'Sleep onset responder was defined as follows: sSOL at study Baseline was greater than or equal to (\\>=) 30 minutes and mean sSOL at 6 months was less than or equal to (\\<=) 20 minutes. Sleep maintenance responder was defined as follows: sWASO at study Baseline was \\>=60 minutes and mean sWASO at 6 months was \\<=60 minutes and showed a reduction of greater than (\\>)10 minutes compared to Study Baseline.'}, {'measure': 'Percentage of Sleep Onset Responders and Sleep Maintenance Responders at Month 12', 'timeFrame': 'Month 12', 'description': 'Sleep onset responder was defined as follows: sSOL at study Baseline was \\>=30 minutes and mean sSOL at 6 months was \\<=20 minutes. Sleep maintenance responder was defined as follows: sWASO at study Baseline was \\>=60 minutes and mean sWASO at 6 months was \\<=60 minutes and showed a reduction of \\> 10 minutes compared to study Baseline.'}, {'measure': 'Change From Baseline in Insomnia Severity Index (ISI) Daytime Functioning Score at Months 1, 3, and 6', 'timeFrame': 'Baseline, Months 1, 3, and 6', 'description': 'The ISI is a 4-7 item, self-report questionnaire assessing the nature, severity, and impact of insomnia. The dimensions evaluated were: 1. severity of sleep onset; 2. sleep maintenance; 3. early morning awakening problems; 4. sleep dissatisfaction; 5. interference of sleep difficulties with daytime functioning; 6. noticeability of the sleep problems by others; and 7. distress caused by the sleep difficulties. A 5-point Likert scale was used to rate each item (from 0=no problem to 4=very severe problem). Daytime functioning score (sum of items 4 to 7) were analyzed. Higher score indicated severe insomnia problem. The total score range for sum of items is 0-16.'}, {'measure': 'Change From Baseline in Fatigue Severity Scale (FSS) Total Score at Months 1, 3 and 6', 'timeFrame': 'Baseline, Months 1, 3 and 6', 'description': 'The FSS is a self-reported scale on which participants were instructed to choose a number from 1 to 7 that indicated their degree of agreement with 9 statements about their fatigue where "1" indicates strongly disagree and "7", strongly agree. The FSS total score was the sum of all responses to the 9 questions. Higher total scores and average item scores indicated greater fatigue. Total score range is 9 to 63.'}, {'measure': 'Change From Baseline in Mean Rating on the Morning Sleepiness Item of the Sleep Diary at the Beginning of Treatment (Mean of the 7 Nights After the First Dose in Placebo-Controlled Period), and at Months 1, 3 and 6', 'timeFrame': 'Baseline, (mean of 7 nights [approximately Week 1]) in placebo-controlled period, Month 1, 3, 6', 'description': 'The Sleep Diary was used to assess subjective ratings of morning sleepiness with the following question:\n\n"How sleepy/alert do you feel this morning?" Participants rated their sleepiness/alertness level on a scale from 1 to 9, with 1 being extremely poor (sleepy) and 9 being extremely good (alert). Higher score indicated better outcome.'}, {'measure': 'Change From Baseline in Mean Rating on the Morning Sleepiness Item of the Sleep Diary at the Beginning of Treatment (Mean of the 7 Nights After the First Dose in Active Treatment Period)', 'timeFrame': 'Baseline, First 7 nights (approximately Week 1) in active treatment period'}, {'measure': 'Change From Screening in Mean Rating on the Morning Sleepiness Item of the Sleep Diary at the First and Second 7 Mornings of the Follow-up Period', 'timeFrame': 'Screening, First and second 7 mornings in follow-up period (Week 52 to 54)', 'description': 'The Sleep Diary was used to assess subjective ratings of morning sleepiness with the following question:\n\n"How sleepy/alert do you feel this morning?" Participants rated their sleepiness/alertness level on a scale from 1 to 9, with 1 being extremely poor (sleepy) and 9 being extremely good (alert). Higher score indicated better outcome.'}, {'measure': 'Change From Baseline in Mean Rating on the Morning Sleepiness Item of the Sleep Diary at Months 1, 3, 6, 9 and 12', 'timeFrame': 'Baseline, Months 1, 3, 6, 9 and 12', 'description': 'The Sleep Diary was used to assess subjective ratings of morning sleepiness with the following question:\n\n"How sleepy/alert do you feel this morning?" Participants rated their sleepiness/alertness level on a scale from 1 to 9, with 1 being extremely poor (sleepy) and 9 being extremely good (alert). Higher score indicated better outcome.'}, {'measure': 'Rebound Insomnia: Mean sSOL on Each of the First 3 Nights, First 7 Nights, and Last 7 Nights of the Follow-up Period', 'timeFrame': 'First 3 nights, first and Last 7 nights of the follow up period (Week 52 to 54)', 'description': 'Rebound Insomnia: Rebound insomnia was defined as insomnia that occurred following discontinuation of a sedative substance taken to relieve primary insomnia. sSOL was defined as estimated minutes from the time that the participant attempted to sleep until sleep onset.'}, {'measure': 'Rebound Insomnia: Mean sWASO on Each of the First 3 Nights, First 7 Nights, and Last 7 Nights of the Follow-up Period', 'timeFrame': 'First 3 nights, first and last 7 nights of the follow up period (Week 52 to 54)', 'description': 'Rebound Insomnia: Rebound insomnia was defined as insomnia that occurred following discontinuation of a sedative substance taken to relieve primary insomnia. sWASO was defined as sum of estimated minutes of wake during the night after initial sleep onset until the time the participant stopped trying to sleep for the night, operationalized as the time the participant got out of bed for the day.'}, {'measure': 'Rebound Insomnia: Percentage of Participants Whose sSOL Was Longer Than at Screening for First 3 Nights of the Follow-up Period, or Whom Mean sSOL Was Longer Than at Screening for First 7 Nights or Last 7 Nights of the Follow-up Period', 'timeFrame': 'First 3 nights, first and last 7 nights of the follow up period (Week 52 to 54)', 'description': 'Rebound Insomnia: Rebound insomnia was defined as insomnia that occurred following discontinuation of a sedative substance taken to relieve primary insomnia. sSOL was defined as estimated minutes from the time that the participant attempted to sleep until sleep onset.'}, {'measure': 'Rebound Insomnia: Percentage of Participants Whose sWASO is Higher Than at Screening for First 3 Nights of the Follow-up Period, or Whose Mean sWASO is Higher Than at Screening for the First 7 Nights or Last 7 Nights of the Follow-up Period', 'timeFrame': 'First 3 nights, First and Last 7 nights of the follow up period (Week 52 to 54)', 'description': 'Rebound Insomnia: Rebound insomnia was defined as insomnia that occurred following discontinuation of a sedative substance taken to relieve primary insomnia. sWASO was defined as sum of estimated minutes of wake during the night after initial sleep onset until the time the participant stopped trying to sleep for the night, operationalized as the time the participant got out of bed for the day.'}, {'measure': 'Persistence of Effect: Mean Change From Baseline in sSOL, sWASO, and sTST at Months 3, 6, 9, and 12 Compared to Month 1', 'timeFrame': 'Baseline, Month 1, 3, 6, 9, 12', 'description': 'sSOL was defined as estimated minutes from the time that the participant attempted to sleep until sleep onset. sWASO was defined as sum of estimated minutes of wake during the night after initial sleep onset until the time the participant stopped trying to sleep for the night, operationalized as the time the participant got out of bed for the day. sTST: minutes of sleep from sleep onset to time stopped trying to sleep for the night. At each month beyond Month 1, the change from Baseline was compared to either the lower bound of the 95% CI (for sTST) or the upper bound of the 95% CI (for sSOL and sWASO) at Month 1. Persistence of efficacy was defined as present if the mean change from Baseline at Month 6 was above the lower bound of the 95% CI at Month 1 for sTST and below the upper bound of the 95% CI at Month 1 for sSOL and sWASO.'}, {'measure': 'Persistence of Effect: Mean Change From Baseline in sSE at Months 3, 6, 9, and 12 Compared to Month 1', 'timeFrame': 'Baseline, Months 1, 3, 6, 9, and 12', 'description': 'sSE was defined as percentage of sTST per subjective time spent in bed, calculated as the interval from the time the participant reports attempting to sleep until the time the participant stopped trying to sleep for the night (operationalized as the time the participant got out of bed for the day), and time spent asleep derived from subjective time spent in bed minus sWASO. At each month beyond Month 1, the change from Baseline was compared to the lower bound of the 95% CI at Month 1. Persistence of efficacy was defined as present if the mean change from Baseline at Month 6 was above the lower bound of the 95% CI at Month 1 for sSE.'}, {'measure': 'Persistence of Effect: Mean Change From Period 2 Baseline (Month 6) in sSOL, sWASO, and sTST at Months 9 and 12 Compared to Month 7', 'timeFrame': 'Baseline, Month 7, 9, 12', 'description': 'sSOL is defined as estimated minutes from the time that the participant attempted to sleep until sleep onset. sWASO: sum of estimated minutes of wake during the night after initial sleep onset until the time the participant stopped trying to sleep for the night, operationalized as the time the participant got out of bed for the day. sTST: minutes of sleep from sleep onset to time stopped trying to sleep for the night. At each month beyond Month 7, the change from Baseline was compared to either the lower bound of the 95% CI for sTST or the upper bound of the 95% CI (for sSOL and sWASO) at Month 7. Persistence of effect was defined as present if the mean change from Baseline at Month 12 was above the lower bound of the 95% CI at Month 7 for sTST and below the upper bound of the 95% CI at Month 7 for sSOL and sWASO.'}, {'measure': 'Persistence of Effect: Mean Change From Period 2 Baseline (Month 6) in sSE at Months 9 and 12 Compared to Month 7', 'timeFrame': 'Baseline, Month 7, 9, 12', 'description': 'sSE: percentage of sTST per subjective time spent in bed, calculated as the interval from the time the participant reports attempting to sleep until the time the participant stopped trying to sleep for the night (operationalized as the time the subject got out of bed for the day), and time spent asleep derived from subjective time spent in bed minus sWASO. At each month beyond Month 7, the change from Baseline was compared to the lower bound of the 95% CI for sSE at Month 7. Persistence of effect was defined as present if the mean change from Baseline at Month 12 was above the lower bound of the 95% CI at Month 7 for sSE.'}, {'measure': 'Persistence of Effect: Mean Change From Study Baseline and Period 2 Baseline (Month 6) in sSOL, sWASO, and sTST at Months 3 and 6 Exposure Compared to Month 1', 'timeFrame': 'Baseline, Month 1, 3, 6', 'description': 'sSOL was defined as estimated minutes from the time that the participant attempted to sleep until sleep onset. sWASO: sum of estimated minutes of wake during the night after initial sleep onset until the time the participant stopped trying to sleep for the night, operationalized as the time the participant got out of bed for the day. sTST: minutes of sleep from sleep onset to time stopped trying to sleep for the night. At 3 and 6 months of exposure, the change from Baseline was compared to either the lower bound of the 95% CI for sTST or the upper bound of the 95% CI (for sSOL and sWASO) at 1 month of exposure. Persistence of effect was defined as present if the mean change from Baseline at 6 months of exposure was above the lower bound of the 95% CI at 1 month of exposure for sTST and below the upper bound of the 95% CI at 1 month of exposure for sSOL and sWASO.'}, {'measure': 'Persistence of Effect: Mean Change From Study Baseline and Period 2 Baseline (Month 6) in sSE at Months 3 and 6 Exposure Compared to Month 1', 'timeFrame': 'Baseline, Month 1, 3, 6', 'description': 'sSE was defined as percentage of sTST per subjective time spent in bed, calculated as the interval from the time the participant reports attempting to sleep until the time the participant stopped trying to sleep for the night (operationalized as the time the participant got out of bed for the day), and time spent asleep derived from subjective time spent in bed minus sWASO. At 3 and 6 months of exposure, the change from Baseline was compared to the lower bound of the 95% CI for sSE at 1 month of exposure. Persistence of effect was defined as present if the mean change from Baseline at 6 months of exposure was above the lower bound of the 95% CI at 1 month of exposure for sSE.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True}, 'conditionsModule': {'keywords': ['insomnia'], 'conditions': ['Insomnia Disorder']}, 'referencesModule': {'references': [{'pmid': '39823487', 'type': 'DERIVED', 'citation': 'Chepke C, Cote KA, Pinner K, Yardley J, Lundwall C, Moline M. Effect of Lemborexant on Daytime Functioning in Adults With Insomnia: Patient-Reported Outcomes From a Phase 3 Clinical Trial. Prim Care Companion CNS Disord. 2025 Jan 16;27(1):24m03810. doi: 10.4088/PCC.24m03810.'}, {'pmid': '38748321', 'type': 'DERIVED', 'citation': 'Arnold V, Ancoli-Israel S, Dang-Vu TT, Mishima K, Pinner K, Malhotra M, Moline M. Efficacy of Lemborexant in Adults >/= 65 Years of Age with Insomnia Disorder. Neurol Ther. 2024 Aug;13(4):1081-1098. doi: 10.1007/s40120-024-00622-9. Epub 2024 May 15.'}, {'pmid': '37796657', 'type': 'DERIVED', 'citation': 'Citrome L, Juday TR, Lundwall C. Lemborexant and Daridorexant for the Treatment of Insomnia: An Indirect Comparison Using Number Needed to Treat, Number Needed to Harm, and Likelihood to Be Helped or Harmed. J Clin Psychiatry. 2023 Oct 2;84(6):23m14851. doi: 10.4088/JCP.23m14851.'}, {'pmid': '37339396', 'type': 'DERIVED', 'citation': 'Terauchi M, Cheng JY, Yardley J, Pinner K, Moline M, Malhotra M, Inabe K, Nishida M, Pappadopulos E. Efficacy and safety of lemborexant in midlife women with insomnia disorder. Menopause. 2023 Aug 1;30(8):839-848. doi: 10.1097/GME.0000000000002209. Epub 2023 Jun 20.'}, {'pmid': '35402894', 'type': 'DERIVED', 'citation': 'Dash A, Pinner K, Inoue Y, Hayashida K, Lim SC, Yun CH, Lan TH, Huang CL, Yardley J, Kubota N, Moline M. Efficacy and safety of lemborexant over 12 months in Asian adults with insomnia disorder. Sleep Med X. 2022 Mar 24;4:100044. doi: 10.1016/j.sleepx.2022.100044. eCollection 2022 Dec.'}, {'pmid': '35254948', 'type': 'DERIVED', 'citation': 'Chepke C, Jain R, Rosenberg R, Moline M, Yardley J, Pinner K, Kumar D, Perdomo C, Filippov G, Atkins N, Malhotra M. Improvement in fatigue and sleep measures with the dual orexin receptor antagonist lemborexant in adults with insomnia disorder. Postgrad Med. 2022 Apr;134(3):316-325. doi: 10.1080/00325481.2022.2049553. Epub 2022 Mar 20.'}, {'pmid': '35220140', 'type': 'DERIVED', 'citation': 'Roth T, Rosenberg R, Morin CM, Yardley J, Pinner K, Perdomo C, Atkins N Jr, Pappadopulos E, Malhotra M, Moline M. Impact of lemborexant treatment on insomnia severity: analyses from a 12-month study of adults with insomnia disorder. Sleep Med. 2022 Feb;90:249-257. doi: 10.1016/j.sleep.2022.01.024. Epub 2022 Feb 8.'}, {'pmid': '34077032', 'type': 'DERIVED', 'citation': 'Citrome L, Juday T, Frech F, Atkins N Jr. Lemborexant for the Treatment of Insomnia: Direct and Indirect Comparisons With Other Hypnotics Using Number Needed to Treat, Number Needed to Harm, and Likelihood to Be Helped or Harmed. J Clin Psychiatry. 2021 Jun 1;82:20m13795. doi: 10.4088/JCP.20m13795.'}, {'pmid': '33636648', 'type': 'DERIVED', 'citation': 'Yardley J, Karppa M, Inoue Y, Pinner K, Perdomo C, Ishikawa K, Filippov G, Kubota N, Moline M. Long-term effectiveness and safety of lemborexant in adults with insomnia disorder: results from a phase 3 randomized clinical trial. Sleep Med. 2021 Apr;80:333-342. doi: 10.1016/j.sleep.2021.01.048. Epub 2021 Feb 1.'}, {'pmid': '33576735', 'type': 'DERIVED', 'citation': 'Inoue Y, Watanabe T, Takashima S, Takase T, Ishikawa K, Kubota N, Yardley J, Moline M. Efficacy and safety of lemborexant in adults with insomnia: comparing Japanese and non-Japanese subgroups from the global, phase 3, randomized, double-blind, placebo-controlled SUNRISE 2 study. J Clin Sleep Med. 2021 May 1;17(5):1067-1074. doi: 10.5664/jcsm.9148.'}, {'pmid': '32585700', 'type': 'DERIVED', 'citation': 'Karppa M, Yardley J, Pinner K, Filippov G, Zammit G, Moline M, Perdomo C, Inoue Y, Ishikawa K, Kubota N. Long-term efficacy and tolerability of lemborexant compared with placebo in adults with insomnia disorder: results from the phase 3 randomized clinical trial SUNRISE 2. Sleep. 2020 Sep 14;43(9):zsaa123. doi: 10.1093/sleep/zsaa123.'}]}, 'descriptionModule': {'briefSummary': 'The key objectives of this study are to determine, using sleep diaries, whether lemborexant at the doses 5 milligrams (mg) and 10 mg is superior to placebo on subjective sleep onset, subjective sleep efficiency, and subjective sleep maintenance in participants with insomnia disorder.', 'detailedDescription': 'This is a long-term (approximately 1 year), multicenter, randomized, controlled, double-blind, parallel group study of two doses of lemborexant and placebo in approximately 900 male or female participants with insomnia disorder. Approximately 40% of participants will be age 65 years or older. The study will last a maximum of 60 weeks, and will include a Screening Period, an approximately 54-week Treatment Period (during which study medication will be administered), and a 2-week Follow-up Period. All participants will receive lemborexant for at least 6 months and will receive placebo at some point during the study. Participants will not know which medication they receive (lemborexant or placebo) until the study has been completed, and will not know the timings at which the medication will change.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female, age 18 years or older at the time of informed consent\n* Meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5) criteria for Insomnia Disorder, as follows:\n\n * Complains of dissatisfaction with nighttime sleep in the form of difficulty getting to sleep, difficulty staying asleep, and/or awakening earlier in the morning than desired despite adequate opportunity for sleep\n * Frequency of complaint ≥3 times per week\n * Duration of complaint ≥3 months\n * Associated with complaint of daytime impairment\n* History of (Subjective Sleep Onset Latency) sSOL ≥30 minutes on at least 3 nights per week in the previous 4 weeks and/or subjective Wake after Sleep Onset (sWASO) ≥60 minutes on at least 3 nights per week in the previous 4 weeks\n* History of regular time spent in bed, either sleeping or trying to sleep, between 7 and 9 hours\n* Regular bedtime, between 21:00 and 01:00 and regular wake time, the time the participant gets out of bed for the day, between 05:00 and 10:00\n* Insomnia Severity Index (ISI) score ≥15\n* Confirmation of current insomnia symptoms as determined from the Sleep Diary completed on at least 7 consecutive mornings (minimum 5 of 7 for eligibility), such that sSOL ≥30 minutes on at least 3 of the 7 nights and/or sWASO ≥60 minutes on at least 3 of the 7 nights\n* Confirmation of time spent in bed, as determined from on the Sleep Diary completed on 7 mornings between the first and second screening visit, such that there are not more than 2 nights with duration of time spent in bed 7 hours and 10 hours\n* Confirmation of regular bedtimes and wake times such that the participant has a regular time spent in bed, either sleeping or trying to sleep, between 7 and 10 hours for the final 7 nights of the before visit 3.\n* Confirmation of regular bedtime between 21:00 and 01:00 and time of getting out of bed for the day between 05:00 and 10:00 for the final 7 nights of the before visit 3.\n* Willing and able to comply with all aspects of the protocol, including staying in bed for at least 7 hours each night\n* Willing to not start a behavioral or other treatment program for insomnia during the participants participation in the study\n\nExclusion Criteria:\n\n* A current diagnosis of sleep-related breathing disorder, periodic limb movement disorder, restless legs syndrome, circadian rhythm sleep disorder, or an exclusionary score on screening instruments to rule out individuals with symptoms of certain sleep disorders other than insomnia.\n\n * STOPBang score greater than or equal to (\\>=) 5\n * International Restless Legs Scale (IRLS) score \\>=16\n * Epworth Sleepiness Scale (ESS) score \\>15\n* Reports symptoms potentially related to narcolepsy that in the clinical opinion of the investigator indicates the need for referral for a diagnostic evaluation for the presence of narcolepsy\n* Reports a history of sleep-related violent behavior, or sleep driving, or any other complex sleep-related behavior, eg, making phone calls, or preparing and eating food while asleep\n* For participants who underwent polysomnography (PSG) within the previous year:\n\n * Age 18 to 64 years: Apnea Hypopnea Index ≥10, or Periodic Limb Movements with Arousal Index ≥10\n * Age ≥65 years: Apnea Hypopnea Index \\>15, or Periodic Limb Movements with Arousal Index \\>15\n* Beck Depression Inventory - II (BDI II) score \\>19 at Screening\n* Beck Anxiety Inventory (BAI) score \\>15 at Screening\n* Habitually naps more than 3 times per week\n* Females who are breastfeeding or pregnant at Screening or Study Baseline\n* Females of childbearing potential who are not practicing acceptable pregnancy prevention methods (NOTE: All females will be considered to be of childbearing potential unless they are postmenopausal or have been sterilized surgically.)\n* Excessive caffeine use that in the opinion of the investigator contributes to the participant's insomnia, or habitually consumes caffeine-containing beverages after 18:00 and is unwilling to forego caffeine after 18:00 for the duration of his/her participation in the study\n* History of drug or alcohol dependency or abuse within approximately the previous 2 years\n* Reports habitually consuming more than 14 drinks containing alcohol per week (females) or more than 21 drinks containing alcohol per week (males), or unwilling to limit alcohol intake to no more than 2 drinks per day or forego having alcohol within the 3 hours before bedtime for the duration of his/her participation in the study\n* A prolonged QT/QT interval corrected by Fridericia's formula (QTcF \\>450 ms) as demonstrated by a repeated electro cardiogram(ECG) at Screening (repeated only if initial ECG indicates a QTcF interval \\>450 ms)\n* Current evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal, neurological \\[including participants who lack capacity and/or whose cognitive decline indicates disorientation to person/place/time and/or situation\\], or psychiatric disease or malignancy other than basal cell carcinoma) or chronic pain that in the opinion of the investigator(s) could affect the participant's safety or interfere with the study assessments\n* Comorbid nocturia resulting in frequent need to get out of bed to use the bathroom during the night\n* Scheduled for major surgery during the study\n* Used any prohibited prescription or over-the-counter concomitant medications within 1 week before the first dose of study medication\n* Used any modality of treatment for insomnia, including cognitive behavioral therapy or marijuana within 2 weeks before Screening\n* Failed treatment with suvorexant (Belsomra®) (efficacy and/or safety) following treatment with an appropriate dose and of adequate duration in the opinion of the investigator\n* Transmeridian travel across more than 3 time zones in the 2 weeks before Screening, or between Screening and Study Baseline\n* Previously participated in any clinical trial of lemborexant"}, 'identificationModule': {'nctId': 'NCT02952820', 'briefTitle': 'Long-term Study of Lemborexant in Insomnia Disorder (SUNRISE 2)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eisai Inc.'}, 'officialTitle': 'A Long-Term Multicenter, Randomized, Double-Blind, Controlled, Parallel Group Study of the Safety and Efficacy of Lemborexant in Subjects With Insomnia Disorder (SUNRISE 2)', 'orgStudyIdInfo': {'id': 'E2006-G000-303'}, 'secondaryIdInfos': [{'id': '2015-001463-39', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'lemborexant 5 milligrams (mg)', 'description': 'Lemborexant 5 mg will be taken orally in tablet form at home each night immediately before the time the participant intends to try to sleep.', 'interventionNames': ['Drug: lemborexant']}, {'type': 'EXPERIMENTAL', 'label': 'lemborexant 10 mg', 'description': 'Lemborexant 10 mg will be taken orally in tablet form at home each night immediately before the time the participant intends to try to sleep.', 'interventionNames': ['Drug: lemborexant']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo matched to lemborexant', 'description': 'Lemborexant-matched placebo will be taken orally in tablet form at home each night immediately before the time the participant intends to try to sleep.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'lemborexant', 'type': 'DRUG', 'armGroupLabels': ['lemborexant 10 mg', 'lemborexant 5 milligrams (mg)']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo matched to lemborexant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'Facility # 1', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'Facility # 2', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '72758', 'city': 'Rogers', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Facility # 1', 'geoPoint': {'lat': 36.33202, 'lon': -94.11854}}, {'zip': '90210', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Facility # 1', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Facility # 2', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90069', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Facility # 1', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92374', 'city': 'Redlands', 'state': 'California', 'country': 'United States', 'facility': 'Facility # 1', 'geoPoint': {'lat': 34.05557, 'lon': -117.18254}}, {'zip': '95821', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Facility # 1', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Facility # 1', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '90502', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Facility # 1', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '80909', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Facility # 1', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '34747', 'city': 'Celebration', 'state': 'Florida', 'country': 'United States', 'facility': 'Facility # 1', 'geoPoint': {'lat': 28.32529, 'lon': -81.53313}}, {'zip': '33016', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Facility # 1', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '33030', 'city': 'Homestead', 'state': 'Florida', 'country': 'United States', 'facility': 'Facility # 1', 'geoPoint': {'lat': 25.46872, 'lon': -80.47756}}, {'zip': '32256', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Facility # 1', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33319', 'city': 'Lauderhill', 'state': 'Florida', 'country': 'United States', 'facility': 'Facility # 1', 'geoPoint': {'lat': 26.14036, 'lon': -80.21338}}, {'zip': '32751', 'city': 'Maitland', 'state': 'Florida', 'country': 'United States', 'facility': 'Facility # 1', 'geoPoint': {'lat': 28.62778, 'lon': -81.36312}}, {'zip': '33161', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 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