Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2026-02-23 @ 8:57 PM
Study NCT ID:
NCT00770692
Status:
COMPLETED
Last Update Posted:
2012-11-22
First Post:
2008-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase III Study of Eszopiclone in Patients With Insomnia (Study SEP 190-150)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'D000069582', 'term': 'Eszopiclone'}, {'id': 'D000375', 'term': 'Aging'}], 'ancestors': [{'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011719', 'term': 'Pyrazines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D048788', 'term': 'Growth and Development'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'a-kamijo@hhc.eisai.co.jp', 'phone': '+81-3-3817-5245', 'title': 'Atsushi Kamijo, Study Director', 'organization': 'Eisai Co., Ltd.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Eszopiclone 2 mg- Non-elderly', 'description': 'Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks.\n\nDose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment.', 'otherNumAtRisk': 84, 'otherNumAffected': 69, 'seriousNumAtRisk': 84, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Eszopiclone 3 mg- Non-elderly', 'description': 'Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.\n\nDose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment.', 'otherNumAtRisk': 77, 'otherNumAffected': 67, 'seriousNumAtRisk': 77, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Eszopiclone 1 mg- Elderly', 'description': 'Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.\n\nDose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment.', 'otherNumAtRisk': 81, 'otherNumAffected': 66, 'seriousNumAtRisk': 81, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'Eszopiclone 2 mg Elderly', 'description': 'Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks.\n\nDose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment.', 'otherNumAtRisk': 83, 'otherNumAffected': 66, 'seriousNumAtRisk': 83, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 44}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 23}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Thirst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Glucose urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 2}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Oral Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Reflux Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Hepatic Function Abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Thermal Burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Alanine Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Blood Triglycerides Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Eosinophil Count Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Gamma-glutamyltransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'White Blood Cell Count Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Blood Urine Present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 2}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Musculoskeletal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Musculoskeletal Stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Dermatitis Contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA (13.0)'}], 'seriousEvents': [{'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Clavicle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Completed suicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Type 1 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Major depressive disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Sick sinus syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Oesophagitis haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Calculus ureteric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Heat illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA (13.0)'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Mean Change From Baseline In Sleep Latency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Eszopiclone 1 mg- Elderly', 'description': 'Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.\n\nDose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment.'}, {'id': 'OG001', 'title': 'Eszopiclone 2 mg- Elderly', 'description': 'Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks.\n\nDose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment.'}, {'id': 'OG002', 'title': 'Eszopiclone 2 mg- Non-elderly', 'description': 'Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks.\n\nDose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment.'}, {'id': 'OG003', 'title': 'Eszopiclone 3 mg- Non-elderly', 'description': 'Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.\n\nDose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '65.5', 'spread': '40.5', 'groupId': 'OG000'}, {'value': '70.7', 'spread': '47.1', 'groupId': 'OG001'}, {'value': '71.8', 'spread': '53.5', 'groupId': 'OG002'}, {'value': '64.0', 'spread': '42.2', 'groupId': 'OG003'}]}]}, {'title': 'Overall Period (Change From Baseline)', 'categories': [{'measurements': [{'value': '-32.1', 'spread': '35.6', 'groupId': 'OG000'}, {'value': '-37.0', 'spread': '42.7', 'groupId': 'OG001'}, {'value': '-36.7', 'spread': '51.8', 'groupId': 'OG002'}, {'value': '-32.8', 'spread': '35.4', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (screening period) and 4 weeks of treatment', 'description': 'Based on subjective symptoms, the participants recorded their sleep latency (the amount of time measured in minutes it takes to fall asleep) in a sleep diary questionnaire for the week preceding the start of the study treatment (the day on which the patient was enrolled in the treatment period), as well as between the day on which the study treatment started and the Week 4 visit. For pre-treatment (screening period), the representative value was calculated from the data of the 7 days preceding enrollment in the treatment period. A median of all the data between the day of enrollment in the treatment period and the day before dose escalation judgment was presented as the data of the overall period. The change was calculated as the sleep latency of the overall period assessment - sleep latency at baseline (screening period).', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis set: all of the 161 non-elderly participants who were enrolled in the treatment period. Among the 164 elderly participants who were enrolled in the treatment period, 163 (80 in the 1 mg group and 83 in the 2 mg group) were included in the efficacy set, excluding 1 participant in the 1 mg group who had no evaluable efficacy data.'}, {'type': 'PRIMARY', 'title': 'Incidence of Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Eszopiclone 1 mg- Elderly', 'description': 'Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.\n\nDose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment.'}, {'id': 'OG001', 'title': 'Eszopiclone 2 mg- Elderly', 'description': 'Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks.\n\nDose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment.'}, {'id': 'OG002', 'title': 'Eszopiclone 2 mg- Non-elderly', 'description': 'Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks.\n\nDose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment.'}, {'id': 'OG003', 'title': 'Eszopiclone 3 mg- Non-elderly', 'description': 'Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.\n\nDose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '81.5', 'groupId': 'OG000'}, {'value': '79.5', 'groupId': 'OG001'}, {'value': '82.1', 'groupId': 'OG002'}, {'value': '87.0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 25 weeks (24 weeks treatment period & 1 week follow-up)', 'description': 'Incidence of adverse events was defined as: (number of participants with adverse events/ number of participants analyzed in the safety analysis set)\\*100.\n\nAn adverse event was defined as any unwanted or untoward disease or its symptom, sign, or abnormality in laboratory parameters in a subject who receives a study drug. An adverse event does not necessarily have a causal relationship with the study drug. The investigator or subinvestigator evaluated adverse events and recorded the results in the case report form (CRF). The investigator or subinvestigator recorded all adverse events occurring after the start of study treatment in the CRF, irrespective of the causal relationship with the study drug or the study procedures. All data collected from the follow-up was recorded in CRF.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set: All 161 non-elderly participants who were enrolled in the treatment period were included. All 164 elderly patients who were enrolled in the treatment period were included. The participant who was excluded from the efficacy analysis set was included in the safety analysis set because the participant had evaluable safety data.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Wake Time After Sleep Onset (WASO)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Eszopiclone 1 mg- Elderly', 'description': 'Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.\n\nDose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment.'}, {'id': 'OG001', 'title': 'Eszopiclone 2 mg- Elderly', 'description': 'Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks.\n\nDose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment.'}, {'id': 'OG002', 'title': 'Eszopiclone 2 mg- Non-elderly', 'description': 'Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks.\n\nDose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment.'}, {'id': 'OG003', 'title': 'Eszopiclone 3 mg- Non-elderly', 'description': 'Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.\n\nDose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '61.6', 'spread': '52.3', 'groupId': 'OG000'}, {'value': '68.8', 'spread': '63.0', 'groupId': 'OG001'}, {'value': '53.2', 'spread': '41.8', 'groupId': 'OG002'}, {'value': '42.3', 'spread': '40.8', 'groupId': 'OG003'}]}]}, {'title': 'Overall Period (Change From Baseline)', 'categories': [{'measurements': [{'value': '-30.8', 'spread': '39.9', 'groupId': 'OG000'}, {'value': '-35.1', 'spread': '-25.0', 'groupId': 'OG001'}, {'value': '-32.4', 'spread': '36.9', 'groupId': 'OG002'}, {'value': '-23.3', 'spread': '31.1', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (screening period) and 4 weeks of treatment', 'description': 'Based on subjective symptoms, the participants recorded their WASO defined as total awakening time from falling asleep to final awakening in a sleep diary questionnaire for the week preceding the start of the study treatment (the day on which the patient was enrolled in the treatment period), as well as between the day on which the study treatment started and the Week 4 visit. For pre-treatment (screening period), the representative value was calculated from the data of the 7 days preceding enrollment in the treatment period. A median of all the data between the day of enrollment in the treatment period and the day before dose escalation judgment was presented as the data of the overall period. The change was calculated as the WASO of the overall period assessment - WASO at baseline (screening period).', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis set: all of the 161 non-elderly participants who were enrolled in the treatment period. Among the 164 elderly participants who were enrolled in the treatment period, 163 (80 in the 1 mg group and 83 in the 2 mg group) were included in the efficacy set, excluding 1 participant in the 1 mg group who had no evaluable efficacy data.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Total Sleep Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Eszopiclone 1 mg- Elderly', 'description': 'Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.\n\nDose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment.'}, {'id': 'OG001', 'title': 'Eszopiclone 2 mg- Elderly', 'description': 'Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks.\n\nDose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment.'}, {'id': 'OG002', 'title': 'Eszopiclone 2 mg- Non-elderly', 'description': 'Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks.\n\nDose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment.'}, {'id': 'OG003', 'title': 'Eszopiclone 3 mg- Non-elderly', 'description': 'Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.\n\nDose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '314.2', 'spread': '73.2', 'groupId': 'OG000'}, {'value': '307.9', 'spread': '60.0', 'groupId': 'OG001'}, {'value': '290.7', 'spread': '44.0', 'groupId': 'OG002'}, {'value': '308.2', 'spread': '57.7', 'groupId': 'OG003'}]}]}, {'title': 'Overall Period (Change From Baseline)', 'categories': [{'measurements': [{'value': '63.6', 'spread': '64.1', 'groupId': 'OG000'}, {'value': '74.2', 'spread': '61.4', 'groupId': 'OG001'}, {'value': '70.2', 'spread': '50.2', 'groupId': 'OG002'}, {'value': '61.8', 'spread': '54.7', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (screening period) and 4 weeks of treatment', 'description': 'Based on subjective symptoms, the participants recorded their total sleep time defined as total sleeping time from bedtime to final awakening in a sleep diary questionnaire for the week preceding the start of the study treatment (the day on which the patient was enrolled in the treatment period), as well as between the day on which the study treatment started and the Week 4 visit. For pre-treatment (screening period), the representative value was calculated from the data of the 7 days preceding enrollment in the treatment period. A median of all the data between the day of enrollment in the treatment period and the day before dose escalation judgment was presented as the data of the overall period. The change was calculated as the total sleep time of the overall period assessment - total sleep time at baseline (screening period).', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis set: all of the 161 non-elderly participants who were enrolled in the treatment period. Among the 164 elderly participants who were enrolled in the treatment period, 163 (80 in the 1 mg group and 83 in the 2 mg group) were included in the efficacy set, excluding 1 participant in the 1 mg group who had no evaluable efficacy data.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Total Number of Awakenings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Eszopiclone 1 mg- Elderly', 'description': 'Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.\n\nDose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment.'}, {'id': 'OG001', 'title': 'Eszopiclone 2 mg- Elderly', 'description': 'Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks.\n\nDose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment.'}, {'id': 'OG002', 'title': 'Eszopiclone 2 mg- Non-elderly', 'description': 'Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks.\n\nDose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment.'}, {'id': 'OG003', 'title': 'Eszopiclone 3 mg- Non-elderly', 'description': 'Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.\n\nDose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1.8', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '0.9', 'groupId': 'OG002'}, {'value': '1.6', 'spread': '1.1', 'groupId': 'OG003'}]}]}, {'title': 'Overall Period (Change From Baseline)', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '-0.7', 'spread': '0.9', 'groupId': 'OG002'}, {'value': '-0.7', 'spread': '0.9', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (screening period) and 4 weeks of treatment', 'description': 'Based on subjective symptoms, the participants recorded their number of awakenings defined as total number of spontaneous awakenings from falling asleep to final awakening in a sleep diary questionnaire for the week preceding the start of the study treatment (the day on which the patient was enrolled in the treatment period), as well as between the day on which the study treatment started and the Week 4 visit. For pre-treatment (screening period), the representative value was calculated from the data of the 7 days preceding enrollment in the treatment period. A median of all the data between the day of enrollment in the treatment period and the day before dose escalation judgment was presented as the data of the overall period. The change was calculated as the total number of awakenings of the overall period assessment - total number of awakenings at baseline (screening period).', 'unitOfMeasure': 'Number of Awakenings', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis set: all of the 161 non-elderly participants who were enrolled in the treatment period. Among the 164 elderly participants who were enrolled in the treatment period, 163 (80 in the 1 mg group and 83 in the 2 mg group) were included in the efficacy set, excluding 1 participant in the 1 mg group who had no evaluable efficacy data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Eszopiclone 1 mg- Elderly', 'description': 'Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.\n\nDose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment.'}, {'id': 'FG001', 'title': 'Eszopiclone 2 mg- Elderly', 'description': 'Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks.\n\nDose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment.'}, {'id': 'FG002', 'title': 'Eszopiclone 2 mg- Non-elderly', 'description': 'Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks.\n\nDose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment.'}, {'id': 'FG003', 'title': 'Eszopiclone 3 mg- Non-elderly', 'description': 'Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.\n\nDose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '1 participant whose compliance was unknown, was regarded as a "treatment compliance unknown"', 'groupId': 'FG000', 'numSubjects': '81'}, {'groupId': 'FG001', 'numSubjects': '83'}, {'groupId': 'FG002', 'numSubjects': '84'}, {'groupId': 'FG003', 'numSubjects': '77'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '69'}, {'groupId': 'FG001', 'numSubjects': '74'}, {'groupId': 'FG002', 'numSubjects': '70'}, {'groupId': 'FG003', 'numSubjects': '66'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Investigator judgment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': '181 non-elderly \\& 188 elderly participants were enrolled in the screening period 1 week prior to the first dose. Among these, 20 non-elderly \\& 24 elderly participants discontinued during the screening period. 161 non-elderly and 164 elderly participants enrolled. 1 elderly participant enrolled for treatment did not receive treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}, {'value': '77', 'groupId': 'BG003'}, {'value': '324', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Eszopiclone 1 mg- Elderly', 'description': 'Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.\n\nDose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment.'}, {'id': 'BG001', 'title': 'Eszopiclone 2 mg- Elderly', 'description': 'Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks.\n\nDose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment.'}, {'id': 'BG002', 'title': 'Eszopiclone 2 mg- Non-elderly', 'description': 'Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks.\n\nDose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment.'}, {'id': 'BG003', 'title': 'Eszopiclone 3 mg- Non-elderly', 'description': 'Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.\n\nDose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70.4', 'spread': '4.5', 'groupId': 'BG000'}, {'value': '70.7', 'spread': '4.7', 'groupId': 'BG001'}, {'value': '40.1', 'spread': '10.8', 'groupId': 'BG002'}, {'value': '41.9', 'spread': '11.5', 'groupId': 'BG003'}, {'value': '55.6', 'spread': '17.1', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '185', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}, {'value': '139', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 369}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-24', 'studyFirstSubmitDate': '2008-10-09', 'resultsFirstSubmitDate': '2012-10-24', 'studyFirstSubmitQcDate': '2008-10-09', 'lastUpdatePostDateStruct': {'date': '2012-11-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-10-24', 'studyFirstPostDateStruct': {'date': '2008-10-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-11-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Adverse Events', 'timeFrame': 'Up to 25 weeks (24 weeks treatment period & 1 week follow-up)', 'description': 'Incidence of adverse events was defined as: (number of participants with adverse events/ number of participants analyzed in the safety analysis set)\\*100.\n\nAn adverse event was defined as any unwanted or untoward disease or its symptom, sign, or abnormality in laboratory parameters in a subject who receives a study drug. An adverse event does not necessarily have a causal relationship with the study drug. The investigator or subinvestigator evaluated adverse events and recorded the results in the case report form (CRF). The investigator or subinvestigator recorded all adverse events occurring after the start of study treatment in the CRF, irrespective of the causal relationship with the study drug or the study procedures. All data collected from the follow-up was recorded in CRF.'}], 'secondaryOutcomes': [{'measure': 'Mean Change From Baseline In Sleep Latency', 'timeFrame': 'Baseline (screening period) and 4 weeks of treatment', 'description': 'Based on subjective symptoms, the participants recorded their sleep latency (the amount of time measured in minutes it takes to fall asleep) in a sleep diary questionnaire for the week preceding the start of the study treatment (the day on which the patient was enrolled in the treatment period), as well as between the day on which the study treatment started and the Week 4 visit. For pre-treatment (screening period), the representative value was calculated from the data of the 7 days preceding enrollment in the treatment period. A median of all the data between the day of enrollment in the treatment period and the day before dose escalation judgment was presented as the data of the overall period. The change was calculated as the sleep latency of the overall period assessment - sleep latency at baseline (screening period).'}, {'measure': 'Mean Change From Baseline in Wake Time After Sleep Onset (WASO)', 'timeFrame': 'Baseline (screening period) and 4 weeks of treatment', 'description': 'Based on subjective symptoms, the participants recorded their WASO defined as total awakening time from falling asleep to final awakening in a sleep diary questionnaire for the week preceding the start of the study treatment (the day on which the patient was enrolled in the treatment period), as well as between the day on which the study treatment started and the Week 4 visit. For pre-treatment (screening period), the representative value was calculated from the data of the 7 days preceding enrollment in the treatment period. A median of all the data between the day of enrollment in the treatment period and the day before dose escalation judgment was presented as the data of the overall period. The change was calculated as the WASO of the overall period assessment - WASO at baseline (screening period).'}, {'measure': 'Mean Change From Baseline in Total Sleep Time', 'timeFrame': 'Baseline (screening period) and 4 weeks of treatment', 'description': 'Based on subjective symptoms, the participants recorded their total sleep time defined as total sleeping time from bedtime to final awakening in a sleep diary questionnaire for the week preceding the start of the study treatment (the day on which the patient was enrolled in the treatment period), as well as between the day on which the study treatment started and the Week 4 visit. For pre-treatment (screening period), the representative value was calculated from the data of the 7 days preceding enrollment in the treatment period. A median of all the data between the day of enrollment in the treatment period and the day before dose escalation judgment was presented as the data of the overall period. The change was calculated as the total sleep time of the overall period assessment - total sleep time at baseline (screening period).'}, {'measure': 'Mean Change From Baseline in Total Number of Awakenings', 'timeFrame': 'Baseline (screening period) and 4 weeks of treatment', 'description': 'Based on subjective symptoms, the participants recorded their number of awakenings defined as total number of spontaneous awakenings from falling asleep to final awakening in a sleep diary questionnaire for the week preceding the start of the study treatment (the day on which the patient was enrolled in the treatment period), as well as between the day on which the study treatment started and the Week 4 visit. For pre-treatment (screening period), the representative value was calculated from the data of the 7 days preceding enrollment in the treatment period. A median of all the data between the day of enrollment in the treatment period and the day before dose escalation judgment was presented as the data of the overall period. The change was calculated as the total number of awakenings of the overall period assessment - total number of awakenings at baseline (screening period).'}]}, 'conditionsModule': {'keywords': ['insomnia', 'primary insomnia', 'insomnia associated with psychiatric or physical disorder(s)'], 'conditions': ['Insomnia']}, 'referencesModule': {'references': [{'pmid': '22731653', 'type': 'DERIVED', 'citation': 'Uchimura N, Kamijo A, Takase T. Effects of eszopiclone on safety, subjective measures of efficacy, and quality of life in elderly and nonelderly Japanese patients with chronic insomnia, both with and without comorbid psychiatric disorders: a 24-week, randomized, double-blind study. Ann Gen Psychiatry. 2012 Jun 25;11(1):15. doi: 10.1186/1744-859X-11-15.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the long-term safety of eszopiclone (2, 3 mg) in non-elderly patients with insomnia and eszopiclone (1, 2 mg) in elderly patients with insomnia.', 'detailedDescription': 'This is a multicenter, randomized, double-blinded study to evaluate the long-term safety of SEP-190 (2, 3 mg) in non-elderly patients with insomnia and SEP-190 (1, 2 mg) in elderly patients with insomnia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '84 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Participants who submit written informed consent for study entry.\n2. Participants aged greater than or equal to 20 and less than 85 years of age at the time of obtaining informed consent.\n3. Participants diagnosed with primary insomnia based on the Diagnostic and Statistical Manual of Mental Disorders, text revision (DSM-IV-TR) Japanese version or diagnosed with insomnia associated with psychiatric or physical disorder(s).\n4. Participants with both of the following conditions which are persistent for 4 weeks or longer before the start of observation period:\n\n * Total sleep time is less than or equal to 390 minutes for more than or equal to 3 days a week\n * Time to fall asleep taking more than or equal to 30 minutes for more than or equal to 3 days a week\n5. Participants with data at least 2 consecutive days in diary entries during observation period and confirmed to meet the following two criteria:\n\n * Total sleep time of less than or equal to 390 minutes for more than or equal to 3 days a week\n * Time to fall asleep taking more than or equal to 30 minutes for more than or equal to 3 days a week\n\nExclusion criteria:\n\n1. Participants with a present or history of the following disease specified in\n\n Mini-International Neuropsychiatric Interview (M.I.N.I.) Japanese version 5.0:\n * Risk of suicide\n * (Mild) manic episode\n * Post-traumatic stress disorder (PTSD)\n * Alcohol dependence and abuse\n * Drug (non-alcohol) dependence and abuse\n * Anorexia nervosa\n * Bulimia nervosa\n * Anti-social personality disorder\n2. Participants with pharmacologically induced insomnia (drug-induced insomnia).\n3. Participants with comorbid primary sleep disorders (circadian rhythm disorder, restless legs movement syndrome, periodic limb movement disorder, sleep apnea syndrome, etc.) other than primary insomnia.\n4. Participants with symptoms that significantly disturb sleep such as pain, fever, diarrhea, frequent micturation, and cough.\n5. Participants with unstable primary disease presenting insomnia during 4 weeks before the start of observation period.\n6. Participants with organic mental disorder.'}, 'identificationModule': {'nctId': 'NCT00770692', 'briefTitle': 'A Phase III Study of Eszopiclone in Patients With Insomnia (Study SEP 190-150)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eisai Inc.'}, 'officialTitle': 'A Phase III Study of SEP-190 (Eszopiclone) in Patients With Insomnia', 'orgStudyIdInfo': {'id': '190-150'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Eszopiclone 1 mg- Elderly', 'interventionNames': ['Drug: Eszopiclone 1 mg- Elderly']}, {'type': 'EXPERIMENTAL', 'label': 'Eszopiclone 2 mg- Elderly', 'interventionNames': ['Drug: Eszopiclone 2 mg- Elderly']}, {'type': 'EXPERIMENTAL', 'label': 'Eszopiclone 2 mg- Non-elderly', 'interventionNames': ['Drug: Eszopiclone 2 mg- Non-elderly']}, {'type': 'EXPERIMENTAL', 'label': 'Eszopiclone 3 mg- Non-elderly', 'interventionNames': ['Drug: Eszopiclone 3 mg- Non-elderly']}], 'interventions': [{'name': 'Eszopiclone 1 mg- Elderly', 'type': 'DRUG', 'otherNames': ['SEP-190'], 'description': 'Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.\n\nDose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment.', 'armGroupLabels': ['Eszopiclone 1 mg- Elderly']}, {'name': 'Eszopiclone 2 mg- Elderly', 'type': 'DRUG', 'otherNames': ['SEP-190'], 'description': 'Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks.\n\nDose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment.', 'armGroupLabels': ['Eszopiclone 2 mg- Elderly']}, {'name': 'Eszopiclone 3 mg- Non-elderly', 'type': 'DRUG', 'otherNames': ['SEP-190'], 'description': 'Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.\n\nDose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment.', 'armGroupLabels': ['Eszopiclone 3 mg- Non-elderly']}, {'name': 'Eszopiclone 2 mg- Non-elderly', 'type': 'DRUG', 'otherNames': ['SEP-190'], 'description': 'Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks.\n\nDose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment.', 'armGroupLabels': ['Eszopiclone 2 mg- Non-elderly']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'city': 'Akita', 'state': 'Akita', 'country': 'Japan', 'geoPoint': {'lat': 39.71667, 'lon': 140.11667}}, {'city': 'Fukuoka', 'state': 'Fukuoka', 'country': 'Japan', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Iizuka', 'state': 'Fukuoka', 'country': 'Japan', 'geoPoint': {'lat': 33.63654, 'lon': 130.68678}}, {'city': 'Kitakyushu', 'state': 'Fukuoka', 'country': 'Japan', 'geoPoint': {'lat': 33.85181, 'lon': 130.85034}}, {'city': 'Koga', 'state': 'Fukuoka', 'country': 'Japan', 'geoPoint': {'lat': 33.86429, 'lon': 130.68709}}, {'city': 'Kurume', 'state': 'Fukuoka', 'country': 'Japan', 'geoPoint': {'lat': 33.31667, 'lon': 130.51667}}, {'city': 'Maebashi', 'state': 'Gunma', 'country': 'Japan', 'geoPoint': {'lat': 36.4, 'lon': 139.08333}}, {'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Itami', 'state': 'Hyōgo', 'country': 'Japan', 'geoPoint': {'lat': 34.78427, 'lon': 135.40126}}, {'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'city': 'Yokoyama', 'state': 'Kanagawa', 'country': 'Japan', 'geoPoint': {'lat': 35.56568, 'lon': 139.36552}}, {'city': 'Kochi', 'state': 'Kochi', 'country': 'Japan', 'geoPoint': {'lat': 33.55, 'lon': 133.53333}}, {'city': 'Kumamoto', 'state': 'Kumamoto', 'country': 'Japan', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'city': 'Kyoto', 'state': 'Kyoto', 'country': 'Japan', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'city': 'Kashiba', 'state': 'Nara', 'country': 'Japan', 'geoPoint': {'lat': 34.53472, 'lon': 135.70925}}, {'city': 'Urazoe', 'state': 'Okinawa', 'country': 'Japan', 'geoPoint': {'lat': 26.25444, 'lon': 127.70639}}, {'city': 'Ibaraki', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.81641, 'lon': 135.56828}}, {'city': 'Kishiwada', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.46667, 'lon': 135.36667}}, {'city': 'Osaka', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Fujimi', 'state': 'Saitama', 'country': 'Japan', 'geoPoint': {'lat': 35.96851, 'lon': 139.58364}}, {'city': 'Kusatsu', 'state': 'Shiga', 'country': 'Japan', 'geoPoint': {'lat': 35.01667, 'lon': 135.96667}}, {'city': 'Arakawa-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'city': 'Chuo-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'city': 'Edogawa-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'city': 'Kodaira', 'state': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.72603, 'lon': 139.48508}}, {'city': 'Koto-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'city': 'Minato-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'city': 'Musashino', 'state': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.70611, 'lon': 139.55944}}, {'city': 'Ōta-ku', 'state': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.56126, 'lon': 139.71605}}, {'city': 'Shinagawa-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'city': 'Shinjuku-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'city': 'Toshima-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'city': 'Sagamihara', 'state': 'Yokohama', 'country': 'Japan', 'geoPoint': {'lat': 35.56707, 'lon': 139.24167}}], 'overallOfficials': [{'name': 'Atsushi Kamijo', 'role': 'STUDY_DIRECTOR', 'affiliation': 'New Product Development Department, Clinical Research Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eisai Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}