Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-29 @ 2:11 AM
Study NCT ID:
NCT01552057
Status:
COMPLETED
Last Update Posted:
2015-01-16
First Post:
2012-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Duloxetine in Fibromyalgia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068736', 'term': 'Duloxetine Hydrochloride'}], 'ancestors': [{'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline through 1 week post last dose', 'description': 'Randomized who received at least 1 dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Duloxetine 60 mg', 'description': 'Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).\n\nDuring the 1-week taper, the daily dosage was gradually reduced. For the first 3 days: 40-mg dose of duloxetine (two 20-mg capsules) administered orally once daily. For the remaining 4 days: 20-mg dose of duloxetine (one 20-mg capsule) administered orally once daily.', 'otherNumAtRisk': 194, 'otherNumAffected': 147, 'seriousNumAtRisk': 194, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.\n\nDuring the 1-week taper, the number of placebo capsules was gradually reduced. For the first 3 days: 2 placebo capsules administered orally once daily. For the remaining 4 days: 1 placebo capsule administered orally once daily.', 'otherNumAtRisk': 196, 'otherNumAffected': 122, 'seriousNumAtRisk': 196, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Vitreous floaters', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 29, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Dyschezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Food poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Glossitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Irritable bowel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 44, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Periodontal disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Feeling abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Feeling cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Thirst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Gingivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hand-foot-and-mouth disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Herpes simplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hordeolum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Impetigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Keratitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 39, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 37, 'numAffected': 29}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Paronychia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Periodontitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pertussis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Tinea pedis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Excoriation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hand fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Heat illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 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'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hypertonic bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Oliguria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Erectile dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Menopausal symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Metrorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hyperventilation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Oropharyngeal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Upper respiratory tract inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Yawning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Drug eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Miliaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Prurigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Rash papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}], 'seriousEvents': [{'term': 'Liver disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to 14-Week Endpoint in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine 60 mg', 'description': 'Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.90', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '-1.58', 'spread': '0.23', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0988', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.32', 'ciLowerLimit': '-0.70', 'ciUpperLimit': '0.06', 'pValueComment': 'Statistical tests were conducted at a 2-sided alpha level of 0.05.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 14 weeks', 'description': 'BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).'}, {'type': 'SECONDARY', 'title': 'Patients Global Impression of Improvement (PGI-I) at Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine 60 mg', 'description': 'Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.83', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '3.32', 'spread': '0.16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.49', 'ciLowerLimit': '-0.76', 'ciUpperLimit': '-0.22', 'pValueComment': 'Statistical tests were conducted at a 2-sided alpha level of 0.05.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '14 weeks', 'description': "PGI-I measures the participant's perception of improvement at the time of assessment compared with the start of treatment. Scores ranged from 1 (very much better) to 7 (very much worse). LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).'}, {'type': 'SECONDARY', 'title': 'Clinical Global Impression of Improvement (CGI-I) at Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine 60 mg', 'description': 'Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.83', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '3.27', 'spread': '0.16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0012', 'groupIds': ['OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.44', 'ciLowerLimit': '-0.71', 'ciUpperLimit': '-0.18', 'pValueComment': 'Statistical tests were conducted at a 2-sided alpha level of 0.05.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '14 weeks', 'description': "CGI-I measures the clinician's perception of participant improvement at the time of assessment (compared with the start of treatment). Scores ranged from 1 (very much better) to 7 (very much worse). LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 14-Week Endpoint in Fibromyalgia Impact Questionnaire (FIQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine 60 mg', 'description': 'Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-18.41', 'spread': '2.57', 'groupId': 'OG000'}, {'value': '-13.05', 'spread': '2.65', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0073', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.35', 'ciLowerLimit': '-9.26', 'ciUpperLimit': '-1.45', 'pValueComment': 'Statistical tests were conducted at a 2-sided alpha level of 0.05.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 14 weeks', 'description': 'FIQ is a 20-item, self-administered questionnaire using Likert-type scales to measure participant (pt) outcomes over the past week. Items 1 through 11 measured physical functioning on 4-point scales. Items 12 and 13 measured the number of days a pt felt well and days a pt was unable to work due to fibromyalgia symptoms. Items 14 through 20 were 11-point scales on which a pt rated work difficulty, pain, fatigue, morning tiredness, stiffness, anxiety, and depression. If a pt did not do all the tasks listed, those items were deleted from scoring. Algorithms were used to determine total FIQ scores which ranged from 0 to 100; higher scores indicated a more negative impact. LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between administration groups as fixed effects, and baseline as well as the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 14-Week Endpoint in 36-Item Short-Form (SF-36) Health Survey Domain Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine 60 mg', 'description': 'Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.'}], 'classes': [{'title': 'Physical Functioning', 'categories': [{'measurements': [{'value': '7.40', 'spread': '2.13', 'groupId': 'OG000'}, {'value': '3.06', 'spread': '2.15', 'groupId': 'OG001'}]}]}, {'title': 'Role-Physical', 'categories': [{'measurements': [{'value': '8.20', 'spread': '2.96', 'groupId': 'OG000'}, {'value': '0.44', 'spread': '2.98', 'groupId': 'OG001'}]}]}, {'title': 'Bodily Pain', 'categories': [{'measurements': [{'value': '10.95', 'spread': '2.07', 'groupId': 'OG000'}, {'value': '5.28', 'spread': '2.08', 'groupId': 'OG001'}]}]}, {'title': 'General Health', 'categories': [{'measurements': [{'value': '6.55', 'spread': '1.92', 'groupId': 'OG000'}, {'value': '3.31', 'spread': '1.94', 'groupId': 'OG001'}]}]}, {'title': 'Vitality', 'categories': [{'measurements': [{'value': '10.05', 'spread': '2.51', 'groupId': 'OG000'}, {'value': '3.35', 'spread': '2.53', 'groupId': 'OG001'}]}]}, {'title': 'Social Functioning', 'categories': [{'measurements': [{'value': '10.32', 'spread': '3.04', 'groupId': 'OG000'}, {'value': '3.28', 'spread': '3.06', 'groupId': 'OG001'}]}]}, {'title': 'Role-Emotional', 'categories': [{'measurements': [{'value': '5.50', 'spread': '3.35', 'groupId': 'OG000'}, {'value': '-3.63', 'spread': '3.36', 'groupId': 'OG001'}]}]}, {'title': 'Mental Health', 'categories': [{'measurements': [{'value': '5.91', 'spread': '2.51', 'groupId': 'OG000'}, {'value': '-2.00', 'spread': '2.52', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0049', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.34', 'ciLowerLimit': '1.32', 'ciUpperLimit': '7.35', 'pValueComment': 'Statistical tests were conducted at a 2-sided alpha level of 0.05.', 'groupDescription': 'Physical Functioning', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.76', 'ciLowerLimit': '3.57', 'ciUpperLimit': '11.94', 'pValueComment': 'Statistical tests were conducted at a 2-sided alpha level of 0.05.', 'groupDescription': 'Role-Physical', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.67', 'ciLowerLimit': '2.76', 'ciUpperLimit': '8.59', 'pValueComment': 'Statistical tests were conducted at a 2-sided alpha level of 0.05.', 'groupDescription': 'Bodily Pain', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0192', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.25', 'ciLowerLimit': '0.53', 'ciUpperLimit': '5.96', 'pValueComment': 'Statistical tests were conducted at a 2-sided alpha level of 0.05.', 'groupDescription': 'General Health', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.70', 'ciLowerLimit': '3.15', 'ciUpperLimit': '10.25', 'pValueComment': 'Statistical tests were conducted at a 2-sided alpha level of 0.05.', 'groupDescription': 'Vitality', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0014', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.04', 'ciLowerLimit': '2.74', 'ciUpperLimit': '11.34', 'pValueComment': 'Statistical tests were conducted at a 2-sided alpha level of 0.05.', 'groupDescription': 'Social Functioning', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.12', 'ciLowerLimit': '4.41', 'ciUpperLimit': '13.83', 'pValueComment': 'Statistical tests were conducted at a 2-sided alpha level of 0.05.', 'groupDescription': 'Role-Emotional', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.91', 'ciLowerLimit': '4.39', 'ciUpperLimit': '11.43', 'pValueComment': 'Statistical tests were conducted at a 2-sided alpha level of 0.05.', 'groupDescription': 'Mental Health', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, up to 14 weeks', 'description': "The SF-36 Health Survey is a generic, health-related survey assessing the participant's quality of life on 8 domains: physical functioning, daily functioning (physical), bodily pain, general health, vitality, social functioning, daily functioning (emotional), and mental health. Each domain was scored by summing individual items pertaining to that domain and transforming scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. LS mean was calculated using an ANCOVA approach including administration groups as fixed effects, and baseline as well as the presence or absence of complication by major depressive disorder as covariates.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity); LOCF values were used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 14-Week Endpoint in Beck Depression Inventory-II (BDI-II)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine 60 mg', 'description': 'Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.07', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '-1.22', 'spread': '0.85', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.85', 'ciLowerLimit': '-4.32', 'ciUpperLimit': '-1.38', 'pValueComment': 'Statistical tests were conducted at a 2-sided alpha level of 0.05.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 14 weeks', 'description': 'The BDI-II is a 21-item self-administered questionnaire designed to assess the characteristics of depression. Each item was scored on a 4-point scale ranging from 0 (not present) to 3 (present in the extreme) and was summed to give a total BDI-II score. A total BDI-II score of 0 through 13 was considered minimal, 14 through 19 was mild, 20 through 28 was moderate, and 29 through 63 was severe depression symptoms. LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups and as fixed effects, and baseline as well as the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 14-Week Endpoint in Widespread Pain Index (WPI) and Symptom Severity (SS) in American College of Rheumatology (ACR) Fibromyalgia Diagnostic Criteria 2010', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine 60 mg', 'description': 'Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.'}], 'classes': [{'title': 'WPI', 'categories': [{'measurements': [{'value': '-2.34', 'spread': '0.58', 'groupId': 'OG000'}, {'value': '-1.06', 'spread': '0.60', 'groupId': 'OG001'}]}]}, {'title': 'SS', 'categories': [{'measurements': [{'value': '-1.37', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '-1.00', 'spread': '0.28', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0029', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.28', 'ciLowerLimit': '-2.12', 'ciUpperLimit': '-0.44', 'pValueComment': 'Statistical tests were conducted at a 2-sided alpha level of 0.05.', 'groupDescription': 'WPI', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0906', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.36', 'ciLowerLimit': '-0.79', 'ciUpperLimit': '0.06', 'pValueComment': 'Statistical tests were conducted at a 2-sided alpha level of 0.05.', 'groupDescription': 'Symptom Severity', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 14 weeks', 'description': 'WPI: Participant-reported areas (out of 19 points on the body) in which the participant had pain in the past week. WPI scores ranged from 0 (no areas) to 19 (all areas). SS: The sum of severity scores for fatigue, waking unrefreshed, and cognitive symptoms \\[each rated from 0 (no problem) to 3 (severe; life-disturbing problems)\\] plus the severity of somatic symptoms in general \\[rated from 0 (no symptoms) to 3 (a great deal of symptoms)\\]. The total SS score ranged from 0 and 12. LS mean was calculated using an MMRM approach including administration groups, observation points, interaction between the administration groups and the observation points as fixed effects, and baseline as well as the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 14-Week Endpoint in Average Pain and Worst Pain Severity Score Within 24-Hours in Participant Diary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine 60 mg', 'description': 'Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.'}], 'classes': [{'title': 'Average Pain', 'categories': [{'measurements': [{'value': '-1.82', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '-1.48', 'spread': '0.18', 'groupId': 'OG001'}]}]}, {'title': 'Worst Pain', 'categories': [{'measurements': [{'value': '-1.81', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '-1.34', 'spread': '0.19', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0755', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.33', 'ciLowerLimit': '-0.70', 'ciUpperLimit': '0.03', 'pValueComment': 'Statistical tests were conducted at a 2-sided alpha level of 0.05.', 'groupDescription': 'Average Pain', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0232', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.47', 'ciLowerLimit': '-0.88', 'ciUpperLimit': '-0.06', 'pValueComment': 'Statistical tests were conducted at a 2-sided alpha level of 0.05.', 'groupDescription': 'Worst Pain', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 14 weeks', 'description': 'Each morning participants rated their average pain and worst pain within the past 24 hours on separate 11-point Likert scales with scores ranging from 0 (no pain) through 10 (worst possible pain). These scores were then averaged for the week and compared to baseline. LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and baseline as well as the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 14-Week Endpoint in Brief Pain Inventory-Severity (BPI-S) and Brief Pain Inventory-Interference (BPI-I) Scores on the BPI-Modified Short Form', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine 60 mg', 'description': 'Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.'}], 'classes': [{'title': 'Worst Pain', 'categories': [{'measurements': [{'value': '-1.91', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '-1.35', 'spread': '0.26', 'groupId': 'OG001'}]}]}, {'title': 'Least Pain', 'categories': [{'measurements': [{'value': '-1.72', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '-1.23', 'spread': '0.22', 'groupId': 'OG001'}]}]}, {'title': 'Pain Right Now', 'categories': [{'measurements': [{'value': '-1.77', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '-1.20', 'spread': '0.26', 'groupId': 'OG001'}]}]}, {'title': 'Interference With General Activity', 'categories': [{'measurements': [{'value': '-2.22', 'spread': '0.31', 'groupId': 'OG000'}, {'value': '-1.76', 'spread': '0.32', 'groupId': 'OG001'}]}]}, {'title': 'Interference With Mood', 'categories': [{'measurements': [{'value': '-2.17', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '-1.42', 'spread': '0.33', 'groupId': 'OG001'}]}]}, {'title': 'Interference With Walking Ability', 'categories': [{'measurements': [{'value': '-1.67', 'spread': '0.29', 'groupId': 'OG000'}, {'value': '-1.29', 'spread': '0.30', 'groupId': 'OG001'}]}]}, {'title': 'Interference With Normal Work', 'categories': [{'measurements': [{'value': '-2.18', 'spread': '0.31', 'groupId': 'OG000'}, {'value': '-1.76', 'spread': '0.32', 'groupId': 'OG001'}]}]}, {'title': 'Interference With Relations With Other People', 'categories': [{'measurements': [{'value': '-1.09', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '-0.53', 'spread': '0.30', 'groupId': 'OG001'}]}]}, {'title': 'Interference With Sleep', 'categories': [{'measurements': [{'value': '-1.82', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '-1.57', 'spread': '0.36', 'groupId': 'OG001'}]}]}, {'title': 'Interference With Enjoyment of Life', 'categories': [{'measurements': [{'value': '-1.90', 'spread': '0.31', 'groupId': 'OG000'}, {'value': '-1.24', 'spread': '0.32', 'groupId': 'OG001'}]}]}, {'title': 'Average Interference', 'categories': [{'measurements': [{'value': '-1.95', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '-1.44', 'spread': '0.27', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0126', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.56', 'ciLowerLimit': '-0.99', 'ciUpperLimit': '-0.12', 'pValueComment': 'Statistical tests were conducted at a 2-sided alpha level of 0.05.', 'groupDescription': 'Worst Pain', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0092', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.49', 'ciLowerLimit': '-0.87', 'ciUpperLimit': '-0.12', 'pValueComment': 'Statistical tests were conducted at a 2-sided alpha level of 0.05.', 'groupDescription': 'Least Pain', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0083', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.57', 'ciLowerLimit': '-1.00', 'ciUpperLimit': '-0.15', 'pValueComment': 'Statistical tests were conducted at a 2-sided alpha level of 0.05.', 'groupDescription': 'Pain Right Now', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0807', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.46', 'ciLowerLimit': '-0.98', 'ciUpperLimit': '0.06', 'pValueComment': 'Statistical tests were conducted at a 2-sided alpha level of 0.05.', 'groupDescription': 'Interference With General Activity', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0057', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.75', 'ciLowerLimit': '-1.29', 'ciUpperLimit': '-0.22', 'pValueComment': 'Statistical tests were conducted at a 2-sided alpha level of 0.05.', 'groupDescription': 'Interference With Mood', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1114', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.38', 'ciLowerLimit': '-0.84', 'ciUpperLimit': '0.09', 'pValueComment': 'Statistical tests were conducted at a 2-sided alpha level of 0.05.', 'groupDescription': 'Interference With Walking Ability', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1081', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.42', 'ciLowerLimit': '-0.94', 'ciUpperLimit': '0.09', 'pValueComment': 'Statistical tests were conducted at a 2-sided alpha level of 0.05.', 'groupDescription': 'Interference With Normal Work', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0264', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.55', 'ciLowerLimit': '-1.04', 'ciUpperLimit': '-0.07', 'pValueComment': 'Statistical tests were conducted at a 2-sided alpha level of 0.05.', 'groupDescription': 'Interference With Relationships With Other People', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.3959', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.24', 'ciLowerLimit': '-0.81', 'ciUpperLimit': '0.32', 'pValueComment': 'Statistical tests were conducted at a 2-sided alpha level of 0.05.', 'groupDescription': 'Interference With Sleep', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0119', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.66', 'ciLowerLimit': '-1.18', 'ciUpperLimit': '-0.15', 'pValueComment': 'Statistical tests were conducted at a 2-sided alpha level of 0.05.', 'groupDescription': 'Interference With Enjoyment of Life', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0222', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.52', 'ciLowerLimit': '-0.96', 'ciUpperLimit': '-0.07', 'pValueComment': 'Statistical tests were conducted at a 2-sided alpha level of 0.05.', 'groupDescription': 'Average Interference', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 14 weeks', 'description': 'BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function, respectively. Severity scores ranged from 0 (no pain) to 10 (severe pain) for each question assessing worst pain, least pain, and pain right now. Interference scores ranged from 0 (does not interfere) to 10 (completely interferes) for each question assessing interference of pain in past 24 hours with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference was the average of non-missing scores of individual interference items. LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and baseline as well as the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).'}, {'type': 'PRIMARY', 'title': 'Change From Baseline to 2 Weeks in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine 60 mg', 'description': 'Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.00', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '-0.60', 'spread': '0.22', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0113', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.40', 'ciLowerLimit': '-0.71', 'ciUpperLimit': '-0.09', 'pValueComment': 'Statistical tests were conducted at a 2-sided alpha level of 0.05.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 2 weeks', 'description': 'BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).'}, {'type': 'PRIMARY', 'title': 'Change From Baseline to 4 Weeks in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine 60 mg', 'description': 'Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.55', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '-0.94', 'spread': '0.22', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.61', 'ciLowerLimit': '-0.94', 'ciUpperLimit': '-0.27', 'pValueComment': 'Statistical tests were conducted at a 2-sided alpha level of 0.05.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 4 weeks', 'description': 'BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).'}, {'type': 'PRIMARY', 'title': 'Change From Baseline to 6 Weeks in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine 60 mg', 'description': 'Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.81', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '-1.09', 'spread': '0.23', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.72', 'ciLowerLimit': '-1.07', 'ciUpperLimit': '-0.37', 'pValueComment': 'Statistical tests were conducted at a 2-sided alpha level of 0.05.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 6 weeks', 'description': 'BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).'}, {'type': 'PRIMARY', 'title': 'Change From Baseline to 10 Weeks in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine 60 mg', 'description': 'Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.85', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '-1.41', 'spread': '0.23', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0226', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.44', 'ciLowerLimit': '-0.82', 'ciUpperLimit': '-0.06', 'pValueComment': 'Statistical tests were conducted at a 2-sided alpha level of 0.05.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 10 weeks', 'description': 'BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).'}, {'type': 'PRIMARY', 'title': 'Change From Baseline up to 14-Week Endpoint in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (ANCOVA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine 60 mg', 'description': 'Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.60', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '-1.22', 'spread': '0.26', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0408', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.38', 'ciLowerLimit': '-0.74', 'ciUpperLimit': '-0.02', 'pValueComment': 'Statistical tests were conducted at a 2-sided alpha level of 0.05.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, up to 14 weeks', 'description': 'BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). LS mean was calculated using an analysis of covariance (ANCOVA) approach including administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity); Last Observation Carried Forward (LOCF) values were used.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Duloxetine 60 mg', 'description': 'Treatment Period: Up to 60-milligram (mg) dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).\n\nDuring the 1-week taper, the daily dosage was gradually reduced. For the first 3 days: 40-mg dose of duloxetine (two 20-mg capsules) administered orally once daily. For the remaining 4 days: 20-mg dose of duloxetine (one 20-mg capsule) administered orally once daily.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.\n\nDuring the 1-week taper, the number of placebo capsules was gradually reduced. For the first 3 days: 2 placebo capsules administered orally once daily. For the remaining 4 days: 1 placebo capsule administered orally once daily.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '196'}, {'groupId': 'FG001', 'numSubjects': '197'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '194'}, {'groupId': 'FG001', 'numSubjects': '196'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '166'}, {'groupId': 'FG001', 'numSubjects': '149'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '48'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Entry Criteria Not Met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Randomized participants who completed the 14-week treatment period were considered to have completed the study. After study completion or early discontinuation, participants completed a 1-week taper and were observed 1 week post-treatment for safety.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'BG000'}, {'value': '195', 'groupId': 'BG001'}, {'value': '386', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Duloxetine 60 mg', 'description': 'Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).\n\nDuring the 1-week taper, the daily dosage was gradually reduced. For the first 3 days: 40-mg dose of duloxetine (two 20-mg capsules) administered orally once daily. For the remaining 4 days: 20-mg dose of duloxetine (one 20-mg capsule) administered orally once daily.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.\n\nDuring the 1-week taper, the number of placebo capsules was gradually reduced. For the first 3 days: 2 placebo capsules administered orally once daily. For the remaining 4 days: 1 placebo capsule administered orally once daily.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.8', 'spread': '12.0', 'groupId': 'BG000'}, {'value': '49.5', 'spread': '11.7', 'groupId': 'BG001'}, {'value': '48.7', 'spread': '11.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '157', 'groupId': 'BG000'}, {'value': '164', 'groupId': 'BG001'}, {'value': '321', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Japanese', 'categories': [{'measurements': [{'value': '191', 'groupId': 'BG000'}, {'value': '195', 'groupId': 'BG001'}, {'value': '386', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '191', 'groupId': 'BG000'}, {'value': '195', 'groupId': 'BG001'}, {'value': '386', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Randomized participants who received at least 1 dose of study drug who had at least 1 post-baseline measurement of primary efficacy \\[Brief Pain Inventory (BPI) 24-hour average pain severity\\].'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 393}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-07', 'studyFirstSubmitDate': '2012-03-09', 'resultsFirstSubmitDate': '2014-12-12', 'studyFirstSubmitQcDate': '2012-03-09', 'lastUpdatePostDateStruct': {'date': '2015-01-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-12-12', 'studyFirstPostDateStruct': {'date': '2012-03-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline to 14-Week Endpoint in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)', 'timeFrame': 'Baseline, 14 weeks', 'description': 'BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.'}, {'measure': 'Change From Baseline to 2 Weeks in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)', 'timeFrame': 'Baseline, 2 weeks', 'description': 'BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.'}, {'measure': 'Change From Baseline to 4 Weeks in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)', 'timeFrame': 'Baseline, 4 weeks', 'description': 'BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.'}, {'measure': 'Change From Baseline to 6 Weeks in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)', 'timeFrame': 'Baseline, 6 weeks', 'description': 'BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.'}, {'measure': 'Change From Baseline to 10 Weeks in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)', 'timeFrame': 'Baseline, 10 weeks', 'description': 'BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.'}, {'measure': 'Change From Baseline up to 14-Week Endpoint in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (ANCOVA)', 'timeFrame': 'Baseline, up to 14 weeks', 'description': 'BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). LS mean was calculated using an analysis of covariance (ANCOVA) approach including administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates.'}], 'secondaryOutcomes': [{'measure': 'Patients Global Impression of Improvement (PGI-I) at Endpoint', 'timeFrame': '14 weeks', 'description': "PGI-I measures the participant's perception of improvement at the time of assessment compared with the start of treatment. Scores ranged from 1 (very much better) to 7 (very much worse). LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied."}, {'measure': 'Clinical Global Impression of Improvement (CGI-I) at Endpoint', 'timeFrame': '14 weeks', 'description': "CGI-I measures the clinician's perception of participant improvement at the time of assessment (compared with the start of treatment). Scores ranged from 1 (very much better) to 7 (very much worse). LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied."}, {'measure': 'Change From Baseline to 14-Week Endpoint in Fibromyalgia Impact Questionnaire (FIQ)', 'timeFrame': 'Baseline, 14 weeks', 'description': 'FIQ is a 20-item, self-administered questionnaire using Likert-type scales to measure participant (pt) outcomes over the past week. Items 1 through 11 measured physical functioning on 4-point scales. Items 12 and 13 measured the number of days a pt felt well and days a pt was unable to work due to fibromyalgia symptoms. Items 14 through 20 were 11-point scales on which a pt rated work difficulty, pain, fatigue, morning tiredness, stiffness, anxiety, and depression. If a pt did not do all the tasks listed, those items were deleted from scoring. Algorithms were used to determine total FIQ scores which ranged from 0 to 100; higher scores indicated a more negative impact. LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between administration groups as fixed effects, and baseline as well as the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.'}, {'measure': 'Change From Baseline to 14-Week Endpoint in 36-Item Short-Form (SF-36) Health Survey Domain Scores', 'timeFrame': 'Baseline, up to 14 weeks', 'description': "The SF-36 Health Survey is a generic, health-related survey assessing the participant's quality of life on 8 domains: physical functioning, daily functioning (physical), bodily pain, general health, vitality, social functioning, daily functioning (emotional), and mental health. Each domain was scored by summing individual items pertaining to that domain and transforming scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. LS mean was calculated using an ANCOVA approach including administration groups as fixed effects, and baseline as well as the presence or absence of complication by major depressive disorder as covariates."}, {'measure': 'Change From Baseline to 14-Week Endpoint in Beck Depression Inventory-II (BDI-II)', 'timeFrame': 'Baseline, 14 weeks', 'description': 'The BDI-II is a 21-item self-administered questionnaire designed to assess the characteristics of depression. Each item was scored on a 4-point scale ranging from 0 (not present) to 3 (present in the extreme) and was summed to give a total BDI-II score. A total BDI-II score of 0 through 13 was considered minimal, 14 through 19 was mild, 20 through 28 was moderate, and 29 through 63 was severe depression symptoms. LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups and as fixed effects, and baseline as well as the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.'}, {'measure': 'Change From Baseline to 14-Week Endpoint in Widespread Pain Index (WPI) and Symptom Severity (SS) in American College of Rheumatology (ACR) Fibromyalgia Diagnostic Criteria 2010', 'timeFrame': 'Baseline, 14 weeks', 'description': 'WPI: Participant-reported areas (out of 19 points on the body) in which the participant had pain in the past week. WPI scores ranged from 0 (no areas) to 19 (all areas). SS: The sum of severity scores for fatigue, waking unrefreshed, and cognitive symptoms \\[each rated from 0 (no problem) to 3 (severe; life-disturbing problems)\\] plus the severity of somatic symptoms in general \\[rated from 0 (no symptoms) to 3 (a great deal of symptoms)\\]. The total SS score ranged from 0 and 12. LS mean was calculated using an MMRM approach including administration groups, observation points, interaction between the administration groups and the observation points as fixed effects, and baseline as well as the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.'}, {'measure': 'Change From Baseline to 14-Week Endpoint in Average Pain and Worst Pain Severity Score Within 24-Hours in Participant Diary', 'timeFrame': 'Baseline, 14 weeks', 'description': 'Each morning participants rated their average pain and worst pain within the past 24 hours on separate 11-point Likert scales with scores ranging from 0 (no pain) through 10 (worst possible pain). These scores were then averaged for the week and compared to baseline. LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and baseline as well as the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.'}, {'measure': 'Change From Baseline to 14-Week Endpoint in Brief Pain Inventory-Severity (BPI-S) and Brief Pain Inventory-Interference (BPI-I) Scores on the BPI-Modified Short Form', 'timeFrame': 'Baseline, 14 weeks', 'description': 'BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function, respectively. Severity scores ranged from 0 (no pain) to 10 (severe pain) for each question assessing worst pain, least pain, and pain right now. Interference scores ranged from 0 (does not interfere) to 10 (completely interferes) for each question assessing interference of pain in past 24 hours with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference was the average of non-missing scores of individual interference items. LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and baseline as well as the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Fibromyalgia']}, 'referencesModule': {'references': [{'pmid': '26296539', 'type': 'DERIVED', 'citation': 'Murakami M, Osada K, Mizuno H, Ochiai T, Alev L, Nishioka K. A randomized, double-blind, placebo-controlled phase III trial of duloxetine in Japanese fibromyalgia patients. Arthritis Res Ther. 2015 Aug 22;17(1):224. doi: 10.1186/s13075-015-0718-y.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess the effectiveness and safety of duloxetine in participants with fibromyalgia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants fulfilling the following criteria in the American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia\n* Participants with pain rated severity 4 or over by Brief Pain Inventory (BPI) - average pain severity item (Question 3)\n\nExclusion Criteria:\n\n* Participants with serious cardiovascular, hepatic, renal, respiratory, or hematological disease, or clinically significant laboratory or electrocardiogram abnormality which indicate a serious medical problem or require significant intervention in the judgment of the investigators\n* Participants with alanine aminotransferase/aspartate aminotransferase of not less than 100 international units per liter (IU/L) or total bilirubin of not less than 1.6 milligrams per deciliter (mg/dL)\n* Participants with serum creatinine level of not less than 2.0 mg/dL, participant who has undergone kidney transplantation or hemodialysis\n* Participants with pain difficult to discriminate from pain associated with fibromyalgia or disease which disturbs the assessment\n* Participants with treatment-refractory fibromyalgia\n* Participants with thyroidal dysfunction, excluding those assessed by the investigator that the disorder is controlled as appropriate by 3-month or longer drug therapy\n* Participants with present or past history of rheumatoid arthritis, inflammatory arthritis, infectious arthritis, or auto immune disease rather than thyroid deficiency\n* Participants with an axis I condition according to Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV), currently or within the past year, except for major depressive disorders\n* Participants with a lifetime diagnosis of bipolar disorder or schizoaffective disorder; or any other disorder with psychotic symptoms - based on the clinical opinion of the investigator\n* Participants with personality disorder or mental retardation\n* Participants with uncontrolled angle closure glaucoma\n* Participants with present or past history of uncontrolled seizures or convulsion disorders\n* Participants with suicidal ideation within past 6 months, with suicidal attempt within past 1 year\n* Participants answering "yes" to any of the questions about active suicidal ideation/intent/behaviors occurring within the past 6 months (Columbia Suicide Severity Rating Scale, Suicide Ideation section - Questions 4 and 5; Suicidal Behavior section)\n* Participants with past history of multiple episodes of drug allergy\n* Female participants who are pregnant, lactating, or who want to get pregnant during the study period. Male participants who want his partner to get pregnant\n* Females of child-bearing potential who can\'t agree to utilize medically. acceptable and reliable means of birth control during the study and for 1 month following the last dose of the study\n* Participants with a history of alcohol or any psychoactive substance abuse or dependence (including alcohol, but excluding nicotine and caffeine) within the past 1 year\n* Participants who have a positive urine drug screen for any substance of abuse (phencyclidine, cocaine, antihypnotic agent, or cannabis)\n* Participants previously treated with duloxetine'}, 'identificationModule': {'nctId': 'NCT01552057', 'briefTitle': 'A Study of Duloxetine in Fibromyalgia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase III Clinical Trial of Duloxetine in Participants With Fibromyalgia', 'orgStudyIdInfo': {'id': '14377'}, 'secondaryIdInfos': [{'id': 'F1J-JE-HMGZ', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Duloxetine 60 mg', 'description': 'Duloxetine hydrochloride up to 60 milligrams (mg) orally for 15 weeks', 'interventionNames': ['Drug: Duloxetine 60 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo orally for 15 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Duloxetine 60 mg', 'type': 'DRUG', 'otherNames': ['LY248686', 'Cymbalta'], 'description': 'Duloxetine 60 mg taken orally once every day for 15 weeks', 'armGroupLabels': ['Duloxetine 60 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo taken orally once every day for 15 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '982-0032', 'city': 'Miyagi', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 26.62566, 'lon': 128.18236}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Shionogi', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}